Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease (ABSORB-LONG)

The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.

Study Overview

• Status: Terminated
• Conditions: Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold; Device: everolimus-eluting cobalt-chromium (Xience) stent

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 and more
• Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
• Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

• Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
• Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
• An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
• STEMI requiring primary percutaneous coronary intervention
• Cardiogenic shock
• Restenotic lesions
• Left main
• Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
• Heavy calcification proximal to or within the target lesion
• Compromised left ventricular dysfunction (LVEF <30%)
• At the time of screening, the subject has a malignancy that is not in remission
• Terminal illness with life expectancy <1 year
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
• Patient's pregnant or breast-feeding or child-bearing potential

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: ABSORB BVS	Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold; Other Names: ABSORB BVS
Active Comparator: XIENCE EES	Device: everolimus-eluting cobalt-chromium (Xience) stent; Other Names: XIENCE EES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent thrombosis		5 years
All-cause mortality		5 years
Cardiac death		5 years
Target-vessel myocardial infarction		5 years
Ischemia-driven target-lesion revascularization		5 years
event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction		5 years
Any revascularization	Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven	5 years
Target-vessel failure	death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization	5 years
event rate of device success or procedural success	Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion. Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death.	5 years
Patient-reported angina status measured by Seattle angina questionnaire		5 years

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: coronary artery disease; bioresorbable vascular scaffold
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Trace Elements; Micronutrients; Everolimus; Chromium; Cobalt
• Other Study ID Numbers: AMCCV2016-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is not a publicly funded trial.