- Clinical application of intracoronary beta brachytherapy
using sr/Y90 source trains the European surveillance registry
with the novoste beta-cath system
-
- P. Urban (1), P. Serruys (2), D. Baumgart (3), A. Colombo
(4), S. Silber (5), E. Eeckhout (6), K.-H. Kuck (7), H. Heuer
(8), R. Bonan (9)
1, La Tour Hospital, Cardiovascular Department, Meyrin-Geneva,
Switzerland
2, Heart Center Rotterdam, Department of Cardiologie, Rotterdam,
Netherlands
3, Universitätsklinikum Essen, Zentrum fuer Innere Medizin,
Essen, Germany
4, Centro Cuore Columbus, Departement of Medicine, Milan, Italy
5, Müller Hospital, Munchen, Germany
6, C.H.U.V., Department of Medicine, Lausanne, Switzerland
7, St Georg Hospital, Cardiology, Hamburg, Germany
8, St Johannes Hospital, Cardiology, Dortmund, Germany
9, Institut de Cardiologie de Montréal, Montréal,
Canada
- Eur Heart J 22, Abstract suppl., 4, (2001)
|
Intravascular
brachytherapy (VBT) is now well documented as the most effective
mode of preventing restenosis following PCI, but there are no
data as yet concerning the application of VBT in routine clinical
practice. Between April 1999 and September 2000, 1036 consecutive
patients treated in 47 European centres with the Novoste Beta-Cath™
System were included in RENO, the single largest available registry
of VBT, and 6 months follow-up data have so far been obtained
for 546. 785 (76.7%) patients were males, and mean age was 61.9±10.2
years. 248 (26.3%) had unstable angina, and 238 (23.4%) were
diabetics. 1030 (94.1%) target lesions were in native vessels,
and 65 (5.9%) in a bypass graft; 196 (17.9%) were de novo, 46
(4.2%) were restenotic and 850 (77.6%) were in-stent restenosis.
Mean estimated reference diameter was 3.2±0.5mm, and mean
estimated lesion length was 19.2±12.0 mm. VBT was successful
in 1035/1084 lesions (95.5%), and geographical miss occurred
for 67 (6.2%). 18.8±3.2 Gy were delivered at 2 mm from
the source using a 30 mm (182 lesions), a 40 mm (869 lesions)
or a 60 mm (42 lesions) source train. A pullback stepping manoeuvre
was used for 167 (15.5%) procedures and the dwell time had to
be fractionated because of ischemia for 40 procedures (3.7%).
A new stent was implanted for 327 (30%) lesions. In-hospital
MACE rate was 20/1036 patients (1.9%): 1 death, 2 Q wave AMI,
6 nonQ AMI, and 13 repeat TVR. At discharge, aspirin and clopidogrel
were usually given for at least 6 months. After a 6 months follow-up
period, the MACE rate was 106/546 (19.4%) and comprised 5 (0.9%)
deaths, 20 (3.7%) AMI, 77 (14.1%) PCI and 16 (2.9%) CABG. Angiographic
follow-up was
available for 412/546 patients (75.4%): non-occlusive restenosis
was documented in 16.8% and total occlusion in 5.7% of cases.
A combined end-point for late (30180 days) definite or suspected
target vessel closure was reached in 36 (6.6%) patients (4.2%
total occlusion of target vessel at angiography, 2.9% AMI and
0.4% sudden death). These data, derived from a large cohort of
unselected consecutive patients, suggest that the good results
of recent randomised controlled trials can be replicated in routine
clinical practice. |
