一项关于使用超薄支架无聚合物西罗莫司洗脱支架治疗更多患者人群的研究：一项意大利上市后研究（凯撒注册研究）
A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).
作者信息
Tarantini Giuseppe, Cardaioli Francesco, De Iaco Giuseppe, Tuccillo Bernardino, De Angelis Maria Carmen, Mauro Ciro, Boccalatte Marco, Trivisonno Antonio, Ribichini Flavio, Vadalà Giuseppe, Caramanno Giuseppe, Caruso Marco, Lombardi Mario, Fischetti Dionigi, Danesi Alessandro, Abbracciavento Leonardo, Lorenzoni Giulia, Gregori Dario, Panza Andrea, Nai Fovino Luca, Esposito Giovanni
机构信息
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padova, Italy.
Department of Cardiology, Hospital "Cardinal G. Panico", Tricase, Italy.
出版信息
Front Cardiovasc Med. 2024 Jan 8;10:1326091. doi: 10.3389/fcvm.2023.1326091. eCollection 2023.
INTRODUCTION
The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population.
METHODS
The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year.
RESULTS
A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients.
CONCLUSION
In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.
引言
当代药物洗脱支架（DES）的应用显著改善了接受经皮冠状动脉介入治疗（PCI）的冠心病（CAD）患者的治疗效果。然而，大多数DES所使用的耐用聚合物涂层的长期促炎作用令人担忧，这可能导致长期不良事件。第一代无聚合物支架技术，如西罗莫司和普罗布考洗脱支架（PF-SES），已显示出优异的安全性和有效性。本研究的目的是在更多接受PCI治疗的患者中评估新型超薄Coroflex ISAR NEO PF-SES的安全性和有效性。
方法
CAESAR（一项使用超薄支柱无聚合物西罗莫司支架治疗更多患者的研究：一项意大利上市后研究）注册研究是在意大利进行的一项多中心、前瞻性研究，纳入接受Coroflex ISAR NEO支架PCI治疗的更多CAD患者。排除患有左主干（LM）疾病、心源性休克（CS）或左心室射血分数（LVEF）严重降低的患者。主要终点是1年时的靶病变血运重建（TLR）。
结果
13个中心共纳入425例患者（平均年龄66.9±11.6岁，糖尿病29%，急性冠状动脉综合征67%，慢性完全闭塞9%）。其中，40.9%患有多支血管疾病（MVD），3.3%的病例中靶病变为支架内再狭窄（ISR）。422例（99.6%）患者实现了临床器械成功。1年时，仅2例（0.5%）患者出现缺血驱动的TLR。1年时靶血管血运重建和主要不良心血管事件（MACE）的发生率分别为0.5%和5.1%。4例（1.0%）患者发生大出血。
结论
在这项多中心、前瞻性注册研究中，在更多接受PCI治疗的患者中使用新型超薄Coroflex ISAR NEO PF-SES在1年时显示出良好的安全性和有效性。
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