Original Title: Sealing intermediate non-obstructive coronary SVG lesions with DES as a new approach to maintaining vein graft patency and reducing cardiac events: the VELETI II randomized clinical trial.
Presenter: J. Rodes Cabal.
Non-obstructive SVG lesions affect mid-term prognosis negatively. There is little evidence on the safety and efficacy of non-obstructive intermediate SVG lesions treatment.
This is a multicenter, prospective, randomized study. Researchers estimated a 22% incidence of combined events for the conservative group vs. 12% for the PCI group. Patients with 30 to 60% SVG lesions were randomized. After including 125 patients of the 450 originally planned, the study was interrupted due to the slow inclusion of patients.
There were no events within the first 30 days in both groups. At 3.4 years median follow up, combined events, infarction and repeat revascularization incidence rates were 20% vs. 15% (p=0.33), 7.7% vs. 10% (p=0,73) and 16.9% vs. 15.0% (p=0,59) respectively. Revascularization procedures in the PCI group were due to restenosis (8.3%), vein graft disease progression (5%) and very late thrombosis (1.6%).
The Kaplan-Meier curve analyzis for infarction, revascularization and combined events showed a separation of these in favor of PCI the first 2 years, followed by an increase of events with benefit loss between 2 to 4 years after procedure.
Conclusion
SVG PCI with DES was safe but could not reduce the incidence of ischemic events related to medical treatment at 3 years.