Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy

Prospective, randomized, non-inferiority, multicenter, international study.In total 4000 patients (70 centers in Europe) with de novo lesions in native coronary arteries who meet the eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a second generation DES implantation.

Assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail).

If the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05 (two-tails).

The maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 % more thrombotic events has to be considered together with the lower expected number of bleeding events in the 6-months regimen.

All the analysis will be done as "intention-to-treat" analysis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent
* Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a Resolute drug eluting stent
* Patient is \> 18 years of age (or minimum age as required by local regulations).
* The patient has consented to participate by signing the "Patient Informed Consent Form""
* The patient is willing and able to cooperate with study procedures and required follow up visits
* Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the exclusion criteria.
* At least one second generation DES implanted in the target lesion in the last 24 hours
* No other DES implanted before the target procedure
* No BMS implanted in the 12 months before the target procedure

Exclusion Criteria:

* Patients treated for lesions in venous or arterial grafts
* Patients treated for in-stent restenosis
* Patients treated for Unprotected Left Main lesions
* ST elevation myocardial infarction in the 48 hours prior to the procedure
* Non ST elevation myocardial infarction
* Patients with LVEF≤30%
* Women with known pregnancy or who are lactating
* Patients with hypersensitivity or allergies to hepari, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
* Patients with chronic renal insufficiency
* Contraindication to the use of clopidogrel and/or ASA:

  * History of drug allergy to thienopyridine derivatives or ASA
  * History of clinically significant or persistent thrombocytopenia or neutropenia
  * Active bleeding or significant risk of bleeding, such as elderly patients receining fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
  * Uncontrolled hypertension
* Current medical condition with a life expectancy of less than 24 months.
* The subject is participating in another device or drug study
* Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial.
* Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study