XIENCE 28 USA Study

April 29, 2022 updated by: Abbott Medical Devices
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.

Study Type

Interventional

Enrollment (Actual)

1605

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upr Aus
      • Linz, Upr Aus, Austria, 4021
        • Kepler Universitätsklinikum GmbH
  • Belgium
      • Limbourg, Belgium, 3500
        • Jesse Ziekenhuis Campus Virga Jesse
    • Eflndrs
      • Aalst, Eflndrs, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis Campus Aalst
    • Flemish
      • Gent, Flemish, Belgium, 42100
        • UZ Gent
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Royal Jubilee Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L4L2
        • Saint John Regional Hospital - New Brunswick Heart Centre
    • Quebec
      • Montréal, Quebec, Canada, H1T1C8
        • Institute de Cardiologie de Montreal (Montreal Heart Inst.)
      • Montréal, Quebec, Canada, H4J1C5
        • Hopital du Sacre-Coeur de
  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital
    • N China
      • Changchun, N China, China, 130041
        • The Second Hospital of Jilin University
  • Germany
      • Berlin, Germany, 12200
        • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
      • Hamburg, Germany, 20246
        • UKE Hamburg (Universitatsklinik Eppendorf)
    • Bad-Wur
      • Bad Krozingen, Bad-Wur, Germany, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • N. Rhin
      • Essen, N. Rhin, Germany, 45138
        • Elisabeth-Krankenhaus Essen GmbH
    • Rhinela
      • Mainz, Rhinela, Germany, 55131
        • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzLangenbeckstrasse
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Herzzentrum Leipzig GmbH04289
    • Schlesw
      • Bad Segeberg, Schlesw, Germany, 23795
        • Segeberger Kliniken GmbH Am Kurpark 1
  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital
      • Hong Kong, Hong Kong, 1928
        • The University of Hong Kong (Queen Mary Hospital)
  • Italy
    • Campani
      • Napoli, Campani, Italy, 80122
        • Clinica Mediterranea
      • Napoli, Campani, Italy, 80138
        • AOU Federico II - Università degli Studi di Napoli
    • Emi-rom
      • Cona, Emi-rom, Italy, 44124
        • Az.Osp. Universitaria di Ferrara
      • Parma, Emi-rom, Italy, 43126
        • AOU di Parma
    • Latium
      • Roma, Latium, Italy, 00168
        • Policlinico Universitario A. Gemelli
      • Rome, Latium, Italy, 00161
        • Azienda Ospedaliero Universitaria Policlinico Umberto I
    • Lombard
      • Milano, Lombard, Italy, 20138
        • Centro Cardiologico Monzino
      • Rozzano, Lombard, Italy, 20089
        • Istituto Clinico Humanitas
  • Netherlands
    • Drenthe
      • Emmen, Drenthe, Netherlands, 7824
        • Scheperziekenhuis Boermarkeweg
    • Friesld
      • Leeuwarden, Friesld, Netherlands, 8934
        • Medisch Centrum Leeuwarden
    • Zuid
      • Dordrecht, Zuid, Netherlands, 3318
        • Albert Schweitzer Ziekenhuis Albert Schweitzerplaats
  • Portugal
    • Lisbon
      • Carnaxide, Lisbon, Portugal, 2799-523
        • Hospital de Santa Cruz
      • Lisboa, Lisbon, Portugal, 1649-035
        • Santa Maria Hospital
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169609
        • National Heart Centre
    • Singapore Central
      • Singapore, Singapore Central, Singapore, 308433
        • Tan Tock Seng Hospital
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario Doce de Octubre
    • Andalu
      • Málaga, Andalu, Spain, 29010
        • HCU Virgen de la Victoria Campus Universitario de Teatinos
    • Cantabr
      • Santander, Cantabr, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Catalon
      • Barcelona, Catalon, Spain, 08003
        • Hospital del Mar Passeig Maritim de la Barceloneta
      • Barcelona, Catalon, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
    • Cstleon
      • Valladolid, Cstleon, Spain, 47005
        • Hospital Clínico Universitario de Valladolid
    • Pontev
      • Vigo, Pontev, Spain, 36312
        • Hospital Álvaro Cunqueiro
  • Switzerland
      • Bern, Switzerland, 3010
        • Center Inselspital Bern
      • Luzern, Switzerland, 6004
        • Luzerner Kantonsspital
    • Basel
      • Aarau, Basel, Switzerland, 5001
        • Kantonsspital Aarau
  • Taiwan
    • NTaiwan
      • Linkou, NTaiwan, Taiwan, 333
        • Chang Gung Memorial Hospital
      • Taipei, NTaiwan, Taiwan, 10002
        • National Taiwan University Hospital
    • Ntaiwan
      • Taipei, Ntaiwan, Taiwan, 11217
        • Taipei Veterans General Hospital (VGH)
    • STailwan
      • Kaohsiung, STailwan, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
  • United Kingdom
    • Newcastle Upon Tyne
      • High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
    • Nirelnd
      • Portadown, Nirelnd, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital
    • Soeast
      • Southampton, Soeast, United Kingdom, SO16 6YD
        • Southampton University Hospital
    • Sowest
      • Bournemouth, Sowest, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Exeter, Sowest, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Phoenix Cardiovascular Research Group
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Healthcare Shea
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Clinic
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • Fremont, California, United States, 94538
        • Mission Cardiovascular Research Institute
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital - La Jolla
      • Pasadena, California, United States, 91109
        • Huntington Memorial Hospital
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente - Santa Clara
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Cardiology Associates of Fairfield County, PC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • Via Christi Regional Medical Center - St. Francis Campus
      • Wichita, Kansas, United States, 67226
        • Cardiovascular Research Institute of Kansas
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Isreal Deaconess Medical Center
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • McLaren Health Care Corporation
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Heart Center
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
      • New York, New York, United States, 10019
        • Mount Sinai Hospital
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Research Institute
      • Greensboro, North Carolina, United States, 27401
        • Cone Health Medical Group Heartcare
      • Raleigh, North Carolina, United States, 27607
        • NC Heart & Vascular Research
      • Winston-Salem, North Carolina, United States, 27157- 1045
        • Wake Forest University Medical Center Clinical Sciences
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16550
        • UPMC Hamot
      • Harrisburg, Pennsylvania, United States, 17105
        • Pinnacle Health System
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian Medical Center (PA)
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Reading, Pennsylvania, United States, 19605
        • St. Joseph Medical Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford USD Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • East Tennessee Heart Consultants
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Dallas, Texas, United States, 75226
        • Baylor Scott and White Heart and Vascular Hospital
      • New Braunfels, Texas, United States, 78130
        • Mission Research Institute
      • Richardson, Texas, United States, 75082
        • HeartPlace Methodist Richardson
      • Tyler, Texas, United States, 75701
        • East Texas Medical Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Mary Washington Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:

    1. ≥ 75 years of age.
    2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
    3. History of major bleeding which required medical attention within 12 months of the index procedure.
    4. History of stroke (ischemic or hemorrhagic).
    5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
    6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm3, or any known coagulation disorder associated with increased bleeding risk).
    7. Anemia with hemoglobin < 11g/dl.
  2. Subject must be at least 18 years of age.
  3. Subject must provide written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site prior to any trial related procedure.
  4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
  5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure, except for cases where subject is transferred to the XIENCE 90 study after the 1-month visit assessment

Angiographic Inclusion Criteria

  1. Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note:

    • The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
    • If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
  2. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  3. Exclusive use of XIENCE family of stent systems during the index procedure.
  4. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria:

  1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
  2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  4. Subject has a known left ventricular ejection fraction (LVEF) <30%.
  5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
  6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
  7. Subject with a current medical condition with a life expectancy of less than 12 months.
  8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Transferring to the XIENCE 90 study will not be an exclusion criterion.
  9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

  1. Target lesion is in a left main location.
  2. Target lesion is located within an arterial or saphenous vein graft.
  3. Target lesion is restenotic from a previous stent implantation.
  4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
  5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XIENCE
XIENCE + 1 month DAPT
Device: XIENCE
Subjects who received XIENCE family stent systems will be included.
Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor)
"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Other Names:
  • Dual antiplatelet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile
Time Frame: From 1 to 6 months

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

MI Definition (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Peripheral MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 1 to 6 months
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile
Time Frame: From 6 to 12 months

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

MI Definition (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Peripheral MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 6 to 12 months
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile
Time Frame: From 1 to 12 months

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

MI Definition (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Peripheral MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 1 to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles
Time Frame: From 1 to 6 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

  • Type 2: Any overt, actionable sign of hemorrhage
  • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation
From 1 to 6 months
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles
Time Frame: From 6 to 12 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

  • Type 2: Any overt, actionable sign of hemorrhage
  • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation
From 6 to 12 months
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles
Time Frame: From 1 to 12 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

  • Type 2: Any overt, actionable sign of hemorrhage
  • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation
From 1 to 12 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Time Frame: From 1 to 6 months

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
From 1 to 6 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Time Frame: From 6 to 12 months

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
From 6 to 12 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Time Frame: From 1 to 12 months

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
From 1 to 12 months
Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)
Time Frame: From 1 to 6 months

All Death:

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Vascular death:

Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death:

Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
From 1 to 6 months
Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)
Time Frame: From 6 to 12 months

All Death:

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Vascular death:

Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death:

Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
From 6 to 12 months
Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)
Time Frame: From 1 to 12 months

All Death:

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Vascular death:

Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death:

Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
From 1 to 12 months
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Time Frame: From 1 to 6 months

All Myocardial Infarction (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
From 1 to 6 months
Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Time Frame: From 6 to 12 months

All Myocardial Infarction (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
From 6 to 12 months
Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Time Frame: From 1 to 12 months

All Myocardial Infarction (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
From 1 to 12 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Time Frame: From 1 to 6 months

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 1 to 6 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Time Frame: From 6 to 12 months

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 6 to 12 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Time Frame: From 1 to 12 months

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 1 to 12 months
Number of Participants With Composite of All Death or All MI (Modified ARC)
Time Frame: From 1 to 6 months

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 1 to 6 months
Number of Participants With Composite of All Death or All MI (Modified ARC)
Time Frame: From 6 to 12 months

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 6 to 12 months
Number of Participants With Composite of All Death or All MI (Modified ARC)
Time Frame: From 1 to 12 months

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
From 1 to 12 months
Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)
Time Frame: From 1 to 6 months

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
From 1 to 6 months
Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)
Time Frame: From 6 to 12 months

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
From 6 to 12 months
Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)
Time Frame: From 1 to 12 months

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
From 1 to 12 months
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time Frame: From 1 to 6 months

Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

Clinically Indicated [CI] Revascularization:

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test
  • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
From 1 to 6 months
Number of Participants With CI-TLR
Time Frame: From 6 to 12 months

Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

Clinically Indicated [CI] Revascularization:

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test
  • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
From 6 to 12 months
Number of Participants With CI-TLR
Time Frame: From 1 to 12 months

Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

Clinically Indicated [CI] Revascularization:

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test
  • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
From 1 to 12 months
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time Frame: From 1 to 6 months

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
From 1 to 6 months
Number of Participants With CI-TVR
Time Frame: From 6 to 12 months

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
From 6 to 12 months
Number of Participants With CI-TVR
Time Frame: From 1 to 12 months

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
From 1 to 12 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Time Frame: From 1 to 6 months
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
From 1 to 6 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Time Frame: From 6 to 12 months
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
From 6 to 12 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Time Frame: From 1 to 12 months
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
From 1 to 12 months
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
Time Frame: From 1 to 6 months
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
From 1 to 6 months
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
Time Frame: From 6 to 12 months
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
From 6 to 12 months
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
Time Frame: From 1 to 12 months
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
From 1 to 12 months
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
Time Frame: From 1 to 6 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

  • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation
From 1 to 6 months
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
Time Frame: From 6 to 12 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

  • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation
From 6 to 12 months
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
Time Frame: From 1 to 12 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

  • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation
From 1 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Roxana Mehran, MD, Mount Sinai Medical Center,New York, NY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

August 14, 2020

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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