Clinical trial NCT04236609: Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
Official title: ABILITY Diabetes Global
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Coronary Artery Disease
Acute Coronary Syndrome
Lead sponsor: Concept Medical Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 3050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Target lesions should be treated in accordance with the randomization schedule after meeting the clinical and angiographic inclusion and exclusion criteria following the instruction for use of the study stent.

Additional lesions (other vessels) may be staged up to 45 days post-index procedure but must be treated with the same stent.

Dual antiplatelet therapy must be prescribed in alignment with the Instructions for Use of the DES and the guidelines
Primary purpose: OTHER

Brief summary: To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

Detailed description: This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.

Eligibility criteria: Inclusion Criteria:

Clinical Inclusion Criteria

1. Patient understands the trial requirements and the treatment procedures and provides written informed consent;
2. Age ≥ 18 years of age (\> 19 years of age for South Korea and ≥ 21 years of age for Singapore);
3. Diabetic patient: either:

   1. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
   2. Newly diagnosed diabetes: either:

   i. Fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for ≥8 hours1 or ii. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test or iii. HbA1c level ≥ 7% (53 mmol/mol) Patients who are newly diagnosed are included even if they are not on pharmacological treatment (oral hypoglycemic agents or insulin)
4. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
5. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed \>12 months before index procedure;
6. Patient is willing and able to comply with all protocol-required follow-up evaluations.

   Angiographic Inclusion Criteria (visual estimate)
7. Presence of ≥1 de novo coronary artery stenosis \>50% in a native coronary artery which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with 1 or multiple stents; and
8. No limitation to the number of treated lesions, number of vessels, or lesion length if the patient is judged eligible for PCI by the treating physician according to the local standard of care.

Exclusion Criteria:

Clinical Exclusion Criteria

1. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
2. Patient in cardiogenic shock;
3. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, platinum, chromium, sirolimus, everolimus, radiographic contrast material) that cannot be adequately pre-medicated;
4. Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy (DAPT) can be maintained throughout the peri-surgical period;
5. Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)
6. Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, \< 2 years postmenopausal, or does not consistently use effective methods of contraception\*;
7. Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months;
8. Acute or chronic renal dysfunction (creatinine \>3.0 mg/dl);
9. Currently participating in another investigational drug or device study.

   Angiographic Exclusion Criteria
10. In-stent restenotic lesions;
11. Lesions involving venous or arterial bypass grafts.

Primary outcomes:
measure: Rate of Ischemia-driven TLR
timeFrame: 1 year FU
measure: Rate of Target lesion failure TLF
timeFrame: 1 year FU, powered for non-inferiority
Secondary outcomes:
measure: Safety composite endpoint
timeFrame: 1 year (non-inferiority)
measure: co-primary TLR endpoint
timeFrame: 2 Year FU
measure: Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
timeFrame: 1 year FU
measure: Bleeding
timeFrame: 2 year
Other outcomes:
measure: Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
timeFrame: 2 year FU
measure: Occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
timeFrame: 2 year
measure: All-cause mortality
timeFrame: up to 2 years from procedure
measure: Stroke
timeFrame: up to 2 years from procedure
measure: Stent thrombosis
timeFrame: 2 year
measure: Technical success
timeFrame: 2 year
measure: Clinical procedural success
timeFrame: 2 year
measure: Occurrence of ischemia-driven TLR
timeFrame: 2 year FU
measure: Target vessel revascularization (TVR)
timeFrame: up to 2 years
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Melbourne
country: Australia
facility: St Vincent Hospital
city: Wollongong
country: Australia
facility: The Wollongong Hospital
city: Graz
country: Austria
facility: University Heart Center Graz
city: Schwarzach Im Pongau
country: Austria
facility: Kardinal Schwarzenberg Klinikum
city: Dhaka
country: Bangladesh
facility: National Heart Foundation Hospital & Research Institute
city: Antwerpen
country: Belgium
facility: Antwerp Cardiovascular Center Middelheim
city: Leuven
country: Belgium
facility: UZ Leuven
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: São Paulo
country: Brazil
facility: INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School
city: Brno
country: Czechia
facility: University Hospital Brno, Department of Medecine Cardiology
city: Praha
country: Czechia
facility: University Hospital Královské Vinohrady, Department of Medecine Cardiology
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Brest
country: France
facility: CHRU Brest
city: Fontaine-lès-Dijon
country: France
facility: Clinique de Fontaine
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Marseille
country: France
facility: Hôpital La Timone, Service Cardiologie
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Hôpital Cochin
city: Bad Krozingen
country: Germany
facility: Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie
city: Bad Segeberg
country: Germany
facility: Herzzentrum, Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Charite Berlin, Department of Cardiology, Campus Benjamin Franklin
city: Dachau
country: Germany
facility: Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Hamburg
country: Germany
facility: 121/ MVZ Hamburg, DEU
city: Kiel
country: Germany
facility: UKSH, Campus Kiel, Department of Cardiology
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tubingen, DEU
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH
city: Chennai
country: India
facility: Madras Medical Mission
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
city: Galway
country: Ireland
facility: National University of Ireland, Galway Galway University Hospital
city: San Donato Milanese
country: Italy
facility: IRCCS - Policlinico San Donato
state: Milano
city: Cotignola
country: Italy
facility: GVM - Cotignola
state: Ravenna
city: Brescia
country: Italy
facility: Fondazione Poliambulanza di Brescia
city: Catania
country: Italy
facility: P.O. G. Rodolico
city: Catanzaro
country: Italy
facility: 075/ Magna Graecia University
city: Mercogliano
country: Italy
facility: Casa di Cura Montevergine
city: Milano
country: Italy
facility: Istituto Sant'Ambrogio
city: Milano
country: Italy
facility: San Carlo Clinic
city: Milano
country: Italy
facility: San Raffaele Hospital
city: Napoli
country: Italy
facility: 133/Clinica Mederranea
city: Napoli
country: Italy
facility: Division of Cardiology, University of Campania "Luigi Vanvitelli"
city: Pavia
country: Italy
facility: 156/ Policlinico San Matteo
city: Rivoli
country: Italy
facility: Ospedale degli infermi
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Mexico City
country: Mexico
facility: Instituto nacional de cardiologia ignacio chavez
city: San Luis Potosí
country: Mexico
facility: Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City
city: Torreon
country: Mexico
facility: IMSS Hospital de Especialidades UMAE 71
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Bełchatów
country: Poland
facility: XII Oddział Kardiologiczny PAKS w Bełchatowie
city: Bielsko-Biala
country: Poland
facility: Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
city: Chrzanów
country: Poland
facility: MCSN AHoP Chrzanow
city: Dąbrowa Górnicza
country: Poland
facility: Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca
city: Krakow
country: Poland
facility: University Hospital Krakow
city: Kędzierzyn-Koźle
country: Poland
facility: American Heart of Poland
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia SA
city: Nysa
country: Poland
facility: Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie
city: Pińczów
country: Poland
facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego
city: Sztum
country: Poland
facility: Oddział Kardiologii Szpitale Polskie Sztum
city: Tychy
country: Poland
facility: X Department of Invasive Cardiology, Tychy American Heart of Poland SA
city: Ustroń
country: Poland
facility: I Oddział Kardiologii AHoP
city: Zgierz
country: Poland
facility: Department of Interventional Cardiology Med-Pro American Heart of Poland
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Uppsala
country: Sweden
facility: Uppsala University hosp
city: Örebro
country: Sweden
facility: Örebro Univ. Hospital, Dpt. of cardiology
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Meyrin
country: Switzerland
facility: Hôpital de La Tour
city: Zürich
country: Switzerland
facility: Triemli Hospital
city: Zürich
country: Switzerland
facility: University Hospital Zürich
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Blackburn
country: United Kingdom
facility: Royal blackburn hospital
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University NHS Hospitals Trust
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Craigavon
country: United Kingdom
facility: Craigavon Area Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hopsital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Acute NHS Trust, Worcestershire Royal Hospital
Study officials:
affiliation: Mount Sinai Heart
name: Roxana Mehran
role: STUDY_CHAIR
References:
citation: International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2
citation: Thiele H, Zeymer U. Chapter: Cardiogenic shock in patients with acute coronary syndromes (p. 441), The ESC Textbook of Intensive and Acute Cardiovascular Care (2 ed.) [IACC]. Edited by Marco Tubaro, Pascal Vranckx, Susanna Price, and Christiaan Vrints. Updated on 22 February 2018 DOI: 10.1093/med/9780199687039.003.0049_update_003
citation: Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.
citation: Kufner S, Byrne RA, Dommasch M, Massberg S, Schoemig A, Kastrati A. Comparison of "limus"-eluting stents with permanent-vs biodegradable polymer in patients with diabetes mellitus with coronary artery disease. Eur Heart J 2012; 33: 558-9
citation: Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, Smits PC. Differential clinical responses to everolimus-eluting and Paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011 Aug 23;124(8):893-900. doi: 10.1161/CIRCULATIONAHA.111.031070. Epub 2011 Aug 8.
citation: Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. doi: 10.1161/01.CIR.0000140721.27004.4B. Epub 2004 Aug 30.
citation: Lee TT, Feinberg L, Baim DS, Holmes DR, Aroesty JM, Carrozza JP Jr, Cohen DJ, Ho KK, Cutlip DE. Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials). Am J Cardiol. 2006 Sep 15;98(6):718-21. doi: 10.1016/j.amjcard.2006.03.059. Epub 2006 Jul 13.
citation: Morgan KP, Kapur A, Beatt KJ. Anatomy of coronary disease in diabetic patients: an explanation for poorer outcomes after percutaneous coronary intervention and potential target for intervention. Heart. 2004 Jul;90(7):732-8. doi: 10.1136/hrt.2003.021014.
citation: Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
citation: Schalkwijk CG, Stehouwer CD. Vascular complications in diabetes mellitus: the role of endothelial dysfunction. Clin Sci (Lond). 2005 Aug;109(2):143-59. doi: 10.1042/CS20050025.
citation: Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010 Nov 30;56(23):1897-907. doi: 10.1016/j.jacc.2010.07.028.
citation: Lightell DJ Jr, Woods TC. Relative resistance to Mammalian target of rapamycin inhibition in vascular smooth muscle cells of diabetic donors. Ochsner J. 2013 Spring;13(1):56-60.
citation: Denardo SJ, Carpinone PL, Vock DM, Batich CD, Pepine CJ. Changes to polymer surface of drug-eluting stents during balloon expansion. JAMA. 2012 May 23;307(20):2148-50. doi: 10.1001/jama.2012.4111. No abstract available.
citation: Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE; SIRIUS Investigators. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation. 2004 Dec 21;110(25):3773-80. doi: 10.1161/01.CIR.0000150331.14687.4B. Epub 2004 Dec 13.
citation: Mulukutla SR, Vlachos HA, Marroquin OC, Selzer F, Holper EM, Abbott JD, Laskey WK, Williams DO, Smith C, Anderson WD, Lee JS, Srinivas V, Kelsey SF, Kip KE. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry. JACC Cardiovasc Interv. 2008 Apr;1(2):139-47. doi: 10.1016/j.jcin.2008.02.005.
citation: Stenestrand U, James SK, Lindback J, Frobert O, Carlsson J, Schersten F, Nilsson T, Lagerqvist B; SCAAR/SWEDEHEART study group. Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2010 Jan;31(2):177-86. doi: 10.1093/eurheartj/ehp424. Epub 2009 Nov 10.
citation: Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial. Am J Cardiol. 2009 Feb 1;103(3):345-9. doi: 10.1016/j.amjcard.2008.09.084. Epub 2008 Nov 12.
citation: Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. doi: 10.1056/NEJMoa044372. Epub 2005 Aug 16.
citation: Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
citation: Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009.
citation: Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.
citation: Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.
citation: Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
citation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
citation: Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.