Long-term (>3 Years) outcome and predictors of clinical events after insertion of sirolimus-eluting stent in one or more native coronary arteries (from the Israeli arm of the e-Cypher registry).

The aim of this study was to evaluate long-term (3.4 years) outcomes and predictors of clinical events in patients treated with sirolimus-eluting stents in the Israeli arm of the e-Cypher registry. From July 2002 to October 2003, 488 patients from 8 medical centers in Israel were enrolled in the e-Cypher registry. Nineteen patients with interventions in venous grafts were excluded from the final analysis. Long-term follow-up was completed for 98% of the remaining patients. There were 29 cases (6.3%) of death (3.9% cardiac and 2.4% noncardiac deaths). According to the broad academic research consortium definition of stent thrombosis, there were 19 cases (4%) of stent thrombosis (incidence density 0.9 cases/100 patient-years). There were 46 cases (9.9%) of target lesion revascularization and 76 cases (16.3%) of major adverse cardiac events (combination of death, myocardial infarction, and target lesion revascularization). Independent predictors of stent thrombosis were renal failure (hazard ratio 9.6, 95% confidence interval 1.9 to 47), stent length (hazard ratio 1.1, 95% confidence interval 1 to 1.2), and the off-label use of sirolimus-eluting stents (hazard ratio 5.3, 95% confidence interval 1.2 to 24). In conclusion, during >3 years of follow-up, stent thrombosis, major adverse cardiac events, and target lesion revascularization continued at constant rates over time. Clinical parameters such as renal failure and procedural parameters such as off-label use and stent length were independent predictors of stent thrombosis.

Short- and long-term outcomes of the titanium-NO stent registry.

BACKGROUND: Five to 15% of the population have allergy to nickel, chromium, or molybdenum, which is a potential cause for in-stent restenosis. The Titan stent is made of stainless steel and is coated with titanium-nitride oxide (TiNOX), which completely prevents the discharge of metal elements. We performed a real-life multicenter registry to assess the short- and long-term characteristics of the Titan stent. METHODS AND RESULTS: A total of 103 Titan stents was implanted in 100 patients. Patients were 61.4+/-12.6 years old (81 men). Risk factors included hypercholesterolemia (63%), hypertension (53%), diabetes mellitus (DM; 35%), and current smoking (23%). Indications for PCI (percutaneous coronary intervention) were acute coronary syndromes (ACS) in 68% [acute ST elevation myocardial infarction (MI) in 8%], stable AP (angina pectoris) in 25%, and silent ischemia in 7% of the patients. Fifty-two percent of the treated lesions were of Type B2 or C. Lesion length was 14.3+/-2.9 mm and stent diameter was 3.06+/-0.36 mm. Indications for stenting were prevention of restenosis in 66%, residual stenosis in 33%, dissection in 13%, acute MI in 13%, and in-stent restenosis in 7% of the patients. Procedural success was 100%, with no complications. At 30 days, there were no major adverse cardiac events (MACE), including death, MI, and revascularization. At 180 days, only three patients had TVR (target vessel revascularization); two had TLR (target lesion revascularization) (one PCI and one CABG [coronary artery bypass grafting]), and one patient had a new narrowing proximal to the stent and underwent CABG due to multivessel disease. CONCLUSIONS: The Titan stent has a remarkable safety profile in high-risk patients and complex coronary lesions and excellent short- and long-term outcome with a very low clinical TLR rate.

The Titanium-NO Stent:results of a multicenter registry.

BACKGROUND: Contemporary stents discharge nickel, chromium and molybdenum which might contribute to restenosis. The Titan stent is coated with titanium nitride-oxide that prevents completely discharge of metal elements. AIMS: To assess short and long term outcome of the Titan in a multi-centre registry. METHODS: Included were all patients except those in cardiogenic shock. Titan stents were 2.0-5.0 mm in diameter and 7-28 mm in length. Clinical follow-up was performed at 30 days and 6 months. RESULTS: Total of 333 Titan stents were implanted in 296 patients (age 68.8+/-11.8 years, 81% men). Risk factors included hypercholesterolaemia (61.3%), hypertension (51.3%), diabetes mellitus (DM) (36.6%) and current smoking (27.6%). Eighty-one percent of patients had Acute Coronary Syndrome (ACS). Sixty two percent of treated lesions were B2/C type. Lesion length was 17.5+/-14.8 mm and stent diameter was 3.0+/-2.12 mm.Procedural success was 99.7%. At 180 days, 6.3% of patients had a total of 7.6% MACE including 5.4% TLR, 0.7% MI, 0.7% stent thrombosis and 0.7% death. CONCLUSION: The Titan stent has a remarkable safety profile. Notwithstanding the highly complicated lesion and case mix, the short- and long-term results of this registry approach those of drug-eluting stents.