OrbusNeich has announced that a study published in the World Journal of Cardiovascular Diseases shows that, prior to drug eluting stent implantation, the Scoreflex coronary dilatation catheter is associated with equivalent acute stent expansion and less in-stent late loss vs. a non-compliant balloon.
A press release reports that the study included 46 consecutive patients with de novo lesions in native coronary arteries ≥2.5mm in angiographic diameter who underwent elective drug-eluting stent implantation under intravascular ultrasound guidance. The patients were equally and randomly assigned to pre-dilation with a non-compliant balloon (Hiryu, Terumo) or to pre-dilation with Scoreflex. Major adverse cardiac events were defined as a composite of cardiac death, non-fatal myocardial infarction, target lesion revascularisation and stent thrombosis.
In-stent late loss, as determined by quantitative coronary angiography, was 0.23±0.52mm for patients pre-dilated with a dual wire scoring balloon (Scoreflex) vs. 0.71±0.63mm for patients treated with a non-compliant balloon (p=0.03). Follow-up angiography was performed at nine months following initial coronary intervention in 17 patients from the Scoreflex group and in 16 patients from the non-compliant balloon group.
No significant differences in stent expansion between the two groups were observed, although the balloon size was larger (3.33±0.28 vs. 3.09±0.33mm, p=0.01) and the maximal dilation pressure for pre-dilation was higher (11.6±3.2 vs. 8.6±2.7atm, p<0.01) for the non-compliant balloon group. Two patients pre-dilated with a non-compliant balloon required target lesion revascularisation whereas there was no target lesion revascularisation in the Scoreflex group. In general, no significant difference in major adverse cardiac event rates was observed.
“Pre-dilation with Scoreflex prior to drug-eluting stent implantation may be a more feasible strategy than conventional ballooning because it is less traumatic while associated with equivalent stent expansion,” said Kenji Sadamatsu, the Saga-ken Medical Centre Koseikan, Saga, Japan, and corresponding author of the publication. “The observed reduction in late loss for the Scoreflex group suggests that this novel semi-compliant balloon may have additional long-term advantages, particularly for severely stenotic lesions.”