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

Maximilian Olschewski,Giulio Makmur,Maike Knorr,Majid Ahoopai,Helen Ullrich,Thomas Münzel,Tommaso Gori

doi:10.1007/s00392-021-01972-2

Abstract

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 RegistrationNCT: NCT03714750.Graphical abstract

Highlights

Due to the large size of potentially jeopardized myocardium, unprotected left main coronary artery disease remains a clinical challenge
DK-crush was associated with lower rates of target-lesion revascularization as compared with provisional or culotte stenting in both non-left main and left main coronary bifurcation lesions [6,7,8,9]
Coronary bifurcations represent a challenging subset of lesions for percutaneous coronary interventions, in which the technique used is an important predictor of patient outcomes

Summary

Introduction

Due to the large size of potentially jeopardized myocardium, unprotected left main coronary artery disease remains a clinical challenge. As compared to older techniques, DK-crush requires an additional kissing balloon dilation prior to main branch (MB) stenting. This kissing PTCA facilitates the second rewiring of the SB and the final kissing dilation but obviously implies an extra step. 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. 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.

Results

Discussion

Conclusion