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

当前位置： X-MOL 学术 › Clin. Res. Cardiol. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions
Clinical Research in Cardiology ( IF 3.8 ) Pub Date : 2021-11-24 , DOI: 10.1007/s00392-021-01972-2
Maximilian Olschewski _{1,

2} , Helen Ullrich _{1,

2} , Maike Knorr _{1,

2} , Giulio Makmur _{1,

2} , Majid Ahoopai _{1,

2} , Thomas Münzel _{1,

2} , Tommaso Gori _{1,

2}

Affiliation

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

中文翻译：

比较反向 T 和突出与双亲和挤压支架治疗复杂左主分叉病变的随机非劣效性试验

背景

左主干分叉狭窄的治疗仍然具有挑战性。

宗旨

我们将“反向 T 和突出”（反向 TAP）技术与双亲和挤压（DK-crush）进行比较。

方法

该研究设计为非劣效性试验，主要终点是光学相干断层扫描时开口侧支支架扩张的百分比。

结果

连续 52 名患有左主干复杂冠状动脉分叉病变的患者（13 名女性，17 名糖尿病患者，语法评分 25 [22-29]）以 1:1 的比例随机接受 Reverse-TAP 或 DK-crush 支架置入术。干预是根据方案在两个随机分组的所有患者中进行的。DK-crush 组的侧支支架扩张率为 75 [67-90]%，而反向 TAP 组为 86 [75-95]%（单侧 97.5% 较低参数置信区间：- 0.28%； P < 0.01非劣效性；优越性P = 0.037）。DK-crush 组在最后接吻时侧支球囊压力更高（14 [12-16] vs. reverse-TAP：13 [12-14]；P = 0.043）。反向 TAP 的程序时间更短（DK-crush：32 [24-44] 分钟 vs 反向 TAP：25 [22-33] 分钟；P = 0.044）。其他程序参数在组之间没有差异。长达 1 个月的任何安全性终点都没有差异。