Heart Failure Trials

Question 0

SOLVD

Answer 0

Enalapril vs placebo
2569 patients, NYHA II-III, EF <35%
16% reduction in mortality
26% reduction in mortality/hosp
NEJM 1991

Question 1

CONSENSUS I

Answer 1

Enalapril vs Placebo
253 patients, NYHA IV
40% reduction in crude mortality
NEJM 1987

Question 2

MERIT-HF

Answer 2

Metoprolol XL vs placebo
3991 patients, NYHA II (25mg daily) or III-IV (12.5mg daily), EF <40%
44% reduction in deaths from sudden death and worsening heart failure
Lancet 1999

Question 3

COPERNICUS

Answer 3

Carvedilol vs placebo
2289 patients, NYHA III-IV, EF <25%
80% reduction in all cause mortality in high risk patients
NEJM 1996

Question 4

SAVE

Answer 4

Captopril vs placebo
2231 patients 3-16 days after ACS, EF<40%
19% reduction in mortality, also reduced CV events, CV mortality, new severe HF, CHF hosp, recurrent MI
NEJM 1992

Question 5

VALIANT

Answer 5

Valsartan vs Captopril vs both
14,703 patients post-MI with HF
No difference in benefit, increased risk of AE in combination group
Euro J HF, 2003

Question 6

RALES

Answer 6

Spironolactone vs placebo
1663 patients, NYHA III-IV, EF<35%
25-50mg daily as tolerated (hyperK)
30% reduction of mortality
NEJM 1999

Question 7

PARADIGM-HF

Answer 7

Valsartan/neprilysin vs Enalapril
8399 patients, NYHA II-IV, EF <40%
20% reduction in CV death/hosp
20% reduction in CV mortality
16% reduction in all-cause mortality
(Serious angioedema when tried in combination with enalapril)
NEJM 2014

Question 8

EPHESUS

Answer 8

Eplerenone vs placebo
6632 patients 3-14d post-MI, EF<40%
15% reduction in total mortality
13% reduction in CV mortality/hosp, 21% reduction in SCD
No hyperkalemia deaths
NEJM 2003

Question 9

Val-HeFT

Answer 9

Valsartan vs placebo (on top of standard therapy including ACEi)
5010 patients NYHA II-IV, EF <40%
No difference in mortality
13% reduction in hospitalization
Adverse effect in ACE+ARB+BB
NEJM 2001

Question 10

CIBIS-II

Answer 10

Bisoprolol vs placebo
Beta-1 selective
2647 patients, NYHA III-IV, EF<35%
34% reduction of all-cause mortality
NEJM 1999

Question 11

COMET

Answer 11

Carvedilol 25 vs metoprolol tartrate 50
1511 patients, NYHA II-IV, EF<35%
17% reduction in all-cause mortality in Carvedilol group
Lancet 2003

Question 12

HEAAL

Answer 12

High vs Low-Dose Losartan
3846 patients, NYHA II-IV, EF<40%
150mg vs 50mg
10% reduction in mortality/HF hosp
More renal imp, hypotension, hyperK
Lancet 2009

Question 13

CAPRICORN

Answer 13

Carvedilol vs placebo
1959 patients, post-MI, EF<40%
6.25mg titrate to 25mg BID
23% reduction in all-cause mortality
Reduced CV mortality, recurrent MI
Lancet 2001

Question 14

CHARM-Added

Answer 14

Candesartan vs placebo on ACEi tx
2548 patients, NYHA II-IV, EF<40%
15% reduction in CV death/hosp +/- non-fatal MI, CVA
Reduced CV mortality, but not a planned endpoint
Lancet 2003

Question 15

CHARM-Alternative

Answer 15

Candesartan vs placebo
Patients who can't tolerate ACEi
2028 patients, NYHA II-IV, EF<40%
23% reduction in CV death/hosp
Lancet 2003

Question 16

BLOCK HF

Answer 16

BiV pacing vs RV alone pacing

691 patients requiring pacemaker, NYHA I-III, LVEF

Question 17

CARRESS-HF

Answer 17

Ultrafiltration (200cc/hr) vs medical therapy (Lasix gtt, metolazone, inotropes or vasodilators prn)
188 patients, hospitalized for ADHF, worsening renal function (inc Cr >0.3), volume overload, SBP>90
Change in Cr (significantly worse in UF) and change in weight (no difference) at 96 hours
No other differences
NEJM 2012

Question 18

A-HeFT

Answer 18

ISDN/hydralazine vs placebo
1050 AA patients, NYHA III-IV, LVEF 6.5cm
Reduced all-cause mortality/hosp/QOL score
Reduced all-cause mortality (6.2% vs 10.2%)
NEJM 2004

Question 19

EMPHASIS-HF

Answer 19

Eplerenone vs placebo in NYHA II
2737 patients, NYHA II, LVEF<2.0 in women
34% reduction in CV death/hosp (18.3% vs 25.9%)
23% reduction in CV mortality (10.8% vs 13.5%)
NEJM 2010

Question 20

TOPCAT

Answer 20

Spironolactone vs placebo in HFpEF
3445 patients, LVEF>45%
No difference in composite CV death/cardiac arrest/hospitalization
Did reduce HF hospitalization by 17%
More hyperK, but no diff in serious adverse events, Cr>3, or dialysis
USA vs Russia/Georgia, diff results

Question 21

PARTNER 2

Answer 21

TAVR vs SAVR
699 high-risk patients with severe AS
No diff in all-cause mortality or 2-year stroke rate, higher 30-day stroke rate.
Higher paravalvular regurgitation leading to increased late mortality.
NEJM 2012

Question 22

PARTNER 1

Answer 22

TAVR vs standard therapy
358 patients who could not undergo surgery
Reduced mortality at 1 year
Reduced all-cause mortality at 2 years (43.3% vs 68%) CV death (31% vs 62%), hospitalization, and improved functional status.
Increased major strokes (5.0% vs 1.1%) and major vascular complications (16.2% vs 1.1%)
NEJM 2010

Question 23

AFFIRM

Answer 23

Rate vs rhythm control in AFib
4060 patients with atrial fibrillation
Borderline increased mortality in rhythm-control (23.8% vs 21.3%, p=0.08)
Increased hospitalizations and adverse drug effects in rhythm-control
NEJM 2002

Question 24

RACE II

Answer 24

Lenient vs strict rate control in AFib 614 patients, lenient <80bpm No diff in CV death/HF hosp/CVA/bleeding/life-threatening arrhythmia No diff in symptoms or adverse events Easier to achieve lenient with less visits NEJM 2010

Question 25

JUPITER

Answer 25

Rosuvastatin vs placebo 17,802 healthy patients with LDL<130 but elevated hsCRP 44% reduction in MI/CVA/revasc/UA/CV death Reduction in all individual components including mortality NEJM 2008

Question 26

ROCKET AF

Answer 26

``` Rivaroxaban vs Warfarin 14,264 patients with nonvalvular AFib Noninferior for CVA or systemic embolism No diff in total clinically relevant bleeding Reduced intracranial and fatal bleeding NEJM 2011 ```

Question 27

ARISTOTLE

Answer 27

``` Apixaban vs Warfarin 18,201 patients with nonvalvular AFib Eliquis 5mg PO BID 21% reduction in CVA/systemic embolism 31% reduction in major bleeding 11% reduction in all-cause mortality NEJM 2011 ```

Question 28

MADIT II

Answer 28

ICD vs standard therapy 1232 patients, h/o MI over 1 month prior, LVEF<30% 31% reduction in all-cause mortality (14.2% vs 19.8%), NNT 18 NEJM 2002

Question 29

SCD HeFT

Answer 29

ICD vs amiodarone vs placebo 2521 patients, NYHA II-III, LVEF<35% ischemic or nonischemic 23% reduction in all-cause mortality for ICD vs placebo No difference for amiodarone (but increased mortality in NYHA class III) No benefit for ICDs in NYHA class III NEJM 2005

Question 30

CARE-HF

Answer 30

CRT vs standard therapy 813 patients, NYHA III-IV x6 weeks on OMT, LVEF120ms with conduction delay or QRS>150 37% reduction in all-cause mortality/hospitalization 36% reduction in all-cause mortality (2nd outcome, 20% vs 30%, NNT 10) Improvement in NYHA class, QOL NEJM 2005

Question 31

MIRACLE

Answer 31

CRT vs control (all implanted, pacing vs no pacing x6 months, blinded) 453 patients, NYHA III-IV, LVEF55mm, QRS>130ms, ICMY+NICMY Improvement in NYHA class, improvement in QOL score, improvement in 6-min walk Not powered for all-cause mortality NEJM 2002

Question 32

RAFT

Answer 32

CRT-D vs ICD alone 1798 patients, NYHA II-III, LVEF120ms 25% reduction in all-cause mortality/hosp 25% reduction in all-cause mortality (20.8% vs 26.1%), NNT 19 NEJM 2010

Question 33

AVERROES

Answer 33

``` Apixaban (5mg BID) vs aspirin (81-324mg) 5599 patients with AFib who are "unsuitable" for Warfarin 55% reduction in CVA/systemic embolism Borderline reduction in mortality No increase in major bleeding or ICH NEJM 2011 ```

Question 34

Echo-CRT

Answer 34

CRT vs control (all implanted, pacing vs no pacing) with QRS<130ms, echo e/o LV dyssynchrony No difference in all-cause mortality/HF hosp Increased mortality in CRT group NEJM 2013

Question 35

EVEREST II

Answer 35

MitraClip vs Surgical MVR, 279 patients (55 in EVEREST I feasibility study), 2:1 to MitraClip. Symptomatic EF>25% LVESD40, pHTN, or afib. No death/stroke/MI/surgery. Effectiveness 72% MC vs 88% MVR. Improvement in NYHA class. Results: Noninferior, safer.

Question 36

COAPT

Answer 36

MitraClip in functional MR with EF

Question 37

SHIFT

Answer 37

Ivabradine (Corlanor) vs placebo