Association of mortality with drug-coated devices in femoropopliteal artery based on the nationwide data

Abstract

Purpose: Drug-coated devices have been widely accepted as one of the most promising therapies for femoropopliteal artery revascularization. A recent meta-analysis showed increased mortality in patients treated with drug-coated devices. We sought to examine the association between mortality and drug-coated devices after the treatment of the femoropopliteal artery based on the Korea national administrative claims data. Methods: In the National Health Insurance Service database from August 2015 to December 2017, we identified patients with femoropopliteal artery revascularization using percutaneous transluminal angioplasty (PTA), bare metal stents (BMS), drug-coated balloon (DCB), or drug-eluting stents (DES). Kaplan-Meier methods were used to estimate the survival among devices, and log-rank tests were used to evaluate differences between groups. Adjusted hazard ratios (aHRs) were computed using the inverse probability of treatment weightings (IPTW). Results: There were 1,724 patients (mean age, 70.9 ± 10.7 years; male, 1,350 [78.3%]) included in the analysis. The median follow-up period was 552 days (interquartile range, 404–688 days). There was a difference in IPTW-adjusted mortality risk among device types (26.3% in PTA, 22.1% in BMS, 17.7% in DCB, and 17.8% in DES; P = 0.004). IPTW-adjusted Cox proportional hazard analysis showed that drug-coated devices were associated with decreased all-cause mortality risk (aHR, 0.70; 95% confidence interval, 0.58–0.86). Conclusion: Our real-world analysis showed that there was no evidence of increased all-cause mortality after femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.