Evaluation and efficacy of long length Pronova XR Bioabsorbable Polymer stent in the treatment of long coronary lesions

Abstract

AimThe study aims an observational registry of the long and extra-long length (>33mm) Pronova XR stents in patients with long coronary lesions (>30mm) in a prospective real world study. Methods and resultsCurrent study was conducted at Ruby Hall Clinic Pune, between July 2012 and July 2013 including 30 patients who underwent PTCA using long and extra-long Pronova XR stents. Among the stents used, one stent - 33mm, 2 stents - 38mm, 5 stents - 43mm and 25 stents were of 48mm in length. In particular average stent length for the study was 46.03mm and the average stent diameter was 3.09±0.41mm.For this study coronary angioplasty was performed using femoral approach and standard practice. Lesions were predilated using undersized balloons and study stent was deployed at pressure 7–26atm. (12.8±3.2atm.) The successful delivery of stent at the intended lesion with visual residual stenosis less than 50% was defined as Procedural success. Follow up studies were conducted for all the patients at 30days, 3 months and 6 months intervals. The predefined QCA parameters were calculated using Sanders Data System QCA plus software (Palo Alto, CA, USA).No procedural complication was observed during the whole study. 100% successful stent placement was achieved in all patients. Six months clinical follow-up was available for all patients. No adverse events (Acute closure, angina, REPCI, MI, death, sub acute stent thrombosis) or hospitalization was reported for any of the patients except one. The Quantative Coronary Core Lab analysis post 6 months showed well-flowing stent with average late lumen loss 0.10mm ±0.26. ConclusionIn patients with long coronary lesions and very long length stent implantation series, Pronova XR showed excellent in 6 months results. This is for the first time reported that use of long length Pronova XR stents has shown so low restenosis rate and absent of mortality in six month period. These results offer a new opportunity to single long length stenting.