Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions

被引:605
作者
Colombo, A
Moses, JW
Morice, MC
Ludwig, J
Holmes, DR
Spanos, V
Louvard, Y
Desmedt, B
Di Mario, C
Leon, MB
机构
[1] EMO Ctr Cuore Columbus, I-20145 Milan, Italy
[2] Lenox Hill Hosp, New York, NY 10021 USA
[3] Inst Cardiovasc Paris Sud, Massy, France
[4] Univ Heart Ctr, Erlangen, Germany
[5] Mayo Clin & Mayo Fdn, Rochester, MN 55905 USA
[6] Milan Cardiovasc Res, Milan, Italy
[7] Cordis Corp, Brussels, Belgium
关键词
stents; drugs; restenosis;
D O I
10.1161/01.CIR.0000118474.71662.E3
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1244 / 1249
页数:6
相关论文
共 13 条
[1]   Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions [J].
Al Suwaidi, J ;
Berger, PB ;
Rihal, CS ;
Garratt, KN ;
Bell, MR ;
Ting, HH ;
Bresnahan, JF ;
Grill, DE ;
Holmes, DR .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2000, 35 (04) :929-936
[2]   Modified T-stenting technique with crushing for bifurcation lesions: Immediate results and 30-day outcome [J].
Colombo, A ;
Stankovic, G ;
Orlic, D ;
Corvaja, N ;
Liistro, F ;
Airoldi, F ;
Chieffo, A ;
Spanos, V ;
Montorfano, M ;
Di Mario, C .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2003, 60 (02) :145-151
[3]   BALLOON ANGIOPLASTY OF CORONARY BIFURCATION LESIONS - THE KISSING BALLOON TECHNIQUE [J].
GEORGE, BS ;
MYLER, RK ;
STERTZER, SH ;
CLARK, DA ;
COTE, G ;
SHAW, RE ;
FISHMANROSEN, J ;
MURPHY, M .
CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS, 1986, 12 (02) :124-138
[4]   Directional atherectomy prior to stenting in bifurcation lesions: A matched comparison study with stenting alone [J].
Karvouni, E ;
Di Mario, C ;
Nishida, T ;
Tzifos, V ;
Reimers, B ;
Albiero, R ;
Corvaja, N ;
Colombo, A .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2001, 53 (01) :12-20
[5]  
Lefèvre T, 2000, CATHETER CARDIO INTE, V49, P274, DOI 10.1002/(SICI)1522-726X(200003)49:3<274::AID-CCD11>3.0.CO
[6]  
2-N
[7]   A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. [J].
Morice, M ;
Serruys, PW ;
Sousa, JE ;
Fajadet, J ;
Hayashi, EB ;
Perin, M ;
Colombo, A ;
Schuler, G ;
Barragan, P ;
Guagliumi, G ;
Molnar, F ;
Falotico, R .
NEW ENGLAND JOURNAL OF MEDICINE, 2002, 346 (23) :1773-1780
[8]   Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery [J].
Moses, JW ;
Leon, MB ;
Popma, JJ ;
Fitzgerald, PJ ;
Holmes, DR ;
O'Shaughnessy, C ;
Caputo, RP ;
Kereiakes, DJ ;
Williams, DO ;
Teirstein, PS ;
Jaeger, JL ;
Kuntz, RE .
NEW ENGLAND JOURNAL OF MEDICINE, 2003, 349 (14) :1315-1323
[9]  
Reimers B, 2000, STRATEGIC APPROACHES, P211
[10]   Immediate and long-term results of "T" stenting for bifurcation coronary lesions [J].
Sheiban, I ;
Albiero, R ;
Marsico, F ;
Dharmadhikari, A ;
Tzifos, V ;
Pagnotta, P ;
Montorfano, M ;
Leonardo, F ;
Saba, P ;
Di Mario, C ;
Colombo, A .
AMERICAN JOURNAL OF CARDIOLOGY, 2000, 85 (09) :1141-+