Despite widespread use of atherectomy in endovascular treatment of peripheral artery disease (PAD), it remains unsupported by major international guidelines, due to insufficient evidence of efficacy. This study compared atherectomy and nonatherectomy-based endovascular revascularization for femoropopliteal (FP) artery PAD. We analyzed data from the multicenter XLPAD registry (27 U.S. sites, 2007–2024; NCT01904851) to compare atherectomy versus nonatherectomy interventions for treating FP PAD. The primary outcome was technical failure or need for stenting during the index procedure. Technical failure was defined as the inability to cross the target lesion with a guidewire or a > 30% angiographic residual stenosis following endovascular intervention. Secondary outcomes included periprocedural complication and 1-year major adverse limb events (MALE), a composite of all-cause mortality, clinically driven target lesion revascularization (CD-TLR), and major amputation. Periprocedural (up to 30 days postprocedure) complications included bleeding, hematoma >5 cm, flow-limiting dissection, perforation, distal embolization, and emergency surgery. Of the 4,912 patients, 1,635 (33.3%) underwent intervention with atherectomy and 3,277 (66.7%) without. The mean age was 66.8 ± 10 years; 29% were female, and 80% were Caucasian. Comorbidities including diabetes mellitus (53%), chronic kidney disease (15%), and chronic limb-threatening ischemia (37.6%) were similar across groups. Atherectomy was more frequently used in more complex lesions. The primary outcome occurred in 35% of the atherectomy group versus 67% in the nonatherectomy group (p <0.001; odds ratio 0.28, 95% confidence interval 0.24–0.32), with lower stent utilization (33.6% vs 61.0%; p <0.001) and fewer technical failures (1.7% vs 6.7%; p <0.001) in the atherectomy group. Periprocedural complication rates were similar (6.6% in both groups); distal embolization was significantly higher with atherectomy (1.2% vs 0.4%; p <0.001). At follow-up, the atherectomy group exhibited lower major amputation (2.6% vs 4.3%; p = 0.003), and a numerically lower CD-TLR (3.7% vs 4.1%; p = 0.6). One-year MALE was significantly lower in atherectomy group (9.2% vs 11.6%; p = 0.011). Atherectomy is more frequently used in complex FP interventions and is associated with higher technical success, reduced stent use, and significantly lower 1-year MALE rates, albeit with a higher periprocedural distal embolization.
Peripheral artery disease (PAD) is a major global health burden, and the femoropopliteal (FP) segment remains the most frequent target for endovascular intervention. , As the superficial femoral and popliteal arteries undergo substantial mechanical stress, FP lesions are often long, calcified, and prone to restenosis after conventional balloon angioplasty. Residual plaque, vessel recoil, and barotrauma-driven injury limit durable luminal gain, making plaque debulking with atherectomy an appealing strategy for selected complex lesions.
Atherectomy devices are designed to excise plaque and modify calcification, and prior studies have reported high procedural success with low provisional stenting. , However, current evidence is largely limited to small trials and observational studies, and contemporary guidelines do not support routine atherectomy for FP disease. As a result, real-world data clarifying its role in modern practice are needed.
The excellence in peripheral artery disease (XLPAD) registry offers a multicenter, core laboratory–adjudicated dataset reflecting contemporary infrainguinal interventions. In this study, we evaluated atherectomy use in FP interventions and assessed its association with procedural success, periprocedural complications, and 1-year major adverse limb events (MALE).
Methods
The XLPAD registry is a multicenter, core laboratory–adjudicated registry since 2007 and is recognized now as a Qualified Clinical Data Registry by the U.S. Centers for Medicare & Medicaid Services. It captures comprehensive clinical, procedural, and outcomes data on consecutive patients undergoing lower extremity endovascular revascularization for symptomatic PAD across 33 U.S. hospitals, with 27 sites currently active following the transition of the principal investigator to Baylor Scott & White Health (Dallas, TX). Approximately 30% of data are collected prospectively; the remainder are entered retrospectively. All participating centers have institutional review board (IRB) approval for data collection and study procedures.
Data are recorded in a secure REDCap database managed by the Baylor Scott & White Research Institute. Mandatory index-procedure angiograms are independently adjudicated by the Angiographic and Ultrasound Core Laboratory at Baylor Heart and Vascular Hospital. Periodic data audits, query resolution, and oversight are conducted by an independent data safety monitoring board and the study executive committee. Registry documentation, including the XLPAD Registry Operations Manual, is publicly available.
The initial registry phase (XLPAD v1.0; 2007–2016) included only infrainguinal interventions with limited device specific details and medication use. All atherectomy devices in XLPAD v1.0 were identified as an atherectomy class without specific device names. The current version, (XLPAD v2.0; 2017–present) captures iliac and infrainguinal interventions with granular device-level intervention data and longitudinal follow-up information. Baseline characteristics, laboratory values, medications, and outcomes are abstracted from electronic health records.
In the present analysis, procedures were classified as atherectomy-based when any atherectomy device was used, all others were categorized as nonatherectomy. Device selection including guidewires, support catheters, intravascular imaging, conventional or specialty balloons, drug-coated balloons (DCB), intravascular lithotripsy, and choice of baremetal or drug-eluting stents was at operator discretion. All commercially available endovascular therapies are represented in the registry. Variable definitions and data structure have been previously described.
IRB approval covered all retrospective analyses, which were conducted using deidentified data per institutional guidelines.
Endpoints and Definitions
The primary objective was to compare outcomes of FP interventions performed with versus without atherectomy. The primary endpoint was technical failure or need for stenting during the index procedure. Technical failure was defined as inability to cross the target lesion with a guidewire or achievement of >30% residual angiographic stenosis after endovascular therapy. Secondary endpoints included 1-year MALE, defined as a composite of all-cause mortality, clinically driven target lesion revascularization (CD-TLR), or major amputation. Additional secondary endpoint included periprocedural complications occurring within 30 days, including access-site bleeding, hematoma >5 cm, flow-limiting dissection, perforation, distal embolization, and need for emergency surgery. Procedural success was defined as completion of the procedure without technical failure or periprocedural complications. Major amputation was defined as any amputation above the ankle; below-ankle amputations were considered minor.
Statistical Analysis
Continuous variables are presented as mean ± standard deviation (SD) or median [interquartile range (IQR)] and categorical variables as frequencies and percentages. Normality was assessed using the Shapiro–Wilk test. Group comparisons used Student’s t-test or the Wilcoxon rank-sum test for continuous variables and Chi-square or Fisher’s exact tests for categorical variables. Time-to-event outcomes were evaluated with Kaplan–Meier survival analysis. Multivariable logistic regression identified independent predictors of the primary endpoint. All tests were 2-sided with p <0.05 considered statistically significant. Analyses were conducted using R version 4.4.2 (R Foundation for Statistical Computing, Vienna, Austria).
Results
A total of 4,912 patients who underwent FP endovascular intervention between 2007 and 2024 were included. Atherectomy-based treatment was used in 1,635 patients (33.3%), while 3,277 (66.7%) underwent intervention without atherectomy. Baseline characteristics are summarized in Table 1 . The mean age was 66.8 ± 10.0 years, and 28.7% were women. Hypertension (91.1% vs 88.6%; p = 0.008) and hyperlipidemia (85.5% vs 82.2%; p = 0.004) were more prevalent among patients treated with atherectomy. Rates of diabetes, chronic kidney disease, heart failure, prior myocardial infarction (MI) or stroke, and critical limb threatening ischemia (CLTI) presentation were similarly high in both groups.
Table 1
Baseline characteristics of patients undergoing peripheral arterial intervention with atherectomy and without atherectomy: Demographic, risk factor and symptoms status are derived from registry data entered based on clinical diagnosis and test results available in participant electronic medical records
| Variable | Total ( n = 4,912) | Atherectomy group ( n = 1,635) | No atherectomy group ( n = 3,277) | p-value |
|---|---|---|---|---|
| Age; mean (SD) | 66.76 (9.99) | 67.41 (9.66) | 66.43 (10.14) | 0.004 |
| Female (gender); n (%) | 1,399 (28.7%) | 507 (31.0%) | 892 (27.6%) | 0.012 |
| Race; n (%) | 0.014 | |||
| Caucasian; n (%) | 3,578 (80.2%) | 1,244 (82.9%) | 2,334 (78.9%) | |
| African American; n (%) | 817 (18.3%) | 240 (16.0%) | 577 (19.5%) | |
| Asian; n (%) | 28 (0.6%) | 9 (0.6%) | 19 (0.6%) | |
| Native American, other; n (%) | 38 (0.8%) | 8 (0.6%) | 30 (1.0%) | |
| Hispanic; n (%) | 496 (10.7%) | 126 (8.1%) | 370 (12.1%) | <0.001 |
| Smoking; n (%) | 2,256 (45.9%) | 718 (43.9%) | 1,538 (46.9%) | 0.045 |
| Hypertension; n (%) | 4,395 (89.5%) | 1,490 (91.1%) | 2,905 (88.6%) | 0.008 |
| Diabetes mellitus; n (%) | 2,613 (53.2%) | 843 (51.6%) | 1,770 (54.0%) | 0.10 |
| Hyperlipidemia; n (%) | 4,093 (83.3%) | 1,398 (85.5%) | 2,695 (82.2%) | 0.004 |
| Chronic Kidney Disease; n (%) | 723 (14.7%) | 238 (14.6%) | 485 (14.8%) | 0.8 |
| Heart Failure; n (%) | 725 (14.8%) | 221 (13.5%) | 504 (15.4%) | 0.083 |
| Myocardial Infarction; n (%) | 1,067 (21.7%) | 333 (20.4%) | 734 (22.4%) | 0.10 |
| Prior Stroke; n (%) | 449 (9.1%) | 131 (8.0%) | 318 (9.7%) | 0.053 |
| CLTI; n (%) | 1,847 (37.6%) | 604 (36.9%) | 1,243 (37.9%) | 0.5 |
| ABI; mean (SD) | 0.74 (0.26) | 0.73 (0.25) | 0.74 (0.27) | 0.5 |
Abbreviations: ABI = Ankle-Brachial index (lowest limb value depicted); CLTI = chronic limb threatening ischemia; SD = standard deviation.
Lesion and angiographic findings are shown in Table 2 . The superficial femoral artery was the most frequently treated vessel in both cohorts (84.1% vs 81.4%; p = 0.022), with the atherectomy group demonstrating more frequent popliteal involvement (29.4% vs 23.3%; p <0.001). Atherectomy was also more commonly used for common femoral (9.3% vs 6.6%; p = 0.018) and anterior tibial (8.6% vs 5.4%; p < 0.001) lesions. Moderate-to-severe calcification (42.4% vs 32.3%; p <0.001), multilevel diffuse disease (61.5% vs 51.1%; p <0.001), and in-stent restenosis (19.1% vs 12.1%; p <0.001) were more frequent in the atherectomy group, whereas thrombotic lesions (11.7% vs 15.2%; p = 0.001) and chronic total occlusions (43.4% vs 50.6%; p <0.001) were less commonly treated with atherectomy. In atherectomy group, directional atherectomy was the most frequently used (39.4%), followed by orbital (21.8%), rotational (20.5%), and laser atherectomy (19.1%). DCB use was more common in the atherectomy group compared with the nonatherectomy group (24.1% vs 19.6%; p <0.001). Procedures involving atherectomy were also associated with greater contrast volume (199.40 mL vs 188.71 mL; p <0.001), longer fluoroscopy time (31.14 vs 29.43 minutes; p <0.001), higher heparin dose (8,500.05 vs 7,744.22 units; p <0.001), and more frequent use of embolic protection devices (54.1% vs 12.4%; p <0.001). Distal embolization in the atherectomy group did not differ significantly between procedures performed with and without embolic protection device (1.13% vs 1.33%; p = 0.82), and similar findings were observed in the nonatherectomy group (0.74% vs 0.31%; p = 0.18). postprocedural medical therapy is summarized in Table 3 .
Table 2
Description of peripheral artery lesions and endovascular procedures
| Variable | Total ( n = 4,912) | Atherectomy group ( n = 1,635) | No atherectomy group ( n = 3,277) | p-value |
|---|---|---|---|---|
| Target vessel | ||||
| SFA; n (%) | 4,044 (82.3%) | 1,375 (84.1%) | 2,669 (81.4%) | 0.022 |
| Popliteal; n (%) | 1,242 (25.3%) | 480 (29.4%) | 762 (23.3%) | <0.001 |
| Posterior tibial; n (%) | 135 (2.7%) | 50 (3.1%) | 85 (2.6%) | 0.3 |
| Anterior tibial; n (%) | 317 (6.5%) | 140 (8.6%) | 177 (5.4%) | <0.001 |
| Peroneal; n (%) | 139 (2.8%) | 56 (3.4%) | 83 (2.5%) | 0.076 |
| Tibioperoneal trunk; n (%) | 132 (2.7%) | 54 (3.3%) | 78 (2.4%) | 0.060 |
| Common femoral; n (%) | 199 (7.3%) | 66 (9.3%) | 133 (6.6%) | 0.018 |
| Profunda; n (%) | 39 (0.8%) | 16 (1.0%) | 23 (0.7%) | 0.3 |
| Lesion length (mm); mean (SD) | 146.91 (101.96) | 148.84 (100.42) | 145.88 (102.79) | 0.2 |
| Calcification; n (%) | 1,752 (35.7%) | 694 (42.4%) | 1,058 (32.3%) | <0.001 |
| Multilevel Diffuse disease; n (%) | 2,681 (54.6%) | 1,005 (61.5%) | 1,676 (51.1%) | <0.001 |
| In-stent Restenosis; n (%) | 709 (14.4%) | 313 (19.1%) | 396 (12.1%) | <0.001 |
| Thrombus; n (%) | 690 (14.0%) | 192 (11.7%) | 498 (15.2%) | 0.001 |
| CTO; n (%) | 2,367 (48.2%) | 710 (43.4%) | 1,657 (50.6%) | <0.001 |
| Endovascular treatment | ||||
| Cutting Balloon; n (%) | 200 (4.1%) | 46 (2.8%) | 154 (4.7%) | 0.002 |
| IVL; n (%) | 39 (1.4%) | 1 (0.1%) | 38 (1.9%) | <0.001 |
| Laser; n (%) | 313 (6.4%) | 313 (19.1%) | 0 | <0.001 |
| Directional atherectomy; n (%) | 645 (13.1%) | 645 (39.4%) | 0 | <0.001 |
| Orbital Atherectomy; n (%) | 357 (7.3%) | 357 (21.8%) | 0 | <0.001 |
| Rotational Atherectomy; n (%) | 335 (6.8%) | 335 (20.5%) | 0 | <0.001 |
| Pantheris Atherectomy; n (%) | 18 (0.7%) | 18 (2.5%) | 0 | <0.001 |
| Conventional Balloon; n (%) | 3,743 (76.3%) | 1,181 (72.2%) | 2,562 (78.3%) | <0.001 |
| Drug-Coated Balloon; n (%) | 1,036 (21.1%) | 394 (24.1%) | 642 (19.6%) | <0.001 |
| IVUS; n (%) | 361 (7.3%) | 127 (7.8%) | 234 (7.1%) | 0.4 |
| Contrast Volume (mL); mean (SD) | 192.21 (116.80) | 199.40 (110.45) | 188.71 (119.63) | <0.001 |
| Fluoroscopy time (min); mean (SD) | 30.01 (19.73) | 31.14 (17.80) | 29.43 (20.64) | <0.001 |
| Heparin Dose (Units); mean (SD) | 8,263.51 (3,627.66) | 7,744.22 (3,197.15) | 8,500.05 (3,784.73) | <0.001 |
| Embolic protection; n (%) | 1,290 (26.3%) | 884 (54.1%) | 406 (12.4%) | <0.001 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
