Objective: There have been limited clinical trials comparing drug eluting stents (DESs) and drug coated balloons (DCBs) in the treatment of femoropopliteal artery disease. This two centre retrospective and prospective cohort study sought to compare DES with DCB for the treatment of native femoropopliteal artery disease. Methods: A total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with DESs (Zilver PTX; 102 limbs) or DCBs (IN.PACT Admiral; 186 limbs) in two Korean endovascular centres between 19 January 2013 and 5 May 2018 and followed for a median duration of 19.6 months. The primary endpoint was primary clinical patency. Propensity score matching (PSM, 162 limbs) and inverse probability weighted (IPW) adjustment were performed to adjust for confounding baseline characteristics. Results: The DCB group had fewer lesions with Trans-Atlantic Inter-Society Consensus (TASC) II type C/D (55.9% vs. 70.6%, p =.021) or total occlusions (43.5% vs. 77.5%, p <.001) and showed shorter lesion lengths (164.2 ± 105.4 mm vs. 194.8 ± 86.8 mm, p =.009) than the DES group. After PSM, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the DES group (5.4 ± 0.6 vs. 5.1 ± 0.7, p =.025). Adjunctive atherectomy was performed in 32.1% of the DCB group and in 2.5% of the DES group (p <.001). The provisional stenting was required in 14.8% of the DCB group. At two year follow up, the DCB group showed higher primary clinical patency (74.6% vs. 56.7%, hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.27–0.96, p =.032) and freedom from target lesion revascularisation (85.9% vs. 71.3%, HR 0.39, 95% CI 0.17–0.89, p =.021) than the DES group. Survival from all cause death did not differ between groups (87.6% vs. 92.1%, HR 1.85, 95% CI 0.62–5.52, p =.26). Conclusion: In this two centre cohort, DCBs with selective use of adjunctive atherectomy achieved more favourable outcomes than DESs for native femoropopliteal artery disease.
|Journal||European Journal of Vascular and Endovascular Surgery|
|Publication status||Accepted/In press - 2020|
Bibliographical noteFunding Information:
This study was supported by grants from the , Ministry of Health and Welfare , Republic of Korea (Nos. A085136 and HI15C1277 ), Mid-Career Researcher Program through the National Research Foundation , Ministry of Education, Science and Technology , Republic of Korea (No. 2015R1A2A2A01002731 ), and Cardiovascular Research Centre , Seoul, Korea.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine