Scientific Publications by FDA Staff

Circulation 2015 Aug 4;132(5):388-401

Percutaneous coronary intervention at centers with and without on-site surgical backup: an updated meta-analysis of 23 studies.

Lee JM, Hwang D, Park J, Kim KJ, Ahn C, Koo BK

BACKGROUND: -Emergency coronary artery bypass grafting (CABG) for unsuccessful percutaneous coronary intervention (PCI) is now rare. We aimed to evaluate the current safety and outcomes of primary PCI and non-primary PCI at centers with and without on-site surgical backup. METHODS AND RESULTS: -We performed an updated systematic review and meta-analysis using mixed-effects models. We included 23 high-quality studies that compared clinical outcomes and complication rates of 1,101,123 patients after PCI at centers with or without on-site surgery. For primary PCI for ST-segment elevation myocardial infarction (133,574 patients), all-cause mortality (without on-site surgery vs. with on-site surgery: observed rates, 4.8% vs. 7.2%, pooled OR 0.99, 95% CI 0.91-1.07, p=0.729, I2=3.4%) or emergency CABG rates (observed rates, 1.5% vs. 2.4%, pooled OR 0.76, 95% CI 0.56-1.01, p=0.062, I2=42.5%) did not differ by presence of on-site surgery. For non-primary PCI (967,549 patients), all-cause mortality (observed rates, 1.6% vs. 2.1%, pooled OR 1.15, 95% CI 0.94-1.41, p=0.172, I2=67.5%) and emergency CABG rates (observed rates, 0.5% vs. 0.8%, pooled OR 1.14, 95% CI 0.62-2.13, p=0.669, I2=81.7%) were not significantly different. PCI complication rates (cardiogenic shock, stroke, aortic dissection, tamponade, recurrent infarction) also did not differ by on-site surgical capability. Cumulative meta-analysis of non-primary PCI showed a temporal decrease of the effect size (OR) for all-cause mortality after 2007. CONCLUSIONS: -Clinical outcomes and complication rates of PCI at centers without on-site surgery did not differ from those with on-site surgery, for both primary and non-primary PCI. Temporal trends indicated improving clinical outcomes in non-primary PCI at centers without on-site surgery.