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

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

Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions

“…Baseline clinical characteristics of the patients with follow-up OCT are reported in Supplementary Table S1 , and procedural details are reported in Supplementary Table S2 . Pre-defined protocol and procedural success was achieved in all patients in both arms (definitions previously reported ( 8 , 9 )), with no difference in peak post-procedural troponin between the 2 arms.…”

“…The differences between rTAP and DKC have been extensively described in a previous paper and are summarized in Figure 1 ( 8 ). The major differences include the use of a systematic alternate high-pressure inflation of MB and SB balloons following SB stent implantation and the need for one rewiring in rTAP (instead of two in DKC).…”

“…The baseline clinical characteristics, procedural characteristics, and procedural outcomes, as well as OCT analysis results, of the 52 enrolled patients were previously reported ( 8 ). There were no differences between groups in any of the clinical, procedural, or imaging variables except for ostial side branch expansion, which was significantly larger in the rTAP at the end of the procedure ( 8 ).…”

“…In a recently published paper, we reported the outcomes of a randomized trial comparing DKC with a simplified variant involving a shorter stent crush length and only one rewiring. We reported that this variation, which we called reverse-T-and-protrusion (rTAP) and which resembles a previously reported technique named “cone flare DKC”( 7 ), was non-inferior to DKC in terms of side branch (SB) ostial expansion and was associated with shortened procedural times ( 8 ). In the present study, we compare the intermediate-term outcomes assessed by optical coherence tomography (OCT) of patients with LM bifurcation disease, randomized to either the DKC technique or rTAP.…”

“…In our previous publication, the rTAP technique proved to be non-inferior to the gold standard DKC technique in terms of short-term efficacy and safety in the treatment of complex unprotected LM bifurcation lesions. As compared to DKC, rTAP reduced procedural time and improved side branch ostial expansion ( 8 ). The current study aims to compare the outcomes, as assessed by OCT, of both techniques at the intermediate term, i.e., 6-months follow-up.…”