Bifurcations Bad Krozingen II - BBK II
The goal of the trial was to assess the efficacy of culotte versus T-and-protrusion (TAP) stenting for bifurcation percutaneous coronary intervention (PCI) involving a two-stent strategy.
Contribution to the Literature: The BBK II trial showed that culotte was superior to TAP stenting for angiographic outcomes at 9 months when a two-stent strategy is necessary for bifurcation PCI.
Patients undergoing a two-stent approach for a de novo bifurcation lesion were randomized in a 1:1 fashion to either culotte stenting (n = 150) or TAP stenting (n = 150).
- Total number screened: 2,959
- Total number of enrollees: 300
- Duration of follow-up: 12 months
- Mean patient age: 68 years
- Percentage female: 26%
- Reference diameter of the main branch between 2.5 and 4.0 mm
- Reference diameter of the side branch that was ≥2.25 and ≤1.0 mm smaller than that of the main branch
- Intraluminal thrombus, heavy calcification, severe tortuosity
- Contraindication to dual antiplatelet therapy, intravenous anticoagulants, the stent alloy, or limus drugs
- Acute ST-segment elevation myocardial infarction
- Hemodynamic instability
- History of bleeding diathesis or coagulopathy
Other salient features/characteristics:
- Acute coronary syndrome-PCI: 31%; multivessel PCI: 44%
- Bifurcation location: left main trunk (LMT): 16%; left anterior descending: 55%; left circumflex: 25%
- True bifurcation (1,1,1; 1,0,1; 0,1,1): 97%
- Bifurcation angle pre-PCI: 55 degrees
- Second-generation drug-eluting stent in side branch: 70%
The primary outcome, maximal in-stent percent diameter stenosis at the bifurcation lesion at 9-month angiographic follow-up for culotte vs. TAP stenting, was 21% vs. 27% (p = 0.038).
Secondary outcomes for culotte vs. TAP stenting:
- Binary restenosis (≥50%): 6.5% vs. 17%, p = 0.006
- Target lesion revascularization (TLR) at 12 months: 6.0% vs. 12.0%, p = 0.069; TLR of side branch: 4.7% vs. 8.7%, p = 0.16
- Stent thrombosis at 12 months: 0.7% vs. 0%, p = 0.32
In general, a provisional strategy is preferred for bifurcating PCI when possible. The results of this trial indicate that, when a two-stent strategy is necessary, culotte is superior to TAP stenting for angiographic outcomes at 9 months. This mirrors data from the NORDIC-II trial where culotte stenting was superior to a crush technique, primarily due to a reduction in restenosis. Larger trials powered for clinical outcomes are necessary on this topic. Culotte stenting is a bit more technically challenging (involves crossing stent struts twice), but may be the preferred strategy for lesions such as the distal LMT.
Ferenc M, Gick M, Comberg T, et al. Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial. Eur Heart J 2016;Aug 30:[Epub ahead of print].
Presented by Dr. Miroslaw Ferenc at the European Society of Cardiology Congress, Rome, Italy, August 30, 2016.
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