A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial

被引:23
作者
Cannon, Louis A. [2 ]
Kereiakes, Dean J. [1 ]
Mann, Tift [3 ]
Popma, Jeffrey J. [4 ]
Mooney, Michael R. [5 ]
Mishkel, Gregory J. [6 ]
Lee, Tommy C. [7 ]
Wilson, B. Hadley [8 ]
Stuckey, Thomas D. [9 ]
Orlow, Steven [10 ]
McGarry, Thomas [11 ]
Ring, Michael E. [12 ]
Kellett, Mirle A. [13 ]
Underwood, Paul [14 ]
Dawkins, Keith D. [14 ]
机构
[1] Christ Hosp, Heart & Vasc Ctr, Lindner Ctr Res & Educ, Cincinnati, OH 45219 USA
[2] No Michigan Reg Hosp, Cardiac & Vasc Res Ctr No Michigan, Petoskey, MI USA
[3] Wake Med Ctr, Raleigh, NC USA
[4] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
[5] Minneapolis Heart Inst Fdn, Minneapolis, MN USA
[6] St Johns Hosp, Springfield, IL USA
[7] Bakersfield Mem Hosp, Bakersfield, CA USA
[8] Carolinas Med Ctr, Charlotte, NC 28203 USA
[9] LeBauer Cardiovasc Res Fdn, Greensboro, NC USA
[10] Lutheran Hosp Indiana, Ft Wayne, IN USA
[11] Oklahoma Fdn Cardiovasc Res, Oklahoma City, OK USA
[12] Providence Sacred Heart Med Ctr, Spokane, WA USA
[13] Maine Med Ctr, Portland, ME 04102 USA
[14] Boston Sci Corp, Natick, MA USA
关键词
Paclitaxel; drug-eluting stents; coronary restenosis; platinum chromium; small vessel; thin-strut; LIBERTE STENT; PROGRAM; DISEASE; SYSTEM;
D O I
10.4244/EIJV6I8A161
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberte paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. Methods and results: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length <= 20 mm and vessel diameter >= 2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38 +/- 0.51 versus 0.80 +/- 0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. Conclusions: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.
引用
收藏
页码:920 / 927
页数:8
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