Ann Surg Treat Res.  2021 Jul;101(1):20-27. 10.4174/astr.2021.101.1.20.

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

Affiliations
  • 1Healthcare Economics and Government Affairs, Medtronic Korea Ltd., Seoul, Korea
  • 2Department of Health Convergence, Ehwa Womans University, Seoul, Korea
  • 3Department of Surgery, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, Seoul, Korea
  • 4Department of Physiology, Chung-Ang University School of Medicine, Seoul, Korea
  • 5Department of Medical Device Management & Research, Samsung Advanced Institute for Health Science & Technology, Sungkyunkwan University, Seoul, Korea

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.

Keyword

Angioplasty; Mortality; Paclitaxel; Peripheral arterial occlusive disease; Stents
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