Facilitation of PCI with reteplase plus abciximab or abciximab alone did not significantly improve the 90-day composite clinical outcome compared with primary PCI (9.8%, 10.5%, and 10.7%; P=0.55).
RCT (n=2,452)
double-blind
randomly assigned
Yes
Does early treatment with abciximab plus half-dose reteplase or abciximab alone before PCI improve outcomes in patients with ST-elevation myocardial infarction compared to primary PCI?
Facilitated PCI with reteplase plus abciximab or abciximab alone did not significantly improve 90-day clinical outcomes compared to primary PCI in patients with STEMI.
Absolute Event Rate: 9.8% vs 10.7%
p-value: p=0.55
BACKGROUND: We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI). METHODS: In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization. RESULTS: A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49). CONCLUSIONS: Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 ClinicalTrials.gov.)
Ellis et al. (2008) conducted an RCT in ST-segment elevation myocardial infarction (n=2,452). Combination-facilitated PCI (abciximab plus reteplase) or abciximab-facilitated PCI vs. Primary PCI (abciximab administered immediately before the procedure) was evaluated on Composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days (p=0.55). Facilitation of PCI with reteplase plus abciximab or abciximab alone did not significantly improve the 90-day composite clinical outcome compared with primary PCI (9.8%, 10.5%, and 10.7%; P=0.55).