The objective of the study was to test the use of a new atherectomy device to prepare severely calcified lesions. It was an observational, prospective, multicenter study that included 443 patients from 49 sites with a 30-day follow-up. The lesion was classified as severely calcified, as fluoroscopy showed the presence of calcium on both sides of the vessel in an extension of at least 15 mm. The primary endpoint was a combination of peri-procedural infarction, target vessel revascularization, or cardiac death.
The lesion had to be dilated with a balloon prior to stent implantation and after use of the atherectomy device in 41.1% of patients. The major angiographic complications (dissection, perforation, acute occlusion, persistent slow flow) occurred in 7.2% of cases. The primary endpoint after 30 days was observed in 11.3% of patients, mainly due to the occurrence of peri-procedural myocardial infarction (9.7%). The percentage of patients free of MACE was 89.8%, being no greater than the percentage pre-specified in the design of the study (87-92%).
Conclusion: First large prospective registry that supports the use of the new rotational atherectomy system in real-world patients with severely calcified lesions. Editorial comment: this device, like the Rotablator®, uses a proprietary guide. While the peri-procedural infarction rate was relatively high, the long-term significance of this fact is yet to be known.
jeffrey_chambers_europcr
Jeffrey Chambers, MD.
2013-05-23
Original title: Pivotal trial to evaluate the safety and efficacy of the Diamondback 360°orbital atherectomy system in treating de novo, severely calcified coronarylesions (ORBIT II).