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

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.

Keywords: Coronary bifurcation lesions; Optical coherence tomography; Percutaneous coronary interventions.

Conflict of interest statement

TG has received speaker fees and grant support from Abbott Vascular, Boston Sci., SMT (not in relationship with this research). There is no other conflict of interest with any of the other authors. TG is principal investigator of the DZHK, funded by the Ministry of Research, Germany.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The reverse-TAP technique. Description and comparison with DK-crush in Table 1. The last proximal optimization technique (POT) dilation was not compulsory in either study arm
Fig. 2
Fig. 2
Primary endpoint assessment in the full analysis set population (data are presented at median [IQR] due to non-normal distribution). The lower confidence interval of the differences was higher than the pre-specified non-inferiority margin of 11%. In addition, SB expansion achieved with reverse-TAP was larger than with DK-crush by Mann–Whitney U

References

    1. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO, Group ESCSD 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40:87–165. doi: 10.1093/eurheartj/ehy394.
    1. Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN) Eur Heart J. 2021;42:3829–3839. doi: 10.1093/eurheartj/ehab283.
    1. Ferenc M, Neumann FJ. Towards a lesion-specific approach to percutaneous coronary intervention for bifurcation lesions. Eur Heart J. 2020;41:2537–2540. doi: 10.1093/eurheartj/ehaa559.
    1. Banning AP, Lassen JF, Burzotta F, Lefevre T, Darremont O, Hildick-Smith D, Louvard Y, Stankovic G. Percutaneous coronary intervention for obstructive bifurcation lesions: the 14th consensus document from the European Bifurcation Club. Euro Intervention. 2019;15:90–98.
    1. Shan SJ, Ye F, Liu ZZ, Tian NL, Zhang JJ, Chen SL. Coronary bifurcation lesions treated with double kissing crush technique compared to classical crush technique: serial intravascular ultrasound analysis. Chin Med J (Engl) 2013;126:1247–1251.
    1. Chen SL, Santoso T, Zhang JJ, Ye F, Xu YW, Fu Q, Kan J, Paiboon C, Zhou Y, Ding SQ, Kwan TW. A randomized clinical study comparing double kissing crush with provisional stenting for treatment of coronary bifurcation lesions: results from the DKCRUSH-II (Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions) trial. J Am Coll Cardiol. 2011;57:914–920. doi: 10.1016/j.jacc.2010.10.023.
    1. Chen SL, Zhang JJ, Han Y, Kan J, Chen L, Qiu C, Jiang T, Tao L, Zeng H, Li L, Xia Y, Gao C, Santoso T, Paiboon C, Wang Y, Kwan TW, Ye F, Tian N, Liu Z, Lin S, Lu C, Wen S, Hong L, Zhang Q, Sheiban I, Xu Y, Wang L, Rab TS, Li Z, Cheng G, Cui L, Leon MB, Stone GW. Double kissing crush versus provisional stenting for left main distal bifurcation lesions: DKCRUSH-V randomized trial. J Am Coll Cardiol. 2017;70:2605–2617. doi: 10.1016/j.jacc.2017.09.1066.
    1. Chiabrando JG, Lombardi M, Vescovo GM, Wohlford GF, Koenig RA, Abbate A, Guzman LA, Berrocal DH, Biondi-Zoccai G. Stenting techniques for coronary bifurcation lesions: evidence from a network meta-analysis of randomized clinical trials. Catheter Cardiovasc Interv. 2020 doi: 10.1002/ccd.29097.
    1. Di Gioia G, Sonck J, Ferenc M, Chen SL, Colaiori I, Gallinoro E, Mizukami T, Kodeboina M, Nagumo S, Franco D, Bartunek J, Vanderheyden M, Wyffels E, De Bruyne B, Lassen JF, Bennett J, Vassilev D, Serruys PW, Stankovic G, Louvard Y, Barbato E, Collet C. Clinical Outcomes following coronary bifurcation PCI techniques: a systematic review and network meta-analysis comprising 5,711 patients. JACC Cardiovasc Interv. 2020;13:1432–1444. doi: 10.1016/j.jcin.2020.03.054.
    1. Lavarra F. Proximal side-branch optimization in crush stenting. A step-by-step technical approach in a silicone phantom model. Cardiovasc Revasc Med. 2020 doi: 10.1016/j.carrev.2020.07.037.
    1. Rigatelli G, Zuin M, Dell'Avvocata F, Vassilev D, Daggubati R, Nguyen T, Nguyen MTN, Foin N. Complex coronary bifurcation treatment by a novel stenting technique: bench test, fluid dynamic study and clinical outcomes. Catheter Cardiovasc Interv. 2018;92:907–914. doi: 10.1002/ccd.27494.
    1. Zhang JJ, Ye F, Xu K, Kan J, Tao L, Santoso T, Munawar M, Tresukosol D, Li L, Sheiban I, Li F, Tian NL, Rodriguez AE, Paiboon C, Lavarra F, Lu S, Vichairuangthum K, Zeng H, Chen L, Zhang R, Ding S, Gao F, Jin Z, Hong L, Ma L, Wen S, Wu X, Yang S, Yin WH, Zhang J, Wang Y, Zheng Y, Zhou L, Zhou L, Zhu Y, Xu T, Wang X, Qu H, Tian Y, Lin S, Liu L, Lu Q, Li Q, Li B, Jiang Q, Han L, Gan G, Yu M, Pan D, Shang Z, Zhao Y, Liu Z, Yuan Y, Chen C, Stone GW, Han Y, Chen SL. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020;41:2523–2536. doi: 10.1093/eurheartj/ehaa543.
    1. Rakhimov K, Buono A, Anadol R, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial. BMJ Open. 2020;10:e034264. doi: 10.1136/bmjopen-2019-034264.
    1. Burzotta F, Lassen JF, Lefevre T, Banning AP, Chatzizisis YS, Johnson TW, Ferenc M, Rathore S, Albiero R, Pan M, Darremont O, Hildick-Smith D, Chieffo A, Zimarino M, Louvard Y, Stankovic G (2020) Percutaneous Coronary Intervention For Bifurcation Coronary Lesions: the 15th consensus document from the European Bifurcation Club. EuroIntervention 16(16):1307–1317
    1. Derimay F, Finet G, Souteyrand G, Maillard L, Aminian A, Lattuca B, Cayla G, Cellier G, Motreff P, Rioufol G. Benefit of a new provisional stenting strategy, the re-proximal optimisation technique: the rePOT clinical study. EuroIntervention. 2018;14:e325–e332. doi: 10.4244/EIJ-D-17-00941.
    1. Onuma Y, Katagiri Y, Burzotta F, Holm NR, Amabile N, Okamura T, Mintz GS, Darremont O, Lassen JF, Lefevre T, Louvard Y, Stankovic G, Serruys PW. Joint consensus on the use of OCT in coronary bifurcation lesions by the European and Japanese bifurcation clubs. EuroIntervention. 2019;14:e1568–e1577. doi: 10.4244/EIJ-D-18-00391.
    1. Polimeni A, Weissner M, Schochlow K, Ullrich H, Indolfi C, Dijkstra J, Anadol R, Munzel T, Gori T. Incidence, clinical presentation, and predictors of clinical restenosis in coronary bioresorbable scaffolds. JACC Cardiovasc Interv. 2017;10:1819–1827. doi: 10.1016/j.jcin.2017.07.034.
    1. Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016;67:921–931. doi: 10.1016/j.jacc.2015.12.019.
    1. Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, Morel MA, Cutlip DE, Krucoff MW, Stone GW, Lansky AJ, Mehran R, Spitzer E, Fraser AG, Baumbach A, Serruys PW. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EuroIntervention. 2020;15:1190–1198. doi: 10.4244/EIJ-D-19-00552.
    1. Chen SL, Mintz G, Kan J, Zhang JJ, Hu ZY, Ye F, Tian NL, Zhang JX, Xu T, Liu ZZ. Serial intravascular ultrasound analysis comparing double kissing and classical crush stenting for coronary bifurcation lesions. Catheter Cardiovasc Interv. 2011;78:729–736. doi: 10.1002/ccd.23110.
    1. Chen SL, Ye F, Zhang JJ, Zhu ZS, Lin S, Shan SJ, Liu ZZ, Liu Y, Duan BX, Ge JB. DK crush technique: modified treatment of bifurcation lesions in coronary artery. Chin Med J (Engl) 2005;118:1746–1750.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren