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European Heart Journal 2004 25(13):1163-1170; doi:10.1016/j.ehj.2004.05.006
Copyright © 2004 by the European Society of Cardiology.
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Clinical research

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

Willem R.P Agemaa,b,1, Pascalle S Monraatsa,b,1, Aeilko H Zwindermanc, Robbert J de Winterd, René A Tioe, Pieter A.F.M Doevendansf, Johannes Waltenbergerg, Moniek P.M de Maath, Rune R Frantsi, Douwe E Atsmaa, Arnoud van der Laarsea, Ernst E van der Walla and J.Wouter Jukemaa,b,*

a Department of Cardiology, Leiden University Medical Center, P.O. Box 9600, 2300 Leiden, The Netherlands
b Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, The Netherlands
c Department of Medical Statistics, Academic Medical Center, Amsterdam, The Netherlands
d Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands
e Department of Cardiology, Academic Hospital Groningen, The Netherlands
f Department of Cardiology, University Medical Center Utrecht, The Netherlands
g Department of Cardiology, Academic Hospital Maastricht, The Netherlands
h Gaubius Laboratory, TNO PG, Leiden, The Netherlands
i Department of Human Genetics, Center for Human and Clinical Genetics, Leiden University Medical Center, Leiden, The Netherlands

* Corresponding author. Tel.: +31-71-526-20-20; fax: +31-71-526-68-85
E-mail address: j.w.jukema{at}lumc.nl

Received 23 December 2003; revised 23 April 2004; accepted 5 May 2004

Abstract

Aims To document the practice of interventional cardiology and the clinical restenosis rate, as well 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 transluminal coronary angioplasty (PTCA) in the Netherlands, were included. Patients with acute myocardial infarction were excluded. The pre-defined end-point 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 IIb/IIIa inhibitors. All stented patients received life-long aspirin and ticlopidin/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 myocardial infarction (MI) attributable to the originally treated vessel. Overall, the need for revascularisation, 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, multi-vessel 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-eluting 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 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.

Key Words: Percutaneous transluminal coronary angioplasty • Restenosis • Risk factors


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