Please use this identifier to cite or link to this item:
http://doi.org/10.25358/openscience-7639
Authors: | Olschewski, Maximilian Ullrich, Helen Knorr, Maike Makmur, Giulio Ahoopai, Majid Münzel, Thomas Gori, Tommaso |
Title: | Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions |
Online publication date: | 30-Aug-2022 |
Year of first publication: | 2022 |
Language: | english |
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. |
DDC: | 610 Medizin 610 Medical sciences |
Institution: | Johannes Gutenberg-Universität Mainz |
Department: | FB 04 Medizin |
Place: | Mainz |
ROR: | https://ror.org/023b0x485 |
DOI: | http://doi.org/10.25358/openscience-7639 |
Version: | Published version |
Publication type: | Zeitschriftenaufsatz |
License: | CC BY |
Information on rights of use: | https://creativecommons.org/licenses/by/4.0/ |
Journal: | Clinical research in cardiology 111 |
Pages or article number: | 750 760 |
Publisher: | Springer |
Publisher place: | Berlin |
Issue date: | 2022 |
ISSN: | 1861-0692 |
Publisher DOI: | 10.1007/s00392-021-01972-2 |
Appears in collections: | JGU-Publikationen |
Files in This Item:
File | Description | Size | Format | ||
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randomized_noninferiority_tri-20220826162256890.pdf | 860.89 kB | Adobe PDF | View/Open |