采用含生物可吸收聚合物的铂铬依维莫司洗脱支架治疗急性冠状动脉综合征患者。SYNERGY ACS注册研究结果。
The Pt-Cr everolimus-eluting stent with bioabsorbable polymer in the treatment of patients with acute coronary syndromes. Results from the SYNERGY ACS registry.
作者信息
de la Torre Hernandez Jose M, Moreno Raul, Gonzalo Nieves, Rivera Ricardo, Linares Jose A, Veiga Fernandez Gabriela, Gomez Menchero Antonio, Garcia Del Blanco Bruno, Hernandez Felipe, Benito Gonzalez Tomas, Subinas Asier, Escaned Javier
机构信息
Hospital Universitario Marques de Valdecilla, Dpt. of Interventional Cardiology, IDIVAL, Santander, Spain.
Hospital La Paz, Dpt. of Interventional Cardiology, Madrid, Spain.
出版信息
Cardiovasc Revasc Med. 2019 Aug;20(8):705-710. doi: 10.1016/j.carrev.2018.10.019. Epub 2018 Oct 18.
OBJECTIVES
We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS).
BACKGROUND
A number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm.
METHODS
This is a multicenter registry (10 centers) including consecutive patients with ACS (unstable angina, non-ST elevated myocardial infarction, ST elevated myocardial infarction) who underwent percutaneous revascularization with the implantation of SYNERGY stent. The primary endpoint was the composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months.
RESULTS
A total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01). Cardiac death was 1.3% (1.6%, p = 0.8 and 0.5%, P superiority =0.1 respectively). Myocardial infarction was 1.6% (4.6%, p < 0.01 and 1.8%, P superiority = 0.9 respectively). Target lesion revascularization was 1% (3.4%, p < 0.01 and 5.4%, P superiority <0.01 respectively). Definite or probable thrombosis was 0.9% (2.8%, p ≤ 0.01 and 1.1%, P superiority = 0.8 respectively).
CONCLUSIONS
The results of this registry show a very good safety and efficacy profile at 12 months for the SYNERGY stent in patients with ACS.
SUMMARY
A recent trial (TIDES-ACS) in the context of acute coronary syndromes (ACS) reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY stent control arm. We investigated the safety of SYNERGY stent in a real-world study population with ACS applying the same inclusion/exclusion criteria as used in the TIDES-ACS trial. Primary endpoint was the composite of cardiac death, myocardial infarction and TLR at 12 months. A total of 1008 patients have been included. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01).
目的
我们在一个患有急性冠状动脉综合征（ACS）的真实世界研究人群中，调查了生物可吸收聚合物涂层、依维莫司洗脱冠状动脉支架（SYNERGY支架）的安全性和有效性。
背景
多项临床试验支持SYNERGY支架的总体有效性和安全性。然而，最近一项在ACS背景下进行的试验（TIDES - ACS）报告称，SYNERGY对照组中梗死以及明确/可能的支架血栓形成数据令人担忧。
方法
这是一项多中心注册研究（10个中心），纳入了连续的ACS患者（不稳定型心绞痛、非ST段抬高型心肌梗死、ST段抬高型心肌梗死），这些患者接受了SYNERGY支架植入的经皮血管重建术。主要终点是12个月时的心源性死亡、心肌梗死和靶病变血管重建的复合终点。
结果
共纳入1008例患者，年龄65.4±14.8岁，女性占23.8%，糖尿病患者占24.5%。就临床表现而言，不稳定型心绞痛患者占15.2%，非ST段抬高型心肌梗死患者占43%，ST段抬高型心肌梗死患者占41.8%。3%的患者达到主要结局（SYNERGY TIDES - ACS组为7%，优势比P<0.01；OPTIMAX TIDES - ACS组为6.3%，优势比P<0.01）。心源性死亡为1.3%（分别为1.6%，p = 0.8和0.5%，优势比P = 0.1）。心肌梗死为1.6%（分别为4.6%，p<0.01和1.8%，优势比P = 0.9）。靶病变血管重建为1%（分别为3.4%，p<0.01和5.4%，优势比P<0.01）。明确或可能的血栓形成率为0.9%（分别为2.8%，p≤0.01和1.1%，优势比P = 0.8）。
结论
该注册研究结果显示，SYNERGY支架在ACS患者12个月时具有非常好的安全性和有效性。
总结
最近一项在急性冠状动脉综合征（ACS）背景下进行的试验（TIDES - ACS）报告称，SYNERGY支架对照组中梗死以及明确/可能的支架血栓形成数据令人担忧。我们在一个患有ACS的真实世界研究人群中，采用与TIDES - ACS试验相同的纳入/排除标准，调查了SYNERGY支架的安全性。主要终点是12个月时的心源性死亡、心肌梗死和靶病变血管重建的复合终点。共纳入1008例患者。3%的患者达到主要结局（SYNERGY TIDES - ACS组为7%，优势比P<0.01；OPTIMAX TIDES - ACS组为6.3%，优势比P<0.01）。
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