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Cardiology Trials > Heart Failure Trials > Flashcards

Heart Failure Trials Flashcards

0
Q

SOLVD

A 
Enalapril vs placebo
2569 patients, NYHA II-III, EF <35%
16% reduction in mortality
26% reduction in mortality/hosp
NEJM 1991
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1
Q

CONSENSUS I

A

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

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2
Q

MERIT-HF

A

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

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3
Q

COPERNICUS

A

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

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4
Q

SAVE

A

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

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5
Q

VALIANT

A

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

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6
Q

RALES

A 
Spironolactone vs placebo
1663 patients, NYHA III-IV, EF<35%
25-50mg daily as tolerated (hyperK)
30% reduction of mortality
NEJM 1999
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7
Q

PARADIGM-HF

A 
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
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8
Q

EPHESUS

A 
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
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9
Q

Val-HeFT

A 
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
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10
Q

CIBIS-II

A 
Bisoprolol vs placebo
Beta-1 selective
2647 patients, NYHA III-IV, EF<35%
34% reduction of all-cause mortality
NEJM 1999
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11
Q

COMET

A

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

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12
Q

HEAAL

A 
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
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13
Q

CAPRICORN

A 
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
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14
Q

CHARM-Added

A

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

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15
Q

CHARM-Alternative

A 
Candesartan vs placebo
Patients who can't tolerate ACEi
2028 patients, NYHA II-IV, EF<40%
23% reduction in CV death/hosp
Lancet 2003
16
Q

BLOCK HF

A

BiV pacing vs RV alone pacing

691 patients requiring pacemaker, NYHA I-III, LVEF

17
Q

CARRESS-HF

A

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

18
Q

A-HeFT

A

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

19
Q

EMPHASIS-HF

A

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

20
Q

TOPCAT

A

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

21
Q

PARTNER 2

A

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

22
Q

PARTNER 1

A

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

23
Q

AFFIRM

A

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

24
Q

RACE II

A

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

25
Q

JUPITER

A

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

26
Q

ROCKET AF

A 
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
27
Q

ARISTOTLE

A 
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
28
Q

MADIT II

A

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

29
Q

SCD HeFT

A

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

30
Q

CARE-HF

A

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

31
Q

MIRACLE

A

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

32
Q

RAFT

A

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

33
Q

AVERROES

A 
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
34
Q

Echo-CRT

A

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

35
Q

EVEREST II

A

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.

36
Q

COAPT

A

MitraClip in functional MR with EF

37
Q

SHIFT

A

Ivabradine (Corlanor) vs placebo

Cardiology Trials (3 decks)

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