XIENCE 28 USA Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 1,605
- Locations
- 111
- Primary Endpoint
- Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Angiographic Inclusion Criteria
- •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.
- •Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
- •Exclusive use of XIENCE family of stent systems during the index procedure.
- •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
- •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.
- •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.
- •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.
- •Angiographic Exclusion Criteria
- •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.
Arms & Interventions
XIENCE
XIENCE + 1 month DAPT
Intervention: XIENCE (Device)
XIENCE
XIENCE + 1 month DAPT
Intervention: DAPT (aspirin and/or P2Y12 receptor inhibitor) (Drug)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)(From 1 to 12 months)
- 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 1 to 12 months)
- Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)(From 1 to 12 months)
- Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)(From 1 to 6 months)
- Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)(From 1 to 12 months)
- Number of Participants With Composite of Cardiac Death or MI (Modified ARC)(From 1 to 12 months)
- Number of Participants With Composite of All Death or All MI (Modified ARC)(From 1 to 12 months)
- Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)(From 1 to 12 months)
- Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)(From 1 to 6 months)
- Number of Participants With CI-TVR(From 1 to 12 months)
- Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)(From 1 to 12 months)
- Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)(From 1 to 12 months)
- Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5(From 1 to 12 months)
- Number of Participants With CI-TLR(From 1 to 12 months)
- Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)(From 1 to 6 months)