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

作者：Raber Lorenz; Onuma Yoshinobu; Brugaletta Salvatore; Garcia Garcia Hector M; Backx Bianca; Iniguez Andres; Jensen Lisette Okkels; Cequier Fillat Angel; Pilgrim Thomas; Christiansen Evald Hoi; Hofma Sjoerd H; Suttorp Maarten; Serruys Patrick W^*; Sabate Manel; Windecker Stephan

来源：Eurointervention, 2016, 12(4): 482-489.

DOI：10.4244/EIJY15M08_03

• Absorb BVS
• bioresorbable vascular scaffold
• drug-eluting stent
• optical frequency domain imaging
• ST-elevation myocardial infarction

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.

• 出版日期2016-7