Clinical trial NCT01844284: AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Official title: A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Ischemia
Keywords: Absorb™ BVS
Angioplasty
Bioabsorbable
Bioreabsorbable
BVS
Coronary Artery Disease
Coronary Artery Endothelial Responsiveness
Coronary artery restenosis
Coronary artery stenosis
Coronary scaffold
Coronary Stent
Drug eluting stents
Everolimus
Myocardial ischemia
Stent thrombosis
Stents
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 400
Sex: ALL
Minimum age (years): 20
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-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.

Detailed description: Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.

Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 20 years of age.
2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
6. Female subject of childbearing potential must not be pregnant\* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.

   \* Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure

Exclusion Criteria:

1. Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
2. Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
3. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
4. Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure

   * The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
   * Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
5. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
6. Subject has a known left ventricular ejection fraction (LVEF) \< 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
7. The target vessel was treated by PCI within 12 months.
8. Prior PCI within the non-target vessel is acceptable if performed anytime \> 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
9. Subject requires future staged PCI either in target or non target vessels.
10. Subject has a malignancy that is not in remission.
11. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
12. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
13. Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
15. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
16. Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
17. Subject has known renal insufficiency;

    * Dialysis at the time of screening.
    * An estimated Glomerular filtration rate (GFR) \< 30 ml/min/1.73m2
18. Subject is high risk of bleeding, or difficult to have appropriate treatment;

    * Has a history of bleeding diathesis or coagulopathy
    * Has had a significant gastro-intestinal or significant urinary bleed within the past six months
    * Has prior intracranial bleed
    * Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
    * Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm \> 5 mm, arteriovenous malformation)
    * Subject will refuse blood transfusions
19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
21. Subject has life expectancy \< 3 year.
22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
24. Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.

Primary outcomes:
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 1 month
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 6 months
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 1 year
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 2 years
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 3 years
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 4 years
measure: Number of Participants With Any Death/Any MI/Revascularization (DMR)
timeFrame: 5 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 1 month
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 6 months
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 1 year
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 2 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 5 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 1 month
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 6 months
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 2 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 3 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 4 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 5 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 1 month
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 6 months
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 1 year
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 2 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 3 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 4 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 5 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 1 month
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 6 months
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 2 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 4 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 5 years
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 1 month
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 6 months
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 1 year
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 2 years
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 3 years
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 4 years
measure: Number of Participants With Ischemia-driven TVR (ID-TVR)
timeFrame: 5 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 1 month
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 6 months
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 4 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 5 years
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 1 month
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 6 months
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 1 year
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 2 years
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 3 years
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 4 years
measure: Number of Participants With Ischemia-driven Revascularization (ID-TLR)
timeFrame: 5 years
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 1 month
measure: Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 6 months
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 ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 1 month
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 6 months
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 1 year
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 2 years
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 3 years
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 4 years
measure: Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
timeFrame: 5 years
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 1 month
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 6 months
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 1 year
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 2 years
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 3 years
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 4 years
measure: Number of Participants With Target Vessel MI (TV-MI)
timeFrame: 5 years
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Acute (≤ 1 day)
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Subacute (>1 - 30 days)
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Late (31 - 365 days)
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Very Late (366 - 730 days)
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Very Late (731 - 1095 days)
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Very Late (1096 - 1460 days)
measure: Number of Participants With Stent/Scaffold Thrombosis
timeFrame: Very Late (1461 - 1825 days)
measure: In-segment Late Loss (Non-inferiority)
timeFrame: 13 months
measure: Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)
timeFrame: 2 years
measure: Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation
timeFrame: 2 years
measure: Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)
timeFrame: 2 years
measure: Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)
timeFrame: 5 years
measure: Number of Participants With Not Ischemia-driven TLR (NID-TLR)
timeFrame: 5 years
measure: Number of Participants With Non-Target Vessel MI (NTV-MI)
timeFrame: 5 years
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Toyoake-shi
country: Japan
facility: Fujita Health University
state: Aichi
city: Matsudo-shi
country: Japan
facility: ShinTokyo
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Shinkoga Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hanaoka Seishu Memorial Cardiovascular Clinic
state: Hokkaido
city: Kyoto
country: Japan
facility: Kyoto University
state: Honshu
city: Amagasaki-shi
country: Japan
facility: Kansairosai Hospital
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe University
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: Tsukuba Medical Center
state: Ibaraki
city: Morioka-shi
country: Japan
facility: Iwate Medical University
state: Iwate
city: Isehara-shi
country: Japan
facility: Tokai University
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Shonankamakura General Hospital
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Saiseikai Kumamoto Hospital
state: Kumamoto
city: Miyazaki-shi
country: Japan
facility: Miyazak Medical Association Hospital
state: Miyazaki
city: Tenri-shi
country: Japan
facility: Tenri Hospital
state: Nara
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osaka-shi
country: Japan
facility: Sakurabashi Watanabe Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University
state: Osaka
city: Suita-shi
country: Japan
facility: The National Cerebral and Cardiovascular Center
state: Osaka
city: Saitama-shi
country: Japan
facility: Saitama Medical Center Jichi Medical University
state: Saitama
city: Sayama-shi
country: Japan
facility: Saitama Sekishinkai
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: University of Tokyo
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Museum
state: Tokyo
city: Fuchu-shi
country: Japan
facility: Sakakibara Memorial Hospital
state: Tokyo
city: Itabashi-Ku
country: Japan
facility: Teikyo University
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Minato-Ku
country: Japan
facility: The Cardiovascular Institute Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Tochigi
country: Japan
facility: Dokkyo University
state: Utsunomiya
city: Kimiidera
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Ube-shi
country: Japan
facility: Yamaguchi University
state: Yamaguchi
city: Tokushima
country: Japan
facility: Tokushima Red Cross Hospital
city: Tokyo
country: Japan
facility: Abbott Vascular Japan Co., Ltd.
Study officials:
affiliation: Kyoto University
name: Takeshi Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
citation: Kozuma K, Tanabe K, Hamazaki Y, Okamura T, Ando J, Ikari Y, Nakagawa Y, Kusano H, Ediebah D, Kimura T; ABSORB Japan Investigators. Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent - A Randomized Comparison Through 5 Years in Japan. Circ J. 2020 Apr 24;84(5):733-741. doi: 10.1253/circj.CJ-19-1184. Epub 2020 Mar 26.
citation: Onuma Y, Honda Y, Asano T, Shiomi H, Kozuma K, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Hanaoka KI, Tanabe K, Okada K, Kitahara H, Ono M, Kusano H, Rapoza R, Simonton C, Popma JJ, Stone GW, Fitzgerald PJ, Serruys PW, Kimura T. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years. JACC Cardiovasc Interv. 2020 Jan 13;13(1):116-127. doi: 10.1016/j.jcin.2019.09.047.
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: Okada K, Honda Y, Kitahara H, Otagiri K, Tanaka S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Kimura T; ABSORB Japan Investigators. Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):648-661. doi: 10.1016/j.jcin.2017.11.034.
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: 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: Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.