Medtronic Presents Studies on Utility of Atherectomy to Treat PAD

November 4, 2024—Medtronic announced results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions.

The first study, Total REALITY, retrospectively compared directional atherectomy (DA) versus balloon predilatation before drug-coated balloon (DCB) treatment of long, calcified femoropopliteal lesions. The second study was a systematic literature review and meta-analysis of 305 published clinical studies on atherectomy.

Results from both analyses were released at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the company, the Total REALITY study combined data from the VIVA REALITY study (Rocha-Singh KJ, et al. Catheter Cardiovasc Interv. 2021;98:549-558) study and the Total IN.PACT dataset (Shishehbor MH, et al. J Vasc Surg. 2019;70:1177-1191), in order to address the need for more comparative data regarding atherectomy for femoropopliteal lesions.

The findings were presented at VIVA24 by Venita Chandra, MD, who is Director of Vascular Surgery, Stanford University School of Medicine in Stanford, California.

As summarized by Medtronic, the results showed that DA followed by DCB achieved a significantly lower provisional stent rate with comparable safety and efficacy outcomes compared to standard predilatation before DCB, making it a viable alternative for treating long and highly calcified lesions.

In the analysis, REALITY patients treated with DA+DCB (n = 84) were propensity score matched to eligible patients treated with PTA+DCB from the Total IN.PACT dataset (n = 143).

There were significant differences between the two groups in severe calcification (PACSS 4) even after matching (DA+DCB, 71.4% vs PTA+DCB, 5.9%; P < .001). However, the groups were mostly well-matched on other patient and lesion characteristics.

The Medtronic press release outlined the key findings as follows:

• 1-year primary patency (freedom from both clinically driven target lesion revascularization [TLR] and duplex ultrasound-derived restenosis) did not differ between groups, despite the significant difference in baseline calcification.
• In the DA+DCB arm versus the PTA+DCB arm:
  • There was a trend toward higher stent-free patency through 12 months (79.1% vs 68.1%; P = .09).
  • There was a significantly lower provisional stenting rate (9.5% vs 21.1%; P = .014).
• Major adverse limb events (target vessel revascularization, major target limb amputation, and target lesion thrombosis) through 12 months did not differ between groups.

According to Medtronic, Total REALITY underscores the complexity and high calcification burden of lesions included in the REALITY study. Despite having significantly greater baseline calcification, DA+DCB achieved a significantly lower provisional stent rate with comparable safety and efficacy outcomes compared to PTA+DCB.

These results show that DA followed by DCB is a viable, safe, and effective alternative to DCB with standard predilatation, even when treating long and highly calcified lesions, while reducing the need for permanent implants, stated the company.

The atherectomy systematic literature review and meta-analysis evaluated the amount and rigor of published data on atherectomy.

Medtronic stated that the analysis 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.

The company noted that the highest levels of evidence were represented, including 11 meta-analyses, 19 papers on randomized trials, and 94 papers on prospective observational studies. In addition, there were 136 retrospective observational study papers and 45 case study papers. Most studies (86%) evaluated atherectomy in addition to an adjunctive definitive therapy, most commonly uncoated balloons and DCBs.

As summarize by Medtronic, the key findings from the literature review include:

• 1-year patency (defined as freedom from TLR or freedom from restenosis determined by angiography or duplex ultrasound) was 76.5% among 42 observational studies (4,195 patients) and 72.7% among six randomized controlled trials (RCTs; 172 patients), comparing favorably to published meta-analysis rates for uncoated balloon angioplasty (47.4% across 10 RCTs), and DCB without atherectomy (67.6% in observational studies and 67.9% in RCTs).
• 1-year rates of TLR (16.6% in 56 observational studies, 10.8% in 10 RCTs), major amputation (1.7% in 58 observational studies, 0.9% in 11 RCTs), and mortality (2.8% in 52 observational studies, 2.2% in 11 RCTs) were also similar or better than meta-analysis rates for balloon angioplasty or DCB, with variations based on study design and artery level.
• Compared to uncoated balloon or DCB rates ranging from 9.1% to 20.2%, bailout stenting rates were low following atherectomy in both observational studies (9.3% across 112 studies with 11,731 patients) and RCTs (8.9% across 13 studies with 721 patients).

“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,” commented study investigator Jeffrey Carr MD, in the Medtronic press release. Dr Carr is with Christus Health Heart and Vascular Institute in Tyler, Texas.

Additionally, John Laird, MD, Chief Medical Officer of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic, stated in the press release, “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. 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.”