Remkes Wouter S, Badings Erik A, Hermanides Renicus S, Rasoul Saman, Dambrink Jan-Henk E, Koopmans Petra C, The Salem Hk, Ottervanger Jan Paul, Gosselink A T Marcel, Hoorntje Jan Ca, Suryapranata Harry, van 't Hof Arnoud Wj
Isala heart centre , Zwolle , The Netherlands.
Deventer Ziekenhuis , Deventer , The Netherlands.
Open Heart. 2016 Nov 17;3(2):e000455. doi: 10.1136/openhrt-2016-000455. eCollection 2016.
The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS.
ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome.
178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively.
In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163.
39230163; Post-results.
药物洗脱支架（DES）在ST段抬高型心肌梗死（STEMI）患者中相对于裸金属支架（BMS）的优势已得到充分研究；然而，非ST段抬高型心肌梗死（NSTEMI）患者的随机数据尚缺乏。本研究的目的是调查与BMS相比，使用依维莫司洗脱支架（EES）进行支架置入术能否安全降低NSTEMI患者的再狭窄率。
ELISA-3试验的患者被邀请参加血管造影子研究，并被随机分为接受药物洗脱（Xience V）或裸金属（Vision）支架置入术（ELISA-3组）。主要终点是9个月随访血管造影时的最小管腔直径（MLD）。此外，296例被排除或不想参加ELISA-3试验的NSTEMI患者（RELI组）被随机分为接受药物洗脱或裸金属支架置入术，仅接受临床随访（主要不良心脏事件（MACE）、支架血栓形成（ST））。进行汇总分析以评估对临床结局的影响。
ELISA-3试验的540例患者中有178例参加了血管造影子研究。9个月血管造影时的MLD，药物洗脱支架组为2.37±0.63mm，裸金属支架组为1.84±0.62mm，p<0.001。药物洗脱支架组的二元再狭窄发生率为1.9%，裸金属支架组为16.7%（相对危险度0.11，95%可信区间0.02至0.84，p=0.007）。在汇总分析中，药物洗脱支架组与裸金属支架组在2年随访时的MACE、靶血管血运重建和ST发生率分别为12.5%对16.0%（p=0.28）、4.0%对10.4%（p=0.009）和1.3%对3.0%（p=0.34）。
在NSTEMI患者中，与BMS相比，使用EES是安全的，并且可降低血管造影和临床再狭窄率。http://www.isrctn.com/search?q=39230163。
39230163；结果公布后。
