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 : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Lorenz RäberStephan Windecker

Abstract

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. 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. This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing resp...Continue Reading

References

Dec 15, 2009·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·James P OberhauserRichard J Rapoza
Sep 4, 2013·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Tommaso GoriThomas Münzel
Jan 30, 2014·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Yao-Jun ZhangPatrick W Serruys
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May 23, 2014·Circulation. Cardiovascular Interventions·Lorenz RäberUNKNOWN COMFORTABLE AMI Trial Investigators

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Citations

Jan 15, 2016·JACC. Cardiovascular Interventions·Antonio Colombo, Neil Ruparelia
Sep 13, 2016·Circulation Journal : Official Journal of the Japanese Circulation Society·Kunihiro Shimamura, Giulio Guagliumi
Mar 8, 2016·Revista Española De Cardiología·Iván J Núñez-GilRosa María Lidón
Oct 19, 2016·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Yoshinobu OnumaTakeshi Kimura
Nov 30, 2016·Journal of Interventional Cardiology·Moritz BaquetJulinda Mehilli
Dec 21, 2016·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Pannipa SuwannasomLorenz Räber
Mar 2, 2018·The International Journal of Cardiovascular Imaging·Xucheng LvJunbo Ge
Aug 8, 2018·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Taku AsanoYunDai Chen
Mar 22, 2019·Minerva cardioangiologica·Dhruv Mahtta, Islam Y Elgendy
Feb 8, 2020·JACC. Cardiovascular Interventions·Chun Chin ChangRobert-Jan van Geuns
May 8, 2019·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Krzysztof MilewskiPatrick W Serruys

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