Five-year clinical results of coronary angioplasty with drug-eluting stents. National initiative in strategic innovation, iNOS.

Introduction: The use of drug-eluting stents (DES) is beneficial in patients undergoing percutaneous coronary intervention (PCI) and there is particular interest in long-term follow-up.

Objective: We aimed to assess and characterize early DES use in Portugal during 2003 and patient follow-up over a 5-year period. We developed a web-based database to collect and organize patient and procedural data from PCI performed in ten cardiovascular interventional centers sharing the same database.

Methods: This was a multicenter retrospective study that included 1833 consecutive angiographically successful coronary angioplasties in which a DES was implanted in 2003. A subgroup of patients with 5-year clinical follow-up after the initial procedure was selected for which there was at least a 90% follow-up rate during one quarter of 2003. Demographic, clinical and angiographic characteristics of the entire population were assessed. In the clinical follow-up cohort, the incidence of major adverse cardiac events (MACE)--death, myocardial infarction and surgical or percutaneous target lesion revascularization--was analyzed by survival curves and logistic regression analysis.

Results: Of the total population, 23% were female, and mean age was 62 +/- 11 years (25-92). The main risk factors were hypertension (60.5%), dyslipidemia (42.9%), smoking (45.1%) and diabetes (23.9%, of whom 13.2% were on insulin therapy). There was a history of myocardial infarction, PCI or bypass surgery respectively in 23.1%, 25.1%, and 9.7% of the patients. Multivessel disease was present in 59.9% of patients (mean of 1.86 +/- 0.81 vessels). PCI was performed on average in 1.24 +/- 0.48 lesions, and complete revascularization in 58.8%. A total of 2058 stents were used (mean of 1.62 +/- 0.84) in 1271 patients. The longitudinal substudy included only 320 PCIs, for which follow-up was achieved in 319 (99%; median: 1875 days, P25: 1457 days, P75: 2045 days). Thirty-seven deaths (11.6%) and 61 MACE (19.1%) occurred in this group, with no differences between insulin-treated and other diabetic patients.

Conclusion: This is the first study to analyze the early Portuguese experience with drug-eluting stents. The clinical results compare favorably with the first published international registries. The on-line platform used was successful in collecting data in a standardized format on the clinical experience of multiple centers.