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

Räber, Lorenz; Onuma, Yoshinobu; Brugaletta, Salvatore; Garcia-Garcia, Hector M; Backx, Bianca; Iñiguez, Andres; Jensen, Lisette Okkels; Cequier-Fillat, Àngel; Pilgrim, Thomas; Christiansen, Evald Høi; Hofma, Sjoerd H; Suttorp, Maarten; Serruys, Patrick W; Sabaté, Manel; Windecker, Stephan (2015). 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. EuroIntervention, 11(4), pp. 482-489. Europa Digital & Publishing 10.4244/EIJY15M08_03

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Räber, Lorenz; Pilgrim, Thomas and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1774-024X

Publisher:

Europa Digital & Publishing

Language:

English

Submitter:

Judith Liniger

Date Deposited:

14 Mar 2016 11:04

Last Modified:

21 Jul 2016 01:30

Publisher DOI:

10.4244/EIJY15M08_03

PubMed ID:

26342471

URI:

https://boris.unibe.ch/id/eprint/75910

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