Long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: PARADE II study

Jong-Il Park, Young-Guk Ko, Yong-Joon Lee, Seung-Jun Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Myeong-Ki Hong, Cheol-Woong Yu, Seung-Woon Rha, Jong-Kwan Park, Pil-Ki Min, Chang-Hwan Yoon, Sang-Rok Lee, Sang-Ho Park, Dong-Hoon Choi, Jong-Il Park, Young-Guk Ko, Yong-Joon Lee, Seung-Jun Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Myeong-Ki Hong, Cheol-Woong Yu, Seung-Woon Rha, Jong-Kwan Park, Pil-Ki Min, Chang-Hwan Yoon, Sang-Rok Lee, Sang-Ho Park, Dong-Hoon Choi

Abstract

Background: The efficacy of spot stenting using drug-eluting stents (DES) for the treatment of long femoropopliteal (FP) lesion is unknown. This study aimed to compare clinical outcomes of long full coverage vs. spot coverage with DES for long FP artery disease.

Methods: This multicenter randomized trial compared long DES vs. spot DES for FP lesions longer than 150 mm. All lesions were treated with paclitaxel-eluting stents (Zilver PTX). The primary endpoint was primary patency at 12 months.

Results: The study was terminated early after an interim analysis. A total of 103 patients (55 in the long DES group; 48 in the spot DES group) were eligible for analysis. There were no significant differences in baseline and lesion characteristics between groups. Total stent length was longer in the long DES group than in the spot DES group (225.6 ± 67.2 vs. 131.3 ± 48.7 mm, p < 0.001). Technical success was achieved in all patients. There was a trend toward a higher primary patency rate at 12 months in the long DES group than in the spot DES group (87.5% vs. 67.5%, p = 0.120). The rate of survival free from target lesion revascularization was significantly higher in the long DES group than in the spot DES group (91.7% vs. 72.0%, p = 0.044). In multivariate Cox regression analysis, spot DES [hazard ratio (HR) 2.42, 95% confidence interval (CI) 1.14-5.12, p = 0.021] and postdilation (HR 0.27, 95% CI 0.09-0.79, p = 0.018) were identified as independent predictors for loss of patency at 12 months post-procedure.

Conclusions: Long DES were more effective than spot DES for treating long FP lesions.

Clinical trial registration: Clinicaltrials.gov, identifier: NCT02701881.

Keywords: drug-eluting stent; femoropopliteal artery; patency; peripheral artery disease; restenosis.

Conflict of interest statement

Y-GK and D-HC received institutional research grants from Cook Medical, Medtronic, Boston Scientific, Samjin Pharm, Korea United Pharm, Dong-A Pharm, and Otsuka Korea. None of these companies, including Cook Medical, were involved in developing study protocols or study process of PARADE II. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Park, Ko, Lee, Lee, Hong, Ahn, Kim, Kim, Hong, Yu, Rha, Park, Min, Yoon, Lee, Park and Choi.

Figures

Figure 1
Figure 1
Patient flow diagram. CLTI, chronic limb-threatening ischemia; DES, drug-eluting stents.
Figure 2
Figure 2
Kaplan-Meier survival curves comparing the long drug-eluting stent (DES) group vs. the spot DES group. (A) Primary patency. (B) Target lesion revascularization (TLR)-free survival. Cum, cumulative.

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Source: PubMed

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