Clinical, angiographic, and intravascular ultrasound results of the VestSaync II Trial

ABSTRACT

We sought to assess the long term efficacy of the novel VESTAsyncTM ElutingStent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatitesurface coating impregnated with a polymer-free low-dose of Sirolimus (55 lg). Methods:The Vestasync II trial was a randomized (21), double-blinded, multicenter comparisonof the VES to its platform, the Gen X stent, with microporous hydroxyapatitesurface coating without sirolimus. Patients were eligible if they presented de novolesions in native coronary arteries with 3.0–3.5 mm diameter and 14 mm in length.Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelongaspirin and 6-month clopidogrel were prescribed to all patients. Results: Seventy-fivepatients were enrolled (VES550 pts). Baseline characteristics included mean age of 58years and 29% of diabetics. Reference vessel diameter and lesion length were 2.860.4mm and 13.062.0 mm, respectively. In-stent late loss (0.3960.20 vs. 0.7460.52,P50.03) and % of neointima hyperplasia (9.366.6% vs. 17.669.4%, P50.0016) weresignificantly reduced in the VES cohort. Up to 1 year, there was a single case ofmyocardial infarction and one target lesion revascularization (TLR) (2%) in the VESgroup while in the control cohort there were one TLR (4%) and one cardiac death (4%).Conclusion: The VestSync II trial is a proof-of-concept study and demonstrates thesustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A largertrial, with more complex lesions, clinical endpoints and longer FU period is warranted.