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Thrombolysis Before Angioplasty Leads to Adverse Outcomes

Fibrinolytic agents do not improve outcomes for STEMI patients in whom PCI is delayed.

Among patients with ST-segment–elevation myocardial infarctions (STEMIs), percutaneous coronary intervention (PCI) generally results in better outcomes than does pharmacologic thrombolysis, but the benefits of PCI are greatest if it is performed within 2 to 3 hours of symptom onset, and PCI is not available at all centers. In "facilitated PCI," pharmacologic therapy is given to recanalize occluded infarct vessels and reduce clot burden before PCI is attempted. However, whether thrombolytic agents improve outcomes of delayed angioplasty is unclear.

In this international industry-funded study of facilitated PCI, researchers randomized 1667 STEMI patients (with anticipated delays of 1–3 hours until PCI) to standard PCI or to PCI preceded by a bolus of tenecteplase, a fibrinolytic agent. Due to excess deaths in the facilitated-PCI group, the study was halted early. The combined 90-day endpoint of death, congestive heart failure, or shock occurred significantly more often in the facilitated-PCI group, although the difference in deaths alone did not reach statistical significance. Facilitated PCI led to significantly more total and hemorrhagic strokes than standard PCI did; differences in other major bleeding complications were not significant.

In an accompanying meta-analysis that included data on more than 4500 patients from this study and 16 others, facilitated PCI (with thrombolytic agents alone, glycoprotein IIb/IIIa inhibitors alone, or both agents) was compared with primary PCI (controls). Outcomes were significantly worse in patients assigned to thrombolytic agents alone than in controls. Patients who received GPIIb/IIIa inhibitors alone, or in combination with low-dose thrombolytics, had outcomes that were similar to those in controls.

Comment: These investigators, as well as editorialists, advise against using fibrinolytic agents before angioplasty. A large trial of facilitated PCI with a GPIIb/IIIa inhibitor is in progress.

— Bruce Soloway, MD

Published in Journal Watch General Medicine March 14, 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 intervention 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)

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