Lasala John M, Cox David A, Lewis Stephen J, Tadros Peter N, Haas Robert C, Schweiger Marc J, Chhabra Anil, Untereker William J, Starzyk Ruth M, Mascioli Stephen R, Dawkins Keith D, Baim Donald S
Washington University School of Medicine, St. Louis, MO 63110, USA.
EuroIntervention. 2009 May;5(1):67-77. doi: 10.4244/eijv5i1a11.
We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites).
No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two.
Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.
我们报告了在TAXUS Express2 ARRIVE上市后监测项目（101个美国站点）中，一大组未经筛选的药物洗脱支架人群（N = 7492）的2年随访结果。
未规定具体的纳入/排除标准；患者在手术开始时入组。两年随访率为94%，对主要心脏事件进行独立判定，对发生心脏事件的患者进行监测，并在每个站点额外抽取10 - 20%的样本。大多数ARRIVE病例（64%，n = 4794）代表基于简单使用（单支血管/支架）关键试验人群之外的患者/病变特征的扩大使用。这些扩大使用的患者在2年时的死亡率（7.8%对4.2%，P<0.001）、心肌梗死（MI，3.9%对2.2%，P<0.001）、靶病变血管重建（TLR，9.2%对5.4%，P<0.001）和支架血栓形成（3.3%对1.4%，P<0.001）发生率均高于简单使用的患者。在患有肾脏疾病、慢性完全闭塞（CTO）、病变>28 mm、参考血管直径（RVD）<2.5 mm、多支血管支架置入、急性心肌梗死、分叉病变、静脉桥血管或支架内再狭窄的亚组中，第一年TLR范围为3.8%至8.9%，第二年为1.3%至6.0%。
在关键试验中，扩大使用的患者死亡率和支架相关事件高于简单使用的患者。ARRIVE提供了此类真实世界患者手术及2年随访结果的详细评估。
