TCT-647 Value Of High-Density Lipoprotein Cholesterol In Predicting Future Cardiovascular Events Of Patients With Low-Density Lipoprotein Cholesterol At The Time Of Percutaneous Coronary Intervention

2012 
Background: Implantation of drug-eluting stents in long coronary artery lesions is associated with a higher risk for restenosis and stent thrombosis related to the need for multiple and overlapping stents. The Resolute zotarolimus-eluting stent (R-ZES) is manufactured in a 38 mm length to accommodate longer lesions but clinical data to demonstrate efficacy and safety of the longer stent have not been reported. Methods: A substudy of 2 prospective, multicenter clinical trials; RESOLUTE–US and RESOLUTE-Asia enrolled patients with de novo coronary artery lesions amenable to treatment with the 38-mm-length R-ZES. The target lesion had to be 35 mm long and the primary endpoint was target lesion failure (TLF) defined as the composite of cardiac death, target vessel myocardial infraction (TVMI), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. The rate of TLF at 1 year was compared to a performance goal of 19.0% based on literature suggesting an expected TLF rate of 15.1%. All patients were prescribed dual antiplatelet therapy for a minimum of 6 months. Results: There were 223 patients treated with a 38 mm R-ZES; mean age was 61 years, 78.9% were men, 44.6% were white, 3.6% were black, and 50.9% were Asian. Prior PCI was noted in 27.4% of patients, 37.7% had diabetes mellitus and 53.8% had multivessel disease. Lesions were located in the LAD (52.0%), LCX (20.2%) and RCA (44.4%) and 3.4% were moderately or severely torturous. TIMI flow was 0 or 1 in 6.1% of lesions and 47.9% were branch vessel disease with mean sidebranch stenosis of 30.4%; 91.2% were lesion class B2/C. The primary endpoint was met with a 12-month TLF rate of 4.5% (upper one-sided 95% confidence interval 7.5%). Rates of cardiac death, TVMI, and TLR at 12 months were 0.9%, 3.6%, and 1.4% respectively. Early stent thrombosis ( 30 days) was 0.9% and there were no stent thrombosis events after 30 days. Conclusions: At 12 months the rate of TLF was significantly less than the performance goal of 19% and clinical events rates were low with no late stent thrombosis. The 38 mm length R-ZES was safe and effective in this selected population of long lesion patients.
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