Table 1

Inclusion/Exclusion Criteria

Inclusion CriteriaExclusion Criteria
General
  • 1. Patient must be at least 18 years of age.

  • 2. Written informed consent prior to any study-related procedure.

  • 3. MVD, as documented by coronary angiography, i.e., presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels (15).

  • 4. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the ECG consistent with ischemia).

  • 5. Patient must be an acceptable candidate for CABG surgery.

  • 6. Patient must agree to undergo all protocol-required follow-up examinations.

  • 1. Patient has had a known diagnosis of AMI within 72 h preceding the index procedure (nonprocedural/spontaneous MI, CK-MB ≥2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure.

  • 2. Patient has a known LVEF <30%.

  • 3. Patient is receiving chronic anticoagulation therapy.

  • 4. Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

  • 5. Elective surgery is planned within the first 9 months (±14 days) after the procedure that will require discontinuing either aspirin or clopidogrel.

  • 6. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).

  • 7. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis).

  • 8. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

  • 9. Patient has had a CVA or TIA within the past 6 months.

  • 10. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol, confound the data interpretation, or is associated with a limited life expectancy (i.e., <1 year).

  • 11. Patient is already participating in another investigational-use device or drug study or has completed the follow-up phase of another study within the last 30 days.

Angiographic
  • 7. Patients may receive up to 4 planned XIENCE V EES stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in 1 or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents.

  • 8. Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).

  • 9. Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.

  • 10. Target lesion <28 mm by visual estimation.

  • 12. Target lesion meets any of the following criteria:

    • Left main location.

    • Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and >20% stenosed lesion by visual estimation).

    • Heavy calcification.

  • 13. The patient may need more than 4 planned stents.

AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CK = creatine kinase; CK-MB = creatine kinase–myocardial band; CVA = cerebrovascular accident; ECG = electrocardiogram; EES = everolimus-eluting stent; LVEF = left ventricular ejection fraction; MI = myocardial infarction; MVD = minimal vessel diameter; PCI = percutaneous coronary intervention; TIA = transient ischemic attack; WBC = white blood cell count.