Benefit of warfarin compared with aspirin in patients with heart failure in sinus rhythm : a subgroup analysis of WARCEF, a randomized controlled trial
BACKGROUND: The Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial found no difference in the primary outcome between warfarin and aspirin in 2305 patients with reduced left ventricular ejection fraction in sinus rhythm. However, it is unknown whether any subgroups benefit from warfarin or aspirin.
METHODS AND RESULTS: We used a Cox model stepwise selection procedure to identify subgroups that may benefit from warfarin or aspirin on the WARCEF primary outcome. A secondary analysis added major hemorrhage to the outcome. The primary efficacy outcome was time to the first to occur of ischemic stroke, intracerebral hemorrhage, or death. Only age group was a significant treatment effect modifier (P for interaction, 0.003). Younger patients benefited from warfarin over aspirin on the primary outcome (4.81 versus 6.76 events per 100 patient-years: hazard ratio, 0.63; 95% confidence interval, 0.48-0.84; P=0.001). In older patients, therapies did not differ (9.91 versus 9.01 events per 100 patient-years: hazard ratio, 1.09; 95% confidence interval, 0.88-1.35; P=0.44). With major hemorrhage added, in younger patients the event rate remained lower for warfarin than aspirin (5.41 versus 7.25 per 100 patient-years: hazard ratio, 0.68; 95% confidence interval, 0.52-0.89; P=0.005), but in older patients it became significantly higher for warfarin (11.80 versus 9.35 per 100 patient-years: hazard ratio, 1.25; 95% confidence interval, 1.02-1.53; P=0.03).
CONCLUSIONS: In patients <60 years, warfarin improved outcomes over aspirin with or without inclusion of major hemorrhage. In patients ≥60 years, there was no treatment difference, but the aspirin group had significantly better outcomes when major hemorrhage was included.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2013 |
|---|---|
| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:6 |
|---|---|
| Enthalten in: |
Circulation. Heart failure - 6(2013), 5 vom: 01. Sept., Seite 988-97 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Homma, Shunichi [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 18.11.2013 Date Revised 21.10.2021 published: Print-Electronic ClinicalTrials.gov: NCT00041938 Citation Status MEDLINE |
|---|
| doi: |
10.1161/CIRCHEARTFAILURE.113.000372 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM229420796 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM229420796 | ||
| 003 | DE-627 | ||
| 005 | 20231224082122.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231224s2013 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1161/CIRCHEARTFAILURE.113.000372 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0764.xml |
| 035 | |a (DE-627)NLM229420796 | ||
| 035 | |a (NLM)23881846 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Homma, Shunichi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Benefit of warfarin compared with aspirin in patients with heart failure in sinus rhythm |b a subgroup analysis of WARCEF, a randomized controlled trial |
| 264 | 1 | |c 2013 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 18.11.2013 | ||
| 500 | |a Date Revised 21.10.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00041938 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: The Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial found no difference in the primary outcome between warfarin and aspirin in 2305 patients with reduced left ventricular ejection fraction in sinus rhythm. However, it is unknown whether any subgroups benefit from warfarin or aspirin | ||
| 520 | |a METHODS AND RESULTS: We used a Cox model stepwise selection procedure to identify subgroups that may benefit from warfarin or aspirin on the WARCEF primary outcome. A secondary analysis added major hemorrhage to the outcome. The primary efficacy outcome was time to the first to occur of ischemic stroke, intracerebral hemorrhage, or death. Only age group was a significant treatment effect modifier (P for interaction, 0.003). Younger patients benefited from warfarin over aspirin on the primary outcome (4.81 versus 6.76 events per 100 patient-years: hazard ratio, 0.63; 95% confidence interval, 0.48-0.84; P=0.001). In older patients, therapies did not differ (9.91 versus 9.01 events per 100 patient-years: hazard ratio, 1.09; 95% confidence interval, 0.88-1.35; P=0.44). With major hemorrhage added, in younger patients the event rate remained lower for warfarin than aspirin (5.41 versus 7.25 per 100 patient-years: hazard ratio, 0.68; 95% confidence interval, 0.52-0.89; P=0.005), but in older patients it became significantly higher for warfarin (11.80 versus 9.35 per 100 patient-years: hazard ratio, 1.25; 95% confidence interval, 1.02-1.53; P=0.03) | ||
| 520 | |a CONCLUSIONS: In patients <60 years, warfarin improved outcomes over aspirin with or without inclusion of major hemorrhage. In patients ≥60 years, there was no treatment difference, but the aspirin group had significantly better outcomes when major hemorrhage was included | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a aspirin | |
| 650 | 4 | |a heart failure | |
| 650 | 4 | |a sinus rhythm | |
| 650 | 4 | |a stroke | |
| 650 | 4 | |a warfarin | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
| 650 | 7 | |a Warfarin |2 NLM | |
| 650 | 7 | |a 5Q7ZVV76EI |2 NLM | |
| 650 | 7 | |a Aspirin |2 NLM | |
| 650 | 7 | |a R16CO5Y76E |2 NLM | |
| 700 | 1 | |a Thompson, John L P |e verfasserin |4 aut | |
| 700 | 1 | |a Sanford, Alexandra R |e verfasserin |4 aut | |
| 700 | 1 | |a Mann, Douglas L |e verfasserin |4 aut | |
| 700 | 1 | |a Sacco, Ralph L |e verfasserin |4 aut | |
| 700 | 1 | |a Levin, Bruce |e verfasserin |4 aut | |
| 700 | 1 | |a Pullicino, Patrick M |e verfasserin |4 aut | |
| 700 | 1 | |a Freudenberger, Ronald S |e verfasserin |4 aut | |
| 700 | 1 | |a Teerlink, John R |e verfasserin |4 aut | |
| 700 | 1 | |a Graham, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Mohr, J P |e verfasserin |4 aut | |
| 700 | 1 | |a Massie, Barry M |e verfasserin |4 aut | |
| 700 | 1 | |a Labovitz, Arthur J |e verfasserin |4 aut | |
| 700 | 1 | |a Di Tullio, Marco R |e verfasserin |4 aut | |
| 700 | 1 | |a Gabriel, André P |e verfasserin |4 aut | |
| 700 | 1 | |a Lip, Gregory Y H |e verfasserin |4 aut | |
| 700 | 1 | |a Estol, Conrado J |e verfasserin |4 aut | |
| 700 | 1 | |a Lok, Dirk J |e verfasserin |4 aut | |
| 700 | 1 | |a Ponikowski, Piotr |e verfasserin |4 aut | |
| 700 | 1 | |a Anker, Stefan D |e verfasserin |4 aut | |
| 700 | 0 | |a WARCEF Investigators |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Circulation. Heart failure |d 2008 |g 6(2013), 5 vom: 01. Sept., Seite 988-97 |w (DE-627)NLM187215812 |x 1941-3297 |7 nnns |
| 773 | 1 | 8 | |g volume:6 |g year:2013 |g number:5 |g day:01 |g month:09 |g pages:988-97 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1161/CIRCHEARTFAILURE.113.000372 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 6 |j 2013 |e 5 |b 01 |c 09 |h 988-97 | ||