Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions

Drug-eluting stents meeting study criteria (e.g., sirolimus-, paclitaxel-, or everolimus-eluting stents; specific models selected by operators according to clinical practice) were chosen. Stent diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm of healthy vessel proximal and distal to the lesion. Stents were deployed at 8-16 atm to ensure optimal apposition. Intraoperative angiography confirmed no residual stenosis (\<10%) and TIMI grade 3 flow. When multiple stents were required, an overlapping technique was utilized to ensure complete lesion coverage.

Drug-coated balloons meeting study criteria (e.g., paclitaxel- or sirolimus-coated DCB; specific models selected by operators according to clinical practice) were chosen. DCB diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm proximal and distal to the lesion. DCB inflation was maintained for ≥60 seconds at 8-12 atm to ensure adequate drug delivery to the vessel wall. Intraoperative angiography confirmed \<50% residual stenosis, TIMI grade 3 flow, and absence of serious complications. DES implantation was permitted (recorded as hybrid strategy) if any of the following conditions occurred after DCB application: Residual stenosis ≥50% with hemodynamic significance; Non-flow-limiting dissection requiring stent support based on operator judgment; Other technical difficulties resulting in DCB-alone treatment failure. DES selection was consistent with the DES-only group.