|
74th Scientific Sessions of the American Heart Association
(AHA), November 2001, Anaheim, California |
- Intracoronary beta-brachytherapy with a Sr/Y90 source
train for restenosis prevention in routine clinical practice
- A report from the RENO registry
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- Philip M Urban, Cardiovascular Dept. La Tour Hospital, Geneva
Switzerland; Patrick W Serruys, Dept. of Cardiology Heart Center,
Rotterdam Netherlands; Dietrich Baumgart, Zentrum fuer Innere
Medizin Universitaetsklinikum, Essen Germany; Antonio Colombo,
Dept. of Medicine Centro Cuore Columbus, Milan Italy; Sigmund
M Silber, Kardiologie Praxis, Munchen Germany; Eric Eeckhout,
Dept. of Medicine C.H.U.V., Lausanne Switzerland; Humbertus Heuer,
Cardiology St. Johannes Hospital, Dortmund Germany; Raoul Bonan,
Institut de Cardiologie, Montreal Canada
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- Circulation, 104, II-577 (2001)
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| Intravascular
brachytherapy (VBT) is now an established mode of therapy for
preventing restenosis following PCI, but there are no data concerning
the application of VBT in routine clinical practice. Between
April 1999 and September 2000, 1091 consecutive patients treated
in 47 European centers with the Novoste Beta-Cath™ System
were included in the RENO registry, and 6 months follow-up data
have so far been obtained for 727 patients. 827 (76.6%) patients
were males, and mean age was 62.0±10.1 years. 265 (26.7%)
had unstable angina, and 251 (23.4%) were diabetics. 1087 (94.1%)
target lesions were in native vessels, and 63 (5.9%) in a bypass
graft; 205 (17.7%) were de novo, 47 (4.1%) restenotic and 898
(77.7%) in-stent restenosis. Mean estimated reference diameter
was 3.2±0.5mm, and mean lesion length was 19.2±11.9
mm. VBT was successful in 1095/1144 lesions (95.7%), and geographical
miss occurred for 69 (6.0%). 18.8±3.2 Gy were delivered
at 2 mm from the source using a 30 mm (187 lesions), a 40 mm
(916 lesions) or a 60 mm (49 lesions) source train. A pullback
stepping maneuver was used for 186 (16.2%) procedures. A new
stent was implanted for 340 (29.6%) lesions. In-hospital MACE
rate was 20/1091 patients (1.8%): 2 deaths, 2 Q wave AMI, 5 non-Q
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 129/727 (17.7%) and comprised 9 (1.2%)
deaths, 21 (2.9%) AMI, and 113 (15.5%) TVR. Angiographic follow-up
was available for 553/727 patients (76.1%): non-occlusive restenosis
was documented in 14.5% and total occlusion in 5.5% of cases.
A combined end-point for late (30-180 days) definite or suspected
target vessel closure was reached in 42 (5.8%) patients (4.0%
total occlusion at angiography, 2.2% AMI and 0.4% sudden death).
These data, derived from a large cohort of unselected consecutive
patients, suggest that the good results of recent randomized
controlled trials can be replicated in routine clinical practice.
A multivariate analysis for predictors of success will be done
when follow-up is complete. |
