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BEST OF ESC 2020
Dr. Nagula Praveen, MD,DM
Assistant Professor of Cardiology,
Osmania General Hospital, Hyderabad
drpraveennagula@gmail.com
@kizashipraveen
HEART FAILURE
BEST OF ESC 2020
HEART FAILURE WITH
REDUCED EJECTION FRACTION
HFrEF
Can there be a Emperor for this entity management?
EMPEROR-Reduced Trial
Effect of Empagliflozin on Cardiovascular
and Renal Events in Heart Failure With a
Reduced Ejection Fraction
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EMPEROR-Reduced Trial
• Double-blind, placebo-controlled, randomized trial
• 3730 patients in 565 centers in 20 countries
• Men and women with mild, moderate or severe HFrEF (EF ≤ 40%), who were
already receiving all appropriate treatments for heart failure
• With and without type 2 diabetes (half did not have diabetes)
• Randomly assigned to placebo or Empagliflozin 10 mg once daily, which was
added to existing treatment.
• Study medication was continued for median of 16 months (up to 34 months)
• Many patients with more advanced disease compared to DAPA HF trial.
Primary Endpoint
Composite of cardiovascular death
or heart failure hospitalization
25% in risk
P < 0.001
First Secondary Endpoint
Total (first and recurrent
heart failure hospitalizations)
30% in risk
P < 0.001
Second Secondary Endpoint
Slope of decline in glomerular
filtration rate over time
P < 0.001
(50% in renal
events)
SGLT2 Inhibition With Empagliflozin Is Effective in Heart Failure
With a Reduced Ejection Fraction With or Without Diabetes
Also achieved success on composite renal endpoint, KCCQ clinical summary score,
and total number of hospitalizations for any reason (all nominal P < 0.01)
Placebo
Empagliflozin
Empagliflozin Prevented Both Serious Heart Failure
and Serious Kidney Failure Events
Empagliflozin
Cumulativeincidence(%)
Weeks After Randomization
Placebo
Empagliflozin
Cumulativeincidence(%)
0 26 52 78 104 13026 52 78 104 1300
Weeks After Randomization
Hazard ratio 0.75 (25% reduction in risk)
(95% CI 0.65, 0.86), P < 0.0001
Hazard ratio 0.50 (50% reduction in risk)
(95% CI 0.32, 0.77), P = 0.0019
Cardiovascular Death or
Hospitalization for Heart Failure
Composite Renal Endpoint
Slope of decline in Glomerular filtration Rate – Hierarchical
endpoint # 3
EMPEROR-Reduced: Safety
Empagliflozin (n=1863) Placebo (n=1863)
Serious adverse events 772 (41.4) 896 (48.1)
Related to cardiac disorder 500 (26.8) 634 (34.0)
Related to worsening renal function 59 (3.2) 95 (5.1)
Selected adverse events of interest
Volume depletion 197 (10.6) 184 (9.9)
Hypotension 176 (9.4) 163 (8.7)
Symptomatic hypotension 106 (5.7) 103 (5.5)
Hypoglycemia 27 (1.4) 28 (1.5)
Ketoacidosis 0 (0.0) 0 (0.0)
Urinary tract infections 91 (4.9) 83 (4.5)
Genital tract infections 31 (1.7) 12 (0.6)
Bone fractures 45 (2.4) 42 (2.3)
Lower limb amputations 13 (0.7) 10 (0.5)
Key messages
 Added with results of DAPA HF, this will be having great impact in
management of patients with HFrEF with/or without diabetes.
 They have clinically important benefits, are given once daily, require no dose
adjustment, and are well tolerated.
 There is compelling evidence that SGLT2 inhibitors should now be added to
currently recommended treatments for this disease.
EMPEROR-Reduced Trial Has Major
Implications for Clinical Practice
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VERTIS CV TRIAL
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Study design:
 VERTIS-CV trial was a multicentre, randomized, double-blind, placebo-controlled, event driven trial to prove
cardiovascular safety
 More than 8000 participants were randomized in a 1:1:1 manner either to placebo or Ertugliflozin 5mg or
Ertugliflozin 15mg
Primary endpoint:
 Composite outcome of MACE (CV death, nonfatal MI, nonfatal stroke)
Secondary endpoints:
 Composite outcome of CV death/HHF, CV death, Renal composite (renal death, dialysis/transplant, doubling
of serum creatinine)
Primary and Secondary endpoints
A weak trend for CV death and hospitalisation for heart failure was seen with Ertigluflozin
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HFPEF
Should we still feel the beneficial effects in this entity as parallax or real/definite?
Sacubitril/Valsartan versus Individualized RAAS Blockade in Patients
with HFpEF
Aim:
 To evaluate the effect of sacubitril/valsartan (S/V) in comparison to individualized medical therapy (IMT) for
cardiovascular and related co-morbidities on NT-proBNP, functional capacity, symptoms, and quality of life
in patients with HF and ejection fraction (EF) >40%
Design:
 N=2566, 24 week randomized, double blind parallel-group, active controlled, or placebo-controlled trial in
patients with LVEF >40%, New York Heart Association (NYHA) class II–IV symptoms, elevated NT-proBNP,
and evidence of structural heart disease
 The optimal individualized background therapy was either ACE inhibitor enalapril, ARB valsartan or placebo
Endpoints
Primary Endpoints: Change in plasma NT-proBNP concentration from baseline to 12
weeks and the change from baseline in functional capacity ( 6 min walk distance) at 24
weeks
Secondary: Quality of life ( Kansas City Cardiomyopathy Questionnaire; KCCQ) and NYHA
functional class
Exploratory endpoints: Change in eGFR, HF hospitalization and HF death
• Sacubitril/valsartan showed a significant 16.4% greater reduction in NT-proBNP than those patients treated with
optimal individualized medical therapy after 12 weeks (p<0.0001)
• However, there was no significant difference between groups in terms of improvement in six-minute walk distance
at 24 weeks
PARALLAX: Secondary outcomes
• Quality of life improved in both groups and was better with sacubitril/valsartan than the
comparator at week 4 but there was no difference between groups at week 24
• Changes in NYHA class were similar in both groups at week 24
PARALLAX: Post hoc analysis outcomes
• A post hoc analysis showed that sacubitril/valsartan reduced the risk for heart failure hospitalisation by 50% (p=0.005)
• Patients in the sacubitril/valsartan group also had a significantly lower decline in renal function (estimated glomerular
filtration rate; eGFR) at 24 weeks
Decline in eGFR
PARALLAX: Summary and Conclusion
 There are no established pharmacotherapies for HFpEF, and RAAS inhibitors are often
recommended for treating co-morbidities.
 PARALLAX evaluated benefits of S/V compared to individualised medical therapy in patients with
HFpEF and HFmrEF (LVEF >40%) a high prevalence of co-morbidities and impaired QoL
 PARALLAX demonstrated a significant reduction in NT-proBNP levels with S/V compared with
individualised medical therapy
 S/V had no additional benefit on 6MWD, KCQ improved in both treatments groups with an early
benefit of S/V that was no longer significant after 24 weeks
 These findings are consistent with findings of PARAGON-HF trial and provide further evidence for
potential benefits of S/V in patients with HF and mid range or preserved ejection fraction.
BB IN HF
Main results of the beta-blockers in heart failure
collaborative group
Global partnership that over a 10-year period has harmonized individual patient data from landmark double blind RCTs
in heart failure to answer key clinical questions about prognosis and efficacy and safety of beta blockers
Effect of beta-blockers on sinus rhythm vs. atrial fibrillation
Beta-blockers caused substantial reduction in mortality when patients are in sinus rhythm, whereas
no effect on mortality was seen when patients are in atrial fibrillation
Effect of beta-blockers depending on the heart rate values
Effect of beta-blockers is independent of the heart rate values at baseline, lower the heart rate at
baseline, lower is the all-cause mortality
Outcomes according to LVEF in sinus rhythm
• Beta-blockers halved the risk of mortality in patients with mid-range ejection fraction
• Beta-blockers also improved surivial in all ejection fraction groups except those with ejection fraction of ≥ 50% at baseline
Summary and Conclusion
Beta blockers do not reduce mortality in HFrEF plus AF, but are safe
Lack of efficacy may relate to distinct relationships with heart rate
Substantial reduction in mortality with beta blockers in patients with sinus rhythm
irrespective of heart rate, age, gender and if LVEF <40% or 40-49%
Concomitant renal dysfunction had a major impact on prognosis in sinus rhythm beta
blockers remain effective down to an eGFR of 30 ml/min
HYPERTROPHIC
CARDIOMYOPATHY
Can’t we explore further in pharmacological management????
EXPLORER HCM
BEST OF ESC 2020
Evaluation of Mavacamten in Adults With Symptomatic Obstructive
Hypertrophic Cardiomyopathy
Aim:
 To assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic
obstructive hypertrophic cardiomyopathy
Primary endpoint:
 1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2) and at least one NYHA class
reduction or a 3·0 mL/kg per min or greater pVO 2 increase without NYHA class worsening
Secondary endpoints:
 Changes in post-exercise LVOT gradient, pVO 2, NYHA class, Kansas City Cardiomyopathy Questionnaire-
Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-
of-Breath subscore (HCMSQ-SoB)
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ATRIAL FIBRILLATION
Does the GUIDELINES from the EAST NET work have an IMPACT in AF?
2020 ESC Guidelines on Atrial Fibrillation: Key highlights
Class 1 recommendation
 Opportunistic screening for AF by pulse taking or electrocardiogram (ECG) rhythm strip in patients at least
65 years of age
 Systematic ECG screening should also be considered to detect AF in individuals at least 75 years of age, or
those at high risk for stroke
 Inform individuals undergoing screening about the significance and treatment implications of detecting AF
and to have a structured referral platform in place for further physician-led evaluation.
 A definite diagnosis of clinical AF is established only after confirmation by a conventional 12-lead ECG or
single-lead ECG strip with at least 30 seconds of AF
 The new iteration classifies AF as first diagnosed, paroxysmal, persistent, long-standing persistent, and
permanent
 Atrial High Rate Episodes (AHRE)
 Clinical vs subclinical AF
 Oppurtunistic screening vs Systematic screening
 Structured characteristic
 Patient reported outcomes , patient centered approach
 CHA2DS2 VASc score of 0,1
 HAS BLED high – is not a contraindication
 Aspirin Plus clopidogrel plus OAC – 1week then Dual treatment for 12 months
 Lenient heart rate control is enough
2020 ESC Guidelines on Atrial Fibrillation: Characterisation
S-AF scheme for a structured characterisation of atrial fibrillation that takes into account Stroke risk,
severity of Symptoms, Severity of atrial fibrillation burden, and Substrate severity
Management approach
Key highlights
 Supports the formal risk score–based assessment of bleeding risk in all patients, including use of the HAS-
BLED score to help address modifiable bleeding risk factors and to identify patients at high bleeding risk (HAS-
BLED score ≥3) for early and more frequent follow-up
 Weight loss in obese patients with AF, particularly those being evaluated for ablation.
 In patients already receiving vitamin K antagonists with low time in the therapeutic range, they recommend
switching to a different NOAC but ensuring good adherence and persistence with therapy (class I
recommendation) or efforts to improve time in therapeutic range (class IIa)
• Catheter ablation takes on a more prominent role for rhythm control and is now
recommended after one antiarrhythmic drug therapy failure to improve symptoms of AF
recurrence in patients with paroxysmal AF, or persistent AF with or without major risk
factors for recurrence.
• Amiodarone not be used first-line for long-term rhythm control in all patients with AF,
including those with heart failure with reduced ejection fraction, given its extracardiac
toxicity
Effects of Early Rhythm Control Therapy in Patients with Atrial
Fibrillation
Aim:
 EAST AFNET prospectively tests the hypothesis that an early, structured rhythm control therapy based on
antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in
patients with AF when compared to usual care
Method:
 Trial Design: N=2789, multi-centered, prospective, randomized, open blinded study
Primary Endpoints:
 Composite of cardiovascular death, stroke, worsening of heart failure, or acute coronary syndrome,
 Nights spent in hospital per year
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Primary outcome
Each patient in the early
rhythm control group had a
lower statistically primary
endpoint events
Second primary outcome and key secondary outcomes
Summary and Conclusion
The EAST-AFNET trial showed that early intervention with structured follow-up
significantly reduced cardiovascular adverse events without affecting nights spent in
hospital
It provided reassuring evidence that early rhythm control with a structured follow-up is
safe for patients with AF and no-to-mild/moderate structural heart disease
However, the role of early rhythm control in the observed difference in event rates is
unclear.
IMPACT-Afib
Implementation of Stroke Prevention in Atrial Fibrillation (AF)
Aim:
To determine whether education on stroke prevention in AF among AF patients and their
providers can result in increased use of OAC for stroke prevention among those AF
patients
Method:
47,333 patients were included in the analysis
Average age of participants was 78 years
Primary Outcome: At least one OAC fill
Among a population indication for OAC for stroke prevention with AF, there was no statistically
significant difference in rates of OAC initiation at 1 year with a single education mailing
Summary and Conclusions
 Numerically more patients initiated OAC early after mailing, raising questions of whether multiple
mailing or further contact may have been beneficial
 It was feasible to identify, enroll and obtain outcomes through this novel study design the FDA
catalyst network
 The randomized design with no intervention control arm through 1 year was critical to evaluate
the intervention given a nearly 10% increase in OAC use without intervention.
POPULAR TAVI TRIAL
Does the DAPT is POPULAR in reducing the events?
Aim:
 The current study ( Cohort A) of POPULAR TAVI investigated the optimal antithrombotic therapy after
Transcatheter aortic valve implantation (TAVI) in patients not taking oral anticoagulants
Primary Endpoints:
 The co-primary outcomes were all bleeding (VARC-2) and non-procedural bleeding (BARC)
Secondary Endpoints:
 Two secondary outcomes, first examined bleeding and thromboembolic events and was a composite of CV
mortality, non-procedural bleeding, all-cause stroke, or MI. The second examined only thromboembolic events
and was a combination of CV mortality, ischemic stroke or MI.
POPULAR TAVI: Design
POPULAR TAVI: Primary outcomes
 The primary co-outcome, all bleeding (minor, major, and life-threatening or disabling bleeding) at 12
months, occurred in 15.1% of the aspirin alone group compared with 26.6% of the aspirin plus clopidogrel
group (p = 0.001)
 The primary co-outcome, nonprocedure-related bleeding at 12 months, occurred in 15.1% of the aspirin
alone group compared with 24.9% of the aspirin plus clopidogrel group (p = 0.005).
Procedural Characteristics
Aspirin
(N=331)
Aspirin + Clopidogrel
(N=334)
Approach
Transfemoral 302 (91.2) 292 (87.4)
Other 29 (8.8) 42 (12.6)
Unfractionated heparin – no. (%) 331 (100.0) 334 (100.0)
Maximal ACT – seconds [IQR] 272 (218-306) 259 (224-312)
Prosthesis – no. (%)
Sapien 3, Edwards Lifesciences 149 (45.0) 147 (44.0)
CoreValve Evolut R/Pro, Medtronic 127 (38.4) 120 (35.9)
Other 55 (16.6) 67 (20.1)
Embolic protection device use – no. (%) 19 (5.7) 17 (5.1)
All Bleeding
RR 0.57
95% CI 0.42 to 0.77
P = 0.001
26.6%
15.1%
Days since TAVI−procedure
Non-Procedural Bleeding
RR 0.61
95% CI 0.44 to 0.83
P = 0.005
15.1%
24.9%
Days since TAVI−procedure
CV Mortality, Non-Procedural Bleeding, Stroke, MI
RR 0.74
95% CI 0.57 to 0.95
-8.2% (-14.9 to -1.5)
Non-inferiority margin +7.5%
P = <0.001 (noninferiority)
P = 0.04 (superiority)
31.1%
23.0%
Days since TAVI−procedure
CV Mortality, Ischemic Stroke, MI
RR 0.98
95% CI 0.62 to 1.55
-0.2% (-4.7 to 4.3)
Non-inferiority margin +7.5%
P = 0.04 (noninferiority)
P = 0.93 (superiority)
9.9%
9.7%
Days since TAVI−procedure
Secondary outcomes
VARC major bleeding at 12 months: 2.4% of the aspirin alone group compared with 7.5%
of the aspirin plus clopidogrel group (p < 0.05)
VARC major, life-threatening, or disabling bleeding at 12 months: 5.1% of the aspirin alone
group compared with 10.8% of the aspirin plus clopidogrel group (p < 0.05)
Symptomatic aortic valve thrombosis at 12 months: 0.9% of the aspirin alone group
compared with 0.3% of the aspirin plus clopidogrel group (p = non significant)
Increased aortic valve gradient >10 mm Hg at 12 months: 3.0% of the aspirin alone group
compared with 3.3% of the aspirin plus clopidogrel group (p < 0.05)
Summary and Conclusion
 Aspirin alone as compared to aspirin with clopidogrel reduced the bleeding rate significantly, with
an absolute reduction of more than 10%
 Among patients who underwent TAVI and did not have an indication for anticoagulation, aspirin
alone was associated with a reduction in all bleeding and non-procedure-related bleeding
compared with aspirin plus clopidogrel
 This benefit was largely due to a significant reduction in major bleeding events
 At the same time, aspirin alone compared to aspirin with clopidogrel did not result in an
increase in thromboembolic events as captured in the secondary outcomes
 The trial shows that aspirin alone should be used in patients undergoing transcatheter aortic
valve implantation who are not on oral anticoagulation and have not recently undergone
coronary stenting
Primary and Secondary Outcome Components
Aspirin
(N=331)
Aspirin + Clopidogrel
(N=334)
Risk Ratio
(95% CI)
Death
Death from any cause 21 (6.3) 19 (5.7) 1.12 (0.61 to 2.04)
Death from cardiovascular causes 14 (4.2) 13 (3.9) 1.09 (0.52 to 2.28)
Stroke
Ischemic 17 (5.1) 18 (5.4) 0.95 (0.50 to 1.82)
Hemorrhagic 0 (0) 1 (0.3)
Myocardial infarction 4 (1.2) 6 (1.8) 0.67 (0.19 to 2.36)
VARC-2 bleeding
Major, life-threatening, or disabling 17 (5.1) 36 (10.8) 0.48 (0.27 to 0.83)
Minor 33 (10.0) 56 (15.9) 0.63 (0.42 to 0.94)
VARC-2 vascular complications
Major 11 (3.3) 23 (6.9)
Minor 22 (6.6) 33 (9.9)
Conclusions POPULAR TAVI - COHORT A
As with cohort B of the POPULAR TAVI trial
In patients without a chronic indication for oral anticoagulation
Aspirin alone as compared to aspirin + 3 months clopidogrel:
‒Reduces the rate of bleeding events, including major, life-threatening, or
disabling bleeding
‒Does not increase the rate of thromboembolic events
ATPCI TRIAL
Can we reduce the angina AT PCI than AFTER PCI ?
Aim:
 Assess the efficacy and safety of Trimetazidine added to standard, guideline recommended medical therapy
in patients who had recent successful PCI ( elective or urgent) for stable angina or non-ST elevated
myocardial infarction
Trial Design:
 N=6007, Phase 3, international, multi-center (365 sites, 27 countries), randomized, double-blind, placebo-
controlled trial, event driven study design
Primary Endpoints:
 Composite of cardiac death, hospitalization for cardiac events, recurrent/persistent angina leading to
adding, switching or increasing the dose of anti-anginal therapies or to coronary angiography.
Patients and follow-up
Primary endpoint results
No difference was observed
between Trimetazidine and
placebo with respect to the
primary endpoints
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Summary and Conclusion
The prophylactic use of Trimetazidine added to optimal medical therapy did not improve
the outcome in patients who had recent successful elective or urgent PCI
There was no difference in the primary outcome according to elective or urgent PCI
No Trimetazidine-related safety issues were identified
2020 NSTE ACS
GUIDELINES
Diagnosis
For diagnosis with rapid ‘rule-in’ and ‘rule-out’ algorithms, it is now recommended to use
the ESC 0 h/1 h algorithm (best option, blood draw at 0 h and 1 h) or the ESC 0 h/2 h
algorithm (second-best option, blood draw at 0 h and 2 h) if a high-sensitivity cardiac
troponin (hs-cTn) test with a validated algorithm is available
Diagnosis
 Initial cTn levels add prognostic information in terms of short- and long-term mortality to clinical and ECG
variables
 The higher the hs-cTn levels, the greater the risk of death
 Serum creatinine and eGFR should also be determined in all patients with NSTE-ACS because they affect
prognosis and are key elements of the GRACE risk score, in which assessment is superior to (subjective)
physician assessment for the occurrence of death or MI
 In addition, natriuretic peptides may provide incremental prognostic information.
 If elective non-invasive or invasive imaging is needed after the rule-out of myocardial infarction (MI),
invasive coronary angiography is deemed to be the best option in patients with very high clinical likelihood
of unstable angina.
 However, stress testing with imaging or coronary computed tomography angiography (CCTA) is seen as the
best option in patients with low-to-modest clinical risk.
Pharmacological therapy
For patients with atrial fibrillation and an indication for oral anticoagulation, the new default recommendation is a dual
antithrombotic strategy after a short period of triple antithrombotic therapy (<7 days). For those patients at high ischaemic
risk, triple antithrombotic therapy may be extended up to 4 weeks.
Pharmacological therapy
 It is not recommended to administer routine P2Y12 receptor inhibitor pre-treatment in NSTE-ACS
patients in whom coronary anatomy is not known and an early invasive management is planned,
given the lack of established benefit, although it may be considered in selected cases and
according to bleeding risk
 Post-treatment, dual antiplatelet therapy (DAPT) consisting of a potent P2Y12 receptor inhibitor
and aspirin is recommended for 12 months, irrespective of the stent type, unless there are
contraindications
 However, new scenarios have been implemented, such that DAPT duration can be shortened (<12
months), extended (>12 months) or modified by switching DAPT or de-escalation, based on the
individual characteristics of the patients and drug availability
REALITY TRIAL
Does the Transfusions in REALITY matter in MI patients?
A Trial of Transfusion Strategies for Myocardial Infarction and
Anemia
Aim:
 To assess the safety and efficacy of a restrictive versus liberal red blood cell (RBC) transfusion
strategy among patients with acute myocardial infarction (AMI) and anemia.
Design:
 668 patients hospitalized at 35 centers in France and Spain with acute myocardial infarction and
anemia (Hb: 10 g/dL or below, but above 7 g/dL)
 Patients were randomized to:
 The restrictive strategy, transfusion was withheld unless Hb dropped to 8 g/dL
 The liberal strategy, transfusion was given as soon as Hb was 10 g/dL or below
Primary clinical outcome: Per protocol population
The primary clinical outcome occurred in 36 patients (11%) assigned to the restrictive strategy
group compared with 45 patients (14%) assigned to the liberal strategy group
Secondary efficacy outcomes
All trends were in favour of restrictive strategy over liberal strategy
Summary and Conclusions
The REALITY trial supports the use of a restrictive strategy for blood transfusion in
myocardial infarction patients with anaemia
In addition, infections and acute lung injury were higher with a more liberal strategy
The restrictive strategy saves blood, is safe, and is at least as effective in preventing 30-
day cardiac events compared to a liberal strategy, while saving money
HOME PE TRIAL
Can PE be managed at HOME ?
Hospitalisation or Outpatient Management of PE Patients - HESTIA vs.
Simplified PESI
Aim:
 To examine whether a strategy based on the Hestia criteria was at least as safe as a strategy
based on the sPESI score to select patients for home treatment
 To evaluate whether the Hestia method was more efficient compared to the sPESI score.
Design:
 Randomised, open-label non-inferiority trial comparing the two triaging strategies
 1,974 patients with normal BP presenting to the emergency department with acute PE were
included from 2017-2019
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SPESI score
Randomisation and Endpoint
Randomisation:
 Patients randomised to the sPESI group were eligible for outpatient care if the score was 0;
otherwise they were hospitalised
 Patients randomised to the Hestia group were eligible for outpatient care if all 11 criteria were
negative; otherwise they were hospitalised
 In both groups, the physician in charge could overrule the decision on treatment location for
medical or social reasons
Primary outcome:
 Composite of recurrent VTE, major bleeding, and all-cause death within 30 days
Primary outcome- Safety
HESTIA was non-inferior to the sPESI on the rate of composite of recurrent VTE, major bleeding
and death at 30 days
Efficacy
Summary and Conclusion
These results support outpatient management of acute pulmonary embolism patients
using either the HESTIA method or the sPESI score with the option for physicians to
override the decision
In hospitals organised for outpatient management, both triaging strategies enable more
than a third of pulmonary embolism patients to be managed at home with a low rate of
complications
BPLTTC TRIAL
Blood Pressure Lowering for Prevention of Cardiovascular Events across
Different Levels of Blood Pressure
Aim:
 To investigate the effects of BP-lowering treatment on cardiovascular outcomes, stratified by CVD status
and SBP at baseline
Design:
 Meta-analysis of data from 348,854 participants from 48 clinical trials from around the world
 Participants were divided into two groups: those with a prior diagnosis of cardiovascular disease and those
without
 Each group was then further divided into seven subgroups based on systolic blood pressure at study entry
(less than 120, 120-129, 130-139, 140-149, 150-159, 160-169, and 170 and above mmHg)
 Average follow-up was four years
BPLTTC: Primary outcome
Each 5 mmHg reduction in systolic blood pressure lowered the relative risk of major cardiovascular
events by about 10%
BPLTTC: Secondary outcome
The risks for stroke, ischaemic heart disease, heart failure and death from cardiovascular disease were reduced by 13%,
7% and 14% and 5%, respectively.
Summary and Conclusions
 Tthere was no evidence that proportional effects varied by baseline BP values, down to the lowest
systolic BP category of <120 mmHg, in both primary and secondary prevention settings
 Decision to prescribe BP-lowering medication should not be based simply on a prior diagnosis of
cardiovascular disease or an individual's current BP
 Instead it should be used as "risk modifying treatments for prevention of incident or recurrent
cardiovascular events, regardless of BP values at baseline
2020 ESC ACHD
GUIDELINES
Key Highlights
 In low- and intermediate-risk patients with repaired simple lesions and precapillary pulmonary
hypertension, initial oral combination therapy or sequential combination therapy is recommended, and
high-risk patients should be treated with initial combination therapy including parenteral prostanoids (Class
I)
 In Eisenmenger patients with reduced exercise capacity (6-minute hall walk distance <450 m), a treatment
strategy with initial endothelin receptor antagonist monotherapy should be considered followed by
combination therapy if patients fail to improve (Class Iia)
 In patients with lesions associated with pulmonary valve regurgitation and no native outflow tract, catheter
intervention should be performed if anatomically feasible
Key Highlights
 Anticoagulation for patients with Fontan circulation is indicated in the presence, or with a history,
of atrial thrombus, atrial arrhythmias, or thromboembolic events (Class I)
 It is recommended that women with a Fontan circulation and any complication are counseled
against pregnancy (Class I). Regular liver imaging (ultrasound, computed tomography, cardiac
magnetic resonance [CMR]) should be considered for patients with Fontan circulation (Class IIa)
 Endothelin receptor antagonists and phosphodiesterase-5 inhibitors may be considered in
selected patients with Fontan circulation and elevated pulmonary pressures/resistance in the
absence of elevated ventricular end-diastolic pressure (Class IIa)
 Routine imaging to assess for cerebral aneurysms in asymptomatic patients with coarctation of
the aorta was not recommended in these guidelines.
Key Highlights
 Consistent with the 2018 American Heart Association/American College of Cardiology Guidelines
for Adults With Congenital Heart Disease, it was felt there was not sufficient evidence to make a
recommendation regarding medical therapy for systemic RV dysfunction in patients after atrial
switch procedures.
 Implantable cardioverter-defibrillator (ICD) implantation should be considered in selected TOF
patients with multiple risk factors for sudden cardiac death, including left ventricular dysfunction,
nonsustained, symptomatic ventricular tachycardia (VT), QRS duration >180 ms, extensive RV
scarring on CMR, or inducible VT at programmed electrical stimulation (Class IIa).
ACEI/ARBS
BRACE CORONA: Continuing vs. Suspending ACE Inhibitors
and ARBs in COVID-19
Aim:
To evaluate suspending compared with continuing angiotensin-converting enzyme
inhibitors (ACEI)/angiotensin-receptor blockers (ARB) among patients hospitalized with
coronavirus disease 2019 (COVID-19) infection
Design: Randomized, Parallel
Eligible patients were randomized to temporary suspension of ACEI/ARB (n = 334) versus
continued use of ACEI/ARB (n = 325)
Total number of enrollees: 659,Duration of follow-up: 30 days
Mean patient age: 55 years,Percentage female: 41%
Percentage with diabetes: 33%
BRACE CORONA: Primary outcome- Days alive and out of
hospital at 30 days
The average number of days alive and out of hospital was 21.9 days for patients who stopped ACE
inhibitors/ARBs and 22.9 days for patients who continued these medications
Clinical Status at Day 30
Proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE
inhibitor/ARB group was 91.8% versus 95% in the continuing group
A similar 30-day mortality rate was seen for patients who suspended and continued the ACE
inhibitor/ARB (2.7% vs. 2.8%)
All cause mortality at 30 days
Summary and Conclusions
There is no clinical benefit from routinely interrupting ACE inhibitor/ARB group
medications in hospitalised patients with mild to moderate COVID-19, they should
generally be continued for those with an indication
Suspending ACE inhibitors and ARBs in patients hospitalised with COVID-19, for 30 days
did not impact the number of days alive and out of hospital
Take home points
 Empagliflozin, is beneficial in HFREF with or without diabetes – increasing the armamentarium of drugs in management
of HF.
 Ertugliflozin appears to safe with relation to CV events, though the effects are not same as the Empagliflozin.
 Sacubitril Valsartan combination does not prove to be efficacious in HFPEF with relation to symptoms
 Macimentan the myosin inhibitor appears to be efficacious in symptomatic HCM and could be the drug of choice for
(PSRT)
 Early Rhythm control strategy is beneficial for AF patients
 Prophylactic trimetazidine is not beneficial in patients undergoing PCI.
 Dual APT is not beneficial post TAVR considering increased bleeding events compared to aspirin.
 Home based management of PE is efficacious provided strict evaluation of patient is done.
 ACEI/ARBs to be continued in patients with COVID – benefit > risk
 Liberal transfusion is not advised in MI patients ( forego the 10/30 rule)
YOU

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  • 4. HEART FAILURE WITH REDUCED EJECTION FRACTION HFrEF Can there be a Emperor for this entity management?
  • 5. EMPEROR-Reduced Trial Effect of Empagliflozin on Cardiovascular and Renal Events in Heart Failure With a Reduced Ejection Fraction
  • 9. EMPEROR-Reduced Trial • Double-blind, placebo-controlled, randomized trial • 3730 patients in 565 centers in 20 countries • Men and women with mild, moderate or severe HFrEF (EF ≤ 40%), who were already receiving all appropriate treatments for heart failure • With and without type 2 diabetes (half did not have diabetes) • Randomly assigned to placebo or Empagliflozin 10 mg once daily, which was added to existing treatment. • Study medication was continued for median of 16 months (up to 34 months) • Many patients with more advanced disease compared to DAPA HF trial.
  • 10. Primary Endpoint Composite of cardiovascular death or heart failure hospitalization 25% in risk P < 0.001 First Secondary Endpoint Total (first and recurrent heart failure hospitalizations) 30% in risk P < 0.001 Second Secondary Endpoint Slope of decline in glomerular filtration rate over time P < 0.001 (50% in renal events) SGLT2 Inhibition With Empagliflozin Is Effective in Heart Failure With a Reduced Ejection Fraction With or Without Diabetes Also achieved success on composite renal endpoint, KCCQ clinical summary score, and total number of hospitalizations for any reason (all nominal P < 0.01)
  • 11. Placebo Empagliflozin Empagliflozin Prevented Both Serious Heart Failure and Serious Kidney Failure Events Empagliflozin Cumulativeincidence(%) Weeks After Randomization Placebo Empagliflozin Cumulativeincidence(%) 0 26 52 78 104 13026 52 78 104 1300 Weeks After Randomization Hazard ratio 0.75 (25% reduction in risk) (95% CI 0.65, 0.86), P < 0.0001 Hazard ratio 0.50 (50% reduction in risk) (95% CI 0.32, 0.77), P = 0.0019 Cardiovascular Death or Hospitalization for Heart Failure Composite Renal Endpoint
  • 12. Slope of decline in Glomerular filtration Rate – Hierarchical endpoint # 3
  • 13. EMPEROR-Reduced: Safety Empagliflozin (n=1863) Placebo (n=1863) Serious adverse events 772 (41.4) 896 (48.1) Related to cardiac disorder 500 (26.8) 634 (34.0) Related to worsening renal function 59 (3.2) 95 (5.1) Selected adverse events of interest Volume depletion 197 (10.6) 184 (9.9) Hypotension 176 (9.4) 163 (8.7) Symptomatic hypotension 106 (5.7) 103 (5.5) Hypoglycemia 27 (1.4) 28 (1.5) Ketoacidosis 0 (0.0) 0 (0.0) Urinary tract infections 91 (4.9) 83 (4.5) Genital tract infections 31 (1.7) 12 (0.6) Bone fractures 45 (2.4) 42 (2.3) Lower limb amputations 13 (0.7) 10 (0.5)
  • 14. Key messages  Added with results of DAPA HF, this will be having great impact in management of patients with HFrEF with/or without diabetes.  They have clinically important benefits, are given once daily, require no dose adjustment, and are well tolerated.  There is compelling evidence that SGLT2 inhibitors should now be added to currently recommended treatments for this disease. EMPEROR-Reduced Trial Has Major Implications for Clinical Practice
  • 19. Study design:  VERTIS-CV trial was a multicentre, randomized, double-blind, placebo-controlled, event driven trial to prove cardiovascular safety  More than 8000 participants were randomized in a 1:1:1 manner either to placebo or Ertugliflozin 5mg or Ertugliflozin 15mg Primary endpoint:  Composite outcome of MACE (CV death, nonfatal MI, nonfatal stroke) Secondary endpoints:  Composite outcome of CV death/HHF, CV death, Renal composite (renal death, dialysis/transplant, doubling of serum creatinine)
  • 20. Primary and Secondary endpoints A weak trend for CV death and hospitalisation for heart failure was seen with Ertigluflozin
  • 28. HFPEF Should we still feel the beneficial effects in this entity as parallax or real/definite?
  • 29. Sacubitril/Valsartan versus Individualized RAAS Blockade in Patients with HFpEF Aim:  To evaluate the effect of sacubitril/valsartan (S/V) in comparison to individualized medical therapy (IMT) for cardiovascular and related co-morbidities on NT-proBNP, functional capacity, symptoms, and quality of life in patients with HF and ejection fraction (EF) >40% Design:  N=2566, 24 week randomized, double blind parallel-group, active controlled, or placebo-controlled trial in patients with LVEF >40%, New York Heart Association (NYHA) class II–IV symptoms, elevated NT-proBNP, and evidence of structural heart disease  The optimal individualized background therapy was either ACE inhibitor enalapril, ARB valsartan or placebo
  • 30. Endpoints Primary Endpoints: Change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in functional capacity ( 6 min walk distance) at 24 weeks Secondary: Quality of life ( Kansas City Cardiomyopathy Questionnaire; KCCQ) and NYHA functional class Exploratory endpoints: Change in eGFR, HF hospitalization and HF death
  • 31. • Sacubitril/valsartan showed a significant 16.4% greater reduction in NT-proBNP than those patients treated with optimal individualized medical therapy after 12 weeks (p<0.0001) • However, there was no significant difference between groups in terms of improvement in six-minute walk distance at 24 weeks
  • 32. PARALLAX: Secondary outcomes • Quality of life improved in both groups and was better with sacubitril/valsartan than the comparator at week 4 but there was no difference between groups at week 24 • Changes in NYHA class were similar in both groups at week 24
  • 33. PARALLAX: Post hoc analysis outcomes • A post hoc analysis showed that sacubitril/valsartan reduced the risk for heart failure hospitalisation by 50% (p=0.005) • Patients in the sacubitril/valsartan group also had a significantly lower decline in renal function (estimated glomerular filtration rate; eGFR) at 24 weeks Decline in eGFR
  • 34. PARALLAX: Summary and Conclusion  There are no established pharmacotherapies for HFpEF, and RAAS inhibitors are often recommended for treating co-morbidities.  PARALLAX evaluated benefits of S/V compared to individualised medical therapy in patients with HFpEF and HFmrEF (LVEF >40%) a high prevalence of co-morbidities and impaired QoL  PARALLAX demonstrated a significant reduction in NT-proBNP levels with S/V compared with individualised medical therapy  S/V had no additional benefit on 6MWD, KCQ improved in both treatments groups with an early benefit of S/V that was no longer significant after 24 weeks  These findings are consistent with findings of PARAGON-HF trial and provide further evidence for potential benefits of S/V in patients with HF and mid range or preserved ejection fraction.
  • 36. Main results of the beta-blockers in heart failure collaborative group Global partnership that over a 10-year period has harmonized individual patient data from landmark double blind RCTs in heart failure to answer key clinical questions about prognosis and efficacy and safety of beta blockers
  • 37. Effect of beta-blockers on sinus rhythm vs. atrial fibrillation Beta-blockers caused substantial reduction in mortality when patients are in sinus rhythm, whereas no effect on mortality was seen when patients are in atrial fibrillation
  • 38. Effect of beta-blockers depending on the heart rate values Effect of beta-blockers is independent of the heart rate values at baseline, lower the heart rate at baseline, lower is the all-cause mortality
  • 39. Outcomes according to LVEF in sinus rhythm • Beta-blockers halved the risk of mortality in patients with mid-range ejection fraction • Beta-blockers also improved surivial in all ejection fraction groups except those with ejection fraction of ≥ 50% at baseline
  • 40. Summary and Conclusion Beta blockers do not reduce mortality in HFrEF plus AF, but are safe Lack of efficacy may relate to distinct relationships with heart rate Substantial reduction in mortality with beta blockers in patients with sinus rhythm irrespective of heart rate, age, gender and if LVEF <40% or 40-49% Concomitant renal dysfunction had a major impact on prognosis in sinus rhythm beta blockers remain effective down to an eGFR of 30 ml/min
  • 41. HYPERTROPHIC CARDIOMYOPATHY Can’t we explore further in pharmacological management????
  • 44. Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Aim:  To assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive hypertrophic cardiomyopathy Primary endpoint:  1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2) and at least one NYHA class reduction or a 3·0 mL/kg per min or greater pVO 2 increase without NYHA class worsening Secondary endpoints:  Changes in post-exercise LVOT gradient, pVO 2, NYHA class, Kansas City Cardiomyopathy Questionnaire- Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness- of-Breath subscore (HCMSQ-SoB)
  • 59. ATRIAL FIBRILLATION Does the GUIDELINES from the EAST NET work have an IMPACT in AF?
  • 60. 2020 ESC Guidelines on Atrial Fibrillation: Key highlights Class 1 recommendation  Opportunistic screening for AF by pulse taking or electrocardiogram (ECG) rhythm strip in patients at least 65 years of age  Systematic ECG screening should also be considered to detect AF in individuals at least 75 years of age, or those at high risk for stroke  Inform individuals undergoing screening about the significance and treatment implications of detecting AF and to have a structured referral platform in place for further physician-led evaluation.  A definite diagnosis of clinical AF is established only after confirmation by a conventional 12-lead ECG or single-lead ECG strip with at least 30 seconds of AF  The new iteration classifies AF as first diagnosed, paroxysmal, persistent, long-standing persistent, and permanent
  • 61.  Atrial High Rate Episodes (AHRE)  Clinical vs subclinical AF  Oppurtunistic screening vs Systematic screening  Structured characteristic  Patient reported outcomes , patient centered approach  CHA2DS2 VASc score of 0,1  HAS BLED high – is not a contraindication  Aspirin Plus clopidogrel plus OAC – 1week then Dual treatment for 12 months  Lenient heart rate control is enough
  • 62. 2020 ESC Guidelines on Atrial Fibrillation: Characterisation S-AF scheme for a structured characterisation of atrial fibrillation that takes into account Stroke risk, severity of Symptoms, Severity of atrial fibrillation burden, and Substrate severity
  • 64. Key highlights  Supports the formal risk score–based assessment of bleeding risk in all patients, including use of the HAS- BLED score to help address modifiable bleeding risk factors and to identify patients at high bleeding risk (HAS- BLED score ≥3) for early and more frequent follow-up  Weight loss in obese patients with AF, particularly those being evaluated for ablation.  In patients already receiving vitamin K antagonists with low time in the therapeutic range, they recommend switching to a different NOAC but ensuring good adherence and persistence with therapy (class I recommendation) or efforts to improve time in therapeutic range (class IIa)
  • 65. • Catheter ablation takes on a more prominent role for rhythm control and is now recommended after one antiarrhythmic drug therapy failure to improve symptoms of AF recurrence in patients with paroxysmal AF, or persistent AF with or without major risk factors for recurrence. • Amiodarone not be used first-line for long-term rhythm control in all patients with AF, including those with heart failure with reduced ejection fraction, given its extracardiac toxicity
  • 66. Effects of Early Rhythm Control Therapy in Patients with Atrial Fibrillation Aim:  EAST AFNET prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care Method:  Trial Design: N=2789, multi-centered, prospective, randomized, open blinded study Primary Endpoints:  Composite of cardiovascular death, stroke, worsening of heart failure, or acute coronary syndrome,  Nights spent in hospital per year
  • 69. Primary outcome Each patient in the early rhythm control group had a lower statistically primary endpoint events
  • 70. Second primary outcome and key secondary outcomes
  • 71. Summary and Conclusion The EAST-AFNET trial showed that early intervention with structured follow-up significantly reduced cardiovascular adverse events without affecting nights spent in hospital It provided reassuring evidence that early rhythm control with a structured follow-up is safe for patients with AF and no-to-mild/moderate structural heart disease However, the role of early rhythm control in the observed difference in event rates is unclear.
  • 72. IMPACT-Afib Implementation of Stroke Prevention in Atrial Fibrillation (AF) Aim: To determine whether education on stroke prevention in AF among AF patients and their providers can result in increased use of OAC for stroke prevention among those AF patients Method: 47,333 patients were included in the analysis Average age of participants was 78 years
  • 73. Primary Outcome: At least one OAC fill Among a population indication for OAC for stroke prevention with AF, there was no statistically significant difference in rates of OAC initiation at 1 year with a single education mailing
  • 74. Summary and Conclusions  Numerically more patients initiated OAC early after mailing, raising questions of whether multiple mailing or further contact may have been beneficial  It was feasible to identify, enroll and obtain outcomes through this novel study design the FDA catalyst network  The randomized design with no intervention control arm through 1 year was critical to evaluate the intervention given a nearly 10% increase in OAC use without intervention.
  • 75. POPULAR TAVI TRIAL Does the DAPT is POPULAR in reducing the events?
  • 76. Aim:  The current study ( Cohort A) of POPULAR TAVI investigated the optimal antithrombotic therapy after Transcatheter aortic valve implantation (TAVI) in patients not taking oral anticoagulants Primary Endpoints:  The co-primary outcomes were all bleeding (VARC-2) and non-procedural bleeding (BARC) Secondary Endpoints:  Two secondary outcomes, first examined bleeding and thromboembolic events and was a composite of CV mortality, non-procedural bleeding, all-cause stroke, or MI. The second examined only thromboembolic events and was a combination of CV mortality, ischemic stroke or MI.
  • 78. POPULAR TAVI: Primary outcomes  The primary co-outcome, all bleeding (minor, major, and life-threatening or disabling bleeding) at 12 months, occurred in 15.1% of the aspirin alone group compared with 26.6% of the aspirin plus clopidogrel group (p = 0.001)  The primary co-outcome, nonprocedure-related bleeding at 12 months, occurred in 15.1% of the aspirin alone group compared with 24.9% of the aspirin plus clopidogrel group (p = 0.005).
  • 79. Procedural Characteristics Aspirin (N=331) Aspirin + Clopidogrel (N=334) Approach Transfemoral 302 (91.2) 292 (87.4) Other 29 (8.8) 42 (12.6) Unfractionated heparin – no. (%) 331 (100.0) 334 (100.0) Maximal ACT – seconds [IQR] 272 (218-306) 259 (224-312) Prosthesis – no. (%) Sapien 3, Edwards Lifesciences 149 (45.0) 147 (44.0) CoreValve Evolut R/Pro, Medtronic 127 (38.4) 120 (35.9) Other 55 (16.6) 67 (20.1) Embolic protection device use – no. (%) 19 (5.7) 17 (5.1)
  • 80. All Bleeding RR 0.57 95% CI 0.42 to 0.77 P = 0.001 26.6% 15.1% Days since TAVI−procedure
  • 81. Non-Procedural Bleeding RR 0.61 95% CI 0.44 to 0.83 P = 0.005 15.1% 24.9% Days since TAVI−procedure
  • 82. CV Mortality, Non-Procedural Bleeding, Stroke, MI RR 0.74 95% CI 0.57 to 0.95 -8.2% (-14.9 to -1.5) Non-inferiority margin +7.5% P = <0.001 (noninferiority) P = 0.04 (superiority) 31.1% 23.0% Days since TAVI−procedure
  • 83. CV Mortality, Ischemic Stroke, MI RR 0.98 95% CI 0.62 to 1.55 -0.2% (-4.7 to 4.3) Non-inferiority margin +7.5% P = 0.04 (noninferiority) P = 0.93 (superiority) 9.9% 9.7% Days since TAVI−procedure
  • 84. Secondary outcomes VARC major bleeding at 12 months: 2.4% of the aspirin alone group compared with 7.5% of the aspirin plus clopidogrel group (p < 0.05) VARC major, life-threatening, or disabling bleeding at 12 months: 5.1% of the aspirin alone group compared with 10.8% of the aspirin plus clopidogrel group (p < 0.05) Symptomatic aortic valve thrombosis at 12 months: 0.9% of the aspirin alone group compared with 0.3% of the aspirin plus clopidogrel group (p = non significant) Increased aortic valve gradient >10 mm Hg at 12 months: 3.0% of the aspirin alone group compared with 3.3% of the aspirin plus clopidogrel group (p < 0.05)
  • 85. Summary and Conclusion  Aspirin alone as compared to aspirin with clopidogrel reduced the bleeding rate significantly, with an absolute reduction of more than 10%  Among patients who underwent TAVI and did not have an indication for anticoagulation, aspirin alone was associated with a reduction in all bleeding and non-procedure-related bleeding compared with aspirin plus clopidogrel  This benefit was largely due to a significant reduction in major bleeding events  At the same time, aspirin alone compared to aspirin with clopidogrel did not result in an increase in thromboembolic events as captured in the secondary outcomes  The trial shows that aspirin alone should be used in patients undergoing transcatheter aortic valve implantation who are not on oral anticoagulation and have not recently undergone coronary stenting
  • 86. Primary and Secondary Outcome Components Aspirin (N=331) Aspirin + Clopidogrel (N=334) Risk Ratio (95% CI) Death Death from any cause 21 (6.3) 19 (5.7) 1.12 (0.61 to 2.04) Death from cardiovascular causes 14 (4.2) 13 (3.9) 1.09 (0.52 to 2.28) Stroke Ischemic 17 (5.1) 18 (5.4) 0.95 (0.50 to 1.82) Hemorrhagic 0 (0) 1 (0.3) Myocardial infarction 4 (1.2) 6 (1.8) 0.67 (0.19 to 2.36) VARC-2 bleeding Major, life-threatening, or disabling 17 (5.1) 36 (10.8) 0.48 (0.27 to 0.83) Minor 33 (10.0) 56 (15.9) 0.63 (0.42 to 0.94) VARC-2 vascular complications Major 11 (3.3) 23 (6.9) Minor 22 (6.6) 33 (9.9)
  • 87. Conclusions POPULAR TAVI - COHORT A As with cohort B of the POPULAR TAVI trial In patients without a chronic indication for oral anticoagulation Aspirin alone as compared to aspirin + 3 months clopidogrel: ‒Reduces the rate of bleeding events, including major, life-threatening, or disabling bleeding ‒Does not increase the rate of thromboembolic events
  • 88. ATPCI TRIAL Can we reduce the angina AT PCI than AFTER PCI ?
  • 89. Aim:  Assess the efficacy and safety of Trimetazidine added to standard, guideline recommended medical therapy in patients who had recent successful PCI ( elective or urgent) for stable angina or non-ST elevated myocardial infarction Trial Design:  N=6007, Phase 3, international, multi-center (365 sites, 27 countries), randomized, double-blind, placebo- controlled trial, event driven study design Primary Endpoints:  Composite of cardiac death, hospitalization for cardiac events, recurrent/persistent angina leading to adding, switching or increasing the dose of anti-anginal therapies or to coronary angiography.
  • 91. Primary endpoint results No difference was observed between Trimetazidine and placebo with respect to the primary endpoints
  • 93. Summary and Conclusion The prophylactic use of Trimetazidine added to optimal medical therapy did not improve the outcome in patients who had recent successful elective or urgent PCI There was no difference in the primary outcome according to elective or urgent PCI No Trimetazidine-related safety issues were identified
  • 95. Diagnosis For diagnosis with rapid ‘rule-in’ and ‘rule-out’ algorithms, it is now recommended to use the ESC 0 h/1 h algorithm (best option, blood draw at 0 h and 1 h) or the ESC 0 h/2 h algorithm (second-best option, blood draw at 0 h and 2 h) if a high-sensitivity cardiac troponin (hs-cTn) test with a validated algorithm is available
  • 96. Diagnosis  Initial cTn levels add prognostic information in terms of short- and long-term mortality to clinical and ECG variables  The higher the hs-cTn levels, the greater the risk of death  Serum creatinine and eGFR should also be determined in all patients with NSTE-ACS because they affect prognosis and are key elements of the GRACE risk score, in which assessment is superior to (subjective) physician assessment for the occurrence of death or MI  In addition, natriuretic peptides may provide incremental prognostic information.  If elective non-invasive or invasive imaging is needed after the rule-out of myocardial infarction (MI), invasive coronary angiography is deemed to be the best option in patients with very high clinical likelihood of unstable angina.  However, stress testing with imaging or coronary computed tomography angiography (CCTA) is seen as the best option in patients with low-to-modest clinical risk.
  • 97. Pharmacological therapy For patients with atrial fibrillation and an indication for oral anticoagulation, the new default recommendation is a dual antithrombotic strategy after a short period of triple antithrombotic therapy (<7 days). For those patients at high ischaemic risk, triple antithrombotic therapy may be extended up to 4 weeks.
  • 98. Pharmacological therapy  It is not recommended to administer routine P2Y12 receptor inhibitor pre-treatment in NSTE-ACS patients in whom coronary anatomy is not known and an early invasive management is planned, given the lack of established benefit, although it may be considered in selected cases and according to bleeding risk  Post-treatment, dual antiplatelet therapy (DAPT) consisting of a potent P2Y12 receptor inhibitor and aspirin is recommended for 12 months, irrespective of the stent type, unless there are contraindications  However, new scenarios have been implemented, such that DAPT duration can be shortened (<12 months), extended (>12 months) or modified by switching DAPT or de-escalation, based on the individual characteristics of the patients and drug availability
  • 99. REALITY TRIAL Does the Transfusions in REALITY matter in MI patients?
  • 100. A Trial of Transfusion Strategies for Myocardial Infarction and Anemia Aim:  To assess the safety and efficacy of a restrictive versus liberal red blood cell (RBC) transfusion strategy among patients with acute myocardial infarction (AMI) and anemia. Design:  668 patients hospitalized at 35 centers in France and Spain with acute myocardial infarction and anemia (Hb: 10 g/dL or below, but above 7 g/dL)  Patients were randomized to:  The restrictive strategy, transfusion was withheld unless Hb dropped to 8 g/dL  The liberal strategy, transfusion was given as soon as Hb was 10 g/dL or below
  • 101. Primary clinical outcome: Per protocol population The primary clinical outcome occurred in 36 patients (11%) assigned to the restrictive strategy group compared with 45 patients (14%) assigned to the liberal strategy group
  • 102. Secondary efficacy outcomes All trends were in favour of restrictive strategy over liberal strategy
  • 103. Summary and Conclusions The REALITY trial supports the use of a restrictive strategy for blood transfusion in myocardial infarction patients with anaemia In addition, infections and acute lung injury were higher with a more liberal strategy The restrictive strategy saves blood, is safe, and is at least as effective in preventing 30- day cardiac events compared to a liberal strategy, while saving money
  • 104. HOME PE TRIAL Can PE be managed at HOME ?
  • 105. Hospitalisation or Outpatient Management of PE Patients - HESTIA vs. Simplified PESI Aim:  To examine whether a strategy based on the Hestia criteria was at least as safe as a strategy based on the sPESI score to select patients for home treatment  To evaluate whether the Hestia method was more efficient compared to the sPESI score. Design:  Randomised, open-label non-inferiority trial comparing the two triaging strategies  1,974 patients with normal BP presenting to the emergency department with acute PE were included from 2017-2019
  • 108. Randomisation and Endpoint Randomisation:  Patients randomised to the sPESI group were eligible for outpatient care if the score was 0; otherwise they were hospitalised  Patients randomised to the Hestia group were eligible for outpatient care if all 11 criteria were negative; otherwise they were hospitalised  In both groups, the physician in charge could overrule the decision on treatment location for medical or social reasons Primary outcome:  Composite of recurrent VTE, major bleeding, and all-cause death within 30 days
  • 109. Primary outcome- Safety HESTIA was non-inferior to the sPESI on the rate of composite of recurrent VTE, major bleeding and death at 30 days
  • 111. Summary and Conclusion These results support outpatient management of acute pulmonary embolism patients using either the HESTIA method or the sPESI score with the option for physicians to override the decision In hospitals organised for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications
  • 113. Blood Pressure Lowering for Prevention of Cardiovascular Events across Different Levels of Blood Pressure Aim:  To investigate the effects of BP-lowering treatment on cardiovascular outcomes, stratified by CVD status and SBP at baseline Design:  Meta-analysis of data from 348,854 participants from 48 clinical trials from around the world  Participants were divided into two groups: those with a prior diagnosis of cardiovascular disease and those without  Each group was then further divided into seven subgroups based on systolic blood pressure at study entry (less than 120, 120-129, 130-139, 140-149, 150-159, 160-169, and 170 and above mmHg)  Average follow-up was four years
  • 114. BPLTTC: Primary outcome Each 5 mmHg reduction in systolic blood pressure lowered the relative risk of major cardiovascular events by about 10%
  • 115. BPLTTC: Secondary outcome The risks for stroke, ischaemic heart disease, heart failure and death from cardiovascular disease were reduced by 13%, 7% and 14% and 5%, respectively.
  • 116. Summary and Conclusions  Tthere was no evidence that proportional effects varied by baseline BP values, down to the lowest systolic BP category of <120 mmHg, in both primary and secondary prevention settings  Decision to prescribe BP-lowering medication should not be based simply on a prior diagnosis of cardiovascular disease or an individual's current BP  Instead it should be used as "risk modifying treatments for prevention of incident or recurrent cardiovascular events, regardless of BP values at baseline
  • 118. Key Highlights  In low- and intermediate-risk patients with repaired simple lesions and precapillary pulmonary hypertension, initial oral combination therapy or sequential combination therapy is recommended, and high-risk patients should be treated with initial combination therapy including parenteral prostanoids (Class I)  In Eisenmenger patients with reduced exercise capacity (6-minute hall walk distance <450 m), a treatment strategy with initial endothelin receptor antagonist monotherapy should be considered followed by combination therapy if patients fail to improve (Class Iia)  In patients with lesions associated with pulmonary valve regurgitation and no native outflow tract, catheter intervention should be performed if anatomically feasible
  • 119. Key Highlights  Anticoagulation for patients with Fontan circulation is indicated in the presence, or with a history, of atrial thrombus, atrial arrhythmias, or thromboembolic events (Class I)  It is recommended that women with a Fontan circulation and any complication are counseled against pregnancy (Class I). Regular liver imaging (ultrasound, computed tomography, cardiac magnetic resonance [CMR]) should be considered for patients with Fontan circulation (Class IIa)  Endothelin receptor antagonists and phosphodiesterase-5 inhibitors may be considered in selected patients with Fontan circulation and elevated pulmonary pressures/resistance in the absence of elevated ventricular end-diastolic pressure (Class IIa)  Routine imaging to assess for cerebral aneurysms in asymptomatic patients with coarctation of the aorta was not recommended in these guidelines.
  • 120. Key Highlights  Consistent with the 2018 American Heart Association/American College of Cardiology Guidelines for Adults With Congenital Heart Disease, it was felt there was not sufficient evidence to make a recommendation regarding medical therapy for systemic RV dysfunction in patients after atrial switch procedures.  Implantable cardioverter-defibrillator (ICD) implantation should be considered in selected TOF patients with multiple risk factors for sudden cardiac death, including left ventricular dysfunction, nonsustained, symptomatic ventricular tachycardia (VT), QRS duration >180 ms, extensive RV scarring on CMR, or inducible VT at programmed electrical stimulation (Class IIa).
  • 122. BRACE CORONA: Continuing vs. Suspending ACE Inhibitors and ARBs in COVID-19 Aim: To evaluate suspending compared with continuing angiotensin-converting enzyme inhibitors (ACEI)/angiotensin-receptor blockers (ARB) among patients hospitalized with coronavirus disease 2019 (COVID-19) infection Design: Randomized, Parallel Eligible patients were randomized to temporary suspension of ACEI/ARB (n = 334) versus continued use of ACEI/ARB (n = 325) Total number of enrollees: 659,Duration of follow-up: 30 days Mean patient age: 55 years,Percentage female: 41% Percentage with diabetes: 33%
  • 123. BRACE CORONA: Primary outcome- Days alive and out of hospital at 30 days The average number of days alive and out of hospital was 21.9 days for patients who stopped ACE inhibitors/ARBs and 22.9 days for patients who continued these medications
  • 124. Clinical Status at Day 30 Proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group
  • 125. A similar 30-day mortality rate was seen for patients who suspended and continued the ACE inhibitor/ARB (2.7% vs. 2.8%) All cause mortality at 30 days
  • 126. Summary and Conclusions There is no clinical benefit from routinely interrupting ACE inhibitor/ARB group medications in hospitalised patients with mild to moderate COVID-19, they should generally be continued for those with an indication Suspending ACE inhibitors and ARBs in patients hospitalised with COVID-19, for 30 days did not impact the number of days alive and out of hospital
  • 127. Take home points  Empagliflozin, is beneficial in HFREF with or without diabetes – increasing the armamentarium of drugs in management of HF.  Ertugliflozin appears to safe with relation to CV events, though the effects are not same as the Empagliflozin.  Sacubitril Valsartan combination does not prove to be efficacious in HFPEF with relation to symptoms  Macimentan the myosin inhibitor appears to be efficacious in symptomatic HCM and could be the drug of choice for (PSRT)  Early Rhythm control strategy is beneficial for AF patients  Prophylactic trimetazidine is not beneficial in patients undergoing PCI.  Dual APT is not beneficial post TAVR considering increased bleeding events compared to aspirin.  Home based management of PE is efficacious provided strict evaluation of patient is done.  ACEI/ARBs to be continued in patients with COVID – benefit > risk  Liberal transfusion is not advised in MI patients ( forego the 10/30 rule)
  • 128. YOU

Editor's Notes

  1. The procedural characteristics are shown on this slide. Most TAVI procedures were performed using the transfemoral route, with a Sapien 3 or an Evolut R/pro device. Cerebral embolic protection devices were infrequently used.
  2. The primary outcome all bleeding is shown on this slide. All bleeding occurred in 15,1% of patients on aspirin alone and 26,6% of patients receiving aspirin plus clopidogrel, and was significantly reduced with a aspirin alone strategy, with a risk ratio of 0,57 and a p-value of 0.001
  3. All bleeding occurred in 15.1% of patients on aspirin alone and 24.9% of patients receiving aspirin plus clopidogrel, Also non-procedural bleeding was significantly reduced with a aspirin alone strategy, with a risk ratio of 0,61 and a p-value of 0.005
  4. The composite of CV mortality, non-procedural bleeding, stroke, or MI is shown on this slide. The secondary outcome occurred in 23% of patients receiving aspirin alone and in 31.% of patients receiving aspirin plus clopidgrel, with a risk ratio of 0.74 and met the criteria for non-inferiority of aspirin alone with a absolute difference of -8.2 percent and a p-value of <0.001, and also reached superiority with a p-value of 0.04
  5. The second secondary outcome, a composite of CV mortality, ischemic stroke, or MI is shown on this slide and occurred in 9.1% of patients receiving aspirin alone and in 9.9% of patients receiving aspirin plus clopidogrel, with a risk ratio of 0.98 and met the criteria for non-inferiority of aspirin alone with a absolute difference of -8.2 percent and a p-value of 0.04, but not for superiority.
  6. The absolute event rates of the components of the primary and secondary outcomes are shown on this slide. The individual incidences of cardiovascular mortality, ischemic stroke, and myocardial infarction were comparable between both groups.
  7. The conclusions of Cohort A of the POPular TAVI trial As with cohort B of the trial, were an oral anticoagulation alone strategy without clopidogrel was associated with a reduction of bleeding events, and no increase of thromboembolic events after TAVI. In cohort A, including patients without a chronic indication for oral anticoagulation, we show that an aspirin alone strategy without clopidogrel also reduces the rate of bleeding events, including major, life-threatening, or disabling bleeding and does not increase the rate of thromboembolic events.