Retrospective Review of Directional Atherectomy and Drug-Coated Balloon Use in a PAD Safety-Net Population

Abstract

BACKGROUND: Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities and vulnerable populations often present with CLTI and experience worse outcomes. The use of directional atherectomy (DA) and drug-coated balloon (DCB) during lower-extremity revascularization (LER) has not been previously described in a safety-net population. OBJECTIVE: To review demographic and clinical characteristics, and short- intermediate term outcomes of patients presenting to a safety-net hospital with PAD treated with DA and DCB during LER. METHODS: In this retrospective, observational cohort study, chart review was performed of all patients who underwent DA and DCB during LER for PAD from April 2016 to January 2020 in a safety-net hospital. RESULTS: The analysis included 58 patients, with 41% female, 24% Black/African American, and 31% Hispanic. From this group, 17% spoke a non-English primary language and 10% reported current or previous housing insecurity. Most (65%) presented with CLTI and had undergone a previous index leg LER (58%). The combination of DA and DCB was efficacious, resulting in low rates of bail-out stenting (16%) and target-vessel revascularization (26%) at 2 years. Low complication rates (tibial embolism in 12% and vessel perforation in 2% of cases) were also observed. Most patients (67%) with Rutherford category 5 experienced wound healing by 2 years. CONCLUSION: In this safety-net population, the majority presented with CLTI and a previous LER of the index leg. The combination of DA and DCB resulted in low complication rates, and good short-intermediate outcomes in this frequently undertreated population.

J INVASIVE CARDIOL 2023;35(4):E205-E216.

Key words: directional atherectomy, drug-coated balloon, lower-extremity revascularization

Peripheral artery disease (PAD) is a common condition affecting millions of Americans and is associated with functional impairment, morbidity, and mortality.¹ While aggressive risk-factor modification and medical management are the mainstays of treatment,¹ lower-extremity revascularization (LER) via a surgical or percutaneous approach improves function and decreases the risk of leg amputation in those with limb threat due to critical limb threatening ischemia (CLTI), the most severe stage of PAD.² Minorities and patients who are under- and uninsured are at particular risk, as they are more likely to present with CLTI, are less likely to undergo LER for limb salvage, and are more likely to have limb amputation.^3-5
Numerous devices are used during percutaneous LER, including balloons, stents, drug-coated technology, intravascular lithotripsy, and atherectomy.² However, for the femoropopliteal arteries (superficial femoral and popliteal arteries), a gold-standard treatment algorithm has yet to be determined,⁶ particularly for long and complex disease.^7,8 Thus, the standard of care for many years has been balloon angioplasty and provisional stenting for flow-limiting dissections. While stenting for flow-limiting dissections improves short-term vessel patency, it is associated with high rates of in-stent restenosis and need for subsequent intervention.^9-10 Newer, drug (paxclitaxel)-coated balloon (DCB) technology use has resulted in better short- and long-term patency in this segment, making a “leave nothing behind” approach possible.^11,12 Due to concerns about drug update in heavily calcified vessels, atherectomy is often used to modify plaque and thus increase drug uptake by the vessel wall, as well as decrease the need for stenting.¹¹ To date, only 2 small randomized controlled trials have specifically looked at directional atherectomy (DA) plus DCB. Furthermore, the vast majority of patients had less severe disease—presenting with claudication and not CLTI.^13,14 Therefore, the objective of this study was to examine patient characteristics, short- and intermediate-term efficacy, and safety of DA plus DCB during LER in a safety-net population.

Methods

Institutional EPIC records were reviewed by SEH, from April 12, 2016 until January 1, 2020. Patients were identified by reviewing the cardiac catheterization schedule (where all procedures occurred) for each day within this timeframe. Charts were reviewed for patients who underwent any type of peripheral procedure. Those who underwent DA plus DCB were included, and demographic, medical, anatomic, and outcome data were collected.

Femoropopliteal anatomy was classified using the Trans-Atlantic Inter-Society Consensus Document on the Management of Peripheral Arterial Disease II guidelines.¹⁵ Anatomy was classified as Type A, B, C, or D based on the number and length of lesions, the presence and location of chronic total occlusions, and the presence of heavy calcification. Type A disease is the least severe and the most likely to be successfully treated with percutaneous LER, whereas Type D is the most severe and the least likely to be treated successfully with percutaneous LER.

For patients presenting with lower-extremity wounds, the Wound, Ischemia, foot Infection (WIfI) scoring system was used, which takes into account the presence, location, and extent of the wound, the presence of ischemia based on non-invasive pressure testing (ankle-brachial index [ABI] and/or toe pressure), and the presence of wound infection. WIfI scores were determined using the Society of Vascular Surgery (SVC) calculator.¹⁶

Ethical approval for this research was obtained from Denver Health’s institutional review board, SPARO, and from the University of Colorado institutional review board, COMIRB. All information was compiled in REDCap and statistical analyses were performed using REDCap and Excel.

Results

Between April 12, 2016 and January 1, 2020, a total of 58 patients underwent percutaneous LER including both DA and DCB treatment. The median patient age at the time of index LER was 66 years, 41% were female, 72% were white, 31% were Hispanic, and 24% were Black/African American (Table 1). Seventeen percent of patients spoke a non-English primary language, and 10% reported current or previous housing insecurity. The majority had diabetes mellitus, hypertension, a history of tobacco use, and dyslipidemia (Table 1). Furthermore, most patients (58%) had undergone previous LER of the index leg (of which 61% had previous LER of an index vessel), and 19% had undergone a previous minor amputation of the index leg. At the time of presentation to a vascular medicine provider, most patients were on antiplatelet and statin therapies (Table 1).

All patients underwent LER at Denver Health Hospital in Denver, Colorado. All procedures were performed by 1 of 3 interventional cardiologists employed by Denver Health (SEH, MH, JB). The decision to use DA plus DCB was at the discretion of each operator—no formal algorithm was utilized, although the goal of all 3 operators was to use this approach if “leave no stent behind” was possible based on a patient’s anatomy. The DA device used for all cases was the Medtronic HawkOne device. The DCB used for all cases was the Medtronic InPact Admiral DCB.

Clinical presentation. Sixty-five percent of patients presented with CLTI—roughly 10% with ischemic rest pain (Rutherford category 4), more than half with non-healing minor foot wounds (Rutherford category 5), and 3.4% with extensive, non-healing leg wounds (Rutherford category 6). The majority of those presenting with foot wounds were WIfI clinical stages 3 and 4. The median ABI was 0.80, toe-brachial-index (TBI) was 0.35, and toe pressure was 45 mm Hg (Table 2).

Anatomic disease in index leg. Seventy-nine percent of patients had obstructive disease involving the superficial femoral artery while 64% had disease in the popliteal artery; the majority also had obstructive infratibial disease (Table 2). The TASC fem-pop classification was fairly evenly distributed, although most patients had very complex disease (TASC D). Fifty percent of patients had a chronic total occlusion (CTO) that was intervened upon and 55% had calcified vessels (Table 2).

Percutaneous vascular intervention (PVI). DA was most commonly performed in the superficial femoral (74% of patients) and popliteal artery (60% of patients), although it was also utilized in the tibial arteries (42% of patients, most often in the tibial-peroneal trunk) (Table 3). The pattern of DCB use was similar—most treatment was performed in the superficial femoral and popliteal arteries (76% and 62%, respectively), but some use occurred in the infratibial arteries and rarely in the iliac and common femoral arteries and once in a surgical bypass graft (Table 3).

Bail-out stenting for flow-limiting dissection or vessel perforation was required in 9 patients (16%).

Procedural adverse events. Procedure-related adverse outcome rates were low (Figure 1). Four patients had a bleeding event (half of these were Thrombolysis in Myocardial infarction [TIMI] minor bleeding and half were TIMI minimal bleeding) and 1 had a vessel perforation requiring the placement of a covered stent. Seven patients (12%) had an embolic event down the tibial artery during DA, but 6 of these were successfully treated with manual aspiration thrombectomy (the 7th required repeat intervention the following day).

Post-PVI course. The median follow-up was 128 weeks (interquartile range, 73-182). Following PVI, the median ABI increased to 1, the toe-brachial index to 0.7, and the toe pressure to 87 mm Hg. Of patients with 1-month follow-up, most with presenting CLTI reported improved Rutherford category 1-3 symptoms. For those presenting with wounds, 2 in 3 experienced index wound healing (approximately 10% within the first month, 50% between 1-3 months, and 30% between 6-12 months).

At 2 years, 26% of patients required target vessel revascularization (TVR) (Figure 1); almost half of these events occurred within the first month after index PVI. Chronic (CLI) and acute limb ischemia (ALI) admissions for the index leg occurred in 17% and 9%, respectively, of patients during this timeframe. Minor vascular amputation occurred in 33% of patients and major vascular amputation was required in 14%. One patient with chronic renal insufficiency at baseline (stage 3B) developed contrast-induced nephropathy after requiring 2 back-to-back interventions (index intervention and then next-day intervention for vessel closure). He required temporary dialysis, but his kidney function eventually returned to baseline. Twenty-four percent of patients with data at 2 years had died (Figure 2).

Of Rutherford 5 patients presenting with non-healing ischemic leg and foot wounds, 75% healed their wounds. Of those who healed, nearly all (>90%) healed within 12 months and >70% healed within 6 months. Not surprisingly, CLTI admissions (29%) and minor vascular amputations (52%) at 2 years were higher than those presenting with Rutherford 2-4 and the major amputation rate for this group (19%) was lower than in patients presenting with Rutherford 6 (100%).

Major vascular amputation. Eight patients required major vascular amputation of the index leg within 2 years of index PVI. Compared with the rest of the cohort, these patients were younger (median age, 60 years), were more likely to be male (75%), and were more likely to be diabetic (88%) and hypertensive (100%). Six of the 8 had non-compressible ABIs on presentation, and the median presenting toe pressure was 30 mm Hg. All these patients were Rutherford category 5 and 6 on presentation, with WIfI stage 3 and 4 stage wounds. These patients had similar anatomy and intervention as the rest of the population included. Only 1 of the 6 experienced an improvement in Rutherford category (to category 3) 1 month after revascularization. Half of the patients required TVR, all within 6 months. CLI admission rates at 2 years were higher (75%, all within 6 months) but ALI rates were lower (no events). Nearly all major amputations (7 of 8) occurred within 6 months. Half of these patients died by 2 years.

TASC classification. Bail-out stenting rates were low for the spectrum of disease severity, and (not-surprisingly) TVR rates at 2 years increased with disease complexity (Figure 3).

Discussion

This retrospective, observational review of a symptomatic PAD population who underwent LER at a safety-net hospital between April 2016 to January 2020 demonstrated that DA plus DCB use was associated with low bail-out stent rates, low short-term TVR rates, low complication rates, and improved clinical outcomes. Furthermore, these outcomes were observed in the setting of late-stage disease in a historically underserved population. This study has 2 unique features: it examines the use of a specific endovascular technique in the treatment of PAD, and it also features an undertreated and high-risk population.

Directional atherectomy plus drug-coated balloon use. While many new devices and techniques have evolved over the past decade, a standard and durable treatment of complex femoropopliteal disease has not been established.¹⁷ Atherectomy devices debulk and remove atherosclerotic plaque by cutting, pulverizing, and shaving.⁸ A variety of atherectomy devices are available and use rotational, orbital, directional, excisional, and laser technologies.¹⁸ Compared with PTA and stent implantation, atherectomy offers the potential theoretical advantages of decreasing arterial wall stretch injury, decreasing dissection (and thus the need for stenting), and reducing recoil and subsequent restenosis.⁸ The DEFINITIVE LE trial assessed DA safety and effectiveness in patients with symptomatic PAD and demonstrated high vessel patency and freedom from unplanned target-limb amputation at 12 months with low rates of periprocedural adverse events. However, only 15% of the 799 patients enrolled presented with non-healing ischemic ulcers.¹⁹

Other studies have shown mixed results with DA use, although many of these trials enrolled a small number of patients^20,21 or had flawed designs.²² The most recent Cochrane review of 7 studies (527 participants) examining the effectiveness of atherectomy during percutaneous intervention for PAD concluded that there is uncertain evidence that atherectomy improves vessel patency, mortality, and cardiovascular event rates compared with balloon angioplasty with or without stenting.²³ It is notable that the review included different atherectomy types and was not focused on DA. Additionally, the review did not include treatment with DCB technology, which has been shown to improve patency compared with both balloon angioplasty and implantation of bare-metal stents.²⁴

The use of combined atherectomy (most often directional and orbital) and DCB has been studied, and has been shown to improve vessel patency compared with non-coated balloon angioplasty.²⁵ A meta-analysis of 6 studies (2 randomized controlled trials and 4 retrospective cohort studies) including 470 patients found that atherectomy plus DCB resulted in lower incidence of bail-out stenting compared with DCB alone.¹¹ In the DEFINITIVE AR trial, 102 patients were randomized to DA plus DCB vs DCB alone. DA plus DCB was found to be safe and effective, but there was no difference in clinically TLR between groups (P=.90). It is notable that again the vast majority of patients presented with claudication, not CLTI.¹³

Safety-net population. In the Institute of Medicine’s publication, “America’s Health Care Safety Net: Intact but Endangered,” safety net providers were defined by 2 characteristics: (1) access to care regardless of a person’s ability to pay; and (2) a large proportion of uninsured, Medicaid, and/or vulnerable patients.²⁶ A prospective, multicenter PAD registry (the PORTRAIT study) showed that patients with financial barriers to medical care (defined as those who were uninsured as well as underinsured patients reporting financial concerns due to medical care) were more likely to have a delayed presentation (60% presented with symptoms lasting >1 year), were less likely to be compliant with prescribed medications and had worse health status (more functional limitations, more symptoms, lower social functioning, less treatment satisfaction, worse quality of life) at presentation and at 12 months.³

The population included in this analysis is unique, as the setting was Colorado’s primary safety-net medical institution, which cares for one-third of Denver’s population. As of 2022, this population is approximately 70% White, 13% Black, 4% Asian, and 35% Hispanic. Astonishingly, 74% of the hospital’s population has no insurance coverage. Otherwise, 15% of the population is covered by Medicaid, 4% by commercial insurance, 2.5% by Medicare, and 4% by hospital-run assistance programs. While the majority speak English as their primary language, 16% speak Spanish and the remainder speak other languages (including Arabic, Vietnamese, Russian, Nepalese, Amharic, Somalese, Burmese, French, Chinese, Tigrinya, Dari, Sahili, Pashto, and Korean). The population also includes prisoners—2 of the 58 individuals in this analysis were currently or recently incarcerated—as well as individuals with current or previous housing insecurity (10%).

In addition to what is known about health care for safety-net populations, a substantial body of research has established the differential risk factor control, PAD diagnosis and management in United States (US) minority populations.²⁷ An analysis of more than 2000 US patients with symptomatic PAD in the REACH registry revealed that—compared with non-Hispanic Whites—Blacks and Hispanics had worse blood pressure and lipid control and were less likely to be on aspirin and statin therapy. Additionally, Blacks were significantly less likely to undergo lower-extremity bypass surgery.²⁸ A devastating sequela of CLTI is major lower-extremity amputation. It has been more than 2 decades since initial observations of higher lower-extremity amputation rates for PAD in Black and Hispanic populations were made,²⁹ and—shockingly—this disparity continues to exist.²⁷ One review of inpatients from 1998 to 2002 showed that patients were more likely to undergo primary amputation for lower-extremity ischemia if they were non-White (odds ratio [OR], 1.91; 95% confidence interval [CI], 1.65-2.20), low income (OR, 1.41; 95% CI, 1.18-1.60), and covered by Medicare or Medicaid (OR, 1.81; 95% CI, 1.66-1.97).⁵ Major leg amputation is associated with significant morbidity and mortality; of Medicare beneficiaries who underwent a lower-limb amputation for a vascular disease in 1996, a total of 26% required a subsequent amputation procedure within 12 months and over one-third died within 1 year of the index amputation. It is estimated that acute and postacute medical costs associated with caring for these patients exceeded $4.3 billion US dollars.³⁰

Given what is known about safety-net and minority PAD populations, it is not surprising that most of this cohort (53%) presented with Rutherford category 5 symptoms. However, the majority (three-quarters) of these patients went on to heal their wounds after revascularization, most within 6 months. While healing rates were similar to a cohort treated with surgical revascularization for critical limb ischemia, our population did not experience the adverse events associated with surgery—incisional wound healing time, loss of ambulatory function, and loss of independent living status.³¹ Also, while many of the patients in this analysis underwent evaluation for surgical revascularization, including vein mapping, this information was not collected during chart abstraction.

Effective CLTI management, including successful and durable LER, is necessary to keep these patients out of the hospital and functioning at a high level. Because our patients present with more severe disease, are more likely to be lost to follow-up, and are at even higher risk for the destabilizing effects of leg amputation, our group strives to achieve the best LER result possible. Furthermore, our multidisciplinary Limb Salvage Program—which includes a spectrum of disciplines (among them interventional cardiology, vascular surgery, vascular medicine, podiatry, infectious disease, primary care, geriatrics, physical medicine and rehabilitation)—is essential to address many of the concurrent issues these patients are facing. This analysis demonstrates that DA and DCB during LER, in addition to good medical therapy and multidisciplinary care, are safe and associated with successful clinical outcomes in a high-risk and late-presenting population.

Strengths and limitations. A major strength of this study was the direct verification of DA and DCB during a percutaneous vascular intervention by chart (not ICD code) review. Another strength is the time of observation (for some patients >2 years).

There are several limitations to this study, the first of which is its observational design. Furthermore, the study was limited to a single center and included a small number of patients. Since a treatment algorithm was not utilized, treatment bias was likely present.

Conclusions

Directional atherectomy and DCB use during endovascular revascularization for symptomatic PAD in a safety-net population was associated with low complication rates, high rates of wound healing, and relatively low major leg amputation rates in this high-risk and diverse patient population.

Acknowledgments. Study data were collected and managed using REDCap electronic data capture tools hosted at the University of Colorado Denver.^32-34 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources.

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Affiliations and Disclosures

From ¹Denver Health, Denver, Colorado; ²University of Colorado School of Medicine, Aurora, Colorado; ³CPC Clinical Research, Aurora, Colorado; ⁴University of Colorado Anschutz Department of Medicine, Aurora, Colorado; ⁵University of Colorado Anschutz Graduate Program, Aurora, Colorado; and ⁶University of Colorado Anschutz Department of Surgery, Aurora, Colorado.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Funding: This project/publication is supported in part by NIH/NCATS Colorado CTSA Grant Number UL1 TR002535.³⁴ Contents are the authors’ sole responsibility and do not necessarily represent official NIH views.

Manuscript accepted February 1, 2023.

Address for correspondence: Pamela Peterson, MD, MPH, University of Colorado School of Medicine, Aurora, CO 80045. Email: pamela.peterson@cuanschutz.edu