Vascular brachytherapy: from investigation to approval

Abstract

There is little information on the performance of the new generation of stents with bioabsorbable polymers in the Latin American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable-polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers.We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers. The primary endpoint was defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization at 1-year follow-up.From April 2017 to February 2019, 520 patients were enrolled in the registry, more frequently male (74.6%), with a mean age of 62.7 ± 10.8 years and a high prevalence of diabetes (40.2%). The clinical presentation was stable angina in 41.1% (n = 214), acute MI in 52.5% (n = 167 [32.1%] ST-elevation MI and n = 106 [20.4%] non-ST-elevation MI), and unstable angina in 6.3% (n = 33). Of 610 treated lesions, 425 (69.7%) were American College of Cardiology/American Heart Association type B or C lesions. Device and procedural success were achieved in 99.4% and 98.7% of the patients, respectively. The primary endpoint of the study occurred in 4%, primarily driven by cardiac death.The results of the ROSES multicenter registry indicated good clinical outcomes of BPSES Orsiro in all-comers Latin Americann patients undergoing PCI, despite the high-risk patients and treated lesions.