Ong Andrew T L, Hoye Angela, Aoki Jiro, van Mieghem Carlos A G, Rodriguez Granillo Gaston A, Sonnenschein Karel, Regar Evelyn, McFadden Eugene P, Sianos Georgios, van der Giessen Willem J, de Jaegere Peter P T, de Feyter Pim, van Domburg Ron T, Serruys Patrick W
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
J Am Coll Cardiol. 2005 Mar 15;45(6):947-53. doi: 10.1016/j.jacc.2004.09.079.
We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation.
Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice.
The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES.
In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST.
The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.
我们试图确定在裸金属支架（BMS）、西罗莫司洗脱支架（SES）和紫杉醇洗脱支架（PES）植入后的前30天内，在无限制人群中血管造影证实的和可能的支架血栓形成（ST）的真实世界发生率。
目前关于药物洗脱支架（DES）中ST的数据来自具有严格入选标准的随机试验，这限制了它们在日常实践中的普遍性。
研究人群包括三个连续队列，分别为506例连续接受BMS治疗的患者、1017例连续接受SES治疗的患者和989例连续接受PES治疗的患者。
在支架植入后的前30天内，6例BMS患者（1.2%，95%置信区间[CI]0.5%至2.6%；p = 0.9）、10例SES患者（1.0%，95%CI 0.5%至1.8%）和10例PES患者（1.0%，95%CI 0.6%至1.9%）发生了血管造影证实的ST。在大多数ST患者中发现了多种潜在危险因素。急性心肌梗死情况下的分叉支架置入是整个人群血管造影ST的独立危险因素（优势比[OR]12.9，95%CI 4.7至35.8，p < 0.001）。在发生血管造影ST的DES患者中，30天死亡率为15%，而另外60%发生了非致命性心肌梗死；在六个月的随访期间没有进一步死亡。包括可能的病例，7例BMS患者（1.4%，95%CI 0.7%至2.8%）、15例SES患者（1.5%，95%CI 0.9%至2.4%）和16例PES患者（1.6%，95%CI 1.0%至2.6%）发生了ST。
SES或PES的无限制使用与BMS预期范围内的ST发生率相关。支架血栓形成与高发病率和死亡率相关。在急性心肌梗死患者中进行分叉支架置入与ST风险增加相关。
