Early invasive versus conservative treatment in patients with failed fibrinolysis—no late survival benefit: The final analysis of the Middlesbrough Early Revascularisation to Limit Infarction (MERLIN) randomized trial

Abstract

Early (30 days) and midterm (6 months) clinical outcomes in trials comparing rescue angioplasty (rescue percutaneous coronary intervention [rPCI]) with conservative treatment of failed fibrinolysis complicating ST-segment elevation myocardial infarction have shown variable results. Whether early rPCI confers late (up to 3 years) clinical benefits is not known. The MERLIN trial compared rPCI and a conservative strategy in patients with failed fibrinolysis complicating ST-segment elevation myocardial infarction. Three hundred seven patients with electrocardiographic evidence of failure to reperfuse at 60 minutes were included. Patients in cardiogenic shock were excluded. Thirty-day and 1-year results have been reported. Results of 3 years of follow-up are presented. Three-year mortality in the conservative arm and rPCI, respectively, was 16.9% versus 17.6% (P = .9, relative difference [RD] -0.8, 95% CI [-9.3 to 7.8]). Death rates were similar (3.9% vs 3.2%) between 1- and 3-year follow-up, respectively. The incidence of the composite secondary end point of death, reinfarction, stroke, unplanned revascularization, or heart failure was significantly higher in the conservative arm (64.3% vs 49%, P = .01, RD 15.3, 95% CI [4.2-26]). There was no significant difference in the rate of reinfarction (0.7% vs 0.7%) or heart failure (1.3% vs 2.7%) between 1 and 3 years between the conservative and rPCI arms, respectively. The incidence of subsequent unplanned revascularization at 3 years was significantly higher in the conservative arm (33.8% vs 14.4%, P < .01, RD 19.4, 95% CI [10-28.7]), most of which occurred within 1 year; the rates between 1 and 3 years were 3.9% in the conservative arm versus 2% in the rPCI arm. There was a trend toward fewer strokes in the conservative arm at 3 years (conservative arm 2.6% vs rPCI 6.5%, P = .1, RD -3.9%, 95% CI [-9.4 to 0.8]), with similar stroke rates (1.3% vs 1.3%) between 1- and 3-year follow-up. Rescue angioplasty did not confer a late survival advantage at 3 years. The composite end point occurred less often in the rPCI arm mainly because of fewer unplanned revascularization procedures in the early phase of follow-up. The highest risk of clinical events in patients with failed reperfusion is in the first year, beyond which the rate of clinical events is low.