Ultimaster TANSEI Stent in Complex Coronary Lesions: The EPIC08 TANSEI COMPLEX Study.
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Palma-Carbajal Ricardo, Belahnech Yassin, de la Torre Hernández José María, García Camarero Tamara, Vegas Valle José Miguel, Rondán Murillo Juan, Menchero Antonio-Gómez, Pérez de Prado Armando, Pinar Bermúdez Eduardo, Martín Lorenzo Pedro, Jiménez Mazuecos Jesús, García San Román Koldobika, Vaquerizo Beatriz, Calviño Santos Ramón, Lozano Ruiz-Poveda Fernando, Ojeda Pineda Soledad, Perea Armijo Jorge, Bayón Jeremías, Goicolea Ruigómez Javier, Alonso Briales Juan H, Sanchis Juan, García Del Blanco Bruno, and the EPIC08 TANSEI COMPLEX Study Group
Аннотация
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).