氮化钛-氧化硅涂层与依维莫司洗脱支架治疗急性冠状动脉综合征：TIDES-ACS 随机临床试验 5 年临床结局。
Titanium-Nitride-Oxide-Coated vs Everolimus-Eluting Stents in Acute Coronary Syndrome: 5-Year Clinical Outcomes of the TIDES-ACS Randomized Clinical Trial.
机构信息
Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium.
Departement of Cardiology, Toulouse University Hospital, Toulouse, France.
出版信息
JAMA Cardiol. 2023 Jul 1;8(7):703-708. doi: 10.1001/jamacardio.2023.1373.
IMPORTANCE
Titanium-nitride-oxide (TiNO)-coated stents show faster strut coverage compared with drug-eluting stents without excessive intimal-hyperplasia observed in bare metal stents. It is important to study long-term clinical outcomes after treatment of patients with an acute coronary syndrome (ACS) by TiNO-coated stents, which are neither drug-eluting stents nor bare metal stents.
OBJECTIVE
To compare the rate of main composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 5 years in patients with ACS randomized to receive either a TiNO-coated stent or a third-generation everolimus-eluting stent (EES).
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, randomized, controlled, open-label trial was conducted in 12 clinical sites in 5 European countries and enrolled patients from January 2014 to August 2016. Patients presenting with ACS (ST-segment elevation MI, non-ST-segment elevation MI, and unstable angina) with at least 1 de novo lesion were randomized to receive either a TiNO-coated stent or an EES. The present report analyzes the long-term follow-up for the main composite outcome and its individual components. Analysis took place between November 2022 to March 2023.
MAIN OUTCOME
The primary end point was a composite of cardiac death, MI, or target lesion revascularization at 12-month follow-up.
RESULTS
A total of 1491 patients with ACS were randomly assigned to receive either TiNO-coated stents (989 [66.3%]) or EES (502 [33.7%]). The mean (SD) age was 62.7 (10.8) years, and 363 (24.3%) were female. At 5 years, the main composite outcome events occurred in 111 patients (11.2%) in the TiNO group vs 60 patients (12%) in the EES group (hazard ratio [HR], 0.94; 95% CI, 0.69-1.28; P = .69). The rate of cardiac death was 0.9% (9 of 989) vs 3.0% (15 of 502) (HR, 0.30; 95% CI, 0.13-0.69; P = .005), the rate of MI was 4.6% (45 of 989) vs 7.0% (35 of 502) (HR, 0.64; 95% CI, 0.41-0.99; P = .049), the rate of stent thrombosis was 1.2% (12 of 989) vs 2.8% (14 of 502) (HR, 0.43; 95% CI, 0.20-0.93; P = .034), and the rate of target lesion revascularization was 7.4% (73 of 989) vs 6.4% (32 of 502) (HR, 1.16; 95% CI, 0.77-1.76; P = .47) in the TiNO-coated stent arm and in the EES arm, respectively.
CONCLUSION AND RELEVANCE
In this study, patients with ACS had a main composite outcome that was not different 5 years after TiNO-coated stent or EES.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02049229.
重要性：与未观察到裸金属支架中过度内膜增生的药物洗脱支架相比，氮化钛（TiNO）涂层支架显示出更快的支架覆盖率。对于接受急性冠状动脉综合征（ACS）治疗的患者，研究 TiNO 涂层支架的长期临床结果非常重要，因为 TiNO 涂层支架既不是药物洗脱支架，也不是裸金属支架。
目的：比较 ACS 患者接受 TiNO 涂层支架或第三代依维莫司洗脱支架（EES）治疗后 5 年时主要复合终点（心脏死亡、心肌梗死[MI]或缺血驱动的靶病变血运重建）的发生率。
设计、地点和参与者：这是一项多中心、随机、对照、开放性临床试验，在欧洲 5 个国家的 12 个临床中心进行，纳入了 2014 年 1 月至 2016 年 8 月期间出现 ACS（ST 段抬高型心肌梗死、非 ST 段抬高型心肌梗死和不稳定型心绞痛）且至少有 1 个新发病变的患者。患者被随机分配接受 TiNO 涂层支架或 EES 治疗。本报告分析了主要复合终点及其各组成部分的长期随访结果。分析于 2022 年 11 月至 2023 年 3 月进行。
主要终点：主要终点是 12 个月随访时的心脏死亡、MI 或靶病变血运重建的复合终点。
结果：共有 1491 例 ACS 患者被随机分配接受 TiNO 涂层支架（989 [66.3%]）或 EES（502 [33.7%]）治疗。患者的平均（SD）年龄为 62.7±10.8 岁，363 例（24.3%）为女性。5 年后，TiNO 组有 111 例（11.2%）患者发生主要复合结局事件，EES 组有 60 例（12%）患者发生主要复合结局事件（风险比[HR]，0.94；95%CI，0.69-1.28；P=0.69）。心脏死亡发生率为 0.9%（9/989）vs EES 组的 3.0%（15/502）（HR，0.30；95%CI，0.13-0.69；P=0.005），心肌梗死发生率为 4.6%（45/989）vs EES 组的 7.0%（35/502）（HR，0.64；95%CI，0.41-0.99；P=0.049），支架血栓形成发生率为 1.2%（12/989）vs EES 组的 2.8%（14/502）（HR，0.43；95%CI，0.20-0.93；P=0.034），靶病变血运重建发生率为 7.4%（73/989）vs EES 组的 6.4%（32/502）（HR，1.16；95%CI，0.77-1.76；P=0.47）。
结论和相关性：在这项研究中，ACS 患者在接受 TiNO 涂层支架或 EES 治疗 5 年后的主要复合结局没有差异。
试验注册：ClinicalTrials.gov 标识符：NCT02049229。
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