Warfarin and aspirin in patients with heart failure and sinus rhythm
BACKGROUND: It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm.
METHODS: We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause.
RESULTS: The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P=0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P=0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P=0.82).
CONCLUSIONS: Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized. (Funded by the National Institute of Neurological Disorders and Stroke; WARCEF ClinicalTrials.gov number, NCT00041938.).
| Errataetall: |
CommentIn: N Engl J Med. 2012 May 17;366(20):1936-8. - PMID 22551103 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2012 |
|---|---|
| Erschienen: |
2012 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:366 |
|---|---|
| Enthalten in: |
The New England journal of medicine - 366(2012), 20 vom: 17. Mai, Seite 1859-69 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Homma, Shunichi [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 24.05.2012 Date Revised 04.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT00041938 CommentIn: N Engl J Med. 2012 May 17;366(20):1936-8. - PMID 22551103 Citation Status MEDLINE |
|---|
| doi: |
10.1056/NEJMoa1202299 |
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| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM217458645 |
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| 041 | |a eng | ||
| 100 | 1 | |a Homma, Shunichi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Warfarin and aspirin in patients with heart failure and sinus rhythm |
| 264 | 1 | |c 2012 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 24.05.2012 | ||
| 500 | |a Date Revised 04.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00041938 | ||
| 500 | |a CommentIn: N Engl J Med. 2012 May 17;366(20):1936-8. - PMID 22551103 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm | ||
| 520 | |a METHODS: We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause | ||
| 520 | |a RESULTS: The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P=0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P=0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P=0.82) | ||
| 520 | |a CONCLUSIONS: Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized. (Funded by the National Institute of Neurological Disorders and Stroke; WARCEF ClinicalTrials.gov number, NCT00041938.) | ||
| 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 | 7 | |a Anticoagulants |2 NLM | |
| 650 | 7 | |a Platelet Aggregation Inhibitors |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 Pullicino, Patrick M |e verfasserin |4 aut | |
| 700 | 1 | |a Levin, Bruce |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 Ammon, Susan E |e verfasserin |4 aut | |
| 700 | 1 | |a Graham, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Sacco, Ralph L |e verfasserin |4 aut | |
| 700 | 1 | |a Mann, Douglas L |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 Anker, Stefan D |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 Estol, Conrado J |e verfasserin |4 aut | |
| 700 | 1 | |a Lip, Gregory Y H |e verfasserin |4 aut | |
| 700 | 1 | |a Di Tullio, Marco R |e verfasserin |4 aut | |
| 700 | 1 | |a Sanford, Alexandra R |e verfasserin |4 aut | |
| 700 | 1 | |a Mejia, Vilma |e verfasserin |4 aut | |
| 700 | 1 | |a Gabriel, Andre P |e verfasserin |4 aut | |
| 700 | 1 | |a del Valle, Mirna L |e verfasserin |4 aut | |
| 700 | 1 | |a Buchsbaum, Richard |e verfasserin |4 aut | |
| 700 | 0 | |a WARCEF Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Homma, S |e investigator |4 oth | |
| 700 | 1 | |a Thompson, J L P |e investigator |4 oth | |
| 700 | 1 | |a Pullicino, P |e investigator |4 oth | |
| 700 | 1 | |a Freudenberger, R |e investigator |4 oth | |
| 700 | 1 | |a Graham, S |e investigator |4 oth | |
| 700 | 1 | |a Teerlink, J |e investigator |4 oth | |
| 700 | 1 | |a Ammon, S |e investigator |4 oth | |
| 700 | 1 | |a Mann, D |e investigator |4 oth | |
| 700 | 1 | |a Mohr, J P |e investigator |4 oth | |
| 700 | 1 | |a Sacco, R L |e investigator |4 oth | |
| 700 | 1 | |a Massie, B |e investigator |4 oth | |
| 700 | 1 | |a Anker, S |e investigator |4 oth | |
| 700 | 1 | |a Labovitz, A |e investigator |4 oth | |
| 700 | 1 | |a Moy, C |e investigator |4 oth | |
| 700 | 1 | |a Moy, C |e investigator |4 oth | |
| 700 | 1 | |a Gilbert, P |e investigator |4 oth | |
| 700 | 1 | |a Gutmann, L |e investigator |4 oth | |
| 700 | 1 | |a Marler, J |e investigator |4 oth | |
| 700 | 1 | |a Homma, S |e investigator |4 oth | |
| 700 | 1 | |a Mejia, V |e investigator |4 oth | |
| 700 | 1 | |a Gabriel, A |e investigator |4 oth | |
| 700 | 1 | |a Borden, S |e investigator |4 oth | |
| 700 | 1 | |a Peña, E |e investigator |4 oth | |
| 700 | 1 | |a Harris, C |e investigator |4 oth | |
| 700 | 1 | |a Khadouri, R |e investigator |4 oth | |
| 700 | 1 | |a Gohs, D |e investigator |4 oth | |
| 700 | 1 | |a Brown, M |e investigator |4 oth | |
| 700 | 1 | |a Berry, G |e investigator |4 oth | |
| 700 | 1 | |a Disantis, D |e investigator |4 oth | |
| 700 | 1 | |a Scullin, M |e investigator |4 oth | |
| 700 | 1 | |a Smith, P |e investigator |4 oth | |
| 700 | 1 | |a Kohsaka, S |e investigator |4 oth | |
| 700 | 1 | |a Watson, W |e investigator |4 oth | |
| 700 | 1 | |a Guillory, L |e investigator |4 oth | |
| 700 | 1 | |a Thompson, J L P |e investigator |4 oth | |
| 700 | 1 | |a Levin, B |e investigator |4 oth | |
| 700 | 1 | |a Buchsbaum, R |e investigator |4 oth | |
| 700 | 1 | |a Del Valle, M |e investigator |4 oth | |
| 700 | 1 | |a Sanford, A |e investigator |4 oth | |
| 700 | 1 | |a Levy, G |e investigator |4 oth | |
| 700 | 1 | |a Tea, K |e investigator |4 oth | |
| 700 | 1 | |a Grier, J |e investigator |4 oth | |
| 700 | 1 | |a Swydan, L |e investigator |4 oth | |
| 700 | 1 | |a O'Hare, B |e investigator |4 oth | |
| 700 | 1 | |a Prodhan, R |e investigator |4 oth | |
| 700 | 1 | |a Arbing, R |e investigator |4 oth | |
| 700 | 1 | |a Flanagan, E |e investigator |4 oth | |
| 700 | 1 | |a Duverger, E |e investigator |4 oth | |
| 700 | 1 | |a Peljto, A |e investigator |4 oth | |
| 700 | 1 | |a Lo, W |e investigator |4 oth | |
| 700 | 1 | |a Tierney, A |e investigator |4 oth | |
| 700 | 1 | |a Henriquez, A |e investigator |4 oth | |
| 700 | 1 | |a Keen, J |e investigator |4 oth | |
| 700 | 1 | |a del Zoppo, G J |e investigator |4 oth | |
| 700 | 1 | |a Albers, G W |e investigator |4 oth | |
| 700 | 1 | |a Eliasziw, M |e investigator |4 oth | |
| 700 | 1 | |a Hinchey, J A |e investigator |4 oth | |
| 700 | 1 | |a Johnston, K C |e investigator |4 oth | |
| 700 | 1 | |a Lowe, A M |e investigator |4 oth | |
| 700 | 1 | |a Piña, I L |e investigator |4 oth | |
| 700 | 1 | |a Swain, J A |e investigator |4 oth | |
| 700 | 1 | |a Teerlink, J R |e investigator |4 oth | |
| 700 | 1 | |a Ammon, S |e investigator |4 oth | |
| 700 | 1 | |a Slomiak, S |e investigator |4 oth | |
| 700 | 1 | |a Cape, L |e investigator |4 oth | |
| 700 | 1 | |a Barnett, H J M |e investigator |4 oth | |
| 700 | 1 | |a Bruno, A |e investigator |4 oth | |
| 700 | 1 | |a Easton, J D |e investigator |4 oth | |
| 700 | 1 | |a Levine, S |e investigator |4 oth | |
| 700 | 1 | |a Sahlas, D |e investigator |4 oth | |
| 700 | 1 | |a Bleyer, F |e investigator |4 oth | |
| 700 | 1 | |a Carson, P |e investigator |4 oth | |
| 700 | 1 | |a Ellis, A |e investigator |4 oth | |
| 700 | 1 | |a Miller, A |e investigator |4 oth | |
| 700 | 1 | |a Palmeri, S T |e investigator |4 oth | |
| 700 | 1 | |a Labovitz, A |e investigator |4 oth | |
| 700 | 1 | |a Di Tullio, M |e investigator |4 oth | |
| 700 | 1 | |a Bierig, M |e investigator |4 oth | |
| 700 | 1 | |a Liu, R |e investigator |4 oth | |
| 700 | 1 | |a Donato, C |e investigator |4 oth | |
| 700 | 1 | |a Hart, R |e investigator |4 oth | |
| 700 | 1 | |a McKay, C |e investigator |4 oth | |
| 700 | 1 | |a Wilson, L |e investigator |4 oth | |
| 700 | 1 | |a Frey, E |e investigator |4 oth | |
| 700 | 1 | |a Hayward, K |e investigator |4 oth | |
| 700 | 1 | |a Stein-Beal, P |e investigator |4 oth | |
| 700 | 1 | |a Konczarek, L |e investigator |4 oth | |
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| 700 | 1 | |a Rohwedder, M |e investigator |4 oth | |
| 700 | 1 | |a Bohdanowicz-Zazula, M |e investigator |4 oth | |
| 700 | 1 | |a Peerenboom-Fey, C F |e investigator |4 oth | |
| 700 | 1 | |a Vissiennon, M |e investigator |4 oth | |
| 700 | 1 | |a Rex, G |e investigator |4 oth | |
| 700 | 1 | |a Varga, M |e investigator |4 oth | |
| 700 | 1 | |a Kovtun, O |e investigator |4 oth | |
| 700 | 1 | |a Orlyk, V |e investigator |4 oth | |
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| 700 | 1 | |a Jaros, J |e investigator |4 oth | |
| 700 | 1 | |a Ruiz, A |e investigator |4 oth | |
| 700 | 1 | |a Zimmermann, M |e investigator |4 oth | |
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