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CLINICAL STUDY: ACUTE CORONARY SYNDROMES

Ticlopidine versus aspirin after myocardial infarction (stami) trial

Domenico Scrutinio, MD^*, Claudio Cimminiello, MD, Ettore Marubini, PhD, Maria Vittoria Pitzalis, MD, Matteo Di Biase, MD^||, Paolo Rizzon, MD the STAMI Group

^* Division of Cardiology, "S. Maugeri" Foundation, IRCCS, Institute of Rehabilitation, Cassano Murge, Bari, Italy
Medical Department, Azienda Ospedaliera Vimercate Hospital, Milan, Italy
Institute of Medical Statistics and Biometry, University of Milan, Milan, Italy
Institute of Cardiology, University of Bari, Bari, Italy
^|| Division of Cardiology, University of Foggia, Foggia, Italy. This study was supported by a grant from Sanofi-Synthelabo, Milan, Italy

Manuscript received July 26, 2000; revised manuscript received December 13, 2000, accepted January 5, 2001.

Reprint requests and correspondence: Dr. Domenico Scrutinio, Division of Cardiology, "S. Maugeri" Foundation, IRCCS, Institute of Rehabilitation, 70020 Cassano Murge, Bari, Italy
dscrutinio{at}fsm.it

OBJECTIVES

We sought to compare the efficacy of aspirin and ticlopidine in survivors of acute myocardial infarction (AMI) treated with thrombolysis.

BACKGROUND

The role of ticlopidine in secondary prevention after AMI has not yet been explored.

METHODS

Of 4,696 patients with AMI treated with thrombolysis who were screened, 261 died in the hospital (5.6%) and 1,470 were enrolled in this randomized, double-blind, multicenter trial and allocated to treatment with either aspirin (160 mg/day) or ticlopidine (500 mg/day). The most frequent reasons for exclusion were refusal to give informed consent, planned myocardial revascularization, risk of noncompliance with study procedures, need for anticoagulant therapy and contraindications to the study treatments. The primary end point was the first occurrence of any of the following events during the six-month follow-up: fatal and nonfatal AMI, fatal and nonfatal stroke, angina with objective evidence of myocardial ischemia, vascular death or death due to any other cause.

RESULTS

The primary end point was recorded in 59 (8.0%) of the 736 aspirin-treated and 59 (8.0%) of the 734 ticlopidine-treated patients (p = 0.966). Vascular death was the first event in five patients taking aspirin and in six patients taking ticlopidine (0.7% vs. 0.8%; p = NS); nonfatal AMI in 18 and 8 (2.4% vs. 1.1%; p = 0.049); nonfatal stroke in 3 and 4 (0.4% vs. 0.5%; p = NS); and angina in 33 and 40 (4.5% vs. 5.4%; p = NS), respectively. The frequency of adverse reactions was not significantly different between the two groups.

CONCLUSIONS

No difference was found between the ticlopidine and aspirin groups in the rate of the primary combined end point of death, recurrent AMI, stroke and angina.

Abbreviations and Acronyms   ADP = adenosine diphosphate   AMI = acute myocardial infarction   CAD = coronary artery disease   ECG = electrocardiogram

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