Nordic Bifurcation Study at 5 Years: Stick to Simple Stenting Strategy

Most bifurcation lesions are best treated with a simple, 1-stent strategy, with operators adding a second stent for the side branch only when necessary. A more complex, mandatory 2-stent strategy does not improve safety or efficacy, according to 5-year follow-up from the Nordic Bifurcation Study scheduled to be published online April 30, 2013, ahead of print in the Journal of the American College of Cardiology.

Long-term data from the trial were previously presented at the 2011 American College of Cardiology Scientific Session/i2 Summit in New Orleans, LA.

For the Nordic Bifurcation Study, researchers led by Michael Maeng, MD, of Aarhus University Hospital (Aarhus, Denmark), randomized 413 patients with coronary bifurcation lesions to a simple strategy (stenting of the main vessel and optional stenting of the side branch) or a complex strategy (stenting of both the main vessel and side branch). The sirolimus-eluting Cypher Select+ stent was used in all cases (Cordis/Johnson & Johnson; Warren, NJ).

Five-year follow-up data were available for 404 patients (98%). The risk of the composite endpoint (cardiac death, non-procedure-related MI, or TVR) was the same with the complex and simple strategies. The same was true for each of the individual component endpoints as well as all-cause death and definite stent thrombosis (table 1).

Table 1. Five-Year Outcomes by Stenting Strategy

^aCardiac death, non-procedure-related MI, or TVR.

According to the paper, the Nordic Bifurcation Study was designed to address concerns that 2-stent strategies might carry excess risk. Stent thrombosis was a worry, the investigators write, “as multiple layers of stents, deformation of stent architecture, stent strut malapposition, and [side branch] stent jail [were] thought to predispose to early and late thrombotic events.”

In fact, the study demonstrated a trend toward more stent thrombosis with the simple approach. Rates of all adverse outcomes apart from stent thrombosis were numerically higher with the complex strategy, though the differences did not reach statistical significance. “Thus, our data demonstrate a high degree of long-term safety irrespective of the bifurcation stenting strategy used but do support the simple bifurcation strategy whenever feasible.”

Simple Strategy Recommended

In an e-mail communication, Dr. Maeng also emphasized the superiority of the simple strategy. He told TCTMD that the paper represents the “first publication of long-term (5-year) randomized data comparing a simple versus a complex strategy in the treatment of bifurcations. . . . The simple one-stent strategy with provisional stenting of the side branch remains the recommended strategy, at least for the majority of bifurcation lesions.”

However, he noted, “[i]t is still controversial how to treat larger true bifurcation lesions, ie, bifurcation lesions with significant stenoses in both the main vessel and side branch. The Nordic-Baltic Bifurcation Study IV (BIF IV) and the European Bifurcation Club (EBC) TWO trial have both been designed to answer this question. Both studies compare simple versus complex stenting in larger true bifurcations with side branch diameters being at least 2.5 mm.”

As to whether there is a role for dedicated bifurcation stents, Dr. Maeng commented that, “[i]n theory, [such devices] may provide less trauma to the bifurcation area, make it easier to get access to the side branch, and provide optimal stent coverage of the bifurcation.

“It is always worth trying to optimize results, but it is my opinion that it will be difficult for a dedicated bifurcation stent to beat the results obtained with the simple one-stent strategy,” he concluded.