Drug-Coated Balloon Only Percutaneous Coronary Intervention for De-Novo Chronic Total Occlusion: Insights From the Multicenter International CTO-DENOVO Registry.

We aimed to assess the clinical, angiographic, and outcome profiles of patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with the use of drug-coated balloon (DCB)-only approach in a retrospective multicenter international registry. Data from 309 patients with 312 CTO lesions undergoing successful CTO PCI with DCB-only approach at 42 sites were collected. Angiographic and clinical follow-up was performed at 3 and 6 months, respectively. The primary endpoint was target lesion failure (TLF), defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization (TLR). Secondary endpoints included binary restenosis (≥50% stenosis) and late lumen loss (LLL) on angiography. The mean age was 67 ± 10 years, and 58.9% patients were male. The main indication for DCB was small vessel disease (37.1%), and most CTO were recanalized with intraplaque wiring (93%). TLF was 3.5% with no cardiac death at 6 months. Of 157 CTO with angiographic follow-up (50.3%) at a median of 99 days (IQR: 85 to 136 days), the LLL was -0.1 mm (IQR: -0.3 to 0.3 mm), and 47.8% vessels showed positive remodelling. Binary restenosis and re-occlusion were 24.2% and 4.0%, respectively. Coronary CTO with binary restenosis had significantly higher residual stenosis directly post-PCI (p <0.001) than CTO without restenosis. In conclusion, treatment of CTO with a DCB-only approach is safe, with a low number of TLF at 6-month follow-up. In selected population with angiographic follow-up, suboptimal predilatation result was associated with an increased rate of restenosis and warrants further investigation.