Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent - A TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years
Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent - A TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years
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DOI：
10.1016/j.jacc.2007.01.015
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发表时间：
2007-03-13
影响因子：
24
通讯作者：
Stone, Gregg W.
中科院分区：
文献类型：
--
作者：
Ellis, Stephen G.;Colombo, Antonio;Stone, Gregg W.
目的 本研究旨在研究紫杉醇洗脱 Taxus 支架的支架血栓形成。 背景 与裸金属支架植入相比，药物洗脱支架置入后支架血栓的发生率和时间仍不确定，因此风险分层和抗血小板药物的长期建议存在不确定性。 方法 本研究采用基于患者的荟萃分析，使用 4 个主要 TAUS 随机试验（3,445 名患者），其中随访时间为 1 年。结果 3 年时，Taxus 组的累积支架血栓发生率为 1.28% +/- 0.31%，裸金属支架组的累积支架血栓发生率为 0.76% +/- 0.23%（风险比 1.51 [95% 置信区间 0.73 至 3.14]，p = 0.26）。在氯吡格雷处方期间的 6 个月内，Taxus 支架组（0.59 [95% 置信区间 0.22 至 0.951）和裸金属支架组（0.64 [95% 置信区间 0.26 至 1.021]）的风险比（每 6 个月每 100 名患者）相似。然而，从 6 个月到 3 年，Taxus 组的支架血栓发生率更高（风险比 0.19 [95% 置信区间 0.06 至 0.32] vs. 0.02 [95% 置信区间 0.00 至 0.07]，p = 0.049）。 6 个月后出现红豆杉相关血栓的 8 例患者中，0 例持续服用氯吡格雷，2 例未持续服用阿司匹林。 2年后未发生红豆杉相关支架血栓（迄今已随访922例患者3年）。支架血栓形成的独立相关因素是未使用氯吡格雷、男性、吸烟以及可能使用多个非重叠支架。 结论 大约 0.8% 的红豆杉患者在支架植入后的前 6 个月内出现支架血栓，与裸金属支架相似。然而，Taxus 支架超过 6 个月后，风险会略有增加，可能是因为抗血小板药物治疗不足。
Objectives This study sought to study stent thrombosis with the paclitaxel-eluting Taxus stent.Background The incidence and timing of stent thrombosis after drug-eluting stent placement compared with bare-metal stent implantation remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications.Methods This study used a patient-based meta-analysis using the 4 principal TAUS randomized trials (3,445 patients) with a follow-up duration of 1 year.Results Cumulative stent thrombosis occurred in 1.28% +/- 0.31% in the Taxus group and 0.76% +/- 0.23% in the baremetal stent group at 3 years (hazard ratio 1.51 [95% confidence interval 0.73 to 3.14], p = 0.26). Hazard ratios (per 100 patients per 6 months) were similar between the Taxus stent group (0.59 [95% confidence interval 0.22 to 0.951) and the bare-metal stent group (0.64 [95% confidence interval 0.26 to 1.021) through 6 months during the prescribed clopidogrel period. However, from 6 months to 3 years there were more stent thromboses in the Taxus group (hazard ratio 0.19 [95% confidence interval 0.06 to 0.32] vs. 0.02 [95% confidence interval 0.00 to 0.07], p = 0.049). Of 8 patients with Taxus-related thrombosis after 6 months, 0 were taking clopidogrel and 2 were not taking aspirin consistently. No Taxus-related stent thrombosis occurred after 2 years (922 patients thus far followed up for 3 years). Independent correlates of stent thrombosis were nonuse of clopidogrel, male gender, smoking, and possibly use of multiple nonoverlapping stents.Conclusions Approximately 0.8% of Taxus patients have stent thrombosis in the first 6 months after stent implantation, similar to bare-metal stents. However, a modest increase in risk is present with Taxus stents beyond 6 months, possibly because of inadequate antiplatelet drug therapy.