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

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).