The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations

Abstract

Background For the treatment of coronary bifurcation lesions, a provisional strategy is superior to systematic 2-stent techniques for the most bifurcation lesions. However, complex anatomies with large side branches (SBs) with significant ostial disease length are considered by expert consensus to warrant a 2-stent technique upfront. This consensus view has not been scientifically assessed.Methods and Results Symptomatic patients with large caliber true bifurcation lesions (SB diameter 2.5 mm) and significant ostial disease length (5 mm) were randomized to either a provisional T-stent strategy or a dual stent culotte technique. Two hundred patients aged 6410 years, 82% male, were randomized in 20 European centers. The clinical presentations were stable coronary disease (69%) and acute coronary syndromes (31%). SB stent diameter (2.670.27 mm) and length (20.30 +/- 5.89 mm) confirmed the extent of SB disease. Procedural success (provisional 97%, culotte 94%) and kissing balloon inflation (provisional 95%, culotte 98%) were high. Sixteen percent of patients in the provisional group underwent T-stenting. The primary end point (a composite of death, myocardial infarction, and target vessel revascularization at 12 months) occurred in 7.7% of the provisional T-stent group versus 10.3% of the culotte group (hazard ratio, 1.02; 95% confidence interval, 0.78-1.34; P=0.53). Procedure time, x-ray dose, and cost all favored the simpler procedure.Conclusions When treating complex coronary bifurcation lesions with large stenosed SBs, there is no difference between a provisional T-stent strategy and a systematic 2-stent culotte strategy in a composite end point of death, myocardial infarction, and target vessel revascularization at 12 months.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT 01560455.