Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

被引：1875

作者：

Eikelboom, J. W. ^{[1
,2
]}

Connolly, S. J. ^{[1
,2
]}

Bosch, J. ^{[2
]}

Dagenais, G. R. ^{[3
]}

Hart, R. G. ^{[1
,2
]}

Shestakovska, O. ^{[1
,2
]}

Diaz, R. ^{[4
,5
]}

Alings, M. ^{[6
]}

Lonn, E. M. ^{[1
,2
]}

Anand, S. S. ^{[1
,2
]}

Widimsky, P. ^{[7
,8
]}

Hori, M. ^{[9
]}

Avezum, A. ^{[10
]}

Piegas, L. S. ^{[11
]}

Branch, K. R. H. ^{[12
]}

Probstfield, J. ^{[13
]}

Bhatt, D. L. ^{[14
]}

Zhu, J. ^{[15
]}

Liang, Y. ^{[15
]}

Maggioni, A. P. ^{[16
]}

Lopez-Jaramillo, P. ^{[17
]}

O'Donnell, M. ^{[18
]}

Kakkar, A. K. ^{[19
,20
]}

Fox, K. A. A. ^{[21
]}

Parkhomenko, A. N. ^{[24
]}

Ertl, G. ^{[25
,26
]}

Stoerk, S. ^{[25
,26
]}

Keltai, M. ^{[28
]}

Ryden, L. ^{[29
]}

Pogosova, N. ^{[30
]}

Dans, A. L. ^{[31
]}

Lanas, F. ^{[32
]}

Commerford, P. J. ^{[33
]}

Torp-Pedersen, C. ^{[34
]}

Guzik, T. J. ^{[22
,23
]}

Verhamme, P. B. ^{[35
]}

Vinereanu, D. ^{[36
]}

Kim, J. -H. ^{[37
]}

Tonkin, A. M. ^{[38
]}

Lewis, B. S. ^{[39
]}

Felix, C. ^{[40
]}

Yusoff, K. ^{[41
]}

Steg, P. G. ^{[42
]}

Metsarinne, K. P. ^{[43
,44
]}

Bruns, N. Cook ^{[27
]}

Misselwitz, F. ^{[27
]}

Chen, E. ^{[27
]}

Leong, D. ^{[1
,2
]}

Yusuf, S. ^{[1
,2
]}

Aboyans, V.

机构：

[1] McMaster Univ, Populat Hlth Res Inst, David Braley Res Bldg,237 Barton St E, Hamilton, ON L8L 2X2, Canada

[2] Hamilton Hlth Sci, Hamilton, ON, Canada

[3] Inst Univ Cardiol & Pneumol Quebec, Quebec City, PQ, Canada

[4] Estudios Clin Latino Amer, Rosario, Santa Fe, Argentina

[5] Inst Cardiovasc Rosario, Rosario, Santa Fe, Argentina

[6] Amphia Ziekenhuis & Werkgroep Cardiol Ctr Nederla, Utrecht, Netherlands

[7] Charles Univ Prague, Univ Hosp Kralovske Vinohrady, Cardioctr, Prague, Czech Republic

[8] Charles Univ Prague, Fac Med 3, Prague, Czech Republic

[9] Osaka Int Canc Inst, Osaka, Japan

[10] Inst Dante Pazzanese Cardiol, Sao Paulo, Brazil

[11] Hosp Coracao, Sao Paulo, Brazil

[12] Univ Washington, Med Ctr, Seattle, WA 98195 USA

[13] Univ Washington, Seattle, WA 98195 USA

[14] Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA USA

[15] FuWai Hosp, Beijing, Peoples R China

[16] Natl Assoc Hosp Cardiologists Res Ctr ANMCO, Florence, Italy

[17] Fdn Oftalmol Santander FOSCAL Bucaramanga, Res Inst, Bucaramanga, Colombia

[18] Natl Univ Ireland, Galway, Ireland

[19] Thrombosis Res Inst, London, England

[20] UCL, London, England

[21] Univ Edinburgh, Ctr Cardiovasc Sci, Edinburgh, Midlothian, Scotland

[22] Univ Glasgow, Glasgow, Lanark, Scotland

[23] Jagiellonian Univ, Coll Med, Krakow, Poland

[24] Inst Cardiol, Kiev, Ukraine

[25] Univ Wurzburg, Wurzburg, Germany

[26] Univ Hosp, Wurzburg, Germany

[27] Bayer, Leverkusen, Germany

[28] Semmelweis Univ, Budapest, Hungary

[29] Karolinska Inst, Stockholm, Sweden

[30] Natl Res Ctr Preventat Med, Moscow, Russia

[31] Univ Philippines, Manila, Philippines

[32] Univ La Frontera, Temuco, Chile

[33] Univ Cape Town, Cape Town, South Africa

[34] Aalborg Univ, Copenhagen, Denmark

[35] Univ Leuven, Leuven, Belgium

[36] Carol Davila Univ & Emergency Hosp, Univ Med & Pharmacol, Bucharest, Romania

[37] Catholic Univ Korea, Seoul, South Korea

[38] Monash Univ, Melbourne, Vic, Australia

[39] Lady Davis Carmel Med Ctr, Haifa, Israel

[40] Univ Tecnol Equinoccial, Fac Ciencias Salud Eugenio Espejo, Quito, Ecuador

[41] Univ Teknol Mara, Selangor, Malaysia

[42] Univ Paris Diderot, Hop Bichat, AP HP, Paris, France

[43] Turku Univ Cent Hosp, Turku, Finland

[44] Turku Univ, Turku, Finland

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2017年 / 377卷 / 14期

关键词：

SECONDARY PREVENTION; ORAL RIVAROXABAN; CLOPIDOGREL; TRIAL; RISK;

D O I：

10.1056/NEJMoa1709118

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

BACKGROUND We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P< 0.001; z = -4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P< 0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P = 0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban- alone group. CONCLUSIONS Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.

引用

页码：1319 / 1330

页数：12

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