SECOND GENERATION DRUG ELUTING STENTS IMPLANTATION FOLLOWED BY SIX VERSUS TWELVE MONTH DUAL ANTIPLATELET THERAPY.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria
1. 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, according to the usual practice of the centre.
2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary
artery, treated with a second generation drug eluting stent
3. Patient is > 18 years of age (or minimum age as required by local regulations).
4. The patient has consented to participate by signing the *Patient Informed Consent Form*.
5. The patient is willing and able to cooperate with study procedures and required follow up
visits.
6. Any type of lesion or number of lesion can be included in this trial unless specifically
detailed in the exclusion criteria.
7. At least one second generation DES implanted in the target lesion in the last 24 hours.
8. No other DES implanted before the target procedure
9. No BMS implanted in the 3 months before the target procedure

Exclusion Criteria

1. Patients treated for lesions in venous or arterial grafts.
2. Patients treated for in-stent restenosis.
3. Patients treated for Unprotected Left Main lesions.
4. ST elevation myocardial infarction in the 48 hours prior to the procedure.
5. Non ST elevation myocardial infarction in the previous six months.
6. Patients with LVEF<=30%.
7. Women with known pregnancy or who are lactating.
8. Patients with hypersensitivity or allergies to heparin,, drugs such as ABT-578, or any other
analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
9. Patients with chronic renal insufficiency (creatinine >2mg or mg or 180 mmol/l)
10. Contraindication to the use of thienopyridines and/or ASA:
a. History of drug allergy to thienopyridine derivatives or ASA;
b. History of clinically significant or persistent thrombocytopenia or neutropenia
11. Active bleeding or significant risk of bleeding, such as elderly patients receiving fibrinolytic
therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic
ulceration., proliferative diabetic retinopathy.
12. Uncontrolled hypertension.
13. Current medical condition with a life expectancy of less than 24 months.
14. 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.
15. Patients with medical conditions that preclude the follow-up as defined in the protocol or that
otherwise limits participation in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the composite of cardiac death, myocardial infarction,<br /><br>stroke, definite or probable stent thrombosis or BARC type 2, 3 or 5 bleeding<br /><br>at 12 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• the composite of cardiac death, myocardial infarction, stroke, definite<br /><br>or probable stent thrombosis or BARC type 2, 3 or 5 bleeding at 24 months<br /><br>• cumulative occurrence of the individual components of the primary<br /><br>endpoint at 12 and 24 months<br /><br>• Myocardial infarction at 30 days, 6, 12 and 24 months<br /><br>• Urgent target vessel revascularization (cardiac bypass surgery, or repeat<br /><br>PTCA) at 30 days, 6, 12 and 24 months<br /><br>• Possible stent thrombosis rate between 6 and 24 months<br /><br>• Economic evaluation and comparison between the two arms at 24<br /><br>months<br /><br>• All bleeding events (major and minor)<br /><br>• All cause mortality at 6, 12 and 24 months</p><br>

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