Blich Miry, Zeidan-Shwiri Tawfiq, Petcherski Sirouch, Osherov Azriel, Hammerman Haim
Rambam Health Care Campus, Department of Cardiology, Haalia, Haifa, 91096 Israel.
J Invasive Cardiol. 2010 Oct;22(10):461-4.
Traditionally, stent thrombosis (STH) has been regarded as a complication of percutaneous coronary interventions during the first 30 post-procedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents (DES) may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials.
To evaluate the incidence, predictors and clinical outcomes of STH and premature discontinuation of thienopyridines after implantation of DES in real-world practice.
We prospectively collected data from consecutive unselected patients who underwent at least 1 DES implantation at our center from February 2006 until January 2007. The patients were followed by a phone interview or by collecting data from admission files over the course of 2 years after the implantation. Confirmed and suspected STH was defined as accepted in the medical literature.
Three hundred fourteen patients were successfully treated with DES (436 lesions). At 20 ± 6.7 months' follow up (median 22 months), 14 patients (4.4%) had STH (incidence density 2.7 cases/100 patients-years). Five patients had early thrombosis (0-30 days), 5 patients had late STH (31-360 days from the procedure) and 4 patients had very late STH (> 360 days). Five of the 14 patients with STH died (case fatality rate, 36%). In multivariant logistic regression analysis, history of a non-cardiac thrombotic event was a risk factor for STH (p = 0.006, odds ratio [OR] 7.7, confidence interval [CI] 1.8-32.9). Clopidogrel therapy lasting less than 3 months was an independent predictor of late and very late STH (p = 0.001, OR 10.8, CI 2.7-42.9). Independent predictors of early discontinuation of thienopyridines (≤ 3 months) were Arab ethnic origin (p = 0.005, OR 19.2, CI 2.4-142), absence of cardiology follow up (p = 0.05, OR 4.7, CI 1-23.1) and absence of explanation about the clopidogrel importance at the time of hospital discharge (p = 0.001, OR 10.8, CI 2.7-42.9).
The incidence of STH at 22- month follow up in real-world patients was substantially higher than the rate reported in previous clinical trials. Subsidizing the cost of thienopyridines, providing a clear explanation to the patient and encouraging cardiology follow up may prevent premature discontinuation of thienopyridines after implantation of DES and reduce the incidence of STH after DES implantation.
传统上，支架血栓形成（STH）一直被视为经皮冠状动脉介入治疗术后前30天内的一种并发症。然而，与药物洗脱支架（DES）植入相关的延迟内皮化可能会使血栓形成风险延长至30天以上。关于这一现象在临床试验之外的风险和影响的数据有限。
评估在实际临床实践中，DES植入术后STH的发生率、预测因素及临床结局，以及噻吩并吡啶类药物提前停药的情况。
我们前瞻性收集了2006年2月至2007年1月在本中心接受至少1次DES植入的连续入选患者的数据。在植入术后2年期间，通过电话随访或从入院病历中收集数据对患者进行随访。确诊和疑似STH的定义与医学文献一致。
314例患者成功接受了DES治疗（436处病变）。在20±6.7个月的随访期（中位数22个月），14例患者（4.4%）发生了STH（发病密度为2.7例/100患者-年）。5例患者发生早期血栓形成（0-30天），5例患者发生晚期STH（术后31-360天），4例患者发生极晚期STH（>360天）。14例发生STH的患者中有5例死亡（病死率36%）。在多变量逻辑回归分析中，非心脏血栓形成事件史是STH的一个危险因素（p = 0.006，比值比[OR]7.7，置信区间[CI]1.8-32.9）。氯吡格雷治疗持续时间少于3个月是晚期和极晚期STH的独立预测因素（p = 0.001，OR 10.8，CI 2.7-42.9）。噻吩并吡啶类药物提前停药（≤3个月）的独立预测因素为阿拉伯族裔（p = 0.005，OR 19.2，CI 2.4-142）、无心脏病学随访（p = 0.05，OR 4.7，CI 1-23.1）以及出院时未对氯吡格雷的重要性进行解释（p = 0.001，OR 10.8，CI 2.7-42.9）。
在实际临床实践中，对患者进行22个月随访时STH的发生率显著高于既往临床试验报道的发生率。补贴噻吩并吡啶类药物费用、向患者进行明确解释并鼓励心脏病学随访，可能会预防DES植入术后噻吩并吡啶类药物提前停药，并降低DES植入术后STH的发生率。
