Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD: 3-Year Follow-Up of REC-CAGEFREE I Trial.

However, in the REC-CAGEFREE I study, the strategy of DCB angioplasty with rescue stenting failed to achieve noninferiority to intended DES implantation for treating de novo lesions at 2 years.

然而，在REC-CAGEFREE I研究中，DCB血管成形术联合备用支架植入策略在治疗新发病变方面，未能在2年内达到预期的药物洗脱支架植入的非劣效性。

This study sought to investigate the 3-year outcomes of the REC-CAGEFREE I trial and assess the mid-term effects of DCBs compared with DES.

本研究旨在调查REC-CAGEFREE I试验的3年结果，并评估与药物洗脱支架（DES）相比，药物涂层球囊（DCBs）的中期效果。

Methods

REC-CAGEFREE I was an open-label, randomized, noninferiority trial conducted across 43 sites in China.

REC-CAGEFREE I是一项在中国43个地点进行的开放标签、随机、非劣效试验。

After successful lesion predilation, 2,272 patients with de novo coronary artery disease (regardless of target vessel diameter) were randomly assigned (1:1) to paclitaxel-coated balloon angioplasty with the option of rescue stenting (DCB arm) vs up-front deployment of second-generation thin-strut sirolimus-eluting stents (DES arm).

在成功进行病变预扩张后，2,272名新发冠状动脉疾病患者（无论目标血管直径如何）被随机分配（1:1）至紫杉醇涂层球囊血管成形术组，并可选择性地进行补救性支架植入（DCB组）与直接部署第二代细支架丝雷帕霉素洗脱支架组（DES组）。

The primary outcome was the device-oriented composite endpoint (DOCE; including cardiovascular death, target vessel myocardial infarction [TV-MI], and clinically and physiologically indicated target lesion revascularization [CPI-TLR]) assessed in the intention-to-treatpopulation.

主要结果是设备导向的复合终点（DOCE；包括心血管死亡、靶血管心肌梗死[TV-MI]，以及临床和生理学上指示的靶病变血运重建[CPI-TLR]），在意向治疗人群中进行评估。

The extended follow-up is ongoing and will continue for up to 10 years.

延长随访正在进行中，将持续至多10年。

Results

From February 5, 2021, to May 1, 2022, 1,133 patients were randomly assigned to the DCB arm and 1,139 to the DES arm.

从2021年2月5日至2022年5月1日，共有1,133名患者被随机分配至药物涂层球囊（DCB）组，1,139名患者被分配至药物洗脱支架（DES）组。

The median diameter of devices was at 3.00 ± 0.46 mm.

设备的中位直径为3.00 ± 0.46毫米。

Rescue DES implantation after unsatisfactory DCB angioplasty was performed in 106 patients (9.4%).

在106名（9.4%）患者中，对不满意的结果进行了药物洗脱支架（DES）植入术。

At 3 years, the DOCE occurred in 92 patients (8.2%) in the DCB arm and 56 (5.0%) in the DES arm (difference: 3.21%; 95% CI: 1.17%-5.26%; P = 0.002).

在3年时，药物涂层球囊（DCB）组有92名患者（8.2%）和药物洗脱支架（DES）组有56名患者（5.0%）发生了晚期管腔丢失（DOCE）（差异：3.21%；95%置信区间：1.17%-5.26%；P = 0.002）。

Landmark analyses showed that the rates of difference in the DOCE at 0 to 1, 1 to 2, and 2 to 3 years were 1.69% (95% CI: 0.32%-3.06%), 1.10% (95% CI: -0.13% to 2.32%), and 0.58% (95% CI: -0.51% to 1.66%), respectively (Ptrend = 0.023).

里程碑分析显示，在0至1年、1至2年和2至3年期间，晚期管腔丢失（DOCE）的差异率分别为1.69%（95%置信区间：0.32%-3.06%）、1.10%（95%置信区间：-0.13%至2.32%）和0.58%（95%置信区间：-0.51%至1.66%）（Ptrend = 0.023）。

Conclusions

In patients with de novo coronary artery disease, DCB angioplasty with rescue stenting was associated with a higher rate of the DOCE compared with up-front DES implantation regarding the DOCE at 3 years.

在新发冠状动脉疾病患者中，与初次植入药物洗脱支架（DES）相比，DCB血管成形术联合紧急支架植入在3年时的确定性临床事件（DOCE）发生率更高。

(Paclitaxel-Coated Balloon for Treatment of De-Novo Noncomplex Coronary Artery Lesions; NCT04561739).

(用于治疗新发非复杂冠状动脉病变的紫杉醇涂层球囊；NCT04561739)。