A Randomized Trial of a Dedicated Bifurcation Stent Versus Provisional Stenting in the Treatment of Coronary Bifurcation Lesions

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:65

Article

Genereux, Philippe^1,2,3  Kumsars, Indulis⁴  Lesiak, Maciej⁵  Kini, Annapoorna⁶  Fontos, Geza⁷  Slagboom, Ton⁸  Ungi, Imre^9,10  Metzger, D. Christopher¹¹  Wykrzykowska, Joanna J.¹²  Stella, Pieter R.¹³  Bartorelli, Antonio L.¹⁴  Fearon, William F.¹⁵  Lefevre, Thierry¹⁶  Feldman, Robert L.¹⁷  LaSalle, Laura²  Francese, Dominic P.²  Onuma, Yoshinobu¹⁸  Grundeken, Maik J.¹²  Garcia-Garcia, Hector M.¹⁸  Laak, Linda L.¹⁹  Cutlip, Donald E.²⁰  Kaplan, Aaron V.^19,21  Serruys, Patrick W.¹⁸  Leon, Martin B.^1,2 

[1] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY 10032 USA

[2] Cardiovasc Res Fdn, New York, NY USA

[3] Hop Sacre Coeur, Montreal, PQ H4J 1C5, Canada

[4] Paul Stradins Clin Univ Hosp, Latvian Ctr Cardiol, Riga, Latvia

[5] Univ Med Sci, Dept Cardiol 1, Poznan, Poland

[6] Mt Sinai Med Ctr, New York, NY 10029 USA

[7] Gottsegen Hungarian Inst Cardiol, Budapest, Hungary

[8] Onze Lieve Vrouw Hosp, Dept Cardiol, Amsterdam, Netherlands

[9] Univ Szeged, Dept Med 2, Szeged, Hungary

[10] Univ Szeged, Dept Cardiol, Fac Med, Albert Szent Gyorgyi Clin Ctr,Ctr Cardiol, Szeged, Hungary

[11] Wellmont CVA Heart Inst, Kingsport, TN USA

[12] Amsterdam Med Ctr, Dept Cardiol, Amsterdam, Netherlands

[13] Univ Med Ctr Utrecht, Dept Intervent Cardiol, Utrecht, Netherlands

[14] Univ Milan, Ctr Cardiol Monzino, Milan, Italy

[15] Stanford Univ, Med Ctr, Div Cardiovasc Med, Stanford, CA 94305 USA

[16] Hop Prive Jacques Cartier, Inst Cardiovasc Paris Sud, Massy, France

[17] MediQuest Res Grp, Ocala, FL USA

[18] Erasmus MC, Thoraxctr, Rotterdam, Netherlands

[19] Tryton Med Inc, Durham, NC USA

[20] Beth Israel Deaconess Med Ctr, Harvard Clin Res Inst, Boston, MA 02215 USA

[21] Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA

关键词: coronary bifurcation;    coronary stent;    PCI;   

DOI  :  10.1016/j.jacc.2014.11.031

来源: Elsevier

【 摘 要 】

BACKGROUND Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). OBJECTIVES The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. METHODS We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. RESULTS We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p = 0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis >= 50%) at 9 months follow-up (22.6% vs. 26.8%, p = 0.44). CONCLUSIONS Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972) (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

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