XIENCE 28 USA Study

NCT03815175 | Completed Results DMC FDA Device

• 1 other identifier: ABT-CIP-10402
• Study Type: interventional
• Target: 1,605
• Locations: 15 countries
• Sites: 111

Brief Summary

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.

Conditions

Bleeding Disorder; Ischemic Stroke; Hemorrhagic Stroke; Hematological Diseases; Thrombocytopenia; Coagulation Disorder; Anemia; Renal Insufficiency; Coronary Artery Disease

Keywords

High Bleeding Risk (HBR); Dual antiplatelet therapy (DAPT); Drug eluting stent (DES); XIENCE; Percutaneous coronary intervention (PCI); Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile

  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

  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

  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 Outcomes (36)

• Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles

  From 1 to 6 months

• Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles

  From 6 to 12 months

• Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles

  From 1 to 12 months

• Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

  From 1 to 6 months

• Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

  From 6 to 12 months

Study Arms (1)

XIENCE

EXPERIMENTAL

XIENCE + 1 month DAPT

Device: XIENCE; Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor)

Interventions

XIENCE DEVICE

Subjects who received XIENCE family stent systems will be included.

XIENCE

DAPT (aspirin and/or P2Y12 receptor inhibitor) DRUG

"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.

Also known as: Dual antiplatelet therapy

XIENCE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥ 75 years of age.
• Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
• History of major bleeding which required medical attention within 12 months of the index procedure.
• History of stroke (ischemic or hemorrhagic).
• Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
• 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).
• Anemia with hemoglobin \< 11g/dl.
• Subject must be at least 18 years of age.
• 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.
• Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
• 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
• 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.

You may not qualify if:

• Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
• 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.
• Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
• Subject has a known left ventricular ejection fraction (LVEF) \<30%.
• Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
• Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
• Subject with a current medical condition with a life expectancy of less than 12 months.
• 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.
• 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.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Target lesion is in a left main location.
• Target lesion is located within an arterial or saphenous vein graft.
• Target lesion is restenotic from a previous stent implantation.
• Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
• Target lesion is implanted with overlapping stents, whether planned or for bailout.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (111)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Scottsdale Healthcare Shea

Scottsdale, Arizona, 85260, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Scripps Memorial Hospital - La Jolla

La Jolla, California, 92037, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91109, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Kaiser Permanente - Santa Clara

Santa Clara, California, 95051, United States

Location

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, 06851, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214-3882, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

McLaren Health Care Corporation

Auburn Hills, Michigan, 48326, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Missouri Heart Center

Columbia, Missouri, 65201, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Mount Sinai Hospital

New York, New York, 10019, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, 28204, United States

Location

Cone Health Medical Group Heartcare

Greensboro, North Carolina, 27401, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, 27157- 1045, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States

Location

Presbyterian Medical Center (PA)

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

St. Joseph Medical Center

Reading, Pennsylvania, 19605, United States

Location

Anmed Health

Anderson, South Carolina, 29621, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

East Tennessee Heart Consultants

Knoxville, Tennessee, 37920, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Mission Research Institute

New Braunfels, Texas, 78130, United States

Location

HeartPlace Methodist Richardson

Richardson, Texas, 75082, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Mary Washington Hospital

Fredericksburg, Virginia, 22401, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Kepler Universitätsklinikum GmbH

Linz, UPR AUS, 4021, Austria

Location

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, 9300, Belgium

Location

UZ Gent

Ghent, Flemish, 42100, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Jesse Ziekenhuis Campus Virga Jesse

Limbourg, 3500, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, E2L4L2, Canada

Location

Institute de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T1C8, Canada

Location

Hopital du Sacre-Coeur de

Montreal, Quebec, H4J1C5, Canada

Location

Beijing AnZhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

The Second Hospital of Jilin University

Changchun, N China, 130041, China

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Bad-Wur, 79189, Germany

Location

Elisabeth-Krankenhaus Essen GmbH

Essen, N. Rhin, 45138, Germany

Location

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzLangenbeckstrasse

Mainz, Rhinela, 55131, Germany

Location

Herzzentrum Leipzig GmbH04289

Leipzig, Saxony, 04289, Germany

Location

Segeberger Kliniken GmbH Am Kurpark 1

Bad Segeberg, Schlesw, 23795, Germany

Location

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12200, Germany

Location

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, 20246, Germany

Location

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, 1928, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Clinica Mediterranea

Napoli, Campani, 80122, Italy

Location

AOU Federico II - Università degli Studi di Napoli

Napoli, Campani, 80138, Italy

Location

Az.Osp. Universitaria di Ferrara

Cona, Emi-rom, 44124, Italy

Location

AOU di Parma

Parma, Emi-rom, 43126, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Umberto I

Rome, Lazio, 00161, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

Location

Centro Cardiologico Monzino

Milan, Lombard, 20138, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombard, 20089, Italy

Location

Scheperziekenhuis Boermarkeweg

Emmen, Drenthe, 7824, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Friesld, 8934, Netherlands

Location

Albert Schweitzer Ziekenhuis Albert Schweitzerplaats

Dordrecht, Zuid, 3318, Netherlands

Location

Hospital de Santa Cruz

Carnaxide, Lisbon District, 2799-523, Portugal

Location

Santa Maria Hospital

Lisbon, Lisbon District, 1649-035, Portugal

Location

National Heart Centre

Singapore, Central Singapore, 169609, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore Central, 308433, Singapore

Location

HCU Virgen de la Victoria Campus Universitario de Teatinos

Málaga, Andalu, 29010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, 39008, Spain

Location

Hospital del Mar Passeig Maritim de la Barceloneta

Barcelona, Catalon, 08003, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, 08036, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Cstleon, 47005, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Pontev, 36312, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, 28041, Spain

Location

Kantonsspital Aarau

Aarau, Basel, 5001, Switzerland

Location

Center Inselspital Bern

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6004, Switzerland

Location

Chang Gung Memorial Hospital

Linkou District, NTaiwan, 333, Taiwan

Location

National Taiwan University Hospital

Taipei, NTaiwan, 10002, Taiwan

Location

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, 11217, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, STailwan, 83301, Taiwan

Location

Freeman Hospital

High Heaton, Newcastle Upon Tyne, NE7 7DN, United Kingdom

Location

Craigavon Area Hospital

Portadown, Nirelnd, BT63 5QQ, United Kingdom

Location

Southampton University Hospital

Southampton, Soeast, SO16 6YD, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, Sowest, BH7 7DW, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, Sowest, EX2 5DW, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34794687 DERIVED

• 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.

  PMID: 33031789 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Ischemic Stroke; Hemorrhagic Stroke; Hematologic Diseases; Thrombocytopenia; Anemia; Renal Insufficiency; Coronary Artery Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Blood Platelet Disorders; Cytopenia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Lijuan Jenn Wang
• Organization: Abbott

Lijuan.wang1@abbott.com

01-408-8453133

Study Officials

• Roxana Mehran, MD

  Mount Sinai Medical Center,New York, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 24, 2019
• Study Start: February 25, 2019
• Primary Completion: August 14, 2020
• Study Completion: February 4, 2021
• Last Updated: May 3, 2022
• Results First Posted: December 14, 2021

Record last verified: 2022-04

Locations

GB (6); ES (7); PT (2); TW (4); CA (5); SG (2); HK (3); US (54); BE (4); IT (8); CN (2); NL (3); CH (3); DE (7); AU (1)