分叉病变的介入治疗：以 TIMI 血流分级为指导处理分叉病变分支血管的新概念——一项前瞻性随机临床试验（图林根分叉病变研究，THUEBIS 研究作为预试验）。

Interventional therapy of bifurcation lesions: a TIMI flow-guided concept to treat side branches in bifurcation lesions--a prospective randomized clinical study (Thueringer bifurcation study, THUEBIS study as pilot trial).

机构信息

Krankenhaus Hetzelstift, Clinic of Cardiology, Neustadt an der Weinstrasse, Germany.

出版信息

Circ Cardiovasc Interv. 2009 Dec;2(6):535-42. doi: 10.1161/CIRCINTERVENTIONS.108.833046. Epub 2009 Nov 10.

DOI:10.1161/CIRCINTERVENTIONS.108.833046

PMID:20031771

Abstract

BACKGROUND

Treatment of bifurcations is a complex problem. The clinical value of treating side branches is an unsolved problem in the field of interventional cardiology.

METHODS AND RESULTS

We initiated a prospective randomized controlled trial. One hundred and ten patients with bifurcations were randomly assigned to 2 arms: Stenting of the main branch (MB, Taxus-stent, paclitaxel-eluting stents) and mandatory side branch (SB) percutaneous coronary intervention (PCI; kissing balloons) with provisional SB stenting (therapy A), or stenting of the MB (paclitaxel-eluting stents) with provisional SB-PCI only when the SB had a thrombolysis in myocardial infarction flow <2 (therapy B). The primary end point was target lesion revascularization. The mean ages were 66.8 years (A) versus 65.1 years (B, P=0.4), 71.4% (A) versus 77.8% were men (P=0.4), patients with diabetes were present in 25.0% versus 25.9% (P=0.9). The MB was left anterior descending artery in 80.4% versus 81.5% (A versus B, P=0.9). The SB-PCI and kissing balloon-PCI were performed according to the study protocol in 82.1%/73.2% versus 16.7%/13.0% (P<0.05 for both), while changing of the intended therapy was necessary in 17.9% versus 16.7% (A versus B, P=0.9). A final thrombolysis in myocardial infarction flow 3 (MB) was reached in all patients (groups A and B), final thrombolysis in myocardial infarction flow 3 (SB) was observed in 96.4% versus 88.9% (A versus B, P=0.3). Radiation time (min) and contrast medium (mL) were 14.2/210 (group A) versus 7.8/151.6 (group B; P for both <0.05). Six month - follow up: major adverse cardiac events was 23.2% (A) versus 24.1% (B, P=0.9), target lesion revascularization was 17.9% (A) versus 14.8% (B, P=0.7), and late lumen loss (MB) was 0.2 mm (A) versus 0.3 mm (B, P=0.5). In group B, no PCI of the SB was done during follow up.

CONCLUSIONS

A simple strategy using paclitaxel-eluting stents with only provisional SB-PCI may be of equal value to a more complex strategy with mandatory SB-PCI. Clinical Trial Registration- URL: http://www.controlled.trials.com. Unique identifier: ISRCTN22637771.

摘要

背景

分叉病变的治疗是一个复杂的问题。分支血管的临床治疗价值是介入心脏病学领域尚未解决的问题。

方法和结果

我们开展了一项前瞻性随机对照试验。110 例分叉病变患者被随机分为 2 组：主支（MB，Taxus 支架，紫杉醇洗脱支架）和分支（SB）经皮冠状动脉介入治疗（PCI；球囊对吻）加临时 SB 支架（治疗 A），或 MB 支架置入（紫杉醇洗脱支架），仅当 SB 出现心肌梗死溶栓血流<2 时行 SB-PCI（治疗 B）。主要终点是靶病变血运重建。平均年龄分别为 66.8 岁（A 组）与 65.1 岁（B 组，P=0.4），71.4%（A 组）与 77.8%（B 组）为男性（P=0.4），25.0%（A 组）与 25.9%（B 组）为糖尿病患者（P=0.9）。MB 为左前降支的患者分别占 80.4%（A 组）与 81.5%（B 组，A 组与 B 组，P=0.9）。82.1%/73.2%（A 组与 B 组）与 16.7%/13.0%（P<0.05）的患者分别根据研究方案行 SB-PCI 和球囊对吻 PCI，而需要改变治疗策略的患者分别占 17.9%（A 组）与 16.7%（B 组，A 组与 B 组，P=0.9）。所有患者（A 组和 B 组）的 MB 最终均达到心肌梗死溶栓血流 3 级，96.4%（A 组）与 88.9%（B 组）的 SB 最终达到心肌梗死溶栓血流 3 级（A 组与 B 组，P=0.3）。射线时间（min）和造影剂（mL）分别为 14.2/210（A 组）与 7.8/151.6（B 组；两组均 P<0.05）。6 个月随访：主要不良心脏事件分别为 23.2%（A 组）与 24.1%（B 组，P=0.9），靶病变血运重建分别为 17.9%（A 组）与 14.8%（B 组，P=0.7），MB 晚期管腔丢失分别为 0.2 mm（A 组）与 0.3 mm（B 组，P=0.5）。B 组在随访期间未行 SB-PCI。