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22nd Congress of the European Society of Cardiology, August 2000, Amsterdam, The Netherlands
- Safety and performance of 90 Strontium for treatment of de novo and restenotic lesions. The BRIE trial
P.W. Serruys (1), J. Bonnier (2), P. Urban (3), W. Wijns (4), M. Vandormael (5), R. Dörr (6), S. Silber (7), G. Sianos (1), B. Burette (1), W. Dries (1)
- 1, Interventional Cardiology, Thoraxcenter, Rotterdam, Netherlands
- 2, Catharina Hospital, Eindhoven, Netherlands
- 3, CHUV, Lausanne, Switzerland
- 4, OLVZ, Aalst, Belgium
- 5 , Clinique St. Jean, Brussels, Belgium
- 6, Klinik Weisser Hirsch, Dresden, Germany
- 7, Internistische Klinicum, Munchen, Germany
Eur Heart J, 21: Abstr. Suppl., 398, 2000
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 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 (A) the irradiated segment with a length of 28mm (B), and the entire analysed vessel segment comprised between with a length of 42mm (C) 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%.
Results of each segmental analysis (RR = restenosis rate)
Segment with MLD pre (5mm) Irradiated area (28 mm) and edges Vessel segment (42 mm) post fup post fup post fup Dmin (mm) 2.55 2.28 2.07 1.75 1.92 1.64 loss (mm) 0.26 0.33 0.28 RR (%) 9.9 29.0 33.6
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.