ABSORB II Randomized Controlled Trial

NCT01425281 | Completed Results DMC

• 2 other identifiers: 10-393CIV-11-10-002627
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)

Conditions

Coronary Artery Disease

Keywords

Bioabsorbable; Coronary scaffold; Coronary Stent; Everolimus; Drug eluting stents; Angioplasty; Coronary artery disease; Total coronary occlusion; Coronary artery restenosis; Stent thrombosis; Myocardial ischemia; Coronary artery stenosis

Outcome Measures

Primary Outcomes (2)

• Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)

  In-scaffold:Within the margins of the scaffold.

  3 years

• Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter

  In-scaffold:Within the margins of the scaffold.

  3 years

Secondary Outcomes (104)

• Device Success

  From the start of index procedure to end of index procedure

• Number of Participants With Procedural Success

  From the start of index procedure to end of index procedure

• Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

  In-hospital (≤ 7 days of post index procedure)

• Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

  30 days

• Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

  180 Days

Study Arms (2)

XIENCE™

ACTIVE COMPARATOR

Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System

Device: Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System

ABSORB BVS™

EXPERIMENTAL

Experimental: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

Device: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

Interventions

Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System DEVICE

XIENCE implantation in the treatment of coronary artery disease.

XIENCE™

Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System DEVICE

ABSORB BVS implantation in the treatment of coronary artery disease.

ABSORB BVS™

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age and less than 85 years of age.
• Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS system and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia).
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to European Society of Cardiology Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight
• One or two de novo native lesions each located in a different epicardial vessel.
• If two treatable lesions meet the eligibility criteria, they must be in separate major epicardial vessels (left anterior descending (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
• Lesion(s) must have a visually estimated diameter stenosis of ≥50% and \<100% with a TIMI flow of ≥1.
• Lesion(s) must be located in a native coronary artery with Dmax by on-line quantitative coronary angiography (QCA) of ≥2.25 mm and ≤3.8 mm.
• Lesion(s) must be located in a native coronary artery with lesion(s) length by on-line QCA of ≤48 mm.
• Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥30 days prior to or if planned to be done 2 years after the index procedure.
• Percutaneous intervention for lesions in the target vessel are allowed if done \>6 months prior to or if planned to be done 2 years after the index procedure.

You may not qualify if:

• Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Subject has a known diagnosis of acute myocardial infarction (AMI) at any time preceding the index procedure and relevant cardiac enzymes (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
• Evidence of ongoing acute myocardial infarction in ECG prior to procedure
• Subject has current unstable arrhythmias.
• Left ventricular ejection fraction (LVEF) \< 30%.
• Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
• Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
• Subject is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
• Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted according to local hospital standard procedures.
• Elective surgery is planned within 2 years after the procedure that will require discontinuing either aspirin, clopidogrel, prasugrel or ticlopidine.
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a white blood cell count of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency (e.g., estimated glomerular filtration rate \<60 ml/kg/1.73m² or serum creatinine level of \>2.5 mg/dL, or subject on dialysis).
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular International BVBA

Brussels, 0886.537.933, Belgium

Location

Related Publications (12)

• Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.

  PMID: 31561250 DERIVED

• Grundeken MJ, White RM, Hernandez JB, Dudek D, Cequier A, Haude M, van Boven AJ, Piek JJ, Helqvist S, Sabate M, Baumbach A, Suwannasom P, Ishibashi Y, Staehr P, Veldhof S, Cheong WF, de Winter RJ, Garcia-Garcia HM, Wykrzykowska JJ, Onuma Y, Serruys PW, Chevalier B. The incidence and relevance of site-reported vs. patient-reported angina: insights from the ABSORB II randomized trial comparing Absorb everolimus-eluting bioresorbable scaffold with XIENCE everolimus-eluting metallic stent. Eur Heart J Qual Care Clin Outcomes. 2016 Apr 1;2(2):108-116. doi: 10.1093/ehjqcco/qcv022.

  PMID: 29474621 DERIVED

• Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.

  PMID: 29089314 DERIVED

• Serruys PW, Katagiri Y, Sotomi Y, Zeng Y, Chevalier B, van der Schaaf RJ, Baumbach A, Smits P, van Mieghem NM, Bartorelli A, Barragan P, Gershlick A, Kornowski R, Macaya C, Ormiston J, Hill J, Lang IM, Egred M, Fajadet J, Lesiak M, Windecker S, Byrne RA, Raber L, van Geuns RJ, Mintz GS, Onuma Y. Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. J Am Coll Cardiol. 2017 Jul 4;70(1):60-74. doi: 10.1016/j.jacc.2017.05.028.

  PMID: 28662808 DERIVED

• Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iniguez A, Sabate M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016 Nov 19;388(10059):2479-2491. doi: 10.1016/S0140-6736(16)32050-5. Epub 2016 Oct 30.

  PMID: 27806897 DERIVED

• Sotomi Y, Ishibashi Y, Suwannasom P, Nakatani S, Cho YK, Grundeken MJ, Zeng Y, Tateishi H, Smits PC, Barragan P, Kornowski R, Gershlick AH, Windecker S, van Geuns RJ, Bartorelli AL, de Winter RJ, Tijssen J, Serruys PW, Onuma Y. Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents: Intravascular Ultrasound Assessment From the ABSORB II Trial. JACC Cardiovasc Interv. 2016 Jun 27;9(12):1216-1227. doi: 10.1016/j.jcin.2016.03.022. Epub 2016 Jun 20.

  PMID: 27339838 DERIVED

• Suwannasom P, Sotomi Y, Ishibashi Y, Cavalcante R, Albuquerque FN, Macaya C, Ormiston JA, Hill J, Lang IM, Egred M, Fajadet J, Lesiak M, Tijssen JG, Wykrzykowska JJ, de Winter RJ, Chevalier B, Serruys PW, Onuma Y. The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial. JACC Cardiovasc Interv. 2016 Jun 27;9(12):1231-1242. doi: 10.1016/j.jcin.2016.03.027. Epub 2016 Jun 1.

  PMID: 27262861 DERIVED

• Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.

  PMID: 26825231 DERIVED

• Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.

  PMID: 26585622 DERIVED

• Ishibashi Y, Muramatsu T, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Cho YK, Garcia-Garcia HM, van Boven AJ, Piek JJ, Sabate M, Helqvist S, Baumbach A, McClean D, de Sousa Almeida M, Wasungu L, Miquel-Hebert K, Dudek D, Chevalier B, Onuma Y, Serruys PW. Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent. JACC Cardiovasc Interv. 2015 Jul;8(8):1053-1063. doi: 10.1016/j.jcin.2015.06.001.

  PMID: 26205444 DERIVED

• Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015 Jan 3;385(9962):43-54. doi: 10.1016/S0140-6736(14)61455-0. Epub 2014 Sep 14.

  PMID: 25230593 DERIVED

• Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012 Nov;164(5):654-63. doi: 10.1016/j.ahj.2012.08.010.

  PMID: 23137495 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Susan Veldhof
• Organization: Abbott Vascular International BVBA

susan.veldhof@av.abbott.com

+31653428610

Study Officials

• Patrick W. Serruys, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Bernard Chevalier, MD

  Institut Jacques Cartier (ICPS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 30, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: May 23, 2018
• Last Updated: November 13, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-07

Locations

BE (1)