Myocardial Infarction Clinical Trial
Official title:
Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation currently
represents the dominant treatment strategy in patients undergoing catheter intervention.
However effective neointimal suppression occurs at the cost of a systematic delay in arterial
healing in comparison with after bare metal stenting. This underlies a small but significant
increased risk of stent thrombosis after DES implantation in comparison with bare metal stent
implantation as well as a possible excess of in-stent neoatheroma formation.
Bioresorbable vascular scaffolds (BVS) represent an innovative technology providing
short-term vessel scaffolding and drug delivery without the long-term limitations of metallic
DES and durable polymer coatings. Potential benefits include restoration of normal vasomotor
reactivity, facilitation of positive vessel wall remodelling and facilitation of subsequent
bypass grafting of the stented arterial segment. In addition preliminary reports suggest that
the process of scaffold biodegradation may promote formation of a cohesive tissue layer
covering and stabilizing the underlying atherosclerotic plaque - a so-called plaque-sealing
effect. Although initial results with BVS are encouraging, there is a lack of randomized
clinical trial data and no data exists for outcomes after BVS implantation in patients
undergoing coronary stenting in the setting of acute myocardial infarction (MI).
The aim of the current study is to test the clinical performance of the everolimus-eluting
BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients
undergoing PCI in the setting of acute MI. The primary endpoint will be percentage diameter
stenosis at protocol-mandated 6-8 month angiographic follow-up. Sample size calculation is
based on a non-inferiority assumption in relation to the BVS versus EES. It is planned to
enrol a total of 260 patients. Subsequent clinical follow-up will be undertaken out to 2
years.
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