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Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques.

Abstract：

BACKGROUND AND PURPOSE:Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. METHODS:This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta>4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization. RESULTS:The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups. CONCLUSIONS:Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating. CLINICAL TRIAL REGISTRATION URL:http://www.clinicaltrials.gov. Unique identifier: NCT00235248.

journal_name

Stroke

journal_title

Stroke

authors

Amarenco P,Davis S,Jones EF,Cohen AA,Heiss WD,Kaste M,Laouénan C,Young D,Macleod M,Donnan GA,Aortic Arch Related Cerebral Hazard Trial Investigators.

doi

10.1161/STROKEAHA.113.004251

subject

Has Abstract

pub_date

2014-05-01 00:00:00

pages

1248-57

issue

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.113.004251

journal_volume

pub_type

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Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques.