Background: The advantages of the final kissing balloon technique (FKB) in a provisional 1-stent approach are under debate. Long-term clinical outcomes remain unclear due to limited data.
Methods and results: Of 2,132 patients (2,502 lesions) enrolled in the TAXUS Japan Postmarket Surveillance Study at 56 centers between July 2007 and December 2008, patients having coronary bifurcation treated with a single cross-over stenting with FKB (FKB-group: 132 patients/137 lesions) were compared to those treated without FKB (no-FKB-group: 121 patients/124 lesions). The no-FKB-group was also compared with non-bifurcation patients who had a single-stent implantation (814 patients/937 lesions). The primary outcome was MACE (major adverse clinical events), defined as cardiac death, myocardial infarction and target vessel revascularization (TVR) at 3 years. Higher late loss and binary restenosis were found in the main vessel (MV) of the FKB-group at the 9-month angiogram compared to the no-FKB-group. At 3 years, MACE was numerically higher (14.6% vs. 6.9%, P=0.07) and TVR was significantly higher (14.6% vs. 5.9%, P<0.05) in the FKB-group compared with the no-FKB-group. The rate of MACE (6.9% vs. 10.4%, P=0.34) and TVR (5.9% vs. 7.7%, P=0.57) were similar between the no-FKB and non-bifurcation patients.
Conclusions: In a 1-stent approach, FKB was associated with worse angiographic outcomes in the MV, and did not demonstrate any clinical benefit over the long-term follow-up period. Cross-over stenting without FKB showed similar clinical outcomes to patients without bifurcation.