- Long lesions treated using Sr/Y90 source trains, a sub-analysis
of RENO: a European surveillance registry with the novosteTM
Beta-CathTM system
- A.C. Colombo (1), G.S. Stankovic (1), P. Serruys (2), T.
Schiele (3), E. Eeckhout (4),
S. Silber (5), R. Bonan (6), P. Urban (7)
1, EMO Centro Cuore Columbus, Milan, Italy
2, Heart Center Rotterdam, Rotterdam, Netherlands
3, Clinic Innenstadt, Munich, Germany
4, CHUV, Lausanne, Switzerland
5, Müller Clinic, Munchen, Germany
6, Institut de Cardiologie de Montreal, Montreal, Canada
7, La Tour Hospital, Geneva, Switzerland
- Eur Heart J 22, Abstract suppl., 391, (2001)
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The RENO Registry
with the NovosteTM Beta-CathTM System has been established to
keep track of all patients undergoing Beta-Cath brachytherapy
not suitable for inclusion in any Beta-Cath trial. From the total
of 1036 patients included so far in this Registry, brachytherapy
was delivered with the pullback technique in 162 of these patients
(15.6%)
due to the lesion length. This report presents the acute and
6 month follow-up data of these 162 patients in whom 185 lesions
(171 located in native coronary arteries and 14 in by-pass grafts)
were treated with this technique (1.14 lesion/patient). Mean
age was 61.8±10.9 years and 133 were male (82.1%). 36
patients (22.2%) had diabetes and 37 (22.8%) had unstable angina.
47 lesions were de novo, 10 were restenotic, and 126 were in-stent
restenosis. Reference vessel size was 3.24±0.6 mm and
mean lesion length was 32.78±18.99 mm. Radiation treatment
was performed utilizing a 30 mm (17.4% of lesions), 40 mm (77.7%
of lesions), or 60 mm (4.9% of lesions) long source train, with
a mean dwell time of 7.29±1.24 min delivering 18.94±3.04
Gy at 2 mm from the center of the source. Procedures were successful
in 177 lesions (96.7%). Stents were implanted in 83 lesions (45.9%).
Geographic miss was noticed in 9 lesions (4.9%).
In-hospital outcome: Two patients (1.2%) had myocardial
infarction, and two patients (1.2%) had repeat PTCA. There were
no deaths or CABG. 96 patients were eligible for 6-month follow-up.
The overall incidence of MACEs (death, myocardial infarction
and TVR, including in-hospital events) was 32.3%. Three patients
died (3.1%), 4 patients (4.2%) suffered myocardial
infarction, and 27 patients (28.1%) underwent repeat target vessel
revascularization (23 had rePTCA and 4 had CABG). Angiographic
follow-up was performed in 81 of eligible patients (85.3%). Angiographic
restenosis rate was 34.6%, which includes an incidence of late
total occlusions of12.3%.
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
of in-stent restenosis in the baseline population. |