Uppsala Clinical Research Centre, Uppsala University Hospital, Uppsala, Sweden.
Circ Cardiovasc Interv. 2009 Oct;2(5):401-8. doi: 10.1161/CIRCINTERVENTIONS.108.844985. Epub 2009 Sep 8.
The objective was to evaluate the role of risk factors and stent type for stent thrombosis (ST) using a large real world registry.
We evaluated all consecutive coronary stent implantations in Sweden from May 1, 2005, to June 30, 2007. All cases of ST, documented in the Swedish coronary angiography and angioplasty registry until September 21, 2008, were analyzed. ST was registered in 882 of 73 798 stents. Acute coronary syndromes, insulin-treated diabetes mellitus, smoking, previous coronary intervention, warfarin treatment, small stent diameter, and stenting in restenotic, complex, or bypass graft lesions had the strongest association with ST in the multivariable statistical model. There were considerable differences in the frequency of ST between different stent brands. The overall risk of ST was lower in drug-eluting stents compared with bare metal stents (adjusted risk ratio, 0.79; 99% CI, 0.63 to 0.99). However, from 6 months after stent implantation and onward, the risk for ST was higher in drug-eluting stents compared with bare metal stents (adjusted risk ratio, 2.02; 99% CI, 1.30 to 3.14).
ST is a multifactor disease, and the incidence varies considerably between patients based on clinical, vessel, and stent characteristics. For drug-eluting stents compared with bare metal stents, the risk pattern was biphasic; initially, bare metal stents demonstrated a higher risk of ST; whereas after the first months, ST risk was higher with drug-eluting stents. Our findings highlight the need for prospective randomized studies with head-to-head comparisons between different stents.
本研究旨在通过大型真实世界注册研究评估风险因素和支架类型对支架血栓形成(ST)的作用。
我们评估了 2005 年 5 月 1 日至 2007 年 6 月 30 日期间在瑞典进行的所有连续冠状动脉支架植入术。截至 2008 年 9 月 21 日,在瑞典冠状动脉造影和血管成形术注册中心记录的所有 ST 病例均进行了分析。在 73798 个支架中,有 882 个支架发生 ST。多变量统计模型显示,急性冠脉综合征、胰岛素治疗的糖尿病、吸烟、既往冠状动脉介入治疗、华法林治疗、支架直径小、支架置入在再狭窄病变、复杂病变或旁路移植病变与 ST 有最强的相关性。不同支架品牌之间 ST 的发生频率存在相当大的差异。与金属裸支架相比,药物洗脱支架的 ST 总体风险较低(调整风险比,0.79;99%CI,0.63 至 0.99)。然而,从支架植入后 6 个月开始,药物洗脱支架的 ST 风险高于金属裸支架(调整风险比,2.02;99%CI,1.30 至 3.14)。
ST 是一种多因素疾病,根据临床、血管和支架特征,患者之间的发病率差异很大。与金属裸支架相比,药物洗脱支架的风险模式呈双相性;最初,金属裸支架的 ST 风险较高;而在最初几个月后,药物洗脱支架的 ST 风险更高。我们的研究结果强调需要进行前瞻性随机研究,对头对头比较不同支架。