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).

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: https://www.controlled.trials.com. Unique identifier: ISRCTN22637771.