Aims: Thrombolytic therapy has been known to be effective in reducing clinical outcomes and increasing recanalization rate among patients with ST-segment elevation acute myocardial infarction (STEMI). However, whether post-thrombolysis recanalization could be used as a surrogate for clinical outcomes is unknown.
Methods: We systematically searched PubMed, EMBASE and the Cochrane Library database to identify randomized controlled trials (RCT) that examined effects of thrombolytic agents in STEMI. Recanalization was defined as TIMI grade 2 or 3 flow. The primary outcome was in-hospital all-cause mortality. Secondary outcomes included in-hospital and 30-day recurrent myocardial infarction (re-MI), composite of death and re-MI, major bleeding and all bleeding. Random-effects meta-regression was used for analysis.
Results: We identified 111 eligible study arms and 52 eligible comparisons from 58 RCTs involving 16 536 patients. Our analyses showed that among study arms recanalization rate was significantly inversely associated with the incidence of in-hospital all-cause mortality (β: -0.07, 95% confidence interval [CI]: -0.13 to -0.02), re-MI (β: -0.09, 95%CI: -0.18 to -0.01) and the composite of death and re-MI (β: -0.17, 95%CI: -0.28 to -0.05), and positively associated with in-hospital all bleeding but not with major bleeding. Among paired comparisons, the difference in recanalization rate was associated with the corresponding difference in incidence of in-hospital all-cause mortality (β: -0.15, 95%CI: -0.28 to -0.01) but the relationship was not significant for any other outcome.
Conclusion: Pooled evidence from RCTs suggest the potential use of recanalization as a surrogate for clinical outcomes in evaluating the efficacy of thrombolysis among patients with STEMI.
Keywords: STEMI; clinical outcomes; recanalization; surrogate; thrombolytic therapy.
© 2021 British Pharmacological Society.