A prospective study evaluating efficacy of polymer free Pronova XR stent in treatment of denovo coronary artery stenosis

BACKGROUND: Drug eluting stents have remarkably improved results of percutaneous coronary angioplasty. Most of the currently available drug eluting stents uses a durable polymer as drug carrier which has been implicated in local inflammatory response and continued incidence of late and very late stent thrombosis. The Pronova XR stent is one from those new generation polymer free sirolimus eluting stents in which pharmaceutical excipient is used for the timed release of sirolimus from the XR stent platform instead of a polymeric coating. METHODOLOGY: We consecutively recruited 121 patients undergoing elective or urgent PCI at our center. All the patients were followed up clinically and mandatory follow up angiogram at 6 months was done for one third of the total patients. An independent core lab analyzed paired angiograms. RESULTS: The primary efficacy endpoint was death, MI, TVR at 6 months which occurred in 6.66% patients. The QCA analysis showed reference vessel diameter of 2.5 + 0.44 mm at baseline and the minimal luminal diameter was 0.88 + 0.43 mm giving baseline diameter stenosis of 65.26 + 15.89%. The immediate post procedure in-segment diameter stenosis assessed was 23.68 + 8.96% which increased to 36.02 + 24.48% at follow up with a late lumen loss of 0.25 + 0.76 mm at mean of 191 days. CONCLUSION: Coronary angioplasty with polymer free Pronova XR stents results in acceptable late lumen loss and very low target lesion revascularisation at short and intermediate term in unselected patients.