What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: ST-segment elevation myocardial infarction (STEMI) (n=10085). Intervention: Gp IIb-IIIa inhibitors vs. Control. Primary outcome: Mortality at 30 days (OR 0.96, 95% CI 0.76-1.22, p=0.75).

October 28, 2009Open Access

Risk profile and benefits from Gp IIb-IIIa inhibitors among patients with ST-segment elevation myocardial infarction treated with primary angioplasty: a meta-regression analysis of randomized trials

Key Result

Adjunctive Gp IIb-IIIa inhibitors did not reduce 30-day mortality overall (OR 0.96) in STEMI patients undergoing primary angioplasty, but mortality benefits were significantly related to patient risk profile.

Study Design

Type

Meta-Analysis (n=10,085)

PICO

Population

ST-segment elevation myocardial infarction (STEMI) (n=10,085)

Intervention / Comparator

Gp IIb-IIIa inhibitors vs Control

Primary Outcome

Mortality at 30 days — OR 0.96 (0.76-1.22), p=0.75

Main Result

Effect estimate: OR 0.96 (95% CI 0.76-1.22)

Absolute Event Rate: 2.8% vs 2.9%

p-value: p=0.75

Limitations

Use of mortality in control group as marker of risk profile may produce bias due to regression to the mean
Different clopidogrel regimens across included trials
Analysis limited to short-term outcomes (30 days)
No uniform definition of major bleeding complications across trials
Potential clinical heterogeneity between studies due to different inclusion/exclusion criteria and study drugs

Abstract

AIMS: Several randomized trials and a previous meta-analysis have shown significant benefits from Gp IIb-IIIa inhibitors, especially abciximab. Recent randomized trials (BRAVE-3 and HORIZON trials) have shown no benefits from adjunctive Gp IIb-IIIa inhibitors on the top of clopidogrel administration. However, the relatively low mortality may have hampered the conclusion of these recent trials. Thus, the aim of the current study was to perform an update meta-analysis of randomized trials on adjunctive Gp IIb-IIIa inhibitors in primary angioplasty, and to evaluate by meta-regression analysis, whether the results may be related to risk profile. METHODS AND RESULTS: We obtained results from all randomized trials evaluating the benefits of adjunctive Gp IIb-IIIa inhibitors among STEMI patients undergoing primary angioplasty. The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL) from January 1990 to September 2008. The following key words were used: randomized trial, myocardial infarction, reperfusion, primary angioplasty, Gp IIb-IIIa inhibitors, abciximab, tirofiban, and eptifibatide. Clinical endpoint was mortality at 30 days. Major bleeding complications were assessed as safety endpoint. No language restriction was applied. A total of 16 randomized trials were finally included in the meta-analysis, involving 10 085 patients (5094 or 50.5% in the Gp IIb-IIIa inhibitors group and 4991 or 49.5% in the control group. Gp IIb-IIIa inhibitors did not reduce 30 day mortality (2.8 vs. 2.9%, P = 0.75) or re-infarction (1.5 vs. 1.9%, P = 0.22), but were associated with higher risk of major bleeding complications (4.1 vs. 2.7%, P = 0.0004). However, we observed a significant relationship between patient's risk profile and benefits from adjunctive Gp IIb-IIIa inhibitors in terms of death (P = 0.008) but not re-infarction (P = 0.25). CONCLUSION: This meta-analysis shows a significant relationship between benefits in mortality from Gp IIb-IIIa inhibitors and patient's risk profile. Thus, Gp IIb-IIIa inhibitors should be strongly considered among high-risk patients.

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