Results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions have just been released as late-breaking data presentations at VIVA 2024 (3–6 November, Las Vegas, USA).
The Total REALITY study retrospectively compared directional atherectomy versus balloon predilatation prior to drug-coated balloon (DCB) treatment of long, calcified femoropopliteal lesions. Additionally, results from a systematic literature review and meta-analysis, including 305 published clinical studies on atherectomy, were shared.
Total REALITY study
The Total REALITY study combined data from the VIVA REALITY study and the Total IN.PACT dataset, in order to address the need for more comparative data regarding atherectomy for femoropopliteal lesions. The results, which were presented by Venita Chandra (Stanford University School of Medicine, Stanford, USA), showed that directional atherectomy followed by DCB achieved a significantly lower provisional stent rate with comparable safety and efficacy outcomes compared to standard predilatation prior to DCB, making it a viable alternative for treating long and highly calcified lesions.
REALITY patients treated with directional atherectomy plus DCB (n=84) were propensity score matched to eligible patients treated with percutaneous transluminal angioplasty (PTA) plus DCB from the Total IN.PACT dataset (n=143). While the groups were mostly well-matched on other patient and lesion characteristics, there were significant differences in severe calcification (PACSS 4) even after matching (71.4% directional atherectomy plus DCB vs. 5.9% PTA plus DCB, p<0.001).
Key findings include:
- One-year primary patency (freedom from both clinically driven target lesion revascularisation and duplex ultrasound-derived restenosis) did not differ between groups, despite the significant difference in baseline calcification.
- In the directional atherectomy plus DCB arm, there was a trend toward higher stent-free patency through 12 months (79.1% vs. 68.1%, p=0.09) and a significantly lower provisional stenting rate (9.5% vs. 21.1%, p=0.014).
- Major adverse limb events (target vessel revascularisation, major target limb amputation, and target lesion thrombosis) through 12 months did not differ between groups.
A Medtronic press release notes that Total REALITY underscores the complexity and high calcification burden of lesions included in the REALITY study. Despite having significantly greater baseline calcification, directional atherectomy plus DCB achieved a significantly lower provisional stent rate with comparable safety and efficacy outcomes compared to PTA plus DCB.
“These results show that directional atherectomy 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,” the release reads.
Atherectomy systematic literature review
The atherectomy systematic literature review and meta-analysis evaluated the amount and rigour of published data on atherectomy. 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 highest levels of evidence were represented, including 11 meta-analyses, 19 papers on randomised 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.
Key findings from the literature review include:
- One-year patency (defined as freedom from target lesion revascularisation [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 randomised controlled trials (RCTs; 172 patients), comparing favorably to published meta-analysis rates for uncoated balloon angioplasty (47.4% across 10 randomised controlled trials [RCTs]), and DCB without atherectomy (67.6% in observational studies and 67.9% in RCTs).
- One-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,” said Jeffrey Carr (CHRISTUS Health Heart and Vascular Institute, Tyler, USA), in a Medtronic press release.
