- Safety and Performance of 90-Strontium for Treatment of
De Novo and Restenotic Lesions. The BRIE Trial (Beta Radiation
in Europe).
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- P.W. Serruys (1), J. Bonnier (2), P. Urban (3), W. Wijns
(4), M. Vandormael (5), R. Doerr (6), S. Silber (7), G. Sianos
(8), B. Burette (5), W. Dries (2)
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- 1, Univ Hosp Rotterdam-Dijkzigt, Rotterdam Netherlands
- 2, Catharina Hosp, Eindhoven Netherlands
- 3, CHUV, Lausanne Switzerland
- 4, OLV Hosp, Aalst Belgium
- 5, St Jean Hosp, Brussel Belgium
- 6, Clin Weisser Hirsch, Dresden Germany
- 7, Internistische Clin, Munchen Germany
- 8, Thoraxcenter, Rotterdam Netherlands;
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- Circulation, 102: II-750 (2000)
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| Background: The
BRIE trial is a registry to evaluate the safety and performance
of 90strontium delivered locally (Beta-CathTM system of Novoste)
to de novo and restenotic lesions in patients (pts) with up to
2 discrete lesions in different vessels. Primary clinical endpoint
is MACE at 6 months. The primary angiographic endpoint is restenosis
rate (RR) at 6 months. Results: 175 lesions were treated in 149
patients (pts): 48 pts underwent balloon angioplasty (BA) alone,
11 pts received a stent as rescue and 64 pts followed a strategy
of provisional stenting; 26 pts with 2 vessel treatment received
36 provisional stents, 14 BA and 2 stents rescue. The mean age
was 60 yrs, 14% had diabetes and 34% prior MI. 41% of the lesions
were located in the RCA, 37% in the LAD and 22% in the CFX. The
average vessel size was 3.06 mm with a MLD of 1.01mm and a lesion
length of 11mm The restenosis rate, the MLD and the loss were
determined in 3 regions of interest: in a subsegment of 5mm containing
the original MLD pre (MLD at follow-up: 2.28mm, Late loss: 0.26mm,
RR: 9.9%); the irradiated segment with a length of 28mm (1.75mm,
0.33mm, 29%, respectively), and the entire analysed vessel segment
comprised between with a length of 42mm (1.64mm, 0.28mm, 33.6%,
respectively) comprised between sidebranches with a length of
42mm. These angiographic results include 4.6% total occlusions.
The geographical miss (GM) at the edge of the irradiated area
was observed in 31% of the edges and resulted in a 16.3% incidence
of restenosis, while the restenosis at the edge without GM was
only 4.3%. At 6 months the following incidence of MACE was observed:
Death 2%, QMI 5%, non-Q MI 3%, CABG 3% and rePTCA 21%. Conclusion:
The results of this registry reflect the learning process of
the practitioner. The full therapeutic potential of brachytherapy
with 90strontium can only be unraveled once the incidence of
late stent thrombosis and GM has been eliminated by the prolonged
use of thienopyridine and the appropriate training of the operator
in applying this new modality of prevention of restenosis. |
