Impact of Circumferential Calcification and Acquired Minimum Lumen Area on 1-Year Primary Patency After Drug-Coated Balloon Angioplasty for Femoropopliteal Lesions.

Authors

Shinya Kobata, Makoto Sugihara, Takafumi Fujita, Kaori Mine, Kenji Ogata, Shotaro Furukawa, Takumi Yoshiga, Yuta Ishizaki, Kensuke Oe, Atsushi Kakazu, Ryosuke Yanari, Ryoichi Kyuragi, Shoichiro Furukawa, Saburo Kusumoto, Ryohei Akashi, Eiji Karashima, Hideki Doi, Shin-Ichiro Miura

Published in

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. Sep 16, 2026. Epub Sep 16, 2026.

Abstract

Severe calcification predicts restenosis after drug-coated balloon (DCB) angioplasty for femoropopliteal lesions, but whether an adequate post-procedural minimum lumen area (MLA) can attenuate this effect, and how intravascular ultrasound (IVUS) circumferential calcification compares with angiographic Peripheral Arterial Calcium Scoring System (PACSS), remain unclear.
In this exploratory sub-analysis of the multicenter REAL-LEAD registry, we studied 224 femoropopliteal lesions (222 analyzable) treated with a DCB-only strategy under IVUS guidance across 14 Japanese institutions, classified by IVUS calcification angle (≥ 180° vs. < 180°) and PACSS grade (3-4 vs. 0-2). Cox models assessed 1-year loss of patency; post-procedural MLA was modeled continuously.
Restenosis occurred in 37 lesions (16.7%) over 1 year. An IVUS calcification angle ≥ 180° independently predicted loss of patency (HR 2.17, 95% CI 1.10-4.26, p = 0.025); PACSS grade 3-4 did not retain significance after identical adjustment (HR 1.79, 95% CI 0.91-3.54, p = 0.092). Each 1.0 mm² decrease in MLA increased restenosis hazard by 32% (HR 1.32, 95% CI 1.19-1.47, p < 0.001). Despite comparable external elastic membrane area at the MLA site (p = 0.67), severely calcified lesions acquired a smaller MLA. Severely calcified lesions with an adequate MLA achieved 1-year patency (90.6%) approaching that of low-calcification lesions with an adequate MLA (94.7%), while low-calcification lesions with an inadequate MLA fared worse (73.4%).
IVUS-defined circumferential calcification, but not angiographic PACSS, independently predicted restenosis after DCB-only angioplasty. An adequate post-procedural MLA appeared to attenuate the adverse impact of severe calcification, supporting IVUS-guided optimization of acute luminal gain as an actionable procedural target.

PMID:
42745693
Bibliographic data and abstract were imported from PubMed on 16 Sep 2026.

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