Clinical trial NCT01425281: ABSORB II Randomized Controlled Trial
Official title: ABSORB II RANDOMIZED CONTROLLED TRIAL A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria

* 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

Angiographic Inclusion Criteria

* 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.

Exclusion Criteria:

* 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)
* Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
* Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
* Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.

Angiographic Exclusion Criteria

* Target lesion which prevents adequate (residual stenosis at target lesion(s) is ≤ 40% by visual assessment) coronary pre-dilatation.
* Target lesion in left main trunk.
* Aorto-ostial target lesion (within 3 mm of the aorta junction).
* Target lesion located within 2 mm of the origin of the LAD or LCX.
* Target lesion located distal to a diseased (vessel irregularity per angiogram and \>20% stenosed lesion) arterial or saphenous vein graft.
* Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter, or with a side branch \<2mm in diameter requiring guide wire protection or dilatation.
* Total occlusion (TIMI flow 0), prior to wire crossing
* Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90 °) proximal to or within the target lesion.
* Restenotic from previous intervention
* Heavy calcification proximal to or within the target lesion.
* Target lesion involves myocardial bridge.
* Target vessel contains thrombus as indicated in the angiographic images.
* Additionally clinically significant lesion(s) (≥ 40% diameter stenosis by visual assessment) for which percutaneous coronary intervention may be required \<2 years after the index procedure.
* Subject has received brachytherapy in any epicardial vessel (including side branches)
* Subject has a high probability that a procedure other than pre-dilatation and study device implantation and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)

Primary outcomes:
measure: Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)
timeFrame: 3 years
measure: Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter
timeFrame: 3 years
Secondary outcomes:
measure: Device Success
timeFrame: From the start of index procedure to end of index procedure
measure: Number of Participants With Procedural Success
timeFrame: From the start of index procedure to end of index procedure
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 30 days
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 180 Days
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 1 year
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 2 years
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 3 years
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 4 years
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 5 years
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 30 days
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 180 days
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 1 year
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 2 years
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 3 years
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 4 years
measure: Number of Participants With All Myocardial Infarction (Per Protocol Definition)
timeFrame: 5 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 30 days
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 180 days
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 4 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 5 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 180 days
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 2 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 5 years
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: 30 days
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: 180 days
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: 1 year
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: 2 years
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: 3 years
measure: Number of Participants With Non Target Vessel Revascularization (Non-TVR)
timeFrame: 4 years
measure: Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
timeFrame: 5 years
measure: Number of Participants With All Revascularization
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With All Revascularization
timeFrame: 30 days
measure: Number of Participants With All Revascularization
timeFrame: 180 days
measure: Number of Participants With All Revascularization
timeFrame: 1 year
measure: Number of Participants With All Revascularization
timeFrame: 2 years
measure: Number of Participants With All Revascularization
timeFrame: 3 years
measure: Number of Participants With All Revascularization
timeFrame: 4 years
measure: Number of Participants With All Revascularization
timeFrame: 5 years
measure: Number of Participants Experiencing All Death/All MI
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 30 days
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 180 days
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 1 year
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 2 years
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 3 years
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 4 years
measure: Number of Participants Experiencing All Death/All MI
timeFrame: 5 years
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR)
timeFrame: 30 days
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
timeFrame: 180 days
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
timeFrame: 1 year
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
timeFrame: 2 years
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
timeFrame: 3 years
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
timeFrame: 4 years
measure: Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
timeFrame: 5 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 30 days
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 180 days
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 1 year
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 2 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 3 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 4 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
timeFrame: 5 years
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 30 days
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 180 days
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 1 year
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 2 years
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
timeFrame: 5 years
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 30 days
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 180 days
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 1 year
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 2 years
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 3 years
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 4 years
measure: Number of Participants With DMR (All Death, All MI, All Revascularization)
timeFrame: 5 years
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: In-hospital (≤ 7 days of post index procedure)
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 30 days
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 180 days
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 1 year
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 2 years
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 3 years
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 4 years
measure: Number of Participants Experiencing Cardiac Death/All MI
timeFrame: 5 years
measure: Number of Participants With Acute Stent/Scaffold Thrombosis
timeFrame: <=1 day
measure: Number of Participants With Subacute Stent/Scaffold Thrombosis
timeFrame: > 1-30 days
measure: Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis
timeFrame: 0-30 days
measure: Number of Participants With Late Stent/Scaffold Thrombosis
timeFrame: 31-365 days
measure: Number of Participants With Very Late Stent/Scaffold Thrombosis
timeFrame: > 365 days
measure: Number of Participants With Cumulative Stent/Scaffold Thrombosis
timeFrame: 0-1853 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Abbott Vascular International BVBA
Study officials:
affiliation: Erasmus Medical Center
name: Patrick W. Serruys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Jacques Cartier (ICPS)
name: Bernard Chevalier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.