November 1, 2013 — A new clinical trial showed that a two-stent technique for treatment of bifurcation lesions with a large stenotic side branch was not associated with significant improved outcomes compared to a provisional stenting approach. The findings from the Nordic-Baltic Bifurcation IV study were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
The Nordic-Baltic IV trial was a randomized, controlled, non-blinded, multicenter, superiority trial that compared provisional stenting with a two-stent strategy for the treatment of coronary bifurcation lesions involving a major side branch.
The primary endpoint was the composite of major adverse cardiac events (MACE) including cardiac death, non-procedure-related myocardial infarction, target vessel revascularization and stent thrombosis after six months. Follow up is planned until five years. A total of 450 patients with coronary bifurcation lesions were randomized one-to-one to the provisional strategy (stenting of the main vessel and provisional stenting of the side branch) or a complex two-stent strategy (planned stenting of both the main vessel and the side branch).
After six months, the MACE rate was not significantly different between provisional and two-stent techniques (4.6 percent and 1.8 percent, respectively) (p = 0.09). Individual endpoints were also similar between the two techniques including total death (0 and 0.4 percent (p = 0.32), non-procedural myocardial infarction (1.8 percent and 0.9 percent) (p = 0.50) and target vessel revascularization (3.7 percent and 1.3 percent) (p = 0.11). There were no incidents of cardiac death in either group.
However, in contrast to prior studies, longer and more complex procedures in the two-stent group did not translate into more procedural myocardial infarctions.
“Results of this trial indicate that a two-stent technique does not significantly improve mid-term outcomes for patients with bifurcation lesions compared to provisional stenting,” said Indulis Kumsars, M.D., head of the cardiac catheterization laboratory, Latvian Cardiology Center in Riga, Latvia, and lead investigator of the study.
Given the fact that there was a weak trend towards lower MACE in the two stent strategy and follow-up is continuing for five years, the Nordic-Baltic investigators concluded, “Recommendations on optimal strategies for this lesion subset should await longer term follow up.”
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