Arid
DOI10.1016/S0140-6736(10)61088-4
Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial
Mehta, Shamir R.1,2; Tanguay, Jean-Francois3,4; Eikelboom, John W.1,2; Jolly, Sanjit S.1,2; Joyner, Campbell D.5; Granger, Christopher B.6; Faxon, David P.7; Rupprecht, Hans-Jurgen8; Budaj, Andrzej9; Avezum, Alvaro10; Widimsky, Petr11,20,21; Steg, Philippe Gabriel12,13; Bassand, Jean-Pierre14; Montalescot, Gilles15; Macaya, Carlos16; Di Pasquale, Giuseppe17; Niemela, Kari; Ajani, Andrew E.18; White, Harvey D.19; Chrolavicius, Susan1,2; Gao, Peggy1,2; Fox, Keith A. A.22; Yusuf, Salim1,2
通讯作者Mehta, Shamir R.
来源期刊LANCET
ISSN0140-6736
出版年2010
卷号376期号:9748页码:1233-1243
英文摘要

Background Clopidogrel and aspirin are the most commonly used antiplatelet therapies for percutaneous coronary intervention (PCI). We assessed the effect of various clopidogrel and aspirin regimens in prevention of major cardiovascular events and stent thrombosis in patients undergoing PCI.


Methods The CURRENT-OASIS 7 trial was undertaken in 597 centres in 39 countries. 25 086 individuals with acute coronary syndromes and intended early PCI were randomly assigned to double-dose (600 mg on day 1, 150 mg on days 2-7, then 75 mg daily) versus standard-dose (300 mg on day 1 then 75 mg daily) clopidogrel, and high-dose (300-325 mg daily) versus low-dose (75-100 mg daily) aspirin. Randomisation was done with a 24 h computerised central automated voice response system. The clopidogrel dose comparison was double-blind and the aspirin dose comparison was open label with blinded assessment of outcomes. This prespecified analysis is of the 17 263 individuals who underwent PCI. The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days. Analyses were by intention to treat, adjusted for propensity to undergo PCI. This trial is registered with ClinicalTrials.gov, number NCT00335452.


Findings 8560 patients were assigned to double-dose and 8703 to standard-dose clopidogrel (8558 and 8702 completed 30-day follow-up, respectively), and 8624 to high-dose and 8639 to low-dose aspirin (8622 and 8638 completed 30-day follow-up, respectively). Compared with the standard dose, double-dose clopidogrel reduced the rate of the primary outcome (330 events [3.9%] vs 392 events [4.5%]; adjusted hazard ratio 0.86, 95% Cl 0.74-0.99, p=0.039) and definite stent thrombosis (58 [0.7%] vs 111 [1.3%]; 0.54 [0.39-0.74], p=0.0001). High-dose and low-dose aspirin did not differ for the primary outcome (356 [4.1%] vs 366 [4.2%]; 0.98, 0.84-1.13, p=0.76). Major bleeding was more common with double-dose than with standard-dose clopidogrel (139 [1.6%] vs 99 [1.1%]; 1.41, 1.09-1.83, p=0.009) and did not differ between high-dose and low-dose aspirin (128 [1.5%] vs 110 [1.3%]; 1-18, 0.92-1.53, p=0.20).


Interpretation In patients undergoing PCI for acute coronary syndromes, a 7-day double-dose clopidogrel regimen was associated with a reduction in cardiovascular events and stent thrombosis compared with the standard dose. Efficacy and safety did not differ between high-dose and low-dose aspirin. A double-dose clopidogrel regimen can be considered for all patients with acute coronary syndromes treated with an early invasive strategy and intended early PCI.


类型Article
语种英语
国家Canada ; USA ; Germany ; Poland ; Brazil ; Czech Republic ; France ; Spain ; Italy ; Australia ; New Zealand ; Finland ; Scotland
收录类别SCI-E
WOS记录号WOS:000283003500033
WOS关键词ST-SEGMENT ELEVATION ; ACUTE MYOCARDIAL-INFARCTION ; THROMBOTIC STENT OCCLUSION ; ANTIPLATELET THERAPY ; COLLABORATIVE METAANALYSIS ; INVASIVE STRATEGY ; EUROPEAN-SOCIETY ; ISCHEMIC EVENTS ; CLINICAL-TRIALS ; DOUBLE-BLIND
WOS类目Medicine, General & Internal
WOS研究方向General & Internal Medicine
资源类型期刊论文
条目标识符http://119.78.100.177/qdio/handle/2XILL650/165559
作者单位1.McMaster Univ, Hamilton, ON, Canada;
2.Hamilton Hlth Sci, Populat Hlth Res Inst, Hamilton, ON, Canada;
3.Montreal Heart Inst, Montreal, PQ H1T 1C8, Canada;
4.Univ Montreal, Montreal, PQ, Canada;
5.Univ Toronto, Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada;
6.Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA;
7.Harvard Univ, Brigham & Womens Hosp, Sch Med, Boston, MA 02115 USA;
8.Med Clin 2, Russelsheim, Germany;
9.Grochowski Hosp, Postgrad Med Sch, Warsaw, Poland;
10.Dante Pazzanese Inst Cardiol, Sao Paulo, Brazil;
11.Univ Hosp Kralovske Vinohrady, Prague, Czech Republic;
12.Univ Paris 07, INSERM, U698, Paris, France;
13.AP HP, Paris, France;
14.Univ Hosp Jean Minjoz, Besancon, France;
15.Univ Paris 06, Pitie Salpetriere Hosp, INSERM, Inst Cardiol,CMR937, Paris, France;
16.Univ Hosp Clin San Carlos, Madrid, Spain;
17.Maggiore Hosp, Bologna, Italy;
18.Univ Melbourne, Royal Melbourne Hosp, Melbourne, Vic 3050, Australia;
19.Auckland City Hosp, Green Lane Cardiovasc Serv, Auckland, New Zealand;
20.Univ Hosp Kralovske Vinohrady, Prague, Czech Republic;
21.Tampere Univ Hosp, Ctr Heart, Tampere, Finland;
22.Univ Edinburgh, Royal Infirm, Edinburgh EH3 9YW, Midlothian, Scotland
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Mehta, Shamir R.,Tanguay, Jean-Francois,Eikelboom, John W.,et al. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial[J],2010,376(9748):1233-1243.
APA Mehta, Shamir R..,Tanguay, Jean-Francois.,Eikelboom, John W..,Jolly, Sanjit S..,Joyner, Campbell D..,...&Yusuf, Salim.(2010).Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial.LANCET,376(9748),1233-1243.
MLA Mehta, Shamir R.,et al."Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial".LANCET 376.9748(2010):1233-1243.
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