Nordic-Baltic Bifurcation III: Kissing Balloon Dilatation Does Not Reduce MACE at 5 Years
At 5 years, final kissing balloon dilatation does not impact the rate of MACE in patients with coronary bifurcation lesions who undergo main vessel stenting, according to new findings from the Nordic-Baltic Bifurcation Study III presented at TCT 2015.
However, the group assigned to final kissing balloon dilatation had higher rates of all-cause mortality and cardiac mortality than those assigned no final kissing balloon dilatation, according to Matti Jaakko Niemela, MD, of University of Oulu, Oulu, Finland.
For Nordic-Baltic Bifurcation III, researchers randomized patients with bifurcation lesions to a single-stent technique with (n = 238) or without final kissing balloon dilatation in the side branch vessel (n = 239). All patients received a sirolimus-eluting stent (Cypher Select+, Cordis) that is no longer commonly used and had non-STEMI, stable angina, unstable angina or silent ischemia.
Patients were randomized after stenting of the main vessel and jailing of the side branch wire if TIMI flow 3 occurred in both vessels. Those assigned the extra steps underwent rewiring of the jailed side branch and final kissing balloon dilatation; if the side branch remained at TIMI flow 3, side branch stenting was performed.
Baseline characteristics were similar between the two groups, while procedure time, contrast volume and fluoroscopy time were all greater with kissing balloon compared with control (P < .0001 for all).
Similar MACE, more death with kissing balloon
At 5 years, the rate of MACE (defined as a composite of cardiac death, MI not related to the index procedure, target lesion revascularization and stent thrombosis), was not different between the groups. (Figure.) Similarly, no difference between the kissing balloon and control groups was seen for non-procedural MI (4.3% vs. 4.6%; P = .87), TLR (8.5% vs. 10.1%; P = .55) or definite stent thrombosis (0.8% vs. 1.3%; P = .66).
However, patients in the final kissing balloon cohort had higher rates of all-cause mortality (9.8% vs. 3.8%; P = .01) and cardiac mortality (4.3% vs. 0.8%; P = .02) compared with controls.
Results were similar regardless of whether patients did or did not have true bifurcation lesions, although the differences in all-cause mortality and cardiac mortality were more pronounced in those with non-true bifurcation lesions, Niemela said.
Harm or play of chance?
Some discussants suggested the higher mortality in the kissing balloon cohort might be due to a play of chance, given the similarities in MI and stent thrombosis outcomes.
However, Niemela said the possibility that “maybe you do some harm when you go into the side branch” could not be ruled out. He added that when the study was conducted, stent struts were thicker than they are now, possibly increasing their potential to harm the side branch, but that “kissing as such may outstretch the vessel and cause proximal reformation of the stent.”
- Niemela reports no relevant conflicts of interest.