Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting

Abstract

MD; for the Nordic-Baltic PCI Study GroupBackground-It is unknown whether the preferred 1-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). Therefore, we compared strategies of MV stenting with and without FKBD. Methods and Results-We randomized 477 patients with a bifurcation lesion to FKBD (nϭ238) or no FKBD (nϭ239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-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% (Pϭ1.00) 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. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (Pϭ0.11), in the MV was 3.1% versus 2.5% (Pϭ0.68), and in the side branch was 7.9% versus 15.4% (Pϭ0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (Pϭ0.024) in the FKBD and no-FKBD groups, respectively. Conclusions-MV

Dedicated bifurcation stents or regular drug eluting stents in distal left main stenosis: A retrospective study

“…The stepped design of the BiOSS ® stent delivery balloon theoretically was to ensure a FKB-and POT-like effect, thus allowing operators to frequently omit this part of the procedure. However, as was shown in POLBOS I trial not performing FKB and POT was associated with worse clinical outcomes and is a trend in larger late lumen loss, whereas in the NORDIC 3 study it was proved that FKB reduced angiographic side branch restenosis, especially in patients with true bifurcation lesions [21,22]. These findings were confirmed in the MITO Registry [23].…”

Early and long-term outlook of percutaneous coronary intervention for bifurcation lesions in young patients

“…Even in the modern era, patients undergoing percutaneous coronary interventions (PCI) of bifurcation lesions face lower procedural success, greater complication rates and worse outcome compared with PCI of simple coronary lesions [1,2]. Advanced age has been traditionally identified as an important risk factor for adverse outcome in patients suffering from ischemic heart.…”

“…1 For the Italian Multicenter Registry on Bifurcation Study (I-BIGIS) Group. 2 Both authors equally contributed to this work.…”

Potential Benefit of Final Kissing Balloon Inflation After Single Stenting for the Treatment of Bifurcation Lesions

“…j-circ.or.jp benefit of routine FKI after single stenting of bifurcation lesions. 6 In addition, inadequate side-branch dilatation may result in stent deformation or incomplete stent apposition. 7 In contrast, quantitative coronary angiography (QCA) conducted in the Nordic-Baltic Bifurcation Study III showed better expansion of the side-branch orifice in the FKI group.…”