Preliminary results of the multicentric, double-blinded,randomised, Vestasync II trial

ABSTRACT

Aims: Durable polymers in 1st generation DES have been linked to local coronaryinflammation that could ultimately result in life-threatening adverse events.Polymer-free DES systems have been developed as an attractive alternative tominimise these undesired effects. We sought to assess the safety and efficacy ofthe novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with ananothin-microporous hydroxyapatite surface coating impregnated with apolymer-free low-dose of Sirolimus (55μg). In its first-in-man (FIM) assessment, 15patients were enrolled and at the end of 8 months, late loss and% of stentobstruction considerably low (0.36mm and 4.0%, respectively) with this novelDES.Methods and results: The Vestasync II trial is a randomised (21), double-blindedmulticenter comparison of the VES to its platform, the Gen X stent, withmicroporous hydroxyapatite surface coating but without sirolimus. Patients wereeligible if they presented single de novo lesions in native coronary arteries with3.0-3.5mm diameter and ≤ 14mm in length. Primary endpoint was 9-month in-stentlate loss and% of stent obstruction. Lifelong AAS and 6-month clopidogrel wereprescribed to all pts. Seventy-five patients were enrolled. Baseline characteristicsincluded mean age of 57 years and 23% of diabetics. RVD and lesion length were2.67±0.4mm and 14.0±2.0mm. Procedure success was obtained in all cases.Three patients (4.2%) presented non-Q wave MI during hospitalisation with noother MACE. After discharge, there were two cases of TLR and no MI, death orstent thrombosis. Complete invasive follow-up was achieved for all patients. QCAand IVUS analysis are being processed by independent corelabs and detailedresults will be available at the meeting.Conclusions: In confirming the enthusiastic results of its FIM evaluation, theVESTAsync™ Sirolimus-Eluting Stent should be next evaluated in a larger trial withmore complex angiographic profile and clinical endpoints.