Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
ABILITY
ABILITY Diabetes Global
1 other identifier
interventional
3,050
20 countries
87
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jun 2020
Longer than P75 for not_applicable diabetes
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedStudy Start
First participant enrolled
June 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedMarch 27, 2023
March 1, 2023
3.4 years
January 15, 2020
March 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of Ischemia-driven TLR
powered for non-inferiority and sequentially superiority
1 year FU
Rate of Target lesion failure TLF
composite of cardiovascular death, target vessel myocardial infarction \[MI\], or ischemia driven target lesion revascularization \[idTLR\])
1 year FU, powered for non-inferiority
Secondary Outcomes (4)
Safety composite endpoint
1 year (non-inferiority)
co-primary TLR endpoint
2 Year FU
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
1 year FU
Bleeding
2 year
Other Outcomes (9)
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
2 year FU
Occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
2 year
All-cause mortality
up to 2 years from procedure
- +6 more other outcomes
Study Arms (2)
Abluminus DES+ sirolimus- eluting stents (SES)
ACTIVE COMPARATOREnrolled patients will undergo angioplasty with Abluminus DES+ sirolimus- eluting stents (SES) and will be followed for two years. The DES procedure will be conducted in accordance with the CE mark instructions for use for the Abluminus DES+ sirolimus- eluting stents (SES).
XIENCE Everolimus-Eluting Stents (EES)
ACTIVE COMPARATOREnrolled patients will undergo angioplasty with XIENCE Everolimus-Eluting Stents (EES) and will be followed for two years. The DES procedure will be conducted in accordance with the CE mark instructions for use for the XIENCE Everolimus-Eluting Stents (EES).
Interventions
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
Eligibility Criteria
You may qualify if:
- Patient understands the trial requirements and the treatment procedures and provides written informed consent;
- Age ≥ 18 years of age (\> 19 years of age for South Korea and ≥ 21 years of age for Singapore);
- Diabetic patient: either:
- Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
- 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)
- Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
- Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed \>12 months before index procedure;
- Patient is willing and able to comply with all protocol-required follow-up evaluations.
- 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
- 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.
You may not qualify if:
- Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
- Patient in cardiogenic shock;
- 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;
- 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;
- Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)
- 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\*;
- 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;
- Acute or chronic renal dysfunction (creatinine \>3.0 mg/dl);
- Currently participating in another investigational drug or device study.
- In-stent restenotic lesions;
- Lesions involving venous or arterial bypass grafts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
The Prince Charles Hospital
Chermside, Australia
St Vincent Hospital
Melbourne, Australia
The Wollongong Hospital
Wollongong, Australia
University Heart Center Graz
Graz, Austria
Kardinal Schwarzenberg Klinikum
Schwarzach im Pongau, Austria
National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh
Antwerp Cardiovascular Center Middelheim
Antwerp, Belgium
UZ Leuven
Leuven, Belgium
Instituto Dante Pazzanese de Cardiologia
SĂ£o Paulo, Brazil
INSTITUTO DO CORAĂ‡ĂƒO - InCor University of SĂ£o Paulo Medical School
SĂ£o Paulo, Brazil
University Hospital Brno, Department of Medecine Cardiology
Brno, Czechia
University Hospital KrĂ¡lovskĂ© Vinohrady, Department of Medecine Cardiology
Prague, Czechia
Clinique Axium
Aix-en-Provence, France
CHRU Brest
Brest, France
Clinique de Fontaine
Fontaine-lès-Dijon, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
HĂ´pital La Timone, Service Cardiologie
Marseille, France
Hôpital Privé Jacques Cartier
Massy, France
CHU de Nîmes
Nîmes, France
HĂ´pital Cochin
Paris, France
Klinik fĂ¼r Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany
Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie
Bad Nauheim, Germany
Herzzentrum, Segeberger Kliniken GmbH
Bad Segeberg, Germany
Charite Berlin, Department of Cardiology, Campus Benjamin Franklin
Berlin, Germany
Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology
Dachau, Germany
Elisabeth Krankenhaus Essen
Essen, Germany
121/ MVZ Hamburg, DEU
Hamburg, Germany
UKSH, Campus Kiel, Department of Cardiology
Kiel, Germany
Heart Center Leipzig
Leipzig, Germany
Universitaetsklinikum Tubingen, DEU
TĂ¼bingen, Germany
Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany
Madras Medical Mission
Chennai, India
Krishna Institute of Medical Sciences
Secunderabad, India
National University of Ireland, Galway Galway University Hospital
Galway, Ireland
IRCCS - Policlinico San Donato
San Donato Milanese, Milano, Italy
GVM - Cotignola
Cotignola, Ravenna, Italy
Fondazione Poliambulanza di Brescia
Brescia, Italy
P.O. G. Rodolico
Catania, Italy
075/ Magna Graecia University
Catanzaro, Italy
Casa di Cura Montevergine
Mercogliano, Italy
Istituto Sant'Ambrogio
Milan, Italy
San Carlo Clinic
Milan, Italy
San Raffaele Hospital
Milan, Italy
133/Clinica Mederranea
Napoli, Italy
Division of Cardiology, University of Campania "Luigi Vanvitelli"
Napoli, Italy
156/ Policlinico San Matteo
Pavia, Italy
Ospedale degli infermi
Rivoli, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences
Roma, Italy
Institut Jantung Negara
Kuala Lumpur, Malaysia
Instituto nacional de cardiologia ignacio chavez
Mexico City, Mexico
Grupo IntervenciĂ³n San Luis - Hospital de Especialidades de la Salud - San Luis PotosĂ City
San Luis PotosĂ City, Mexico
IMSS Hospital de Especialidades UMAE 71
TorreĂ³n, Mexico
Amsterdam UMC
Amsterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
XII Oddział Kardiologiczny PAKS w Bełchatowie
BeÅ‚chatĂ³w, Poland
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Bielsko-Biala, Poland
MCSN AHoP Chrzanow
ChrzanĂ³w, Poland
Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca
DÄ…browa GĂ³rnicza, Poland
American Heart of Poland
Kędzierzyn-Koźle, Poland
University Hospital Krakow
Krakow, Poland
Miedziowe Centrum Zdrowia SA
Lubin, Poland
Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie
Nysa, Poland
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
PiÅ„czĂ³w, Poland
Szpital Kliniczny Przemienienia Pańskiego
Poznan, Poland
Oddział Kardiologii Szpitale Polskie Sztum
Sztum, Poland
X Department of Invasive Cardiology, Tychy American Heart of Poland SA
Tychy, Poland
I Oddział Kardiologii AHoP
Ustroń, Poland
Department of Interventional Cardiology Med-Pro American Heart of Poland
Zgierz, Poland
Changi General Hospital
Singapore, Singapore
Gachon University Gil Medical Center
Incheon, South Korea
Ă–rebro Univ. Hospital, Dpt. of cardiology
Ă–rebro, Sweden
Uppsala University hosp
Uppsala, Sweden
Cardiocentro Ticino
Lugano, Switzerland
HĂ´pital de La Tour
Meyrin, Switzerland
Triemli Hospital
Zurich, Switzerland
University Hospital ZĂ¼rich
Zurich, Switzerland
National Cheng Kung University Hospital
Tainan, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Belfast Health and Social Care Trust
Belfast, United Kingdom
Royal blackburn hospital
Blackburn, United Kingdom
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Brighton & Sussex University NHS Hospitals Trust
Brighton, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
Craigavon Area Hospital
Craigavon, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Royal Free Hopsital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Worcestershire Acute NHS Trust, Worcestershire Royal Hospital
Worcester, United Kingdom
Related Publications (27)
International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2
BACKGROUNDThiele 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
BACKGROUNDKereiakes 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.
PMID: 21144968RESULTKufner 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
RESULTStone 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.
PMID: 21824922RESULTCutlip 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.
PMID: 15337693RESULTLee 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.
PMID: 16950169RESULTMorgan 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.
PMID: 15201238RESULTHadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
PMID: 18200806RESULTSchalkwijk 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.
PMID: 16033329RESULTDangas 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.
PMID: 21109112RESULTLightell 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.
PMID: 23532775RESULTDenardo 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.
PMID: 22618916RESULTPopma 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.
PMID: 15596568RESULTMulukutla 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.
PMID: 19212456RESULTStenestrand 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.
PMID: 19903684RESULTMaeng 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.
PMID: 19166687RESULTDibra 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.
PMID: 16105990RESULTStone 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.
PMID: 18430909RESULTMahmud 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.
PMID: 19463432RESULTSerruys 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.
PMID: 19755303RESULTGrube 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.
PMID: 22607866RESULTGarcia-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.
PMID: 29897428RESULTThygesen 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.
PMID: 30153967RESULTLansky 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.
PMID: 28183511RESULTMehran 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.
PMID: 21670242RESULTAbizaid A, Mehran R, Oliva A, Chamie D, Staico R, Malik F, Vink M, Kurniadi A, Cao D, Capranzano P, Faurie B, Garot P, Hildick-Smith D, Ielasi A, Loffelhardt N, Kedev S, Mylotte D, Milewski K, Paradies V, Schmitz T, Teeuwen K, Testa L, Toelg R, Vochelet F, Vogel B, Wykrzykowska J, Sartori S, Colombo A, Saito S, Morice MC; ABILITY Diabetes Global investigators. Abluminus DES+ sirolimus-eluting stent versus everolimus-eluting stent in patients with diabetes and coronary artery disease (ABILITY Diabetes Global): results from a multicentre, randomised controlled trial. Lancet. 2026 Jan 8:S0140-6736(25)02157-9. doi: 10.1016/S0140-6736(25)02157-9. Online ahead of print.
PMID: 41520674DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Roxana Mehran
Mount Sinai Heart
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- The staff (i.e. research nurses, research coordinators and other practitioners) involved in the follow-up care of study subjects and the Clinical Events Committee (CEC) adjudicators will be blinded to the patient assignment;
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 22, 2020
Study Start
June 15, 2020
Primary Completion
October 30, 2023
Study Completion
September 30, 2024
Last Updated
March 27, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share