Background: Published meta-analyses comparing primary percutaneous coronary intervention with fibrinolytic therapy in patients with ST-segment-elevation myocardial infarction include only randomized controlled trials (RCTs). We aim to obviate the limited applicability of RCTs to real-world settings by undertaking meta-analyses of both RCTs and observational studies.
Methods and results: We included all RCTs and observational studies, without language restriction, published up to May 1, 2008. We completed separate bayesian hierarchical random-effect meta-analyses for 23 RCTs (8140 patients) and 32 observational studies (185 900 patients). Primary percutaneous coronary intervention was associated with reductions in short-term (< or =6-week) mortality of 34% (odds ratio, 0.66; 95% credible interval, 0.51 to 0.82) in randomized trials, and 23% lower mortality (odds ratio, 0.77; 95% credible interval, 0.62 to 0.95) in observational studies. Primary percutaneous coronary intervention was associated with reductions in stroke of 63% in RCTs and 61% in observational studies. At long-term follow-up (> or =1 year), primary percutaneous coronary intervention was associated with a 24% reduction in mortality (odds ratio, 0.76; 95% credible interval, 0.58 to 0.95) and a 51% reduction in reinfarction (odds ratio, 0.49; 95% credible interval, 0.32 to 0.66) in RCTs. However, there was no conclusive benefit of primary percutaneous coronary intervention in the long term in the observational studies.
Conclusions: Compared with fibrinolytic therapy, primary percutaneous coronary intervention was associated with short-term reductions in mortality, reinfarction, and stroke in ST-segment-elevation myocardial infarction. Primary percutaneous coronary intervention was associated with long-term reductions in mortality and reinfarction in RCTs, but there was no conclusive evidence for a long-term benefit in mortality and reinfarction in observational studies.