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A Meta-analysis of Randomized Trials

Giuseppe De Luca, MD; Harry Suryapranata, MD, PhD; Gregg W. Stone, MD; David Antoniucci, MD; James E. Tcheng, MD; Franz-Josef Neumann, MD; Frans Van de Werf, MD; Elliott M. Antman, MD; Eric J. Topol, MD

JAMA. 2005;293:1759-1765.

Context  The benefits of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate.

Objective  To combine data from all randomized trials conducted with abciximab in STEMI.

Data Sources  Formal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004.

Study Selection  We examined all completed, published, randomized trials of abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and abciximab.

Data Extraction  Information on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus.

Data Synthesis  Eleven trials were analyzed, involving 27115 patients (12 602 [46.5%] in the abciximab group, 14 513 [53.5%] in the control group). When compared with the control group, abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36).

Conclusions  This meta-analysis shows that, when compared with the control group, adjunctive abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with abciximab in association with fibrinolysis.

Author Affiliations: Isala Klinieken, Hospital De Weezenlanden, Zwolle, the Netherlands (Drs De Luca and Suryapranata); Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York, NY (Dr Stone); Division of Cardiology, Careggi Hospital, Florence, Italy (Dr Antoniucci); Duke Clinical Research Institute, Durham, NC (Dr Tcheng); Medizinische Klinik, Technische Universität Munchen, Munich, Germany (Dr Neumann); Department of Cardiology, Gasthuisberg University Hospital, Leuven, Belgium (Dr Van de Werf); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Mass (Dr Antman); and Cleveland Clinic Foundation, Cleveland, Ohio (Dr Topol).

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