Two-stent approach for certain bifurcation lesions did not improve outcomes

SAN FRANCISCO — A two-stent technique to treat bifurcation lesions with a large stenotic side branch did not improve outcomes compared with provisional stenting at 6 months, according to data presented at TCT 2013.

Results from the randomized, open-label Nordic-Baltic Bifurcation Study IV indicated that there was no difference at 6 months between the groups in MACE, a composite of cardiac death, non-index procedure-related MI, target lesion revascularization and definite stent thrombosis, Indulis Kumsars, MD, head of the cardiac catheterization laboratory at Latvian Cardiology Center in Riva, Latvia, said at a press conference.

“Provisional strategy, which means stenting the main vessel and only stenting the side vessel if compromised, currently was the preferred strategy of treatment for bifurcation lesions,” Kumsars said. “But it was unknown if that also applied to bifurcation lesions involving a large side branch.”

Patients (n=450) with side branch ≥2.75 mm were randomly assigned 1:1 at centers in Denmark, Finland, Latvia, Lithuania, Norway and Sweden to receive the provisional strategy or a two-stent strategy in which both the main vessel and side branch are planned to be stented. Patients received either a sirolimus-eluting stent (Cypher Select+, Cordis) or an everolimus-eluting stent (Xience V, Abbott Vascular). The researchers plan to follow the patients for 5 years.

The two-stent procedure required more time (92.6 minutes vs. 73.9 minutes), more contrast volume (238 mL vs. 187 mL) and more fluoroscopy time (22.8 minutes vs. 14 minutes) compared with the provisional procedure (P<.0001 for all). However, “longer and more complex procedures in the two-stent group did not translate into more procedural MIs,” Kumsars said.

At 6 months, the rate of MACE was 4.6% for the provisional group and 1.8% for the two-stent group (P=.09). Rates of individual secondary endpoints were as follows:

Death: provisional, 0%; two-stent, 0.4%; P=.32
Non-procedural MI: provisional, 1.8; two-stent, 0.9%; P=.5
Stent thrombosis: provisional, 0.9%; two-stent, 0.4%; P=.54
TLR: provisional, 3.2%; two-stent, 1.3%; P=.18
Target vessel revascularization: provisional, 3.7%; two-stent, 1.3%; P=.11

“Our conclusion is that recommendations on optimal strategy for this lesion subset should await longer-term follow-up,” Kumsars said.

For more information:

Kumsars I. Plenary Session VII: Late Breaking Clinical Trials II. Presented at: TCT 2013; Sept. 27-Oct. 1; San Francisco.

Disclosure: The study was primarily funded by participating hospitals, which received unrestricted study grants from Abbott Vascular and Cordis. Kumsars reports no relevant financial disclosures.