A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction

Not Applicable

• Conditions: Cardiovascular Disease; Myocardial Infarction; Thrombus; Primary Angioplasty
• Interventions: Device: Bioresorbable vascular scaffold; Device: Durable polymer everolimus-eluting metallic stent

• Registration Number: NCT01942070
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Primary Completion: 2018-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioresorbable vascular scaffold	Bioresorbable vascular scaffold	Bioresorbable vascular scaffold (BVS)
Everolimus-eluting stent	Durable polymer everolimus-eluting metallic stent	Durable polymer everolimus-eluting metallic stent (EES)

Primary Outcome Measures

Name	Time	Method
Percentage Diameter Stenosis	6-8 months	Percentage diameter stenosis at coronary angiography at 6-8 months follow-up

Secondary Outcome Measures

Name	Time	Method
Device-oriented composite endpoint	12 months	Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR)
Patient-oriented composite endpoint	12 months	The composite of death/any MI/all revascularization
Composite of death or MI	12 months	The composite of cardiovascular death or MI
Stent thrombosis	12 months	The incidence of scaffold or stent thrombosis

Trial Locations

Locations (2)

Deutsches Herzzentrum Munich; 🇩🇪 Munich, Bavaria, Germany

Klinikum Rechts der Isar; 🇩🇪 Munich, Bavaria, Germany