Bifurcations Bad Krozingen II - BBK II

Description:

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.

Study Design

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%

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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%

Principal Findings:

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

Interpretation:

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.

References:

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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