Coronary bifurcations are best treated with culotte stenting, as opposed to T-and-protrusion (TAP) stenting, when there is need for a side-branch stent, according to results of the BBK II Trial presented Aug. 30 during ESC Congress 2016 in Rome, and simultaneously published in the European Heart Journal.

The study included 300 patients with stable or unstable angina and/or a positive stress test who were undergoing percutaneous coronary intervention (PCI) and side-branch stenting of a coronary bifurcation lesion. During the procedure, if a side branch stent was needed and the lesion was deemed amenable for both stenting techniques, patients were randomized to either TAP stenting (n=150) or culotte stenting (N=150). The primary endpoint was maximal in-stent percent diameter stenosis of the bifurcation lesion assessed by follow-up quantitative coronary angiography at nine months.

Results showed a mean maximal percent diameter stenosis of 21 percent in the culotte stenting group vs. 27 percent in the TAP stenting group (P=0.038). Miroslaw Ferenc, MD, PhD, the lead investigator, notes this difference in the primary endpoint was driven almost entirely by differences in the side branch, where the mean percent diameter stenosis was 16 percent in the culotte stenting group vs. 22 percent in the TAP group. In contrast, there were no differences between techniques in the percent diameter stenosis in the main branch.

Ferenc also points out a “highly significant difference” in binary in-stent restenosis at the bifurcation lesion – 6.5 percent after culotte stenting vs. 17 percent TAP; P=0.006). Additionally, there was a 6 percent target bifurcation lesion revascularization rate at one year in the culotte stenting group compared to 12 percent in the TAP group. Death, target vessel MI, and stent thrombosis were infrequent at one year, and did not differ significantly between the two groups.

“This is the first head to head comparison of the two most commonly used techniques in patients needing side branch stenting and having suitable anatomy for both techniques, and it not only provides angiographic follow-up but also demonstrated a clear signal with respect to clinical outcome,” said Ferenc. “Interventional cardiologists can use now culotte stenting with more confidence knowing that this technique is associated with a very low angiographic restenosis rate and lower rate of TLR as compared with TAP stenting – even though it is slightly more challenging and requires appropriate training.”

“Since there was no difference in clinical end points this study should be viewed as hypothesis generating only,” said Kim A. Eagle, MD, MACC, editor in chief of ACC.org.

Keywords: ESC Congress, Drug-Eluting Stents, Stents, Angiography

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