The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients

Hospital Universitario Infanta Cristina

Overview

Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent. The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients undergoing percutaneous coronary intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Diabetes Mellitus Percutaneous Coronary Intervention

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 18 years * Diabetes mellitus according to the World Health Organization Report * Percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft. * Informed Consent "signed" Exclusion Criteria: * Inclusion in another clinical research protocol * Pregnancy * STEMI within 48 hours * Unprotected left main disease * Restenotic lesions * Stent diameter \< 2,5 mm or \> 3,5 mm * Stent length more than 28 mm in \< 3 mm vessels * Chronic total occlusions * Allergy to aspirin, clopidogrel, heparin or abciximab * Active bleeding or a significant increase in bleeding risk * Significant renal insufficiency defined as creatinine \> 2 mg/dl * Severely depressed LV function (EF≤35%) * Cardiogenic shock * Ischemic stroke within the last 6 months * Contraindication for DES * Disease with life expectancy \< 12 months

Locations (8)

Heart Center, Satakunta Hospital, Pori, Finland

Satakunta, Pori, Finland

Hospital de Torrevieja

Torrevieja, Alicante, Spain

Hospital Universitario Infanta Cristina

Badajoz, Badajoz, Spain

Hospital Puerto Real de Cádiz

Puerto Real, Cadiz, Spain

Hospital Juan Ramón Jiménez de Huelva

Huelva, Huelva, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Virgen de la Salud de Toledo

Toledo, Toledo, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Outcomes

Primary Outcomes

Major adverse cardiac events

Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies.

Secondary Outcomes

Late luminal loss

Comparison of late luminal loss within the in-segment zone at 9 months between the two treatment strategies in the subgroup of patients with angiographic follow-up.