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74th Scientific Sessions of the American Heart Association
(AHA), November 2001, Anaheim, California |
- Pullback technique using Sr/Y90 Source Trains for long
coronary lesions, a sub-analysis of RENO: A European Surveillance
Registry with the NovosteTM Beta-CathTM System
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- Antonio Colombo, Goran Stankovic, EMO Centro Cuore Columbus,
Milan Italy; Patrick Serruys, Heart Center Rotterdam, Rotterdam
Netherlands; Thomas Schiele, Clinic Innenstadt, Munchen Germany;
Eric Eeckhout, CHUV, Lausanne Switzerland; Sigmund Silber, Mueller
Clinic, Munchen Germany; Raoul Bonan, Institut de Cardiologie
de Montreal, Montreal Canada; Philip Urban, La Tour Hospital,
Geneva Switzerland
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- Circulation, 104, II-625 (2001)
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| The RENO Registry
with the NovosteTM Beta-CathRM System has been established to
keep track of all patients undergoing Beta-Cath brachytherapy
not suitable for inclusion in any Beta-Cath trial. Until April
2001, total of 1091 pts were included in this Registry (677 male,
mean age 62 ± 10 years, 26.7% unstable angina, and 23.7%
diabetes mellitus). This report presents the acute and 6 month
follow-up data of 179 pts (16,4%) in whom brachytherapy was delivered
with the pullback technique due to the lesion length (LL) 203
lesions (188 located in native coronary arteries and 15 in by-pass
grafts) were treated with this technique (1.13 lesion/patient).
Mean age was 62.1±10.7 years and 150 were male (83.8%).
39 pts (22%) had diabetes and 42 (26.6%) had unstable angina.
Indication for radiation therapy (per lesion) was de novo lesion
24.4%, restenotic lesion 7%, and in-stent restenosis 68.6%. Reference
vessel size was 3.24±0,59 mm and mean LL was 32.10±18.79
mm. Radiation treatment was performed utilizing a 30 mm (16.8%),
40 mm (78.2%), or 60 mm (5.0%) long source train, with a mean
dwell time of 7.29±1.24 min, delivering 18.97±3.07
Gy. Procedural success was 96.5%. Stents were implanted in 86
lesions (43.2%). Geographic miss was noticed in 11 lesions (5.5%).
In-hospital outcome: One patient died (0.6%), two pts (1.1%)
had MI, and two pts (1.1%) had re-PTCA. There were no in-hospital
CABG. 129 pts were eligible for 6-month follow-up. The overall
incidence of MACEs (death, myocardial infarction and TVR, including
in-hospital events) was 30.2%. 5 pts died (3.9%), 5 pts (3.9%)
suffered MI, and 33 pts (25.6%) underwent repeat TVR (29 had
rePTCA and 4 had CABG). Angiographic follow-up was performed
in 105 of eligible pts (82%). Restenosis rate was 33.3%, which
includes an incidence of late total occlusions of 13.6%. Conclusions:
these preliminary results seem to support the fact that the pullback
technique can be safely performed with this beta delivery system.
The follow-up events appear acceptable considering the length
of the lesions treated and the high incidence on in-stent restenosis
in the baseline population. |
