Pharmacologic reperfusion before PCI doesn't improve STEMI outcome

Early reperfusion using abciximab plus reteplase prior to percutaneous coronary intervention (PCI) does not improve outcomes in patients with ST-segment elevation myocardial infarction (STEMI), an international research team reports in The New England Journal of Medicine for May 22.

Early primary PCI is the preferred strategy for reperfusion in the treatment of STEMI. However, as Dr. Stephen G. Ellis and the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) study team point out, logistical difficulties often prevent performance of PCI within the recommended time frame.

In such cases, they hypothesized that pharmacologic reperfusion therapy prior to PCI would improve outcomes. They therefore randomized 2452 patients who presented within six hours of STEMI onset, but whose estimated time to catheterization was one to four hours, to the fibrinolytic agent reteplase plus the glycoprotein IIb/IIIa inhibitor abciximab (combination-facilitated PCI), abciximab alone (abciximab-facilitated PCI), or placebo (primary PCI).

Although significantly more patients who received the combination treatment had early ST-segment resolution, there were no significant differences in any of the treatment groups at 90 days.

The primary composite end point of death from all causes, ventricular fibrillation after 48 hours, cardiogenic shock, and congestive heart failure was 9.8 per cent in the combination-facilitated-PCI group, 10.5 per cent in the abciximab-facilitated-PCI group, and 10.7 per cent in the primary PCI group.

None of the individual components of the primary end point differed significantly either.

Non-intracranial bleeding, both major and minor, and the number of patients requiring transfusions were significantly higher in the combination-facilitated-PCI group compared with the placebo-PCI group.

Dr. Ellis of the Cleveland Clinic in Ohio and his team comment that the major risk of bleeding associated with early pharmacologic reperfusion (25 per 1000 patients treated) outweighed the reduction in the ischemic composite end point (nine of 1000 patients treated).

"The limitations of these facilitated approaches should provide further impetus both to develop triage systems that can shorten the door-to-balloon time for high-quality primary PCI when impediments to rapid PCI exist and to evaluate other treatment strategies," the FINESSE study team concludes.