Medtronic (NYSE:MDT) announced results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions.
The Total REALITY study retrospectively compared directional atherectomy (DA) versus balloon predilatation prior to drug-coated balloon (DCB) treatment of long, calcified femoropopliteal lesions. The company also released results from a systematic literature review and meta-analysis, including 305 published clinical studies on atherectomy.
Medtronic released results from both analyses at the Vascular InterVentional Advances (VIVA) 2024 conference in Las Vegas.
“The data presented at VIVA this week helps to reinforce the use of atherectomy in appropriately selected lesions, and further affirms the breadth of data demonstrating its safety and effectiveness,” said Dr. John Laird, chief medical officer of the Peripheral Vascular Health business, at Medtronic. “This adds further documentation on directional atherectomy that our clinical community has been seeking and supports our commitment to providing evidence to inform treatment decisions.”
Total REALITY study compares atherectomy to drug-coated balloon
Total REALITY combined data from the VIVA REALITY study and the Total IN.PACT dataset. It aimed to address the need for more comparative data regarding atherectomy for femoropopliteal lesions.
Dr. Venita Chandra, director of vascular surgery at the Stanford University School of Medicine, presented the results. They demonstrated that DA followed by DCB achieved a significantly lower provisional stent rate with comparable safety and efficacy outcomes compared to standard predilation prior to DBC.
According to Medtronic, this makes DA followed by DCB a viable alternative for treating long and highly calcified lesions.
REALITY patients treated with DA and DCB (total of 84) were propensity score matched to eligible patients treated with PTA+DCB from the Total IN.PACT dataset (total of 143). One-year primary patency did not differ between groups, despite a significant difference in baseline calcification.
However, in the DA+DCB arm, investigators saw a trend toward higher stent-free patency through 12 months (79.1% vs. 68.1%). They also saw a significantly lower provisional stenting rate (9.5% vs. 21.1%).
Medtronic reported no difference in major adverse limb events through 12 months as well. The company said the reuslts underscore the complexity and high calcification burden of lesions included in the REALITY study. Outcomes highlighted the potential of DA+DCB as a viable, safe and effective alternative to DCB with standard predilation.
Medtronic has more data from a literature review
The company also reported a systematic literature review and meta-analysis evaluating the amount and rigor of published data on atherectomy. It identified 305 original research papers reporting outcomes on atherectomy for endovascular treatment of occlusive or stenotic disease in native, infrainguinal, peripheral arteries through May 2024.
Most studies (86%) evaluated atherectomy in addition to an adjunctive definitive therapy. Most commonly, those came in the form of uncoated balloons and DCBs.
Key findings included one-year patency at 76.5% among 42 observational studies (4,195) patients. One-year patency came in at 72.7% among six randomized controlled trials (172) patients, comparing favorably to uncoated balloon angioplasty and DCB without atherectomy. The analysis defined patency as freedom from target lesion revascularization (TLR) or freedom from restenosis determined by angiography or duplex ultrasound.
One-year rates of TLR, major amputation and mortality for atherectomy also came in as similar or better than the alternatives. Compared to uncoated balloon or DCB rates, bailout stenting rates registered low following atherectomy as well.
“These results show that published evidence supports the use of atherectomy as part of the endovascular treatment algorithm for peripheral arterial disease with publications at the highest level of evidence,” said Dr. Jeffrey Carr of the Christus Health Heart and Vascular Institute in Tyler, Texas.
