PDF(Pubmed)
Abstract：
BACKGROUND: Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain.
METHODS: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization.
CONCLUSIONS: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting.
BACKGROUND: Registered on clinicaltrial.gov (NCT04561739).
METHODS: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization.
CONCLUSIONS: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting.
BACKGROUND: Registered on clinicaltrial.gov (NCT04561739).
摘要：
背景：经皮冠状动脉介入治疗（PCI），这代表支架植入，无论获得满意的结果与球囊血管成形术，已取代传统的普通旧球囊血管成形术和临时支架。带有药物涂层球囊（DCB），对于新发冠状动脉小血管疾病，初次DCB血管成形术和临时支架置入术显示出非劣效性。然而,在无血管直径限制的新生病变中,这种策略对临床终点的主要支架置入术的长期疗效和安全性仍不确定.
方法：REC-CAGEFREEI是研究者发起的，多中心，随机化，开放标签试验旨在招募来自中国43个介入心脏病学中心的2270例急性或慢性冠状动脉综合征患者，以评估初级紫杉醇涂层球囊血管成形术对初级支架置入治疗从头治疗的非劣效性，非复杂病变无血管直径限制。符合所有纳入和排除标准并已成功实现病变预扩张的患者将以1:1的比例随机分配到两臂。在初次DCB血管成形术组中，协议指导的DCB血管成形术和不满意的血管成形术后的救助支架置入是强制性的。第二代西罗莫司洗脱支架将在主要DCB血管成形术组中用作救助支架，在主要支架置入组中用作治疗装置。主要终点是随机化后24个月内面向设备的复合终点（DoCE）的发生率，包括心脏死亡,靶血管心肌梗死,临床和生理指示的靶病变血运重建。
结论：正在进行的REC-CAGEFREEI试验是第一个具有临床终点的随机试验，用于评估原发性DCB血管成形术治疗从头，非复杂病变无血管直径限制。如果显示出非劣效性，采用原发性DCB血管成形术的PCI可能是原发性支架置入术的替代治疗选择。
背景：在clinicaltrial.gov（NCT04561739）注册。
方法：REC-CAGEFREEI是研究者发起的，多中心，随机化，开放标签试验旨在招募来自中国43个介入心脏病学中心的2270例急性或慢性冠状动脉综合征患者，以评估初级紫杉醇涂层球囊血管成形术对初级支架置入治疗从头治疗的非劣效性，非复杂病变无血管直径限制。符合所有纳入和排除标准并已成功实现病变预扩张的患者将以1:1的比例随机分配到两臂。在初次DCB血管成形术组中，协议指导的DCB血管成形术和不满意的血管成形术后的救助支架置入是强制性的。第二代西罗莫司洗脱支架将在主要DCB血管成形术组中用作救助支架，在主要支架置入组中用作治疗装置。主要终点是随机化后24个月内面向设备的复合终点（DoCE）的发生率，包括心脏死亡,靶血管心肌梗死,临床和生理指示的靶病变血运重建。
结论：正在进行的REC-CAGEFREEI试验是第一个具有临床终点的随机试验，用于评估原发性DCB血管成形术治疗从头，非复杂病变无血管直径限制。如果显示出非劣效性，采用原发性DCB血管成形术的PCI可能是原发性支架置入术的替代治疗选择。
背景：在clinicaltrial.gov（NCT04561739）注册。
