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Facilitated PCI Fares Poorly in STEMI

A randomized trial and a meta-analysis show that primary PCI is superior to facilitated PCI in patients with ST-segment-elevation MI.

In patients with ST-segment-elevation MI (STEMI), facilitated percutaneous coronary intervention (PCI) — i.e., early pharmacologic reperfusion therapy followed by immediate mechanical revascularization — has not shown clear benefits in preliminary studies. Still, ACC/AHA PCI guidelines give it a class IIb recommendation in higher-risk patients when PCI is not immediately available and bleeding risk is low (Journal Watch Cardiology Jan 12 2006). Two new studies provide clearer data on facilitated PCI.

In the industry-funded ASSENT-4 PCI trial, 1667 patients with STEMI of <6 hours’ duration were randomly assigned to standard PCI or PCI preceded by full-dose tenecteplase. All patients received aspirin plus a bolus of unfractionated heparin (without an infusion). The trial was stopped early due to a significantly higher in-hospital mortality rate with facilitated PCI than with standard PCI (6% vs. 3%). Facilitated-PCI recipients also had significantly higher rates of the primary endpoint (death, heart failure, or shock within 90 days; 19% vs. 13%) and of hemorrhagic stroke, reinfarction, and repeat target-vessel revascularization (TVR). These outcome disadvantages emerged despite a higher infarct-artery patency rate with facilitated PCI.

In a meta-analysis of 17 randomized trials comparing facilitated and primary PCI in 4504 STEMI patients (including the 1667 ASSENT-4 PCI subjects), facilitated PCI — with fibrinolysis alone, glycoprotein IIb/IIIa inhibitors alone, or both — was associated with significantly higher rates of death, reinfarction, urgent TVR, major bleeding, and hemorrhagic stroke. These disadvantages emerged despite a significantly better rate of preprocedural TIMI-3 flow with facilitated PCI. Findings were consistent whether or not GPIIb/IIIa inhibitors were used with fibrinolytic therapy; upfront use of GPIIb/IIIa inhibitors alone was neither harmful nor beneficial.

Comment: Given the clear outcome disadvantages of facilitated PCI, one can no longer justify pretreatment with fibrinolytics in patients in whom primary PCI is intended. Therefore, current guidelines should be changed. However, an important issue remains unsettled: Are longer delays to primary PCI acceptable (and a routine transfer strategy thus attractive), or should fibrinolytic therapy be given instead? As the editorialists write, "A large-scale randomized trial in patients with significant transfer delays is ... needed to ascertain whether society should truly shift to a policy of primary angioplasty for all."

— Beat J. Meyer, MD

Published in Journal Watch Cardiology December 27, 2006

Citation(s):

Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) Investigators. Primary versus tenecteplase-facilitated percutaneous coronary interventions in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): Randomised trial. Lancet 2006 Feb 18; 367:569-78.

• Medline abstract (Free)

Keeley EC et al. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: Quantitative review of randomised trials. Lancet 2006 Feb 18; 367:579-88.

• Medline abstract (Free)

Stone GW and Gersh BJ. Facilitated angioplasty: Paradise lost. Lancet 2006 Feb 18; 367:543-6.

• Medline abstract (Free)