A new clinical trial shows 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 today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
Coronary bifurcation lesions are caused from a build-up of plaque in the heart at a location where one artery branches from another. In provisional side branch stenting, the main vessel branch is stented and the side branch only if compromised. Currently, provisional side branch stenting is the preferred strategy for treatment of bifurcation lesions.
The safety and effectiveness of provisional stenting for bifurcations that involve a large side branch of the coronary arteries is unknown. 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 1:1 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).