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European Heart Journal 2001 22(8):669-675; doi:10.1053/euhj.2000.2283
Copyright © 2001 by the European Society of Cardiology.
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Clinical and angiographical follow-up after implantation of a 6–12µCi radioactive stent in patients with coronary artery disease

A.J Wardeha, A.H.M Knooka, I.P Kaya, M Sabatéa, V.L.M.A Coenb, D.P Foleya, J.N Hamburgera, P.C Levendagb, W.J van der Giessena and P.W Serruysa,f1

a Thoraxcenter Rotterdam, University Hospital Rotterdam, Dijkzigt, Rotterdam, The Netherlands
b The Daniel den Hoed Cancer Center, Rotterdam, The Netherlands

revised May 15, 2000; accepted May 22, 2000

Abstract

Aims This study is the contribution by the Thoraxcenter, Rotterdam, to the European32P Dose Response Trial, a non-randomized multicentre trial to evaluate the safety and efficacy of the radioactive IsostentTM in patients with single coronary artery disease.

Methods and Results The radioactivity of the stent at implantation was 6–12µCi. All patients received aspirin indefinitely and either ticlopidine or clopidogrel for 3 months. Quantitative coronary angiography measurements of both the stent area and the target lesion (stent area and up to 5mm proximal and distal to the stent edges) were performed pre- and post-procedure and at the 5-month follow-up. Forty-two radioactive stents were implanted in 40 patients. Treated vessels were the left anterior descending coronary artery (n=20), right coronary artery (n=10) or left circumflex artery (n=10). Eight patients received additional non-radioactive stents. Lesion length measured 10±3mm with a reference diameter of 3·07±0·69mm. Minimal lumen diameter increased from 0·98±0·53mm pre-procedure to 2·29±0·52mm (target lesion) and 2·57±0·44mm (stent area) post-procedure. There was one procedural non-Q wave myocardial infarction, due to transient thrombotic closure. Thirty-six patients returned for angiographical follow-up. Two patients had a total occlusion proximal to the radioactive stent. Of the patent vessels, none had in-stent restenosis. Edge restenosis was observed in 44%, occurring predominantly at the proximal edge. Target lesion revascularization was performed in 10 patients and target vessel revascularization in one patient. No additional clinical end-points occurred during follow-up. The minimal lumen diameter at follow-up averaged 1·66±0·71mm (target lesion) and 2·12±0·72 (stent area); therefore late loss was 0·63±0·69 (target lesion) and 0·46±0·76 (stent area), resulting in a late loss index of 0·65±1·15 (target lesion) and 0·30±0·53 (stent area).

Conclusion These results indicate that the use of radioactive stents is safe and feasible, however, the high incidence of edge restenosis makes this technique currently clinically non-applicable.

Key Words: ß-particles, angioplasty, radioisotope, restenosis, stent

f1 Correspondence: Prof. Patrick W. Serruys, MD, PhD, Head of the Department of Interventional Cardiology, Thoraxcenter Bd 406, University Hospital Dijkzigt, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.

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