Test Efficacy With Bioresorbable Polymer Coating Versus Bioresorbable Polymer Backbone (ISAR-RESORB)

A Prospective, Randomized Trial of SYNERGY Bioresorbable Polymer Coated Stents Versus ABSORB Bioresorbable Backbone Stents in Patients Undergoing Coronary Stenting (ISAR-RESORB)

The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy as assessed by angiography at 6-8 months.

Study Overview

• Status: Unknown
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: SYNERGY EES; Device: ABSORB [BVS]

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. To address this issue recent technological advances have focused on bioresorbable polymer coatings and the development of stents with fully resorbable backbones.

Newer generation metallic DES with bioresorbable polymer coatings have been shown to improve vascular healing after coronary stenting. In particular a novel thin-strut bioresorbable polymer everolimus-eluting stent (EES, SYNERGY, Boston Scientific Corp., Natick, MA, USA) has shown high angiographic antirestenotic efficacy as well as high clinical efficacy and safety in early randomized trials. In addition, DES with bioresorbable backbones represent an alternative approach to ensure short-term vessel scaffolding and drug delivery with enhanced vessel healing. The everolimus-eluting bioresorbable backbone stent (ABSORB bioresorbable vascular scaffold [BVS], Abbott Vascular, Santa Rosa, CA, USA) is the most-extensively studied device in this class and early reports in selected patients show encouraging clinical results. However requirement for thicker stent struts and more careful lesion preparation has led to concerns that potential clinical benefits may be offset by erosion of early antirestenotic efficacy and occurrence of clinical events related to limitations of device deployment.

At present there is a lack of randomized clinical trial data examining outcomes of patients treated with these two alternative strategies. The aim of the current ISAR-RESORB study is to test the clinical performance of the bioresorbable-polymer SYNERGY with that of the ABSORB BVS in patients undergoing PCI of de novo coronary lesions. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Secondary clinical endpoint will be assessed at 12 months. Sample size calculation is based on a superiority hypothesis for SYNERGY versus ABSORB BVS. It is planned to enrol a total of 230 patients.

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Byrne, MB BCh PhD; Phone Number: 4587 +49 89 1218; Email: byrne@dhm.mhn.de
• Study Contact Backup: Name: Salvatore Cassese, MD; Phone Number: 4578 +49 89 1218; Email: Cassese@dhm.mhn.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum München
      • Contact: Robert Byrne, MB BCh PhD; Phone Number: 4587 +49-89-1218-; Email: byrne@dhm.mhn.de
      • Contact: Salvatore Cassese, MD; Phone Number: 4578 +49-89-1218-; Email: cassese@dhm.mhn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18 years or older with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in 2 separate vessels)
• Reference diameter ≥2.5 mm and ≤3.9 mm
• Lesion length <28 mm
• Written, informed consent by the patient for participation in the study

Exclusion Criteria:

• Cardiogenic shock
• Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
• Target lesion located in left main trunk or bypass graft
• Severe calcification of the lesion
• Target lesion contains a side branch (diameter ≥2mm) or a bifurcation or is located 2 mm away from a bifurcation
• Ostial lesions
• Severe vessel tortuosity
• Renal insufficiency (most recent serum creatinine within the last 72h prior to randomization > 2 mg/dl or 177 µmol/l)
• Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
• Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
• Contraindications or allergy to platinum, chromium, everolimus or the inability to take antiplatelet therapy for at least 6 months after stenting; known allergy to PLLA, PDLLA or PLGA polymer
• Previous enrollment in this trial
• Patient's inability to fully cooperate with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYNERGY EES; Bioresorbable polymer everolimus-eluting stent	Device: SYNERGY EES; Bioresorbable polymer everolimus-eluting stent
Active Comparator: ABSORB [BVS]; Everolimus-eluting bioresorbable backbone stent	Device: ABSORB [BVS]; Everolimus-eluting bioresorbable backbone stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage diameter stenosis (in-stent) by quantitative coronary angiography analysis	at 6-8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR) (Device-oriented composite endpoint)	at 12 months
Composite of death/any MI/all revascularization (Patient-oriented composite endpoint)	at 12 months
Composite of cardiovascular death or MI	at 12 months
Stent Thrombosis	at 12 months

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Robert Byrne, MB BCh PhD, Deutsches Herzzentrum München

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: De novo stenosis; bioresorbable polymer coating; bioresorbable polymer backbone
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: GE IDE No S03914