Comparison of Drug-Coated Balloon and Drug-Eluting Stent Strategies for High-Risk Coronary Artery Disease Patients Undergoing PCI

What this Trial Is About

Researchers are evaluating treatment strategies for patients with complex coronary artery disease undergoing percutaneous coronary intervention PCI. This international, randomized, open-label clinical trial compares a SeQuent4 SCB drug-coated balloon strategy to a newer drug-eluting stent DES strategy. The study aims to show that the SCB approach is not worse than the DES method regarding a composite outcome called Target Vessel Failure TVF, which includes cardiovascular death, heart attacks related to the treated vessel, repeat procedures on the vessel, and bleeding events as defined by specific bleeding criteria. Participants will be randomly assigned to receive either the SCB-based PCI strategy or the DES-based PCI strategy for all target lesions. In the SCB group, lesions are treated with the SeQuent4 SCB after lesion preparation, with additional interventions if needed. In the DES group, lesions are treated with drug-eluting stents, avoiding drug-coated balloons unless necessary. Both groups have specific procedures for treating complex lesion types such as bifurcations. A subset of patients will receive follow-up angiography one year after treatment. Participants will be followed for clinical outcomes at 3 months, 1 year, 2 years, and 3 years after treatment. The main measures include the composite of TVF and bleeding events at 12 and 36 months. Additional outcomes such as device success, bleeding types, heart attacks, stroke, and hospitalization will also be monitored. An optional extended follow-up up to 6 years may be conducted based on interim results. The total duration of participation may extend accordingly, with regular assessments to track safety and effectiveness of the strategies.

BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)