The Role of Atherectomy in the Treatment of Peripheral Artery Disease

Abstract

Background

Peripheral arterial disease (PAD) is a prevalent and increasingly common condition associated with high morbidity and a growing number of patients worldwide. Atherectomy, a minimally invasive technique to remove or modify atherosclerotic plaques, has gained popularity as an adjunct to vessel preparation before balloon angioplasty, particularly in combination with drug-coated balloons (DCB). Its therapeutic role in PAD appears promising but requires further investigation.

Materials and Methods

A systematic literature search was conducted in the PubMed database. Randomized controlled trials, meta-analyses, registry data, and guideline recommendations regarding atherectomy in PAD were included. The aim was to evaluate evidence on efficacy, safety, and clinical relevance across different anatomical regions and different atherectomy devices.

Results and Conclusion

Atherectomy shows promise as an adjunctive technique in the endovascular treatment of PAD, particularly for complex and calcified lesions in the femoropopliteal segment. While some observational and registry data suggest improved procedural success, luminal gain and reduced need for bailout stenting, randomized controlled trials yield mixed results regarding long-term patency and clinical benefit. In below-the-knee interventions, evidence remains limited and complication rates are of concern.

Overall, atherectomy represents a valuable tool within a tailored treatment approach but requires further clinical validation through high-quality trials to clearly define its therapeutic role.

Key Points

• Atherectomy improves vessel preparation especially in complex femoropopliteal lesions

• Randomized trials show promise but no consistent long-term benefit.

• Below-the-knee use is limited; complication rates remain relatively high.

• Device selection and operator experience are critical for procedural success.

• Atherectomy is valuable in selected cases, pending further evidence.

Citation Format

• Limbrock M, Sunderdiek U, Haage P et al. The Role of Atherectomy in the Treatment of Peripheral Artery Disease. Rofo 2025; DOI 10.1055/a-2718-7990

Zusammenfassung

Hintergrund

Die periphere arterielle Verschlusskrankheit (pAVK) ist eine häufige und zunehmend verbreitete Erkrankung mit hoher Morbidität. Die Atherektomie, ein minimal-invasives Verfahren zur Plaqueentfernung und -modifikation, findet Anwendung als ergänzende Maßnahme vor einer Ballonangioplastie, oft in Kombination mit medikamentenbeschichteten Ballons (DCB). Ihr Nutzen in der pAVK-Therapie ist vielversprechend, muss jedoch weiter erforscht werden.

Methoden

Es wurde eine systematische Literaturrecherche in der PubMed-Datenbank durchgeführt. Berücksichtigt wurden randomisierte kontrollierte Studien, Metaanalysen, Registerdaten sowie aktuelle Leitlinien zur Atherektomie bei pAVK. Ziel war es, Evidenz zu Wirksamkeit, Sicherheit und klinischem Stellenwert in verschiedenen Gefäßregionen und zu unterschiedlichen Atherektomie-Systemen zusammenzufassen.

Ergebnisse und Schlussfolgerung

Die Atherektomie zeigt sich als vielversprechende ergänzende Technik in der endovaskulären Behandlung der pAVK, insbesondere bei komplexen und stark verkalkten Läsionen im femoropoplitealen Bereich. Während Beobachtungsstudien und Registerdaten auf verbesserte Ergebnisse bezüglich des Interventionserfolgs, des gewonnenen Lumens und einen geringeren Bedarf und Stentimplantationen hinweisen, liefern randomisierte Studien uneinheitliche Ergebnisse in Bezug auf die Langzeitoffenheit. Für infrapopliteale Interventionen ist die Evidenzlage begrenzt und die Komplikationsraten sind höher als femoropopliteal.

Insgesamt stellt die Atherektomie ein wertvolles Instrument innerhalb eines individualisierten Behandlungsansatzes dar, erfordert jedoch weitere Validierung durch qualitativ hochwertige Studien, um ihre therapeutische Rolle klarer zu definieren.

Kernaussagen

• Atherektomie verbessert die Gefäßpräparation, insbesondere bei komplexen femoropoplitealen Läsionen.

• Randomisierte Studien zeigen vielversprechende, aber keine einheitlichen Langzeitergebnisse.

• Einsatz crural ist aufgrund erhöhter Komplikationsraten eingeschränkt.

• Auswahl des geeigneten Atherektomie-Systems und die Erfahrung des Anwenders sind wichtig für den Erfolg.

• Atherektomie ist in ausgewählten Fällen sinnvoll, bedarf jedoch weiterer Evidenz.

Keywords

peripheral artery disease - atherectomy - arteries - angiography

Introduction

Peripheral arterial disease (PAD) is a widespread condition characterized by atherosclerotic narrowing or occlusion of peripheral arteries. It affects millions of patients worldwide, resulting in significant limitations in quality of life and a high disease burden. In 2015, an estimated 237 million individuals were affected, representing a 22% increase compared to 202 million in 2010. In Germany, the prevalence of PAD ranges from 3–10% in the general population and increases to as much as 20% among individuals over the age of 70 [1].

Projections suggest that the number of PAD patients will continue to rise due to demographic changes and the growing prevalence of risk factors such as diabetes mellitus. Statistical models predict a further increase in PAD prevalence through at least 2030 [2].

Advances in endovascular therapies have introduced various treatment modalities, including balloon angioplasty, stenting, and vessel preparation, e.g. plaque modification and/or debulking. The benefit and superiority of drug-coated balloons (DCB) over conventional percutaneous transluminal angioplasty (PTA) in symptomatic femoropopliteal PAD, with a favorable safety profile, have been well established for a long time [3]. Atherectomy has emerged as a complementary technique designed to debulk atherosclerotic plaque and optimize vessel preparation before adjunctive therapies such as balloon angioplasty, with or without DCB. The role of atherectomy remains a topic of debate, with ongoing evaluations regarding its impact on long-term patency rates, restenosis reduction, and clinical outcomes. While some studies suggest that atherectomy may enhance luminal gain and vessel compliance, others for example highlight the increased risks of distal embolization and vessel trauma, necessitating careful patient selection and procedural optimization [4] [5].

This narrative review explores the role of atherectomy in the treatment of PAD. Guidelines, current studies, and systematic reviews are considered to evaluate the effectiveness, safety, and significance of this procedure in comparison to other treatment methods.

Therapeutic Recommendations in the S3-AWMF Guideline for Peripheral Arterial Disease (PAD)

The current guidelines on PAD from the German Society for Angiology emphasize structured exercise therapy (SET) and best medical therapy (BMT) as first-line treatment, particularly in Stage II PAD (Claudication), where at least 3–6 months of SET and BMT should precede any invasive intervention. Revascularization is reserved for patients with persistent symptoms or critical limb-threatening ischemia (CLTI, Stage III–IV), where urgent intervention is necessary to prevent limb loss. Both open surgical and endovascular revascularization options are seen as viable approaches, each with their own advantages and limitations. While recent data (e.g. BASIL-2 trial [6]) indicate a possible benefit in amputation-free survival following endovascular treatment, this comes at the cost of a higher rate of reinterventions.

Overall, due to conflicting trial results, treatment selection should be individualized, based on comorbidities, vascular anatomy, and multidisciplinary consultation.

Supervised exercise therapy should continue after revascularization to enhance functional outcomes.

Overview of Atherectomy Systems

An atherectomy is an endovascular procedure designed to remove atherosclerotic plaque from arterial walls, improving blood flow and alleviating symptoms associated with PAD. Various atherectomy systems are available, each with unique mechanisms and applications tailored to different lesion types and anatomical considerations.

The primary categories of atherectomy systems include rotational, directional rotational, orbital rotational, and laser atherectomy, as well as systems designed for mechanical thrombectomy and atherectomy. The choice for a specific atherectomy system depends on several factors, including the lesion’s composition, location, and severity. [Table 1] summarizes the most common atherectomy systems, their mechanisms, and their clinical applications. This review does not examine laser atherectomy in detail due to its currently very limited use in Germany.

Table 1 Overview of the most common atherectomy systems, their mechanisms, and their clinical applications.

Atherectomy System	Examples (Manufacturer)	Mechanism	Applications
Rotational, front-cutting Atherectomy and Thrombectomy	JetStream (Boston Scientific), Phoenix (Philips)	Rotating cutting heads or blades remove plaques; includes aspiration of removed debris.	For soft, calcified and fibrotic plaques; suitable for various vessel sizes and lesion types; suitable for in-stent restenosis.
Directional, rotational Atherectomy	HawkOne System (Medtronic)	Directional blade allows precise plaque removal by targeting specific areas, integrated system captures debris.	For eccentric or localized plaques in peripheral arteries; suitable for in-stent restenosis.
Orbital Rotational Atherectomy	Diamondback 360 (CSI-Cardiovascular Systems)	Orbiting diamond-coated crown sands calcified plaques into micro-particles, no need of capturing debris.	For calcified lesions in small or tortuous vessels; gradual plaque modification.
Rotational Thrombectomy and Atherectomy	Rotarex (BD), ByCross (Taryag Medical)	Rotating spiral creates suction via the Venturi effect (Rotarex), Rotating shaft with expandible cutting wing (ByCross) remove thrombotic and atheromatous material; integrated aspiration system captures debris.	For thrombotic and restenotic plaques; suitable for in-stent restenosis with thrombus.
Laser Atherectomy	Various laser systems (e.g., Spectranetics by Philips)	Uses UV laser energy to vaporize plaque and thrombus	For thrombotic and restenotic plaques.

In essence, atherectomy systems mainly remove atherosclerotic plaque from within the arterial wall, typically in cases of chronic PAD. Thrombectomy systems are designed to extract intravascular thrombi, most commonly in the setting of acute or subacute occlusions. In clinical practice, most atherectomy systems offer a combination of plaque removal and thrombus management. In systems such as Jetstream, Phoenix, HawkOne, and Diamondback, the primary mechanism of action is atherectomy. In contrast, the Rotarex system is a dedicated thrombectomy device.

The Diamondback system is the most extensively studied atherectomy device, largely due to its widespread adoption in North America. However, when evaluating its relevance to PAD, it is important to recognize that much of the available data relates to coronary applications. A notable example is the multi-center, prospective ORBIT II trial, which focused on the treatment of coronary plaque [7] [8].

Atherectomy in the Femoropopliteal Region

Atherectomy is mostly used in femoropopliteal PAD, particularly for lesions with moderate to severe calcification, where conventional balloon angioplasty alone may be insufficient due to risks of arterial recoil and dissection. As shown in [Table 1], several atherectomy devices are available. These devices aim to optimize vessel compliance and enhance luminal gain [9] [10] [11]. Randomized trials and real-world registries have provided contrasting perspectives on the benefits of atherectomy in femoropopliteal lesions, with data suggesting a reduced need for bailout stenting and others indicating no significant long-term benefit over angioplasty alone [12].

A recent prospective, single center observational study from 2024 (n=162) evaluated the safety and effectiveness of the Jetstream Atherectomy System combined with a DCB angioplasty for treating complex and calcified TASC C/D femoropopliteal lesions. On average, the lesion length was 24.2±4.8 cm and >50% showed significant, heavy calcification. The procedural success rate was 99% with low bailout stenting (7.4%) and led to significant clinical improvements at 12 months, including a reduction in Rutherford classification (3.7±0.6 to 1.0±0.9, p<0.05) and a notable increase in ABI (0.4±0.1 to 0.8±0.2, p<0.05). Most patients remained free from target lesion revascularization (TLR) (92.6%) and target vessel revascularization (TVR) (95.1%), though severe arterial calcification was linked to inferior outcomes and higher adverse limb event rates. Importantly, the lesion characteristics in this cohort, i.e. long-segment disease and heavy calcification, closely reflect the profile of patients routinely encountered in daily clinical practice, further underscoring the study’s practical relevance [13].

In contrast, the multi-center JET-RANGER randomized trial (n=43) comparing Jetstream atherectomy combined with DCB versus DCB alone found no significant differences in freedom from TLR at two years, although atherectomy reduced the need for bailout stenting (0% in Jetstream + DCB vs. 50% in DCB group, p<0.0001) [5].

While the previous studies addressed femoropopliteal disease, another recently published ISO-POP trial specifically examined isolated lesions of the popliteal artery, an anatomically mobile segment particularly prone to stent-related complications. The two-center trial (n=62) assessed rotational atherectomy with assisted balloon angioplasty for isolated popliteal artery lesions, directly comparing the Jetstream and Phoenix atherectomy systems. The study demonstrated a high procedural success rate (98.4%) and low bailout stenting (4.8%). Peripheral embolization occurred in 3.7% (subgroup A: rotational atherectomy with Phoenix) and 5.7% (subgroup B: rotational atherectomy with Jetstream) but was successfully managed. Median ABI significantly improved in both subgroups (p<0.001). Based on the very promising study results, the authors advocate for a more liberal application of atherectomy, particularly in anatomically challenging vascular segments that are prone to stent fractures and occlusions [14].

Following the previously presented studies on rotational atherectomy, the next series of investigations focus on directional atherectomy systems.

The first of these studies also targets isolated lesions of the popliteal artery: a single-center study (n=72) compared DCB angioplasty and directional atherectomy with antirestenotic therapy (DAART) for isolated popliteal artery lesions. Technical success was 84% for DCB vs. 93% for DAART (p=0.24). At 12 months, primary patency was significantly higher in the DAART group (82% vs. 65%, p=0.021), while freedom from TLR was similar (82% vs. 94%, p=0.072). Secondary patency was identical for both groups. Bailout stenting was more common after DCB (16% vs. 5%), while DAART had a higher rate of aneurysmal degeneration (7% vs. 0%). The study suggests DAART may improve patency, but both methods showed good long-term outcomes, with potential trade-offs in complications [15].

The prospective, multi-center, randomized DEFINITIVE AR pilot study (n=121) on directional atherectomy in CLTI investigated whether vessel preparation with directional atherectomy (DA) before DCB angioplasty improves outcomes in femoropopliteal lesions. While DA+DCB showed higher technical success (89,6% vs. 64,2%, p=0.004) and fewer flow-limiting dissections (2% vs. 19%, p=0.01), key 12-month outcomes, such as restenosis, reintervention, and patency, were comparable between the groups. Interestingly, a post hoc analysis of the DEFINITIVE AR trial suggested that more effective debulking with ≤30% residual stenosis after DA was associated with improved 12-month patency rates (88.2% angiographic, 84.2% duplex) compared to lesions with >30% residual stenosis (68.8% and 77.8% respectively), highlighting a potential long-term benefit of thorough vessel preparation [16].

Building upon these findings, the VIVA REALITY study, as another prospective, multi-center study (n=102), evaluated the use of DA for vessel preparation prior to DCB angioplasty in patients with symptomatic, severely calcified femoropopliteal PAD. Among the treated subjects, the mean lesion length was 17.9±8.1 cm, with nearly 40% being chronic total occlusions. Provisional stenting was required in only 8.8% of cases. At 12 months, primary patency was 76.7% and freedom from clinically driven TLR reached 92.6%. No device- or procedure-related deaths occurred. These results support DA as a safe and effective strategy in complex, calcified lesions [10].

While endovascular treatment of the common femoral artery (CFA) is typically reserved for highly selected patients, Stavroulakis et al. retrospectively compared directional atherectomy with antirestenotic therapy (DAART) to DCB angioplasty alone for treating CFA atherosclerotic disease (n=47). Technical success rates were similar between the two groups and while primary patency rates at 12 months did not significantly differ (68% for DCB vs. 88% for DAART), the secondary patency rate was significantly higher in the DAART group (100% vs. 81%, p=0.03). DAART was associated with a trend toward improved vessel patency, though statistical significance was not reached. DCB angioplasty resulted in more dissections, but they were not flow-limiting and bailout stenting rates were comparable [17].

In summary, current evidence on atherectomy in femoropopliteal PAD highlights its potential to improve procedural success, reduce bailout stenting, and optimize vessel preparation, particularly in long, calcified, and anatomically challenging lesions. While some prospective and randomized trials suggest advantages in patency or technical outcomes, others demonstrate no clear long-term superiority over angioplasty alone. Directional and rotational atherectomy systems both show safety and feasibility, with emerging data indicating that thorough debulking may translate into improved patency.

Overall, atherectomy appears most relevant in complex, heavily calcified disease and segments at risk for stent-related complications, though its definitive long-term benefit remains to be proven.

Atherectomy in the Crural Region

The role of atherectomy in below-the-knee (BTK) PAD is less established due to anatomical challenges, including smaller vessel diameters and high rates of chronic total occlusions.

The study by Konijn et al. demonstrated distinct calcification patterns in arteries above- and below-the-knee in patients with CLI. In the femoropopliteal arteries, CLI patients predominantly showed severe, thick, irregular, or patchy calcifications, which are consistent with intimal atherosclerotic disease. In contrast, in the crural arteries, calcifications were more frequently annular, thin, and continuous, suggestive of medial artery calcification (MAC). These findings indicate not only a difference in distribution and morphology, but likely also reflect distinct underlying pathophysiological mechanisms: atherosclerosis-driven intimal calcification in proximal segments versus metabolically driven medial calcification distally. These anatomical and etiological distinctions likely have prognostic and therapeutic implications, particularly in tailoring treatment strategies for CLI patients [18]. These morphological differences are particularly relevant when considering endovascular treatment approaches in BTK territory, where the predominance of MAC may limit the mechanical effectiveness of plaque-modifying techniques such as atherectomy.

Limited evidence supports its superiority over today’s standard strategy with PTA or DCB. A retrospective analysis suggests that while atherectomy with the Phoenix atherectomy device may achieve high procedural success rates in BTK interventions, it is associated with higher risks of distal embolization and perforation [11].

Another retrospective analysis of data from the multi-center Excellence in Peripheral Artery Disease (XLPAD) registry analyzed 518 BTK endovascular interventions, with 43% using atherectomy. The specific atherectomy devices used in the data analyzed were not differentiated in the analysis. Atherectomy use was less common in chronic total occlusions (48% vs 58%, p=0.02). No significant associations were found with baseline comorbidities, CLI, ankle-brachial index, vessel run-off or lesion location. However, atherectomy was linked to a lower 1-year repeat target limb revascularization rate (HR 0.41, p<0.01). Overall this analysis suggests that atherectomy improves BTK intervention outcomes [19].

The prospective, multi-center, randomized OPTIMIZE BTK pilot trial (n=66) evaluated orbital atherectomy (OA) + DCB angioplasty versus DCB alone for treating calcified infrapopliteal/crural lesions. The technical success rates were 81.8% for OA + DCB and 89.2% for DCB, with minor complications in both groups. Target lesion primary patency was numerically higher in the OA + DCB group at 6 (88.2% vs 50.0%) and 12 months (88.2% vs 54.5%), though not statistically significant. No differences were observed in MAE, TLR, amputation, or mortality at 12 months. The study concluded that OA + DCB is safe [20].

In summary, infrapopliteal atherectomy faces unique challenges due to small vessel size and the predominance of medial artery calcification, which may limit the mechanical efficacy of plaque-modifying techniques. While retrospective data suggest possible reductions in reintervention rates, safety concerns such as distal embolization and perforation remain.

Early prospective trials indicate that atherectomy combined with DCB angioplasty is safe and may improve patency, but without clear clinical superiority over standard angioplasty. Accordingly, current evidence and guidelines support its use only in selected cases with severe calcification [4].

The following case from our daily clinical routine illustrates the previously mentioned applications of an atherectomy system in the femoropopliteal and crural region.

A 79-year-old male patient presented via the emergency department with PAD at Fontaine stage IIb-III on the left side with a re-occlusion of the popliteal artery following prior recanalization with DCB angioplasty of the popliteal and anterior tibial artery several months earlier. Current imaging revealed an occlusion starting at the mid P2 segment of the popliteal artery, extending through the entire P3 segment, the tibiofibular trunk, and into the proximal anterior tibial artery ([Fig. 1]). In cases where occlusion of the popliteal artery extends into the crural region, it is often beneficial to selectively probe the crural vessels. Therefore, subsequent access, such as to the tibiofibular trunk, is often no longer feasible following prior isolated recanalization of the anterior tibial artery, even without stent-implantation.

Fig. 1 Occlusion starting at the mid P2 segment of the popliteal artery, extending through the entire P3 segment, the tibiofibular trunk, and into the proximal anterior tibial artery.

In this case, an intraluminal recanalization of the occlusion was performed using two 0.014” guidewires, which were advanced into the anterior tibial artery and the tibiofibular trunk ([Fig. 2]). Following successful guidewire passage, a rotational atherectomy was performed using a 2.4/3.4 mm Jetstream system extending into the proximal below-the-knee vessels via both guidewires. The final angiographic control after atherectomy and subsequent DCB angioplasty (not shown) of the popliteal artery, tibiofibular trunk and proximal anterior tibial artery demonstrated restored vessel patency without relevant residual stenosis and no need of stent-implantation ([Fig. 3]).

Fig. 2 Atherectomy was performed using a 2.4/3.4 mm Jetstream system extending into the proximal below-the-knee vessels.

Fig. 3 Final angiographic control after atherectomy and subsequent DCB angioplasty (not shown) of the popliteal artery, tibiofibular trunk, and proximal anterior tibial artery. Restored vessel patency without relevant residual stenosis and no need of stent-implantation.

Comparison with Other Endovascular Strategies

While atherectomy has been the focus in the preceding sections, alternative endovascular strategies also play a critical role in managing PAD. Conventional approaches such as plain old balloon angioplasty (POBA) and DCB have long been established as standard therapies.

As early as 2008, Tepe et al. demonstrated the benefit of DCB over POBA [21]. More recently, novel vessel preparation techniques, including intravascular lithotripsy (IVL), as well as cutting and scoring balloons, have expanded the therapeutic toolbox, particularly for heavily calcified lesions.

A meta-analysis of nine studies (699 patients; 4 randomized, 5 observational) compared atherectomy plus balloon angioplasty (ABA) to balloon angioplasty (BA) alone in femoropopliteal disease. In observational studies, ABA significantly reduced target lesion revascularization (RR = 0.59; 95% CI, 0.40–0.85; p=0.005) and bailout stenting (RR = 0.32; 95% CI, 0.21–0.48; p< 0.0001). However, randomized trials showed no significant difference in TLR or primary patency (RR = 1.04; 95% CI, 0.95–1.14; p=0.37) favoring a balloon angioplasty first strategy [22]. Following these findings, attention also has to be turned to the role of primary stenting as an alternative to balloon-based strategies.

Over ten years ago, the RESILIENT trial showed that primary nitinol stenting significantly improved 12-month patency (81.3% vs. 36.7%, p<0.0001) and reduced reintervention rates compared to BA, despite high bailout stenting in the angioplasty group [23]. Also many years ago, the Zilver PTX trial demonstrated superior 5-year outcome for patency and freedom from reintervention for the paclitaxel-coated drug-eluting Zilver PTX stent (DES) versus standard angioplasty [24] [25].

Since then, potential benefits of drug-eluting stents have been explored in several additional studies. Among these, the work published by Stavroulakis et al. in 2021 [26], as well as the IMPERIAL trial as an direct comparison between the Zilver PTX DES and Eluvia DES [27], are particularly noteworthy.

The recently published, prospective, multi-center, randomized BEST-SFA trial (n=120) compared a stent-avoiding (SA) strategy using DCBs with a stent-preferred (SP) strategy using the Eluvia DES for complex femoropopliteal lesions. At 12 months, primary patency rates were similar (78.2% SA vs. 78.6% SP, p=1.0), and freedom from major adverse events was also comparable (93.1% SA vs. 94.9% SP, p=0.717). Both strategies, emphasizing lesion preparation (both scoring and cutting balloons were used, along with several atherectomy systems, e.g. Jetstream, HawkOne, Diamondback) before drug-eluting device use, demonstrated promising safety and efficacy [28].

In summary primary stenting of femoropopliteal lesions, particularly with DES, has shown good outcomes in terms of freedom from restenosis and need for revascularization, making it a compelling alternative to atherectomy in many cases [29].

Other methods of plaque modification include intravascular lithotripsy (IVL), which alters the mechanical properties of calcified plaque through acoustic pressure waves. IVL does not remove plaque but rather facilitates vessel compliance by fracturing calcium in situ. In the Disrupt PAD III multi-center, randomized trial (n=306), IVL was compared with standard PTA for vessel preparation in patients with moderately to severely calcified femoropopliteal lesions prior to drug-coated balloon angioplasty. IVL demonstrated superior procedural success (65.8% vs. 50.4%; p=0.01), lower rates of flow-limiting dissections and provisional stenting and more frequent achievement of ≤30% residual stenosis was documented. At one year, primary patency was significantly higher in the IVL group (80.5% vs. 68.0%; p=0.017) and remained superior at two years (70.3% vs. 51.3%; p=0.003). Rates of TLR and restenosis were similar between groups. These findings support IVL as a safe and effective vessel preparation strategy in calcified femoropopliteal disease, offering durable results with reduced need for stenting [30] [31].

As a less invasive alternative that avoids extensive plaque modification, scoring balloon angioplasty represents another interesting vessel preparation technique. Although published data on scoring balloon angioplasty in PAD patients are limited, a retrospective single-center study with a relatively large cohort (n=425) evaluated the safety and effectiveness of scoring balloon angioplasty using the AngioSculpt balloon in patients with moderately to severely calcified femoropopliteal lesions. At 24-month follow-up, there were no significant differences in freedom from TLR (82.3% vs. 78.1%; p>0.05), survival, amputation rates, or stent-implantation rates between groups [32].

In addition to endovascular techniques, surgical revascularization remains an important treatment option in patients with CLI, particularly in anatomically suitable cases. This is reflected in key comparative trials such as BASIL and BEST-CLI, which have directly evaluated primary endovascular versus open surgical strategies. BASIL-1 (n=452) found no significant difference in outcomes between surgery and angioplasty, while BASIL-2 (n=345) showed better amputation-free survival and lower mortality with an endovascular-first approach in infra-popliteal PAD [6] [33]. The BEST-CLI trial (n=1830) showed that surgery was superior when a good vein was available (cohort 1), but both approaches had similar outcomes when alternative bypass materials were needed (cohort 2) [34].

These study results of bypass surgery must also be taken into account.

In summary, several alternative strategies, in addition to atherectomy, play a central role in PAD management. Balloon-based approaches, drug-eluting stents and novel vessel preparation techniques such as IVL or scoring balloons have shown favorable outcomes, particularly in calcified femoropopliteal disease. Large, randomized trials demonstrate durable patency and reduced bailout stenting with drug-eluting stents and IVL, while surgical bypass continues to be an important option in CLI patients with suitable anatomy. These findings highlight the importance of tailoring revascularization strategies to lesion characteristics and patient profiles.

Complications and Limitations

Following the discussion of endovascular and surgical treatment strategies, it is essential to address the potential complications associated with these interventions, particularly in the context of atherectomy. Distal embolization is among the most common, particularly in cases of severe or nodular calcification, where fragmented debris may migrate into the distal vasculature. Vessel perforation is another concern, especially in elongated or tortuous arteries, where device manipulation can compromise the vessel wall. Additional risks include dissections pseudoaneurysm formation and vessel spasm, all of which may impact procedural success and long-term outcomes.

A retrospective analysis of large-scale data (n=16.838) from a US- and Canada-wide registry for vascular procedures, published in 2019 found that atherectomy was associated with higher rates of amputation and major adverse limb events (MALEs) compared to stenting and PTA, with a 5-year MALE rate of 38% for atherectomy versus 33% for PTA and 32% for stenting. In the analyzed data, no distinction was made between the different atherectomy systems. Multivariable Cox regression showed a 10% to 14% increased risk of adverse outcomes after atherectomy compared to PTA, which was statistically significant only for MALEs (HR: 1.14; 95% CI, 1.06–1.30). Nearly 1 in 3 patients undergoing atherectomy experienced a MALE within five years. Mentioned risks included embolization rates ranging from 4% to 21%, necessitating the use of embolic protection devices in high-risk cases [35].

Another retrospective analysis of adverse event reports from the FDA’s MAUDE database (n=500) provided insights into real-world complications associated with the Jetstream Atherectomy System for the treatment of PAD. The most frequently reported patient-related events were embolism (4.4%), dissection (3.4%), and vessel perforation (2.4%). Device malfunctions included guidewire entrapment (27%), loss of blade rotation (23%), and aspiration failure (20%) [36]. These device malfunctions, which are likewise encountered in daily routine, underscore the importance of proper device handling and technique to mitigate avoidable complications.

Regarding embolic protection devices (EPDs), several studies demonstrate a clear benefit compared to atherectomy without a filter system. Banerjee et al. showed that the use of the Nav-6 filter during Jetstream atherectomy in complex infrainguinal PAI was associated with numerically lower rates of distal embolization (1.8% vs. 8%; p<0.10) without increasing rates of death or amputation. The filter was more frequently used in longer lesions (146 ± 106 mm vs. 91 ± 72 mm; p<0.01), more severe stenoses (95% vs. 87%; p<0.04) and chronic total occlusions (33% vs. 8.3%; p<0.01) [37]. A comparison and analysis between the Nav-6 EPD and the Spider FX EPD exhibited similar effectiveness in preventing major adverse events (MAEs) in patients with symptomatic PAD, with no significant differences in individual types of MAEs or total number of MAEs between the two groups [38]. In another two-center study, a high rate of peripheral embolization (21%) was observed without the use of distal embolic protection [39].

However, a retrospective study from Fereydooni et al. analyzed the impact of EPDs during atherectomy for peripheral vascular interventions using data from 21,500 procedures. Despite an increase in EPD use from 8.8% to 22.7% (p<0.003) over time (2010–2018), propensity-matched analysis (1,007 patients per group) found no significant difference in short-term outcomes (distal embolization, technical success or 30-day mortality) or 1-year outcomes (primary patency, amputation rates, reintervention or mortality). These findings suggest that EPDs add cost and fluoroscopy time without improving clinical outcomes [40].

Vessel perforation is another significant complication, particularly in severely calcified and curved or elongated lesions, with rates ranging from 2% to 7% in several studies [41]. Other reported complications include slow-flow phenomena, abrupt vessel closure and in rare cases, acute limb ischemia due to large plaque embolization [5]. Therefore, thrombus aspiration techniques should be readily available during the procedure.

Cost-effectiveness remains a debated issue, as atherectomy is significantly more cost-intensive than PTA or DCB alone [42]. Some cost-analysis models suggest that routine atherectomy may not be justified unless used in highly selective patient populations, such as those with heavy calcification, in-stent restenosis, or if a mobile segment is affected [43].

Finally, operator experience and institutional expertise play crucial roles in procedural success. Additionally, the lack of standardization in patient selection, procedural technique, and adjunctive therapies further complicates the assessment of atherectomy’s overall benefit.

Future Perspectives and Clinical Recommendations

Future research should focus on large-scale randomized controlled trials (RCTs) comparing atherectomy plus DCB versus DCB alone or atherectomy plus DCB versus stent-preferred strategy in both femoropopliteal and BTK disease. Accordingly, there is also a need for studies investigating the long-term clinical impact of atherectomy [44]. Standardized patient selection criteria and procedural guidelines must be established to optimize treatment outcomes and improve reproducibility across different healthcare centers.

In the future, the use of intravascular ultrasound (IVUS) should be adopted more widely in PAD treatment to accurately assess vessel size, plaque burden, and to optimize the atherectomy itself. For example, IVUS was already used as early as 2015 in the Jetstream Calcium Study to assess lumen gain following atherectomy [45]. In another retrospective analysis of 43 patients undergoing peripheral endovascular interventions, vessel diameters assessed by digital subtraction angiography were compared to those measured using IVUS. Angiographic estimations, performed independently and blinded to IVUS data, consistently underestimated vessel size, particularly in female patients. IVUS provided more accurate and detailed measurements of the arterial lumen, highlighting its potential value in guiding treatment decisions [46].

The now-discontinued Pantheris atherectomy system by Avinger, Inc. combined directional atherectomy with optical coherence tomography guidance (OCT). OCT-guided atherectomy has proven to be a safe and effective approach for treating femoropopliteal disease. The enhanced precision offered by optical coherence tomography allows for more thorough plaque removal while minimizing damage to the vessel wall [47]. A combination of atherectomy and IVUS within a single device would therefore also be an interesting approach.

Accordingly, it is important for the future to develop and evaluate new atherectomy systems, in order to achieve more effective and safer vessel preparation and ultimately improve outcomes for PAD patients. A retrospective, nonrandomized study evaluated the novel ByCross atherectomy system in 39 patients with 41 complex femorodistal arterial lesions, achieving acute procedural success in 95.1% of cases, including 26.8% without wire guidance. At six months, the mean stenosis was reduced from 96.4% to 21.7%, with a low MAE rate and no device-related complications at 30 days, despite no use of embolic protection. These results suggest that the ByCross system is safe and effective for crossing and treating complex lower-extremity arterial occlusions, with high success rates and sustained patency. Long-term data have not yet been published [48].

Overall, we see the diverse possibilities of atherectomy as a significant expansion of endovascular treatment options.

In our clinical experience with more than 2,000 atherectomy procedures in recent years, such as in long-segment femoropopliteal occlusions, vessel preparation using atherectomy is safe and beneficial with a low rate of stent-implantation.

Achieving good results requires careful intraluminal crossing of the lesion. If necessary, additional retrograde crural access can facilitate intraluminal probing of a femoropopliteal lesion in most cases [49] [50].

[Table 2] summarizes subjective, experience-based indications, based on our daily clinical practice, for specific atherectomy devices according to lesion morphology.

Table 2 Subjective, experience-based indications for specific atherectomy devices according to lesion morphology. Grading of recommendation: – : not recommended; x: conditionally recommended; xx: recommended; xxx: highly recommended.

Device	Jetstream	Phoenix	HawkOne	Diamond-back	Turbo-Elite	Rotarex
Type	Rotational	Rotational	Directional	Orbital	Laser	Rotational
Eccentric lesion	x	–	xxx	x	x	–
Soft/fibrotic plaque	xx	x	xx	–	x	x
Thrombotic lesion	xx	x	x	–	xx	xxx
Calcified lesion	xxx	x	x	xx	–	–
Chronic total occlusion	xxx	x	x	–	x	x
In-stent restenosis	xx	x	xxx	–	x	–
In-stent restenosis with thrombus	xxx	xx	xx	–	xx	xxx

Conclusion

Atherectomy remains a promising technique in the context of modern PAD treatments. While it provides plaque debulking/modification and vessel preparation advantages, its long-term patency benefits need to be investigated further.

Patient selection, lesion characteristics, and device-specific factors should guide its use to ensure optimal outcomes in PAD revascularization.

Conflict of Interest

The authors declare that they have no conflict of interest.

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Publication History

Received: 04 May 2025

Accepted after revision: 05 October 2025

Article published online:
11 November 2025