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74th Scientific Sessions of the American Heart Association (AHA), November 2001, Anaheim, California
- 90Sr/90Y seed-trains to prevent restenosis in bypass grafts. A subgroup analysis of the RENO trial (European Surveillance Registry with the Novoste Beta-Cath System
- Thomas M Schiele, Cardiology Dpt., Medizinische Klinik - Innenstadt University Hospital Munich, Munich Germany; Eric Eeckhout, Centre Hospitalier Universitaire Vaudois, Lausanne Switzerland; Sigmund Silber, Müller Hospital Munich, Munich Germany; Christoph Naber, University Hospital Essen, Essen Germany; William Wijns, Onze Lieve Vrouwziekenhuis Aalst, Aalst Belgium; Wolfgang Rutsch, University Hospital CharitZ( Berlin, Berlin Germany; Volker Klauss, Cardiology Dpt., Medizinische Klinik - Innenstadt, University Hospital Munich, Munich Germany
- Circulation, 104, II-546 (2001)
Introduction: Vascular brachytherapy (VBT) has proven to reduce the incidence of restenosis after percutaneous coronary intervention (PCI). The RENO registry with the Novoste ä Beta-Cath ä System has been established to keep track of all patients (pts) undergoing VBT but are not included in a clinical trial.
Methods: Of 1036 pts included in 47 centers 66 pts underwent PCI and VBT in 70 bypass grafts (SVG). VBT was performed by 90Sr/90Y seed trains of either 30, 40 or 60mm length. Results: Mean age of pts treated in SVG was higher than in pts treated in native vessels (67±10 vs 62±10 years; p<0.001), more pts had unstable angina (39 vs 26%; p=0.018) and were diabetic (32 vs 23%; p=0.096). Reference vessel size was expectedly larger (3.5±0.6 vs 3.2±0.5mm) and mean lesion length was comparable (18.3±15.3 vs 19.2±11.7mm). The 30mm seed train was used in 27% of lesions, the 40mm in 72% and the 60mm in 1%. The mean dwelling time was 3.5±0.5 min delivering 20.3±3.2Gy at 2mm from the center of the source. In 3 pts (4.2%) dose delivery had to be fractionated. Procedures were successful in only 64 lesions (91%) due to insufficient back-up to deliver the Beta-CathTM radiation catheter. Stents were implanted in 23 lesions (33%). Obvious geographical miss occurred in 4 lesions (6%). In-hospital outcome was good: no patient had myocardial infarction or required CABG. One patient (1.5%) had repeat PCI and one patient (1.5%) died from non-target vessel related cardiac causes. Follow-up data at 6 months are available in 38 pts in the SVG group and 689 pts of the remaining population. Incidence of MACEs were comparable (21% vs 18%; p=0.583). 18% underwent repeat PCI (vs 13%; p=0.300). No myocardial infarction occured. One patient (2.6%) died for noncardiac reasons. Angiographic follow-up was performed in 37 pts. Restenosis occurred in 24% (vs 20%; p=0.563). Total graft occlusion was seen in 7% (vs 5% in native vessels; p=0.460).
Conclusions: These preliminary results seem to indicate that beta radiation with 90Sr/90Y administered in SVG is feasible and safe. Considering lesion complexity and intrinsically high incidence of in-stent restenosis in SVG, 6 month outcome seems to be favorable, equalling that of VBT in native vessels.
