Clinical trial NCT01942070: A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Myocardial Infarction
Thrombus
Primary Angioplasty
Keywords: Cardiovascular Disease
Myocardial Infarction
Bioresorbable vascular scaffold
Durable polymer everolimus-eluting stent
Primary angioplasty
Stent
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus
2. Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter ≥2.5 mm and ≤3.9 mm
3. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
4. In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

1. Target lesion located in the left main trunk
2. Severely calcified lesions
3. Bifurcation lesions with side branch diameter \> 2mm
4. In-stent restenosis
5. Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid
6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
7. Pregnancy (present, suspected or planned) or positive pregnancy test.
8. Previous enrolment in this trial
9. Patient's inability to fully cooperate with the study protocol

Primary outcomes:
measure: Percentage Diameter Stenosis
timeFrame: 6-8 months
Secondary outcomes:
measure: Device-oriented composite endpoint
timeFrame: 12 months
measure: Patient-oriented composite endpoint
timeFrame: 12 months
measure: Composite of death or MI
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Munich
state: Bavaria
city: Munich
country: Germany
facility: Klinikum Rechts der Isar
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum Munich
name: Robert A Byrne, MB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.
citation: Byrne RA, Alfonso F, Schneider S, Maeng M, Wiebe J, Kretov E, Bradaric C, Rai H, Cuesta J, Rivero F, Hoppmann P, Schlichtenmaier J, Christiansen EH, Cassese S, Joner M, Schunkert H, Laugwitz KL, Kastrati A. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur Heart J. 2019 Jan 7;40(2):167-176. doi: 10.1093/eurheartj/ehy710.