Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Department of Medical Sciences, Cardiology, Uppsala University, Dag Hammarsköldsväg 14B, 75337, Uppsala, Sweden.
Clin Res Cardiol. 2018 Sep;107(9):816-823. doi: 10.1007/s00392-018-1252-0. Epub 2018 Apr 17.
Old-generation drug-eluting coronary stents (o-DES) have despite being safe and effective been associated with an increased propensity of late stent thrombosis (ST). We evaluated ST rates in o-DES, new-generation DES (n-DES) and bare metal stents (BMS) the first year (< 1 year) and beyond 1 year (> 1 year).
We evaluated all implantations with BMS, o-DES (Cordis Cypher, Boston Scientific Taxus Liberté and Medtronic Endeavor) and n-DES in the Swedish coronary angiography and angioplasty registry (SCAAR) between 1 January 2007 and 8 January 2014 (n = 207 291). All cases of ST (n = 2 268) until 31 December 2014 were analyzed.
The overall risk of ST was lower in both n-DES and o-DES compared with BMS up to 1 year (n-DES versus BMS: adjusted risk ratio (RR) 0.48 (0.41-0.58) and o-DES versus BMS: 0.56 (0.46-0.67), both p < 0.001). From 1 year after stent implantation and onward, the risk for ST was higher in o-DES compared with BMS [adjusted RR, 1.82 (1.47-2.25], p < 0.001). N-DES were associated with similar low ST rates as BMS from 1 year and onward [adjusted RR 1.21 (0.94-1.56), p = 0.135].
New-generation DES were associated with lower ST rates in comparison to BMS during the first-year post-stenting. After 1 year, n-DES and BMS were associated with similar ST rates.
This study was a retrospective observational study and as such did not require clinical trial database registration.
尽管第一代药物洗脱冠状动脉支架(o-DES)安全有效,但与晚期支架血栓形成(ST)的发生率增加有关。我们评估了第一代药物洗脱冠状动脉支架(o-DES)、新一代药物洗脱冠状动脉支架(n-DES)和裸金属支架(BMS)在第一年(<1 年)和超过 1 年(>1 年)时的 ST 发生率。
我们评估了 2007 年 1 月 1 日至 2014 年 1 月 8 日期间在瑞典冠状动脉造影和血管成形术登记处(SCAAR)植入的所有 BMS、o-DES(Cordis Cypher、Boston Scientific Taxus Liberté 和 Medtronic Endeavor)和 n-DES(n=207291)患者的情况。分析了截至 2014 年 12 月 31 日所有 ST(n=2268)病例。
在第一年(n-DES 与 BMS:调整后的风险比(RR)0.48(0.41-0.58)和 o-DES 与 BMS:0.56(0.46-0.67),均 p<0.001),n-DES 和 o-DES 与 BMS 相比,ST 的总体风险均较低。支架植入 1 年后,o-DES 发生 ST 的风险高于 BMS [调整后的 RR,1.82(1.47-2.25],p<0.001]。n-DES 与 BMS 相比,1 年后 ST 发生率相似[调整后的 RR 1.21(0.94-1.56),p=0.135]。
与 BMS 相比,新一代 DES 在支架置入后的第一年 ST 发生率较低。1 年后,n-DES 和 BMS 的 ST 发生率相似。
本研究为回顾性观察性研究,因此无需在临床试验数据库中注册。