Facilitated PCI provides no clinical benefit over primary PCI

A NEJM trial has revealed that a facilitated pharmacological strategy for reperfusion among patients with ST-segment elevation myocardial infarction (MI) -with either abciximab alone or in combination with reteplase- provides no clinical benefit over primary PCI. Primary percutaneous coronary intervention (PCI) is the preferred strategy over fibrinolytic therapy for patients with acute ST-segment elevation, when performed in a timely fashion. Since the time to treatment with primary PCI is a key determinant of clinical outcome, logistical difficulties relating to transfer times and door-to-balloon times can severely limit its use. The optimal pharmacological therapy for reperfusion before and together with primary PCI, particularly when delays in initiation of treatment are experienced, remains unclear. Researchers Ellis et al. sought to clarify this issue. “A therapy for acute ST-segment elevation MI that could initiate reperfusion before PCI without increasing complications might be expected to provide a clinical benefit”, the authors stated. They conducted an international, double-blind, placebo-controlled trial in which 2452 patients with ST-segment elevation MI presenting =6 hours after the onset of symptoms were randomised in a 1:1:1 ratio to one of three treatment strategies: combination-facilitated PCI (half-dose reteplase plus abciximab), abciximab-facilitated PCI (abciximab alone), or placebo (primary PCI, in which abciximab is administered immediately before PCI). Prior to PCI, all patients received unfractionated heparin or enoxaparin and a 12-hour infusion of abciximab after PCI. The primary outcome measure was the occurrence of death from all causes, ventricular fibrillation more than 48 hours after randomisation, cardiogenic shock, and congestive heart failure within 90 days of randomisation. Ellis et al. found that the composite of death from all causes occurred in 9.8%, 10.5%, and 10.7% of patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and the primary-PCI group, respectively (p=0.55). Within 90 days of randomisation, mortality rates dropped to 5.2%, 5.5%, and 4.5%, respectively (p=0.49). The results revealed no significant reductions in the combined clinical end point at 90 days with treatment with combination-facilitated PCI; however, the incidence of major haemorrhage increased. Abciximab-facilitated PCI had no benefit and was also associated with a trend towards increased bleeding. The authors provided four possible explanations as to why enhanced early reperfusion did not significantly improve clinical outcomes. Firstly, they proposed that differences in the time to reperfusion may affect major myocardial salvage only during the first 2 hours after infarction onset. In the current study only 60% of patients had treatment initiated =3 hours. Secondly, if the timing of treatment for myocardial salvage is not as important with PCI as it is with thrombolysis, then promptly opening the infarct-related artery with pharmacological therapy than with PCI alone may not provide a dramatic benefit. Thirdly, only high-risk patients are likely to obtain the greatest benefit from early reperfusion with PCI. Finally, since the rates of major complications and death among patients with ST-segment elevation MI undergoing primary PCI with adjunctive abciximab relatively low, they are difficult to improve. The authors concluded that compared with primary PCI, the results of this trial do not support the use of a facilitated pharmacological strategy for PCI, with either abciximab alone or in combination with reteplase for patients with ST-segment elevation MI....