XIENCE 28 USA Study

NCT ID: NCT03815175

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2021-02-04

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XIENCE

XIENCE + 1 month DAPT

Group Type: EXPERIMENTAL

XIENCE

Intervention Type: DEVICE

Subjects who received XIENCE family stent systems will be included.

DAPT (aspirin and/or P2Y12 receptor inhibitor)

Intervention Type: 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.

Interventions

XIENCE

Subjects who received XIENCE family stent systems will be included.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

Dual antiplatelet therapy

Eligibility Criteria

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roxana Mehran, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Medical Center,New York, NY

Locations

Heart Center Research, LLC

Huntsville, Alabama, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Scottsdale Healthcare Shea

Scottsdale, Arizona, United States

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Scripps Memorial Hospital - La Jolla

La Jolla, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Kaiser Permanente - Santa Clara

Santa Clara, California, United States

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, United States

Washington Hospital Center

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

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Morton Plant Hospital

Clearwater, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Redmond Regional Medical Center

Rome, Georgia, United States

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

McLaren Health Care Corporation

Auburn Hills, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Missouri Heart Center

Columbia, Missouri, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Mount Sinai Hospital

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St. Joseph's Hospital Health Center

Syracuse, New York, United States

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, United States

Cone Health Medical Group Heartcare

Greensboro, North Carolina, United States

NC Heart & Vascular Research

Raleigh, North Carolina, United States

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, United States

Kettering Medical Center

Kettering, Ohio, United States

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

UPMC Hamot

Erie, Pennsylvania, United States

Pinnacle Health System

Harrisburg, Pennsylvania, United States

Presbyterian Medical Center (PA)

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

St. Joseph Medical Center

Reading, Pennsylvania, United States

Anmed Health

Anderson, South Carolina, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

East Tennessee Heart Consultants

Knoxville, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Austin Heart

Austin, Texas, United States

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, United States

Mission Research Institute

New Braunfels, Texas, United States

HeartPlace Methodist Richardson

Richardson, Texas, United States

East Texas Medical Center

Tyler, Texas, United States

Mary Washington Hospital

Fredericksburg, Virginia, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Kepler Universitätsklinikum GmbH

Linz, UPR AUS, Austria

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, Belgium

UZ Gent

Ghent, Flemish, Belgium

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Jesse Ziekenhuis Campus Virga Jesse

Limbourg, , Belgium

Foothills Medical Centre

Calgary, Alberta, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, Canada

Institute de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Hopital du Sacre-Coeur de

Montreal, Quebec, Canada

Beijing AnZhen Hospital

Beijing, Beijing Municipality, China

The Second Hospital of Jilin University

Changchun, N China, China

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Bad-Wur, Germany

Elisabeth-Krankenhaus Essen GmbH

Essen, N. Rhin, Germany

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzLangenbeckstrasse

Mainz, Rhinela, Germany

Herzzentrum Leipzig GmbH04289

Leipzig, Saxony, Germany

Segeberger Kliniken GmbH Am Kurpark 1

Bad Segeberg, Schlesw, Germany

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, , Germany

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, , Germany

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, , Hong Kong

Prince of Wales Hospital

Hong Kong, , Hong Kong

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Clinica Mediterranea

Napoli, Campani, Italy

AOU Federico II - Università degli Studi di Napoli

Napoli, Campani, Italy

Az.Osp. Universitaria di Ferrara

Cona, Emi-rom, Italy

AOU di Parma

Parma, Emi-rom, Italy

Azienda Ospedaliero Universitaria Policlinico Umberto I

Rome, Lazio, Italy

Policlinico Universitario A. Gemelli

Rome, Lazio, Italy

Centro Cardiologico Monzino

Milan, Lombard, Italy

Istituto Clinico Humanitas

Rozzano, Lombard, Italy

Scheperziekenhuis Boermarkeweg

Emmen, Drenthe, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Friesld, Netherlands

Albert Schweitzer Ziekenhuis Albert Schweitzerplaats

Dordrecht, Zuid, Netherlands

Hospital de Santa Cruz

Carnaxide, Lisbon District, Portugal

Santa Maria Hospital

Lisbon, Lisbon District, Portugal

National Heart Centre

Singapore, Central Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore Central, Singapore

HCU Virgen de la Victoria Campus Universitario de Teatinos

Málaga, Andalu, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, Spain

Hospital del Mar Passeig Maritim de la Barceloneta

Barcelona, Catalon, Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Cstleon, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontev, Spain

Hospital Universitario Doce de Octubre

Madrid, , Spain

Kantonsspital Aarau

Aarau, Basel, Switzerland

Center Inselspital Bern

Bern, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Chang Gung Memorial Hospital

Linkou District, NTaiwan, Taiwan

National Taiwan University Hospital

Taipei, NTaiwan, Taiwan

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, STailwan, Taiwan

Freeman Hospital

High Heaton, Newcastle Upon Tyne, United Kingdom

Craigavon Area Hospital

Portadown, Nirelnd, United Kingdom

Southampton University Hospital

Southampton, Soeast, United Kingdom

Royal Bournemouth Hospital

Bournemouth, Sowest, United Kingdom

Royal Devon & Exeter Hospital

Exeter, Sowest, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

Countries

United States; Austria; Belgium; Canada; China; Germany; Hong Kong; Italy; Netherlands; Portugal; Singapore; Spain; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34794687 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33031789 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10402

Identifier Type: -

Identifier Source: org_study_id