Current PTCA practice and clinical outcomes in the Netherlands: the real world in the pre-drug-eluting stent era

Aims To document the practice of interventional cardiology and the clinical restenosis rate, as wet[ as the risk factors for clinical restenosis in an unselected population of patients in daily practice and to provide a perspective for the need of new devices such as drug-eluting stents. Methods and results A total of 3177 consecutive patients, who underwent successful percutaneous transturninal coronary angioplasty (PTCA) in the Netherlands, were included. Patients with acute myocardial infarction (MI) were excluded. The predefined endpoint of clinical restenosis was defined as cardiac death, myocardial infarction and revascularisation of the target vessel. Follow-up (9.6 months, IQR 3.9) was complete in 3146 (99.3%) patients with a mean age of 62.1 +/- 10.7 years. Of them 896 (28.5%) were female, 459 (14.6%) had diabetes and 1459 (46.4%) had multi-vessel disease. Most patients (2105, 66.9%) were treated for stable angina. Of all patients, 819 (26.0%) were treated for multiple lesions, 2340 (74.4%) underwent stenting and 820 (26.1%) received glycoprotein Ilb/IIIa inhibitors. All. stented patients received lifelong aspirin and tictopidin/clopidogrel during at least 1 month after the procedure. Target vessel revascularisation during follow-up by either coronary artery by-pass grafting (CABG) or PTCA was necessary in 304 patients (9.7%). Thirty-three (1.1%) patients died of cardiac disease and 22 (0.7%) patients suffered from MI attributable to the originally treated vessel. Overall, the need for revascutarisation, or the incidence of cardiac death or MI occurred in 346 patients (11.0%), at 9 and 12 months these event-rates were 10.2% and 12.0%, respectively. Diabetes, hypertension, peripheral vessel disease, multivessel disease and treatment of type C lesions prevailed as independent risk factors for clinical restenosis. Longer stents and smaller minimal stent diameter were risk factors for in-stent stenosis. Conclusion In this unselected series of consecutive patients treated for stable and unstable angina in everyday clinical practice in the pre-drug-etuting stent era, clinical restenosis after 9 and 12 months follow-up of the patients occurred in 10.2% and 12.0%, respectively. The risk varies from 8.3% to 17.6% depending on the number of risk factors. A proper selection of patients that benefit from new devices is warranted, since the vast majority are well-treated with standard techniques and proper assignment of expensive new devices is obviously of importance for overall health care. (C) 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.