Randomized comparison of a Gladius first versus standard antegrade wiring strategy for crossing coronary chronic total occlusions: the Gladius first trial.

Abstract

Objectives: Antegrade wiring (AW) is the most common coronary chronic total occlusion (CTO) crossing strategy and usually relies upon stepwise guidewire escalation starting from the low tip-load polymer-jacketed wire (standard guidewire escalation). The authors aimed to investigate whether the upfront use of intermediate tip-load polymer-jacketed guidewire translates into improved procedural outcomes of CTO percutaneous coronary intervention (PCI).

Methods: The Gladius First trial was a single-center, investigator-initiated, randomized, prospective trial. The primary endpoint was the time of AW strategy, while the secondary endpoints included CTO crossing success, procedural success, contrast volume, radiation dose, total procedural time, safety parameters, equipment use, and cost.

Results: Between 2021 and 2023, 69 patients with 70 CTO lesions (J-CTO score ≥ 1) were randomized to either upfront Gladius EX (Asahi Intecc) AW (n = 33) or standard guidewire escalation AW (n = 37). The clinical and angiographic characteristics of 2 groups were similar. Overall, CTO crossing and procedural success were 92.9% and 90%, respectively, and similar between groups. Although the AW time was significantly shorter in the Gladius AW group (10 minutes; IQR: 4-16 minutes) than in the standard AW group (21 minutes; IQR: 11-28 minutes, P = .001), the total procedural time, procedural success, safety parameters, resource use, and equipment cost were similar between groups.

Conclusions: Compared with standard guidewire escalation, the upfront use of the Gladius guidewire was associated with a shorter AW time but similar total procedural time, procedural success, safety, and cost.