Sirolimus-Eluting Iron Bioresorbable Scaffolds vs Everolimus-Eluting Stents for Percutaneous Coronary Intervention: A Randomized Trial (IRONMAN II).

The objective of this study was to compare the IBS with contemporary metallic cobalt chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease.

本研究的目的是比较IBS与当代金属钴铬依维莫司洗脱支架（CoCr-EES）在冠状动脉疾病患者中的效果。

Methods

IRONMAN-II was a prospective, multicenter, single-blinded, noninferiority randomized trial across 36 centers in China.

IRONMAN-II 是一项在中国36个中心进行的前瞻性、多中心、单盲、非劣效性随机试验。

Eligible patients had myocardial ischemia and 1 or 2 de novo target lesions.

符合条件的患者有心肌缺血和1个或2个新发靶病变。

Patients were randomly assigned (1:1) to IBS or CoCr-EES, with allocation masked.

患者被随机分配（1:1）到IBS或CoCr-EES，分配过程是盲法的。

Optical coherence tomography (OCT) was performed in the first 25 participant pairs.

在前25对参与者中进行了光学相干断层扫描（OCT）。

Clinical follow-up was scheduled at 1, 6, and 12 months, and annually to 5 years, with angiographic and OCT follow-up at 2 years.

临床随访计划在1个月、6个月和12个月时进行，并且每年随访至5年，其中在2年时进行血管造影和光学相干断层扫描(OCT)随访。

The primary endpoint was 2-year angiographic in-segment late lumen loss (LLL).

主要终点是2年血管造影的节段内晚期腔内丢失(LLL)。

Powered secondary endpoints included target vessel quantitative flow ratio (QFR) and OCT-derived cross-sectional mean flow area.

次要终点包括目标血管定量血流比(QFR)和OCT导出的横截面平均血流面积。

Other secondary endpoints included target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target vessel revascularization), the patient-oriented composite endpoint (all-cause death, MI, or any revascularization), their individual components, and device thrombosis.

其他次要终点包括目标病变失败（心脏死亡、目标血管心肌梗死[MI]或缺血驱动的目标血管血运重建）、患者导向的复合终点（全因死亡、MI或任何血运重建）、它们的各个组成部分以及器械血栓形成。

Results

Between March 10 and December 13, 2022, 518 patients were randomized to IBS (n = 259) or CoCr-EES (n = 259).

2022年3月10日至12月13日期间，共有518名患者被随机分配至IBS组（n = 259）或CoCr-EES组（n = 259）。

At 2 years, lesion-level in-segment LLL was 0.28 (0.52) mm with IBS and 0.23 (0.43) mm with CoCr-EES (difference: 0.08 mm; 95% CI: -0.02 to 0.18; Pnoninferiority = 0.03).

在2年时，IBS组的病变水平内段晚期丢失（LLL）为0.28（0.52）毫米，而CoCr-EES组为0.23（0.43）毫米（差异：0.08毫米；95%置信区间：-0.02至0.18；非劣效性P值=0.03）。

Mean QFR was 0.90 (0.13) with IBS and 0.92 (0.09) with CoCr-EES (difference: -0.02; 95% CI: -0.04 to 0; Pnoninferiority = 0.05).

使用IBS时，平均QFR为0.90（0.13），而使用CoCr-EES时为0.92（0.09）（差异：-0.02；95%置信区间：-0.04至0；P非劣效性=0.05）。

Mean OCT flow area was 6.92 (3.48) mm2 with IBS and 6.64 (2.44) mm2 with CoCr-EES (difference: 0.27; 95% CI: -0.09 to 0.63; Pnoninferiority < 0.0001).

使用IBS时，平均OCT流动面积为6.92（3.48）mm2，而使用CoCr-EES时为6.64（2.44）mm2（差异：0.27；95%置信区间：-0.09至0.63；P非劣效性<0.0001）。

Two-year target lesion failure occurred in 7.4% of IBS patients and 5.4% of CoCr-EES patients (HR: 1.37; 95% CI: 0.69-2.73; P = 0.37).

IBS患者中两年目标病变失败的发生率为7.4%，而CoCr-EES患者为5.4%（HR: 1.37; 95% 置信区间: 0.69-2.73; P = 0.37）。

No significant between-group differences in the rates of patient-oriented composite endpoint, death, or MI were present between the 2 groups.

两组患者在患者导向的复合终点、死亡或心肌梗死的发生率上没有显著差异。

No scaffold thromboses occurred in the IBS group, whereas 1 stent thrombosis occurred with CoCr-EES.

在IBS组中没有发生支架血栓，而CoCr-EES组发生了1例支架血栓。

Binary restenosis and revascularization rates were higher with IBS, however, most such events were non-ischemia-driven.

二元再狭窄和血运重建率在IBS组中更高，然而，大多数此类事件并非由缺血驱动。

Conclusions

In IRONMAN-II, the sirolimus-eluting IBS was noninferior to CoCr-EES for 2-year in-segment LLL, QFR, and OCT-derived flow area.

在IRONMAN-II研究中，西罗莫司洗脱支架（sirolimus-eluting IBS）在2年内的节段内晚期丢失（in-segment LLL）、定量血流分数（QFR）和光学相干断层扫描（OCT）导出的血流面积方面，与钴铬合金依维莫司洗脱支架（CoCr-EES）相比，显示出非劣效性。

Clinical event rates were also comparable between groups although non-ischemia-driven revascularization rates were higher after IBS.

尽管在IBS组中，非缺血驱动的血运重建率较高，但两组的临床事件发生率也是可比的。

Longer-term follow-up is necessary to demonstrate whether late benefits are realized after complete IBS resorption.

需要更长期的随访来证明，在完全吸收IBS之后是否实现了晚期益处。

(A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease; NCT05206084).

(一项评估IBS在冠状动脉疾病患者中安全性和有效性的临床研究; NCT05206084).