Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions.

backgroundThe treatment of left main bifurcation stenoses remains challenging.

aimsWe compare the "Reverse T and Protrusion" (reverse-TAP) technique to Double-Kissing and crush (DK-crush).

methodsThe study was designed as non-inferiority trial, the primary endpoint was percentage stent expansion in the ostial side branch at optical coherence tomography.

results52 consecutive patients (13 females, 17 diabetics, Syntax score 25 [22-29]) with complex coronary bifurcation lesions of the left main were randomized in a 1:1 ratio to Reverse-TAP or DK-crush stenting. The intervention was performed according to protocol in all patients in both randomization groups. Side branch stent expansion was 75 [67-90]% in the DK-crush group and 86 [75-95]% in the reverse-TAP group (one-sided 97.5% lower parametric confidence interval: - 0.28%; P < 0.01 for non-inferiority; P = 0.037 for superiority). Side branch balloon pressure during final kissing was higher in the DK-crush group (14 [12-16] vs. reverse-TAP: 13 [12-14]; P = 0.043). Procedural time was shorter with reverse-TAP (DK-crush: 32 [24-44] min vs reverse-TAP: 25 [22-33] min; P = 0.044). Other procedural parameters were not different between groups. There was no difference in any of the safety endpoints up to 1 month.

conclusionsA reverse-TAP strategy for the interventional treatment of complex coronary lesions was non-inferior and superior to DK-crush for the primary endpoint side branch expansion while requiring less time. A larger study testing long-term clinical outcomes is warranted. TRAIL REGISTRATION: NCT: NCT03714750.