Heart Failure Trials Flashcards
SOLVD
Enalapril vs placebo 2569 patients, NYHA II-III, EF <35% 16% reduction in mortality 26% reduction in mortality/hosp NEJM 1991
CONSENSUS I
Enalapril vs Placebo
253 patients, NYHA IV
40% reduction in crude mortality
NEJM 1987
MERIT-HF
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
COPERNICUS
Carvedilol vs placebo
2289 patients, NYHA III-IV, EF <25%
80% reduction in all cause mortality in high risk patients
NEJM 1996
SAVE
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
VALIANT
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
RALES
Spironolactone vs placebo 1663 patients, NYHA III-IV, EF<35% 25-50mg daily as tolerated (hyperK) 30% reduction of mortality NEJM 1999
PARADIGM-HF
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
EPHESUS
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
Val-HeFT
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
CIBIS-II
Bisoprolol vs placebo Beta-1 selective 2647 patients, NYHA III-IV, EF<35% 34% reduction of all-cause mortality NEJM 1999
COMET
Carvedilol 25 vs metoprolol tartrate 50
1511 patients, NYHA II-IV, EF<35%
17% reduction in all-cause mortality in Carvedilol group
Lancet 2003
HEAAL
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
CAPRICORN
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
CHARM-Added
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
CHARM-Alternative
Candesartan vs placebo Patients who can't tolerate ACEi 2028 patients, NYHA II-IV, EF<40% 23% reduction in CV death/hosp Lancet 2003
BLOCK HF
BiV pacing vs RV alone pacing
691 patients requiring pacemaker, NYHA I-III, LVEF
CARRESS-HF
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
A-HeFT
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
EMPHASIS-HF
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
TOPCAT
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
PARTNER 2
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
PARTNER 1
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
AFFIRM
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
RACE II
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
JUPITER
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
ROCKET AF
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
ARISTOTLE
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
MADIT II
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
SCD HeFT
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
CARE-HF
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
MIRACLE
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
RAFT
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
AVERROES
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
Echo-CRT
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
EVEREST II
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.
COAPT
MitraClip in functional MR with EF
SHIFT
Ivabradine (Corlanor) vs placebo
