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February 15, 2000Circulation357 citationsOpen Access

A Randomized Comparison of Clopidogrel and Aspirin Versus Ticlopidine and Aspirin After the Placement of Coronary-Artery Stents

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CMChristian MüllerHBHeinz Joachim BüttnerJPJens Petersen

Key Result

After coronary stenting, clopidogrel plus aspirin resulted in similar cardiac events compared to ticlopidine plus aspirin (3.1% vs 1.7%, P=0.24) but fewer noncardiac events (4.5% vs 9.6%, P=0.01).

Study Design

Type

RCT (n=700)

Structured PICO

Does clopidogrel plus aspirin reduce adverse events compared to ticlopidine plus aspirin in patients after successful coronary stenting?

P
Population
700 patients who underwent successful coronary stenting during elective or emergency percutaneous transluminal coronary angioplasty, treated for 4 weeks and evaluated at 30 days.
I
Intervention
4-week course of 75 mg clopidogrel in addition to 100 mg aspirin
C
Comparator
4-week course of 500 mg ticlopidine in addition to 100 mg aspirin
O
Outcome
Composite of cardiac death, urgent target vessel revascularization, angiographically documented thrombotic stent occlusions (TSO), or nonfatal myocardial infarction within 30 dayscomposite

Clopidogrel combined with aspirin provides similar cardiac efficacy but superior safety and tolerability compared to ticlopidine and aspirin after coronary stenting.

Main Result

Absolute Event Rate: 3.1% vs 1.7%

p-value: p=0.24

Abstract

BACKGROUND: The introduction of an effective antiplatelet therapy with aspirin and ticlopidine after the placement of coronary-artery stents has decreased the risk of thrombotic stent occlusions (TSO) and hemorrhagic complications. However, the use of ticlopidine is limited by hematological and gastrointestinal adverse effects. The safety and efficacy of clopidogrel after stenting remains to be established. METHODS AND RESULTS: After successful coronary stenting during elective or emergency percutaneous transluminal coronary angioplasty, 700 patients with 899 lesions were randomly assigned to receive a 4-week course of either 500 mg ticlopidine (n=345) or 75 mg clopidogrel (n=355), in addition to 100 mg aspirin. All the following clinical events reflecting TSO were included in the prespecified primary cardiac endpoint: cardiac death, urgent target vessel revascularization, angiographically documented TSO, or nonfatal myocardial infarction within 30 days. The primary noncardiac endpoint was defined as noncardiac death, stroke, severe peripheral vascular or hemorrhagic events, or any adverse event resulting in discontinuation of study medication. Cardiac events occurred in 17 patients 11 (3.1%) with clopidogrel and 6 (1.7%) with ticlopidine (P=0.24). The primary noncardiac endpoint was observed in 16 patients (4.5%) assigned to receive clopidogrel versus 33 patients (9.6%) assigned to receive ticlopidine (P=0.01). CONCLUSIONS: After the placement of coronary-artery stents in unselected patients, antiplatelet therapy with aspirin and clopidogrel seems to be comparably safe and effective as aspirin and ticlopidine. Noncardiac events were significantly reduced with clopidogrel.

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Cite This Study

Müller et al. (2000) conducted an RCT in Coronary-artery stenting (n=700). Clopidogrel and aspirin vs. 500 mg ticlopidine and 100 mg aspirin was evaluated on Primary cardiac endpoint: cardiac death, urgent target vessel revascularization, angiographically documented thrombotic stent occlusion, or nonfatal myocardial infarction within 30 days (p=0.24). After coronary stenting, clopidogrel plus aspirin resulted in similar cardiac events compared to ticlopidine plus aspirin (3.1% vs 1.7%, P=0.24) but fewer noncardiac events (4.5% vs 9.6%, P=0.01).

synapsesocial.com/papers/6a6a318202245592faf19c2dhttps://doi.org/10.1161/01.cir.101.6.590
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