XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.

A Safety Evaluation of 3-month Dual Antiplatelet Therapy in Subjects at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention With XIENCE.

XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents.

The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS, XIENCE PRO^X EECSS [rebrand of the XIENCE Xpedition Stent System and is only available outside of the United States (OUS)], XIENCE PRO^A EECSS (rebrand of the XIENCE Alpine Stent System and is only available OUS) and XIENCE Sierra EECSS of coronary drug-eluting stents.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Lesions
• Intervention / Treatment: Device: XIENCE; Drug: DAPT

Detailed Description

A. Primary Objective:

To show non-inferiority of the primary endpoint of all death or all MI (modified ARC) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT compared to a historical control after propensity score adjustment.

B. Secondary Objective:

• To show superiority of the major secondary endpoint of major bleeding (Bleeding Academic Research Consortium [BARC] type 2-5) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT compared to a historical control after propensity score adjustment.
• To evaluate stent thrombosis (ARC definite/probable) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT against a performance goal (PG).

All registered subjects will be followed at 3, 6 and 12 months post index procedure.

The data collected from this study will be compared 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, which is a US post-approval study to evaluate the safety of XIENCE V EECSS in "all-comer" population under real-world setting.

• Study Type: Interventional
• Enrollment (Actual): 2047
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital (Heart Center Research LLC)
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare Hospitals (d/b/a HonorHealth - HonorHealth Research Institute)
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Concord, California, United States, 94520
      • John Muir Health Concord
    • Fremont, California, United States, 94538
      • Washington Hospital (Mission Cardiovascular Research Institute)
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital/Prebys Cardiovascular Institute
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Diego, California, United States, 91942
      • Sharp Grossmont Hospital (La Mesa Cardiac Center)
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital / San Diego Cardiac Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital/Sansum Clinic
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Clearwater, Florida, United States, 33756
      • Morton Plant Mease Healthcare System
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovasular Consultants
    • Gainesville, Florida, United States, 32605
      • North Florida Regional / The Cardiac and Vascular Institute
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center (St. Vincent's Healthcare)
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital / Tallahassee Research Institute, Inc.
  • Georgia
    • Augusta, Georgia, United States, 30901
      • University Health, INC/University Cardiology Associates, LLC
    • Augusta, Georgia, United States, 30912
      • Augusta Medical Center
    • Decatur, Georgia, United States, 30033
      • Atlanta Veterans Affairs Medical Center
    • Gainesville, Georgia, United States, 30501
      • North Georgia Heart Foundation, Inc.
  • Illinois
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart General Hospital/Midwest Cardiology Research & Education Foundation
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Physician Network-Indiana Heart Physicians
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas/Via Christi Regional Medical
    • Wichita, Kansas, United States, 67226
      • Kansas Heart Hospital (Cardiovascular Research Institute of Kansas)
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Gill Heart and Vascular Institute
    • Louisville, Kentucky, United States, 40207
      • Baptist Health Louisville/Louisville Cardiology
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center/One Northeast Drive
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic/Lahey Hospital and Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay Region
    • Detroit, Michigan, United States, 48236
      • St John Hospital & Medical Center
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center (Regional Cardiology Associates)
    • Kalamazoo, Michigan, United States, 49048
      • Western Michigan University Homer Stryker M.D. School of Medicine
    • Midland, Michigan, United States, 48670
      • MidMichigan Medical Center Midland
    • Traverse City, Michigan, United States, 49684
      • Traverse Heart and Vascular Munson Medical Center
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital (Michigan Heart)
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital (Minneapolis Heart Institute Foundation)
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • St Dominic-Jackson Memorial Hospital (Jackson Heart Clinic)
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center (Cardiology Associates Research)
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Boone Hospital Center (Missouri Cardiovascular Specialists)
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital/Mid America Heart Institute
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine Barnes Jewish Hospital
  • Montana
    • Missoula, Montana, United States, 59802
      • St. Patrick Hospital International Heart Institute of Montana Foundation
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Local General Hospital (Bryan Medical Center East)
  • New Jersey
    • Camden, New Jersey, United States, 08035
      • Our Lady of Lourdes/Cardiovascular Associates of the Delaware Valley (The Heart House)
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • East Syracuse, New York, United States, 13057
      • St. Joseph's Hospital Health Center
    • Flushing, New York, United States, 11355
      • New York - Presbyterian Queens Lang Research Center
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital - Weill Cornell
    • New York, New York, United States, 10075
      • Lenox Hill Hospital (Northwell)/ Feinstein Institute
    • Stony Brook, New York, United States, 11794-8167
      • Stony Brook University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • The Presbyterian Hospital (d/b/a Novant Health Heart and Vascular Institute) Novant Health Clinical Research
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center (Wake Forest University Health Sciences)/Medical Center Boulevard
  • Ohio
    • Cleveland, Ohio, United States, 44266
      • University Hospitals Cleveland Medical Center
    • Toledo, Ohio, United States, 43608
      • Cardiovascular Research Center, LLC (Mercy Health St. Vincent Medical Center LLC)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center/Integris Cardiovascular Physicians, LLC
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center (Oklahoma Heart Institute)
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Hospital
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Erie, Pennsylvania, United States, 16507
      • UPMC Hamot/Medicor Associates, Inc.,
    • Harrisburg, Pennsylvania, United States, 17101
      • Harrisburg Hospital/Pinnacle Health Cardiovascular Institute, Inc.
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center/Penn Heart and Vascular Pavilion,
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
    • Pittsburgh, Pennsylvania, United States, 15220
      • Allegheny General Hospital
    • Wyomissing, Pennsylvania, United States, 19610
      • St. Joseph Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Clinical Research
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Health
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center (Knoxville HMA Cardiology, LLC)
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center (TriStar Centennial Medical Center)
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann-Hermann Hospital/UTHealth
    • Lubbock, Texas, United States, 79430-7520
      • Texas Tech University Health (University Medical Center)
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital/Inova Heart and Vascular Institute
    • Fredericksburg, Virginia, United States, 22401
      • Mary Washington Hospital/Virginia Cardiovascular Consultants
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center Memorial Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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 > 3-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/mm^3, 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 or a legally authorized representative must provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, 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.

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 patient 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 ≤ 32 mm in length by visual estimation.
3. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
4. Exclusive use of XIENCE family of stent systems during the index procedure.
5. 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 > 0.5 mm or depression lasting > 5 minutes.

General 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 9 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 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months 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.

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.

   Note: Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population

10. Subject is part of a vulnerable population, defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, 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.
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 total occluded lesion (TIMI flow 0).
5. Target lesion contains thrombus as indicated in the angiographic images (per SYNTAX score thrombus definition).
6. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: XIENCE; Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

Device: XIENCE; Subjects who received XIENCE family stent systems will be included.; Drug: DAPT; 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days. Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.; 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 Quintiles	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 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, 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: CK-MB > URL or Troponin > URL with baseline value < UR The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome & the baseline demographic, clinical and procedural covariates as the predictors	From 3 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles	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: ICH; 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 or packed RBC within 48h;Chest tube output ≥ 2L within 24h; Type 5: Fatal bleeding The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome & the baseline demographic, clinical and procedural covariates as the predictors.	From 3 to 12 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable)	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 3 to 12 months
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death	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. 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 3 to 12 months
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)	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 < URLWithin 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 3 to 12 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	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 URL with baseline value < URLWithin 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 3 to 12 months
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke	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 3 to 12 months
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)	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 3 to 12 months
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)	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 3 to 12 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.	From 3 to 12 months
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.	From 3 to 12 months
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	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 or imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding or autopsy or imaging confirmation	From 3 to 12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Roxana Mehran, Abbott Medical Devices

Publications and helpful links

General Publications

• Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074.
• Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): September 4, 2020

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: XIENCE; Drug-eluting stents; Coronary Artery Lesions; Dual Antiplatelet Therapy (DAPT); Reduced DAPT; Risk of bleeding
• Other Study ID Numbers: 16-308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes