Ultimaster TANSEI Stent in Complex Coronary Lesions: The EPIC08 TANSEI COMPLEX Study.

IF 2.8 0 PHILOSOPHY

Interventional Cardiology Review Pub Date : 2026-03-31 eCollection Date: 2026-01-01 DOI:10.15420/icr.2025.33

Ricardo Palma-Carbajal, Yassin Belahnech, José María de la Torre Hernández, Tamara García Camarero, José Miguel Vegas Valle, Juan Rondán Murillo, Antonio-Gómez Menchero, Armando Pérez de Prado, Eduardo Pinar Bermúdez, Pedro Martín Lorenzo, Jesús Jiménez Mazuecos, Koldobika García San Román, Beatriz Vaquerizo, Ramón Calviño Santos, Fernando Lozano Ruiz-Poveda, Soledad Ojeda Pineda, Jorge Perea Armijo, Jeremías Bayón, Javier Goicolea Ruigómez, Juan H Alonso Briales, Juan Sanchis, Bruno García Del Blanco

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引用次数: 0

Abstract

Background: Percutaneous coronary intervention (PCI) for complex anatomy is increasingly common. The third-generation Ultimaster TANSEI drug-eluting stent (DES) was developed to optimise safety and efficacy in challenging lesions.

Methods: This was a prospective, single-arm, multicentre registry (August 2020-November 2022) of patients with complex lesions - left main, bifurcations, small vessels and long lesions - treated with Ultimaster TANSEI DES and followed for 1 year. The primary endpoint was the device-oriented composite endpoint (DoCE), including cardiac death, target-vessel MI, target-vessel revascularisation (TVR) and stent thrombosis. The secondary endpoint was the patient-oriented composite endpoint (PoCE), including all-cause death, any MI and any revascularisation.

Results: In total, 501 patients with 591 complex lesions (mean age 66.7 years; 79.6% male; 33.4% with diabetes) were treated. Lesion types: left main 11%, bifurcations 43.9%, small vessels 40.7%, long lesions 34.3%. At 1 year, incidence rates were: DoCE 3.23 per 100 person-years (95% CI [1.84-5.24]) and PoCE 5.04 per 100 person-years (95% CI [3.26-7.44]). In subgroup analyses, long lesions (>35 mm) showed consistently higher risk: DoCE RR 4.22 (95% CI [1.49-11.95]; p=0.006), PoCE RR 4.93 ([2.10-11.57]; p<0.001), overall mortality RR 4.79 [1.53-15.06]; p=0.007) and TVR RR 17.60 [2.22-139.51]; p<0.001).

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Ultimaster TANSEI支架在复杂冠状动脉病变中的应用：EPIC08 TANSEI复合物研究。

背景：经皮冠状动脉介入治疗（PCI）越来越普遍。第三代Ultimaster TANSEI药物洗脱支架（DES）的开发是为了优化挑战性病变的安全性和有效性。方法：这是一项前瞻性、单臂、多中心注册研究（2020年8月至2022年11月），研究对象是接受Ultimaster TANSEI DES治疗的复杂病变（左主干、分叉、小血管和长病变）患者，随访1年。主要终点是器械导向的复合终点（DoCE），包括心源性死亡、靶血管MI、靶血管重建术（TVR）和支架血栓形成。次要终点是面向患者的复合终点（PoCE），包括全因死亡、任何心肌梗死和任何血运重建。结果：共治疗501例591例复杂病变，平均年龄66.7岁，男性79.6%，糖尿病33.4%。病变类型：左主干11%，分岔43.9%，小血管40.7%，长病变34.3%。在1年时，发病率为：DoCE每100人年3.23 （95% CI[1.84-5.24]）和PoCE每100人年5.04 （95% CI[3.26-7.44]）。在亚组分析中，长病变（bbb35 mm）的风险始终较高：DoCE RR 4.22 (95% CI [1.49-11.95]; p=0.006), PoCE RR 4.93 ([2.10-11.57]

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