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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis: Predictors and Outcomes from a Multicenter
Ye Du1, Zhimin Chen1, Youpeng Zhu1
1Department of Wound Repair and Vascular Surgery, Liyuan Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Hubei Provincial Clinical Research Center for Chronic Wound and Diabetic Foot, Wuhan, China.
Purpose:
To test the hypothesis that procedural technique factors, particularly vessel preparation, would predict outcomes more strongly than anatomic complexity in patients with femoropopliteal in-stent restenosis (FP-ISR) treated with drug-coated balloons (DCBs).
Materials And Methods:
From the PROMISING registry, 281 patients with FP-ISR underwent DCB treatment at 9 centers in China (2021-2023). The cohort had complex disease: 68.0% Tosaka Grade III total in-stent occlusions; mean total treated segment length, 26.0 cm (SD ± 11.4); 85.1% Trans-Atlantic Inter-Society Consensus C/D classification of the overall femoropopliteal segment; and 47.3% critical limb-threatening ischemia (CLTI). Primary endpoints were clinically driven target lesion revascularization (CD-TLR) and major adverse limb events (MALEs) at 12 months. Multivariable Cox regression analysis identified independent predictors.
Results:
At 12 months, cumulative incidence rates were 12.6% for CD-TLR and 14.1% for MALE. Major amputation occurred in 0.7%, and amputation-free survival was 92.9%. Quality of life improved substantially (Vascular Quality of Life questionnaire score, 2.6 [SD ± 0.9] to 5.3 [SD ± 1.2]; P < .001). Predilation was the strongest independent predictor of favorable outcomes (CD-TLR, hazard ratio [HR], 0.28 [95% CI, 0.14-0.59; P < .001]; MALE, HR, 0.28 [95% CI, 0.14-0.58; P < .001]), whereas CLTI predicted worse outcomes (CD-TLR, HR, 2.44 [P = .008]; MALE, HR, 2.25 [P = .015]). Lesion length of ≥250 mm and Tosaka Grade III occlusion patterns were not significant predictors.
Conclusions:
In complex FP-ISR, adequate vessel preparation through predilation before DCB deployment was the strongest predictor of success, superseding anatomic complexity factors. These findings support routine predilation as a modifiable technical factor to optimize DCB outcomes in clinical practice.
