Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1905 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-09-29
Study Completion Date
2019-06-28
Brief Summary
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To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO \[for use outside the United States \[OUS\] only\]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.
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Detailed Description
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Conditions
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Chronic Coronary Occlusion
Unprotected Left Main Coronary Artery Disease
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Percutaneous Coronary Intervention
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Group Type
ACTIVE_COMPARATOR
Percutaneous Coronary Intervention
Intervention Type
DEVICE
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Coronary Artery Bypass Graft
Those patients receiving CABG
Group Type
ACTIVE_COMPARATOR
CABG
Intervention Type
PROCEDURE
Those patients receiving CABG
Interventions
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Percutaneous Coronary Intervention
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Intervention Type
DEVICE
CABG
Those patients receiving CABG
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or
* ULMCA disease with agniographic DS \>=50% but \< 70% requiring revascularization, with one or more of the following present:
* Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or
* IVUS minimum lumen area (MLA) \<= 6.0mm2, and/or
* Fractional Flow Reserve (FFR) \<=0.80
* Left Main Equivalent Disease
* Clinical and anatomic eligibility for both PCI and CABG
* Silent ischemia, stable angina, unstable angina or recent MI
* Ability to sign informed consent and comply with all study procedures including follow-up for at least three years
* ULMCA disease with agniographic DS \>=50% but \< 70% requiring revascularization, with one or more of the following present:
* Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or
* IVUS minimum lumen area (MLA) \<= 6.0mm2, and/or
* Fractional Flow Reserve (FFR) \<=0.80
* Left Main Equivalent Disease
* Clinical and anatomic eligibility for both PCI and CABG
* Silent ischemia, stable angina, unstable angina or recent MI
* Ability to sign informed consent and comply with all study procedures including follow-up for at least three years
Exclusion Criteria
* Prior PCI of the left main trunk at any time prior to randomization
* Prior PCI of any other coronary artery lesions within one year prior to randomization
* Prior CABG at any time prior to randomization
* Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
* CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated
* Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
* Subjects requiring or who may require additional surgery within one year
* The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
* The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
* Pregnancy or intention to become pregnant
* Non cardiac co-morbidities with life expectancy less than 3 years
* Other investigational drug or device studies that have not reached their primary endpoint
* Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
* Left main diameter stenosis \<50%
* SYNTAX score ≥33
* Left main reference vessel diameter \<2.25 mm or \>4.25 mm
* The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
* The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
* Prior PCI of any other coronary artery lesions within one year prior to randomization
* Prior CABG at any time prior to randomization
* Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
* CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated
* Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
* Subjects requiring or who may require additional surgery within one year
* The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
* The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
* Pregnancy or intention to become pregnant
* Non cardiac co-morbidities with life expectancy less than 3 years
* Other investigational drug or device studies that have not reached their primary endpoint
* Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
* Left main diameter stenosis \<50%
* SYNTAX score ≥33
* Left main reference vessel diameter \<2.25 mm or \>4.25 mm
* The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
* The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gregg W Stone, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Patrick W Serruys, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Joseph Sabik, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinical Main Campus
A. Pieter Kappetein, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Abbott Vascular
Santa Clara, California, United States
Site Status
Countries
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United States
References
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Giustino G, Sabik JF 3rd, Serruys PW, Puskas JD, Karmpaliotis D, Kandzari DE, Morice MC, Ragosta M 3rd, Zhang Z, Dressler O, Redfors B, Ben-Yehuda O, Sharma SK, Kappetein AP, Stone GW. Major Bleeding and Mortality After Revascularization of Left Main Disease. J Am Coll Cardiol. 2024 Dec 10;84(24):2335-2346. doi: 10.1016/j.jacc.2024.07.065.
Reference Type
DERIVED
Ali ZA, Garcia JJ, Karimi Galougahi K, Horst J, Gallo A, Shin D, Ben-Yehuda O, Chen S, Redfors B, Kappetein AP, Sabik JF 3rd, Serruys PW, Stone GW. Impact of Incomplete Revascularization After PCI in Left Main Disease: The EXCEL Trial. Circ Cardiovasc Interv. 2024 Mar;17(3):e013192. doi: 10.1161/CIRCINTERVENTIONS.123.013192. Epub 2024 Mar 19.
Reference Type
DERIVED
Gaba P, Sabik JF, Murphy SA, Bellavia A, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Christiansen EH, Holm NR, Nielsen PH, Sabatine MS, Stone GW, Bergmark BA. Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation. 2024 Apr 23;149(17):1328-1338. doi: 10.1161/CIRCULATIONAHA.123.065571. Epub 2024 Mar 11.
Reference Type
DERIVED
Gaba P, Christiansen EH, Nielsen PH, Murphy SA, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Stone GW, Sabik JF, Sabatine MS, Holm NR, Bergmark BA. Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials. JAMA Cardiol. 2023 Jul 1;8(7):631-639. doi: 10.1001/jamacardio.2023.1177.
Reference Type
DERIVED
Magnuson EA, Chinnakondepalli K, Vilain K, Serruys PW, Sabik JF, Kappetein AP, Stone GW, Cohen DJ; EXCEL Investigators. Cost-Effectiveness of Percutaneous Coronary Intervention Versus Bypass Surgery for Patients With Left Main Disease: Results From the EXCEL Trial. Circ Cardiovasc Interv. 2022 Jul;15(7):e011981. doi: 10.1161/CIRCINTERVENTIONS.122.011981. Epub 2022 Jul 19.
Reference Type
DERIVED
Myat A, Hildick-Smith D, de Belder AJ, Trivedi U, Crowley A, Morice MC, Kandzari DE, Lembo NJ, Brown WM III, Serruys PW, Kappetein AP, Sabik JF III, Stone G. Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial. EuroIntervention. 2022 Jan 28;17(13):1081-1090. doi: 10.4244/EIJ-D-21-00338.
Reference Type
DERIVED
Gregson J, Stone GW, Ben-Yehuda O, Redfors B, Kandzari DE, Morice MC, Leon MB, Kosmidou I, Lembo NJ, Brown WM 3rd, Karmpaliotis D, Banning AP, Pomar J, Sabate M, Simonton CA, Dressler O, Kappetein AP, Sabik JF 3rd, Serruys PW, Pocock SJ. Implications of Alternative Definitions of Peri-Procedural Myocardial Infarction After Coronary Revascularization. J Am Coll Cardiol. 2020 Oct 6;76(14):1609-1621. doi: 10.1016/j.jacc.2020.08.016.
Reference Type
DERIVED
Gaba P, Serruys PW, Sabik JF 3rd, Kappetein AP, Chen S, Morice MC, Kandzari DE, Crowley A, Mehran R, Stone GW. Effect of Baseline Anemia on Outcomes After Left Main Coronary Revascularization. J Am Coll Cardiol. 2020 Mar 31;75(12):1493-1495. doi: 10.1016/j.jacc.2020.01.037. No abstract available.
Reference Type
DERIVED
Thuijs DJFM, Milojevic M, Stone GW, Puskas JD, Serruys PW, Sabik JF 3rd, Dressler O, Crowley A, Head SJ, Kappetein AP. Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial. Eur J Heart Fail. 2020 May;22(5):871-879. doi: 10.1002/ejhf.1681. Epub 2020 Feb 11.
Reference Type
DERIVED
Giustino G, Serruys PW, Sabik JF 3rd, Mehran R, Maehara A, Puskas JD, Simonton CA, Lembo NJ, Kandzari DE, Morice MC, Taggart DP, Gershlick AH, Ragosta M 3rd, Kron IL, Liu Y, Zhang Z, McAndrew T, Dressler O, Genereux P, Ben-Yehuda O, Pocock SJ, Kappetein AP, Stone GW. Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial. JACC Cardiovasc Interv. 2020 Feb 10;13(3):375-387. doi: 10.1016/j.jcin.2019.09.019. Epub 2020 Jan 15.
Reference Type
DERIVED
Kandzari DE, Gershlick AH, Serruys PW, Leon MB, Morice MC, Simonton CA, Lembo NJ, Mansour S, Sabate M, Sabik JF 3rd, Kappetein AP, Dressler O, Stone GW. Procedural characteristics and clinical outcomes in patients undergoing percutaneous coronary intervention for left main trifurcation disease: the EXCEL trial. EuroIntervention. 2020 Dec 18;16(12):e982-e988. doi: 10.4244/EIJ-D-19-00686.
Reference Type
DERIVED
Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28.
Reference Type
DERIVED
Shlofmitz E, Genereux P, Chen S, Dressler O, Ben-Yehuda O, Morice MC, Puskas JD, Taggart DP, Kandzari DE, Crowley A, Redfors B, Mehdipoor G, Kappetein AP, Sabik JF 3rd, Serruys PW, Stone GW. Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score. Circ Cardiovasc Interv. 2019 Sep;12(9):e008007. doi: 10.1161/CIRCINTERVENTIONS.118.008007. Epub 2019 Sep 9.
Reference Type
DERIVED
Thuijs DJFM, Habib RH, Head SJ, Puskas JD, Taggart DP, Stone GW, Zhang Z, Serruys PW, Sabik JF 3rd, Kappetein AP. Prognostic performance of the Society of Thoracic Surgeons risk score in patients with left main coronary artery disease undergoing revascularisation: a post hoc analysis of the EXCEL trial. EuroIntervention. 2020 May 20;16(1):36-43. doi: 10.4244/EIJ-D-19-00417.
Reference Type
DERIVED
Modolo R, Chichareon P, Kogame N, Dressler O, Crowley A, Ben-Yehuda O, Puskas J, Banning A, Taggart DP, Kappetein AP, Sabik JA, Onuma Y, Stone GW, Serruys PW. Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease. J Am Coll Cardiol. 2019 Apr 23;73(15):1877-1886. doi: 10.1016/j.jacc.2018.12.090.
Reference Type
DERIVED
Milojevic M, Serruys PW, Sabik JF 3rd, Kandzari DE, Schampaert E, van Boven AJ, Horkay F, Ungi I, Mansour S, Banning AP, Taggart DP, Sabate M, Gershlick AH, Bochenek A, Pomar J, Lembo NJ, Noiseux N, Puskas JD, Crowley A, Kosmidou I, Mehran R, Ben-Yehuda O, Genereux P, Pocock SJ, Simonton CA, Stone GW, Kappetein AP. Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes. J Am Coll Cardiol. 2019 Apr 9;73(13):1616-1628. doi: 10.1016/j.jacc.2019.01.037.
Reference Type
DERIVED
Huang X, Redfors B, Chen S, Liu Y, Ben-Yehuda O, Puskas JD, Kandzari DE, Merkely B, Horkay F, van Boven AJ, Boonstra PW, Sabik JF, Serruys PW, Kappetein AP, Stone GW. Impact of chronic obstructive pulmonary disease on prognosis after percutaneous coronary intervention and bypass surgery for left main coronary artery disease: an analysis from the EXCEL trial. Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1144-1151. doi: 10.1093/ejcts/ezy438.
Reference Type
DERIVED
Kandzari DE, Gershlick AH, Serruys PW, Leon MB, Morice MC, Simonton CA, Lembo NJ, Banning AP, Merkely B, van Boven AJ, Ungi I, Kappetein AP, Sabik JF 3rd, Genereux P, Dressler O, Stone GW. Outcomes Among Patients Undergoing Distal Left Main Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Oct;11(10):e007007. doi: 10.1161/CIRCINTERVENTIONS.118.007007.
Reference Type
DERIVED
Giustino G, Mehran R, Serruys PW, Sabik JF 3rd, Milojevic M, Simonton CA, Puskas JD, Kandzari DE, Morice MC, Taggart DP, Gershlick AH, Genereux P, Zhang Z, McAndrew T, Redfors B, Ragosta M 3rd, Kron IL, Dressler O, Leon MB, Pocock SJ, Ben-Yehuda O, Kappetein AP, Stone GW. Left Main Revascularization With PCI or CABG in Patients With Chronic Kidney Disease: EXCEL Trial. J Am Coll Cardiol. 2018 Aug 14;72(7):754-765. doi: 10.1016/j.jacc.2018.05.057.
Reference Type
DERIVED
Redfors B, Chen S, Crowley A, Ben-Yehuda O, Gersh BJ, Lembo NJ, Brown WM 3rd, Banning AP, Taggart DP, Serruys PW, Kappetein AP, Sabik JF 3rd, Stone GW. B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease: Analysis From the EXCEL Trial. Circulation. 2018 Jul 31;138(5):469-478. doi: 10.1161/CIRCULATIONAHA.118.033631.
Reference Type
DERIVED
Kosmidou I, Chen S, Kappetein AP, Serruys PW, Gersh BJ, Puskas JD, Kandzari DE, Taggart DP, Morice MC, Buszman PE, Bochenek A, Schampaert E, Page P, Sabik JF 3rd, McAndrew T, Redfors B, Ben-Yehuda O, Stone GW. New-Onset Atrial Fibrillation After PCI or CABG for Left Main Disease: The EXCEL Trial. J Am Coll Cardiol. 2018 Feb 20;71(7):739-748. doi: 10.1016/j.jacc.2017.12.012.
Reference Type
DERIVED
Baron SJ, Chinnakondepalli K, Magnuson EA, Kandzari DE, Puskas JD, Ben-Yehuda O, van Es GA, Taggart DP, Morice MC, Lembo NJ, Brown WM 3rd, Banning A, Simonton CA, Kappetein AP, Sabik JF, Serruys PW, Stone GW, Cohen DJ; EXCEL Investigators. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial. J Am Coll Cardiol. 2017 Dec 26;70(25):3113-3122. doi: 10.1016/j.jacc.2017.10.036. Epub 2017 Oct 30.
Reference Type
DERIVED
Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31.
Reference Type
DERIVED
Farooq V, Serruys PW. Bypass Grafting Versus Percutaneous Intervention-Which Is Better in Multivessel Coronary Disease: Lessons From SYNTAX and Beyond. Prog Cardiovasc Dis. 2015 Nov-Dec;58(3):316-34. doi: 10.1016/j.pcad.2015.10.002. Epub 2015 Oct 31.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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10-389
Identifier Type: -
Identifier Source: org_study_id
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