DESTINY TRIAL (Inspiron x Biomatrix)

This is a study of non-inferiority, multicentre, prospective, randomized into two treatment arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a total of 165 randomized patients.

Patients will be followed for 60 months after the procedure. All new patients will be undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months. It is anticipated that the total study duration is 72 months: 12 months to complete the admission of patients and 60 months of follow-up.

Inclusion criteria

• Age > 18 years;
• Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels;
• A(s) lesion(s) to target(m) must be:

• Again (not restenotic);
• Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual);
• Can be treated with a single stent up to 29 mm in length;
• Obstruction with stenosis > 50% diameter (visual);
• Acceptable candidate for CABG;
• The patient will be informed of the nature of the study, agree with their rules and provide a written informed consent approved by the local Ethics Committee.

Exclusion criteria

• Women of childbearing age with no history of surgical sterilization;
• Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure;
• Myocardial infarction with or without Q wave with cardiac markers even at high levels;
• Ejection fraction < 30%;
• Impaired renal function (creatinine> 2.0 mg / dl) or calculated creatinine clearance < 60 ml / min;
• Platelet count <100,000 cells/mm3 or > 700,000 cells/mm3;
• Total leukocyte count <3000 cells/mm3;
• Documented or suspected liver disease (including laboratory evidence of hepatitis);
• Heart transplant recipient;
• Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel;
• Patient with a life expectancy less than 12 months;
• Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study;
• Participation in other research in the last 12 months, unless there is direct benefit to the research subject;
• Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel;
• Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion;
• Coronary angioplasty (with or without stenting) scheduled in the first 12 months after the index procedure in any segment of the target vessel.

Exclusion criteria

angiographic

• Restenotic target lesion;
• Need for treatment for more than one lesion in the same vessel;
• Need for treatment with three or more lesions in the same procedure;
• Target vessel diameter <2.5 mm or> 3.5 mm (visual);
• Target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator;
• Lesion of the coronary artery unprotected ( > 50% stenosis);
• Angiographic thrombus;
• Target lesion in surgical graft;
• Total occlusion (TIMI anterograde flow 0 or 1);
• Ostial lesion;
• The target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting;
• Injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator;
• The target vessel with excessive tortuosity.