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PURPOSE: To assess the effectiveness of nitinol-constrained balloon (NCB; Chocolate; Medtronic, Dublin, Ireland) percutaneous transluminal angioplasty (PTA) for treating Diameter reduction, Spiral shape, Flow impairment, or adverse Morphology (DISFORM) III postangioplasty dissections in chronic total occlusions (CTOs) of the femoropopliteal segment. MATERIALS AND METHODS: The CHOCOlate-STABilization (CHOCO-STAB) study was conducted from February 2019 to February 2022. It included patients with peripheral arterial disease affected by chronic limb-threatening ischemia. This study specifically included patients with DISFORM III postangioplasty dissections who were treated using NCB angioplasty after initial PTA. The main outcomes assessed in this study were technical success and the occurrence of major adverse events. RESULTS: This study included 68 patients with a mean age of 72 years (SD ± 10), of whom 39% had diabetes. The initially treated CTOs had a mean length of 10.32 mm (SD ± 5; interquartile range, 5-15 mm), with moderate or severe calcification in 28%. Forty-seven (69%) patients received initial treatment with drug-coated balloons (DCBs). NCB angioplasty was feasible in all patients, achieving technical success in 62 (91%). Stent placement was required in the remaining 6 (9%) cases. Three-year estimated overall survival was 98.5%, primary patency was 88.2%, freedom from major amputation was 94.1%, and freedom from clinical target lesion revascularization was 94.1%. CONCLUSIONS: Postangioplasty dissections represent a relevant adverse event that necessitates scaffolding in moderate and severe grades. The CHOCO-STAB study demonstrated the safety and potential of NCB angioplasty to reduce stent placement in patients treated with DCB and plain old balloon angioplasty who present with postangioplasty dissections.
Mirabella et al. (Sat,) studied this question.