Korean Circ J.  2024 Aug;54(8):454-465. 10.4070/kcj.2024.0006.

Clinical Outcomes After Drug-Coated Balloon Treatment in Popliteal Artery Disease: K-POP Registry 12-Month Results

• Park JI
• Ko YG
• Lee SJ
• Ahn CM
• Rha SW
• Yu CW
• Park JK
• Park SH
• Lee JH
• Kim SH
• Lee YJ
• Hong SJ
• Kim JS
• Kim BK
• Hong MK
• Choi D

• KMID: 2558536
• DOI: http://doi.org/10.4070/kcj.2024.0006

Abstract

Background and Objectives
The popliteal artery is generally regarded as a “no-stent zone.” Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease.
Methods
This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate.
Results
The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency.
Conclusions
DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.

Keyword

Popliteal artery; Atherosclerosis; Angioplasty

Figure

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  Figure 1 Patient flow diagram.DCB = drug-coated balloon.

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  Figure 2 Distribution of Rutherford categories at different follow-up intervals.

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  Figure 3 Kaplan–Meier survival curves for clinical outcomes at 1 year.TLR = target lesion revascularization; Cum = cumulative.

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  Figure 4 Kaplan–Meier survival curves according to atherectomy and provisional stent use. Kaplan–Meier survival curves at 1 year are presented according to atherectomy and provisional stent use. (A) Clinical primary patency for the use of atherectomy. (B) TLR-free survival for the use of atherectomy. (C) Clinical primary patency for the use of provisional stents. (D) TLR-free survival for the use of provisional stents.Cum = cumulative; DCB = drug-coated balloon; TLR = target lesion revascularization.

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