Orbital atherectomy does not perform better than conventional balloon angioplasty in preparing lesions before implantation of an active stent in severely calcified arteries, shows a randomized study presented Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington.
Orbital atherectomy is a recent technique for preparing calcified lesions before implantation of a stent. It has proven its safety and effectiveness in the ORBIT I and II trials. However, it remains to be determined whether this strategy improves clinical outcomes compared to conventional balloon angioplasty before active stent placement, recalls Ajay Kirtane of New York-Presbyterian/Columbia University Irving Medical Center in New York in his slideshow.
In the ECLIPSE trial, 2,005 patients with severely calcified lesions, in 104 US centers, were randomized between two lesion preparation strategies: orbital atherectomy and conventional balloon angioplasty, before receiving a second-stage active stent. generation. Extremely calcified lesions, deemed impossible to cross or dilate by balloon, were excluded from this study. The primary imaging endpoint, measuring minimal stent expansion at the site of maximum calcification, was similar in both groups. The target vessel failure rate at 1 year was 11.5% with orbital atherectomy versus 10.0% with balloon angioplasty alone. The difference was not statistically significant. There was no difference between the two groups regarding clinical events at one year, whether death, infarction, revascularization guided by ischemia or stent thrombosis.
At 30 days, there was, however, a significant difference, in favor of conventional angioplasty, concerning deaths from cardiac causes (0.3% versus 1.0%). Among the 8 cardiac deaths in the orbital atherectomy group, 2 were considered device-related, 2 others possibly device-related, and 4 not device-related.
“Routine use of orbital atherectomy did not improve stent expansion or reduce target vessel failures at 1 year compared with conventional balloon angioplasty for the preparation of severely calcified coronary lesions before placement of an active stent”summarizes the researcher. “Sufficient stent expansion and low adverse event rates can be achieved with conventional balloon angioplasty in a significant proportion of severely calcified lesions, if meticulous attention (with intravascular imaging) is paid to lesion preparation.” , he concludes, emphasizing that randomized controlled trials are essential to informing therapeutic strategies in this area.
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