Final Kissing Balloon Dilatation Studied in Main Vessel Treatment

January 4, 2011—The Nordic-Baltic Percutanous Coronary Intervention Study Group conducted a study to discover whether the preferred one-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). In the Nordic-Baltic Bifurcation Study III, the investigators compared strategies of MV stenting with and without FKBD. Matti Niemelä, MD, et al published the findings in Circulation (2011;123:79–86).

As detailed in Circulation, the investigators randomized 477 patients with a bifurcation lesion to FKBD (n = 238) or no FKBD (n = 239) after MV stenting. The primary endpoint was major adverse cardiac events: cardiac death, nonprocedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P = 1) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group.

The investigators reported that 326 patients had a quantitative coronary assessment. At 8 months, the rate of binary restenosis in the entire bifurcation lesion (MV and side branch) was 11% versus 17.3% (P = .11), in the MV was 3.1% versus 2.5% (P = .68), and in the side branch was 7.9% versus 15.4% (P = .039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20% (P = .024) in the FKBD and no-FKBD groups, respectively.

The investigators concluded that MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch restenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed, advised the investigators.