The main blood vessels that supply blood and nutrients to your heart are called coronary arteries. If one of your coronary arteries has a significant narrowing that is causing reduced blood flow to your heart, this can cause you to have pain in your chest, shortness of breath either on exercise or at rest, limitation of daily activities and/or other symptoms. You can be treated by placing one or more flexible metal mesh tubes coated with medication (called drug-eluting stent), inside the artery to keep it open. This can improve blood flow to the heart.
Antiplatelet drugs are blood thinning drugs that can prevent blood clots in your blood vessels which can cause a heart attack, stroke, and/or death. The standard of care following a stent procedure includes taking two types of antiplatelet drugs regularly for a period of time, known as dual (two) antiplatelet therapy (DAPT). These two types of antiplatelet drugs are: aspirin and P2Y12 inhibitor drug. P2Y12 inhibitor includes clopidogrel (Plavix®), prasugrel (Effient®), or ticagrelor (Brilinta®). All these drugs are Conformité Européene (“CE”) mark and Food and Drug Administration (“FDA”) approved.
However, the use of these blood thinning medicines can sometimes cause a higher risk of bleeding events. Currently, for coronary (heart) artery disease patients without recent heart attack or coronary procedure and who will receive drug-eluting stents, guidelines developed by an association of heart doctors recommend them to take aspirin indefinitely (no time limit) and P2Y12 inhibitors for at least 3 months if the patient is at high risk of bleeding (older age, history of major bleeding, stoke, anemia, or severe liver disease, etc.), and at least 6 months if the patient is not at high risk of bleeding.
This study is being done to evaluate the safety of taking the CE mark and FDA-approved P2Y12 inhibitor drug for 3 months with indefinite use of aspirin (no time limit) after the implantation of any commercially approved XIENCE stents for patients at high risk of bleeding.
The XIENCE stent is not being investigated in this Study, nor are the antiplatelet drugs. The purpose of the Study is to gather information on the use of the P2Y12 inhibitor drug for a short period of time (3 months) for patients receiving XIENCE stents.
Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute
3300 Gallows Road
Falls Church, VA 22042
General 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:
- a) ≥ 75 years of age.
b) Clinical indication for chronic or lifelong anticoagulation therapy.
c) History of major bleeding which required medical attention within 12 months of the index procedure.
d) History of stroke (ischemic or hemorrhagic).
e) Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
f) 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).
g) Anemia with hemoglobin < 11g/dl.
- Subject must be at least 18 years of age.
- 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.
- Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, 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.
Angiographic Inclusion Criteria
- Up to three target lesions with a maximum of two target lesions per epicardial vessel.
- Target lesion ≤ 32 mm in length by visual estimation.
- 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 instent 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 or depression lasting > 5 minutes.
General Exclusion Criteria:
- Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI) or non ST-segment elevation MI (NSTEMI), defined as acute ischemic symptoms occurring within 72 hours before index procedure and either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis (CK-MB [creatine kinase myocardial-band isoenzyme] or troponin T or I greater than the upper limit of normal; If CK-MB or troponin is not available, total CK (creatine kinase) > 2 times upper limit of normal).
- 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.
- Subjects who had additional clinically significant lesion(s) in target or non-target vessel for which PCI may be required within 12 months after the index procedure.
- 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 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
- Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months 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.
- 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.
- 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.
- 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 total occluded lesion (TIMI flow 0).
- Target lesion contains thrombus as indicated in the angiographic images.
- Target lesion is implanted with overlapping stents, whether planned or for bailout.