Usage Patterns and 2-Year Outcomes With the TAXUS Express Stent: Results of the US ARRIVE 1 Registry

被引:38
作者
Lasala, John M. [1 ]
Cox, David A. [2 ]
Dobies, David [3 ]
Muhlestein, Joseph B. [4 ,5 ]
Katopodis, John N. [5 ]
Revtyak, George [6 ]
Baim, Donald S. [7 ]
机构
[1] Washington Univ, Sch Med, St Louis, MO 63110 USA
[2] Lehigh Valley Heart Specialists, Allentown, PA USA
[3] Genesys Reg Med Ctr, Genesys Heart Inst, Grand Blanc, MI USA
[4] Univ Utah, Dept Internal Med, Salt Lake City, UT 84112 USA
[5] Tallahassee Res Inst, Dept Intervent Cardiol, Tallahassee, FL USA
[6] Methodist Cardiol Phys Inc, Clarian Hlth Partners, Indianapolis, IN USA
[7] Boston Sci Corp, Natick, MA USA
关键词
coronary disease; drug-eluting stents; paclitaxel; restenosis;
D O I
10.1002/ccd.21618
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: It is unclear how well the long-term safety and effectiveness of drug-eluting stents observed in tightly defined randomized controlled trials (RCT) translates to expanded use in routine practice. Methods: The FDA-mandated TAXUS (R) Express(2)(TM) ARRIVE 1 postmarket registry was designed to consecutively enroll patients receiving >= 1 TAXUS stent in low-, medium-, and high-volume US sites (n = 50). All cardiac events plus an additional 20% sample of records were monitored and all endpoints were independently adjudicated. Results: Detailed follow-up data through 2 years were compiled for 2,487 patients (95%). Simple-use (on-label) ARRIVE I patients (35%) had outcomes similar to 4 pooled TAXUS RCTs for death (3.5% vs. 3.4%, respectively, P = 0.78), Q-wave myocardial infarction (QWMI, 0.7% vs. 0.9%, P = 0.72), and stent thrombosis (ST, 2.2% vs. 1.2%, P = 0.12), but lower target vessel revascularization (7.8% vs. 13.4%, P < 0.0001). Compared with simple-use, cases representing expanded use to treat broader patient/lesion characteristics showed higher 2-year rates for death (7.4% vs. 3.5%, respectively, P = 0.0003), target lesion revascularization (9.4% vs. 5.8%, P = 0.0031), and ST (3.4% vs. 2.2%, P = 0.061, concentrated early in the first year). Conclusions: By including methods usually found in RCT, ARRIVE 1 captured a broad spectrum of disease treated in standard practice with high levels of ascertainment of clinical outcomes. In the more complicated cases, expectedly higher adverse event rates were seen compared to that found in the simple-use cases or pivotal RCT. These results have now been included in the Directions for Use, to aid in physician and patient decision-making. (C) 2008 Wiley-uss, Inc.
引用
收藏
页码:433 / 445
页数:13
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