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Background: Recently, cardiologists have treated more complex patients and lesions with drug‐eluting stents (DES). However, long‐term efficacy and safety of the off‐label use of these new devices is yet to be demonstrated. Methods: The Drug‐Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single‐center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end‐point was long‐term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years. Results: A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 ± 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cypher™ was the predominant DES in this registry (83.5%). Mean follow‐up time was 2.6 ± 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6–12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2–5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1–16.7, P < 0.001), and in‐stent residual stenosis (HR 14.5; 95% CI, 10.2–17.6, P < 0.001). Conclusion: The use of DES in unselected population is associated with long‐term safety and effectiveness with acceptable low rates of adverse clinical events.
Journal of Interventional Cardiology – Wiley
Published: Aug 1, 2008
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