Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions

Antonio Colombo, Jeffrey W. Moses, Marie Claude Morice, Josef Ludwig, David R. Holmes, Vassilis Spanos, Yves Louvard, Benny Desmedt, Carlo Di Mario, Martin B. Leon

Research output: Contribution to journalArticle

683 Citations (Scopus)

Abstract

Background-A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. Methods and Results-This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). Conclusions-These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Original languageEnglish
Pages (from-to)1244-1249
Number of pages6
JournalCirculation
Volume109
Issue number10
DOIs
Publication statusPublished - Mar 16 2004

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Sirolimus
Stents
Thrombosis
Metals
Prospective Studies
Safety
Equipment and Supplies

Keywords

  • Drugs
  • Restenosis
  • Stents

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

Colombo, A., Moses, J. W., Morice, M. C., Ludwig, J., Holmes, D. R., Spanos, V., ... Leon, M. B. (2004). Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions. Circulation, 109(10), 1244-1249. https://doi.org/10.1161/01.CIR.0000118474.71662.E3

Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions. / Colombo, Antonio; Moses, Jeffrey W.; Morice, Marie Claude; Ludwig, Josef; Holmes, David R.; Spanos, Vassilis; Louvard, Yves; Desmedt, Benny; Di Mario, Carlo; Leon, Martin B.

In: Circulation, Vol. 109, No. 10, 16.03.2004, p. 1244-1249.

Research output: Contribution to journalArticle

Colombo, A, Moses, JW, Morice, MC, Ludwig, J, Holmes, DR, Spanos, V, Louvard, Y, Desmedt, B, Di Mario, C & Leon, MB 2004, 'Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions', Circulation, vol. 109, no. 10, pp. 1244-1249. https://doi.org/10.1161/01.CIR.0000118474.71662.E3
Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR, Spanos V et al. Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions. Circulation. 2004 Mar 16;109(10):1244-1249. https://doi.org/10.1161/01.CIR.0000118474.71662.E3
Colombo, Antonio ; Moses, Jeffrey W. ; Morice, Marie Claude ; Ludwig, Josef ; Holmes, David R. ; Spanos, Vassilis ; Louvard, Yves ; Desmedt, Benny ; Di Mario, Carlo ; Leon, Martin B. / Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions. In: Circulation. 2004 ; Vol. 109, No. 10. pp. 1244-1249.
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abstract = "Background-A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. Methods and Results-This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5{\%}) and 21 in group B (95.4{\%}). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5{\%}). The total restenosis rate at 6 months was 25.7{\%}, and it was not significantly different between the double-stenting (28.0{\%}) and the provisional SB-stenting (18.7{\%}) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6{\%}). Conclusions-These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.",
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AU - Holmes, David R.

AU - Spanos, Vassilis

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AU - Desmedt, Benny

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AB - Background-A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. Methods and Results-This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). Conclusions-These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

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