The EBC TWO Study (European Bifurcation Coronary TWO)

Abstract

T reatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be fully established. Randomized trials of all-comer bifurcation lesions have demonstrated that there is no advantage to systematic dual drugeluting stent strategies. However, these trials included a high proportion of patients with no disease in the side branch (SB) or relatively small SB vessels. 1-10 See Editorial by De LucaExpert consensus suggests that large caliber bifurcation lesions with significant ostial SB disease probably warrant an upfront 2-stent strategy, but this consensus has not been tested.11 This trial was designed to assess the hypothesis that large true bifurcations with significant SB ostial disease are 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 64±10 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 (2.67±0.27 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.(Circ Cardiovasc Interv. 2016;9:e003643.

Single‐ Versus 2‐Stent Strategies for Coronary Bifurcation Lesions: A Systematic Review and Meta‐Analysis of Randomized Trials With Long‐Term Follow‐up

“…Nine randomized trials met the inclusion criteria, reporting mortality at ≥1 year of follow-up. 4,5,10,11,[13][14][15][16][17][18] A total of 3265 patients were enrolled with weighted mean follow-up of 3.1AE1.8 years. The total loss to follow-up of patients in the study was <1%.…”

“…Forest plot of primary outcome: all-cause mortality according to bifurcation treatment strategy. Nordic 2013, 10 BBK, 11,12 PERFECT, 13 Nordic-Baltic Bifurcation IV, 14 BBC1, 15,16 EBC2, 17 Smart-Strategy, 18 interventional cardiologist. In DK Crush V, operators had to perform at least 300 percutaneous coronary interventions per year for 5 consecutive years to recruit patients into the study.…”

“…The total loss to follow-up of patients in the study was < 1%. Nordic 2013, 10 BBK, 11,12 PERFECT, 13 Nordic-Baltic Bifurcation IV, 14 BBC1, 15,16 EBC2, 17 Smart-Strategy, 18 DK Crush II 2017, 4 DK Crush V. 5 B, Long-term health outcomes of provisional stenting vs a complex strategy for treatment of coronary bifurcation lesions. *Long-term mortality incorporating trials with ≥3 years of clinical follow-up: A prespecified sensitivity analysis was carried out of five studies including 1713 patients followed up for an average of 4.7 years.…”

An Upfront Two-Stent Strategy for True Coronary Bifurcation Lesions with A Large Side Branch in Acute Coronary Syndrome: A Two-Year Follow-Up Study

“…Complex CBLs with large SB with significant ostial disease are best treated with an U2SS based on expert consensus opinion [1]. The European Bifurcation Coronary TWO (EBC-TWO) and the Nordic-Baltic Bifurcation Study-IV studies could not show any significant difference in MACE rate at follow-up in the 2SS when compared to the PSS [17,18]. However, in the DKCRUSH-II, the 2SS was found to be associated with improved outcomes compared with the PSS [7].…”

Коронарные Интервенции На Стволе Левой Коронарной Артерии – Непосредственные Результаты Рутинной Клинической Практики

“…При обсуждении методик стентирования СЛКА следует подчеркнуть, что хотя СЛКА анатомически представляет собой типичную (и самую важную) бифуркацию коронарной артерии, но все же он имеет ряд особенностей: 1) зона кровоснабжения составляет обычно более 50 % общей массы миокарда; 2) боковой ветвью обычно является крупная огибающая артерия, потеря которой в большинстве случаев неприемлема, а доступ к ней часто бывает затруднен; 3) СЛКА -единственная коронарная бифуркация, проксимальная ветвь которой начинается непосредственно от аорты; 4) проксимальный референсный диаметр составляет обычно от 4,5 до 5,5 мм, что является дилатационным лимитом для большинства доступных сейчас стентов; 5) СЛКА часто имеет диффузное поражение, которое может быть недооценено на ангиограмме; 6) трифуркация встречается в 10 % случаев и может требовать специальной интервенционной техники; 7) угол бифуркации СЛКА обычно Т-образный, что имеет влияние как на технику, так и на прогноз после стентирования [14,15]. По данным большинства рандомизированных исследований [16,17], равно как и по мнению консенсуса Европейского бифуркационного клуба [14] двустеновые техники не имеют преимуществ перед более простой стратегией provisional SB stenting. Проходящее в настоящее время рандомизированное исследование EBC MAIN (European Bifurcation Club Left Main) призвано пролить свет на оптимальную стратегию коронарных интервенций на СЛКА [18].…”