Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction: rationale and design of the randomised TROFI II study
Lorenz Räber, Yoshinobu Onuma, Salvatore Brugaletta, Hector M Garcia-Garcia, Bianca Backx, Andres Iñiguez, Lisette Okkels Jensen, Àngel Cequier-Fillat, Thomas Pilgrim, Evald Høi Christiansen, Sjoerd H Hofma, Maarten Suttorp, Patrick W Serruys, Manel Sabaté, Stephan Windecker, Lorenz Räber, Yoshinobu Onuma, Salvatore Brugaletta, Hector M Garcia-Garcia, Bianca Backx, Andres Iñiguez, Lisette Okkels Jensen, Àngel Cequier-Fillat, Thomas Pilgrim, Evald Høi Christiansen, Sjoerd H Hofma, Maarten Suttorp, Patrick W Serruys, Manel Sabaté, Stephan Windecker
Abstract
Aims: The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES.
Methods and results: A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES.
Conclusions: This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.
Source: PubMed