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

Abstract

Abstract Background The treatment of left main bifurcation stenoses remains challenging. Aims We compare the “Reverse T and Protrusion” (reverse-TAP) technique to Double-Kissing and crush (DK-crush). Methods The study was designed as non-inferiority trial, the primary endpoint was percentage stent expansion in the ostial side branch at optical coherence tomography. Results 52 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. Conclusions A 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. Graphical abstract