Department of Cardiology, Wigan Hospital, Wigan, UK.
Department of Cardiology, Leeds General Infirmary, Leeds, UK.
BMJ Open. 2024 Oct 22;14(10):e084028. doi: 10.1136/bmjopen-2024-084028.
We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation.
The study was a prospective, observational, multicentre, single-arm registry.
The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021.
A total of 1904 patients with symptomatic coronary artery disease (age ≥18 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled.
The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2/C lesion defined as per ACC/AHA (American College of Cardiology/American Heart Association) lesion classification and long coronary lesions (>20 mm).
A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20±11.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2/C lesions (1832 lesions) and 985 had long coronary lesions (>20 mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2/C lesion, and 2.7% and 0.3% in long coronary lesions (>20 mm) subgroups, respectively. at 12 months follow-up.
The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis.
ISRCTN39751665 (https://doi.org/10.1186/ISRCTN39751665).
我们评估了 Supraflex Cruz（Sahajanand Medical TechnologiesLtd.，苏拉特，印度）载有雷帕霉素的超薄支架在需要冠状动脉支架植入的所有患者人群中的临床安全性和性能。
这项研究是一项前瞻性、观察性、多中心、单臂注册研究。
这项研究在英国的 19 家 NHS 医院进行，时间为 2020 年 3 月至 2021 年 9 月。
共纳入了 1904 名患有症状性冠状动脉疾病（年龄≥18 岁）的患者，他们接受了至少一枚 Supraflex Cruz SES 的经皮冠状动脉介入治疗。
主要终点是 12 个月时的靶病变失败（TLF），包括心脏死亡、靶血管心肌梗死（TV-MI）和临床指示的靶病变血运重建（CI-TLR）的复合终点。安全性终点是支架血栓形成、全因死亡和任何心肌梗死。预先指定的亚组分析包括糖尿病患者、分叉病变患者、根据 ACC/AHA（美国心脏病学会/美国心脏协会）病变分类定义的 B2/C 型病变患者和长冠状动脉病变（>20mm）患者。
共在 1835 名患者中植入了 2973 枚 Supraflex Cruz SES（平均年龄：65.20±11.03 岁）。其中，404 名患者患有糖尿病（491 个病变），271 名患者有分叉病变（293 个病变），1541 名患者有 B2/C 型病变（1832 个病变），985 名患者有长冠状动脉病变（>20mm，1139 个病变）。在总体人群中，98.2%的病变实现了器械成功。30 天时，12 名（0.7%）患者发生 TLF（0.3%心脏死亡，0.2%TV-MI，0.2%CI-TLR），12 个月随访时，43 名（2.3%）患者发生 TLF（0.8%心脏死亡，0.8%TV-MI，0.8%CI-TLR）。在总体人群中，12 个月时支架血栓形成的发生率为 0.3%。糖尿病患者的 TLF 和支架血栓形成发生率分别为 6.2%和 1%，分叉病变患者分别为 1.8%和无，B2/C 病变患者分别为 2.5%和 0.3%，长冠状动脉病变（>20mm）患者分别为 2.7%和 0.3%。12 个月随访。
S-FLEX UK-II 注册研究证实了 Supraflex Cruz 超薄 SES 在患有复杂冠状动脉疾病的所有患者人群中的临床安全性和性能，显示出较低的 TLF 和支架血栓形成发生率。
ISRCTN39751665（https://doi.org/10.1186/ISRCTN39751665）。
