Atherectomy for Infrainguinal PAD?

Preliminary results from a systematic literature review on the use of atherectomy for infrainguinal peripheral artery disease (PAD) were presented on Tuesday by Ralf Langhoff, an angiologist and Head of Department at Sankt Gertrauden-Krankenhaus (Berlin, Germany). Dr Langhoff first looked at the total number of papers published, the design and rigor of those studies, the atherectomy classes used, and some preliminary information on the typical patient and lesion characteristics.

Atherectomy is a well-established procedure, thus his talk aimed to show the breadth of research on atherectomy use specifically in peripheral interventions. “Increased use of atherectomy in recent years has, in conjunction, come with questions regarding how much published evidence exists supporting its use in peripheral interventions,” he explained.

Dr Langhoff’s group’s systematic review evaluates the full volume of published literature with the aim to provide a clear understanding of the comprehensiveness of the data, and what it has discovered. The final safety and effectiveness outcomes based on this literature review will not be available until autumn. “For now, I can call out a few recent atherectomy studies that have had what I find to be particularly interesting outcomes in support of the use of atherectomy,” he said.

For example, atherectomy can be used either as a primary treatment modality or as an adjunct to percutaneous transluminal angioplasty (PTA) to improve acute outcomes and reduce the need for stent placement. Meta-analyses have reported that compared to PTA alone, a strategy of atherectomy followed by PTA resulted in fewer flow-limiting dissections and a reduced need for stenting in femoropopliteal lesions,¹ as well as lower target lesion revascularization and major target limb amputation rates in infrapopliteal lesions.² 

These findings have been supported by real-world datasets of large US claims analyses, said Dr Langhoff. In analyses of US Medicare³ (and the National Cardiovascular Data Registry PVI Registry), treatment strategies using atherectomy were associated with lower rates of amputation and surgical revascularization compared to strategies not using atherectomy.

Dr Langhoff’s review found a total of 295 published papers on the use of atherectomy and an additional 22 papers evaluating intravascular lithotripsy published by March 2024. “The sheer volume of the publications was surprising,” he commented. In the end, his review included 11 meta-analyses, 21 papers of randomized trials, and 53 papers of prospective multicenter studies, representing the highest levels of evidence.

Additionally, Dr Langhoff noted that it was encouraging to see that as the use of atherectomy has increased in recent years. There has been a simultaneous rise in published research investigating its safety and effectiveness. As the use of this technology has increased, clinical research has as well, providing up-to-date and comprehensive data about treatment outcomes.

However, part of the reason for this review is that there has been recent criticism that atherectomy is overused, especially in the United States. Although guidelines state that atherectomy may be appropriate for femoropopliteal and below-the-knee artery disease, critics have questioned whether the clinical value justifies the procedural cost. “The aim of our analysis is to provide a comprehensive overview of the literature investigating the clinical value of atherectomy as an effective treatment for patients with PAD,” reasoned Dr Langhoff.

Future studies to better understand patient outcomes when treated with atherectomy might look at different classes of atherectomy devices (directional, orbital, rotational, laser) said Dr Langhoff. Outcomes may be different depending on the lesion characteristics; thus it will be important in future studies to understand which atherectomy devices are most effective in which patients, and which lesions. There are also fewer atherectomy studies evaluating interventions below the knee, so that will be important to examine in the future, he added.

Given that atherectomy is a long-established procedure with a great body of high-quality published evidence in support of clinical outcomes, Dr Langhoff hopes that this systematic review and meta-analysis will finally elucidate the depth and breadth of research conducted on atherectomy for PAD. “It will give a comprehensive evaluation of literature to date and provide a clear understanding of what the data shows, including safety and effectiveness outcomes for PAD patients treated with the use of atherectomy,” he concluded.

References

1. Wu Z, Huang Q, Pu H, et al. Atherectomy combined with balloon angioplasty versus balloon angioplasty alone for de novo femoropopliteal arterial diseases: a systematic review and meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg. 2021;62(1):65–73.

2. Wu H, Zheng D, Zhou L, Wang Q, Wang T, Liang S. A systematic review and meta-analysis of atherectomy plus balloon angioplasty versus balloon angioplasty alone for infrapopliteal arterial disease. J Endovasc Ther. Published online November 7, 2023.

3. Krawisz AK, Raja A, Jones WS, et al. Long-term outcomes of peripheral atherectomy for femoropopliteal endovascular interventions. EuroIntervention. 2023;18(16):e1378–e1387.

4. Bailey SR, Beckman JA, Dao TD, et al. ACC/AHA/SCAI/SIR/SVM 2018 appropriate use criteria for peripheral artery intervention: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine. J Am Coll Cardiol. 2019;73(2):214–237.