Patient knowledge and preferences for peripheral artery disease treatment.

BACKGROUND: Shared medical decision making requires patients' understanding of their disease and its treatment options. Peripheral artery disease (PAD) is a condition for which preference-sensitive treatments are available, but for which little is known about patients' knowledge and treatment preferences as it relates to specific treatment goals. METHODS: In a prospective, multicenter registry that involved patients with PAD experiencing claudication, the PORTRAIT Knowledge and Preferences Survey was administered at 1 year. It asks questions about PAD treatment choices, symptom relief options, disease management, and secondary prevention. PAD treatment preferences were also queried, and patients ranked 10 PAD treatment goals (1-10 Likert scale; 10 being most important). RESULTS: Among 281 participants completing the survey (44.8% women, mean age 69.6 ± 9.0 years), 54.1% knew that there was more than one way to treat PAD symptoms and 47.1% were offered more than one treatment option. Most (82.4%) acknowledged that they had to manage their PAD for the rest of their life. 'Avoid loss of toes or legs,' 'decreased risk of heart attack/stroke,' 'long-lasting treatment benefit,' 'living longer,' 'improved quality of life,' and 'doing what the doctor thinks I should do' had mean ratings > 9.0 (SD ranging between 1.21 and 2.00). More variability occurred for 'avoiding surgery.' 'cost of treatment,' 'timeline of pain relief,' and 'return to work' (SD ranging between 2.76 and 3.58). The single most important treatment goal was 'improving quality of life' (31.3%). CONCLUSIONS: Gaps exist in knowledge for patients with PAD who experience claudication, and there is a need for increased efforts to improve support for shared decision-making frameworks for symptomatic PAD.(ClinicalTrials.gov Identifier: NCT01419080).

Guideline-Directed Medical Therapy and Long-Term Mortality and Amputation Outcomes in Patients Undergoing Peripheral Vascular Interventions.

BACKGROUND: Lack of guideline-directed medical therapy (GDMT) in patients undergoing peripheral vascular interventions (PVIs) may increase mortality and amputation risk. OBJECTIVES: The authors sought to study the association between GDMT and mortality/amputation and to examine GDMT variability among providers and health systems. METHODS: We performed an observational study using patients in the Vascular Quality Initiative registry undergoing PVI between 2017 and 2018. Two-year all-cause mortality and major amputation data were derived from Medicare claims data. Compliance with GDMT was defined as receiving a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker if hypertensive. Propensity 1:1 matching was applied for GDMT vs no GDMT and survival analyses were performed to compare outcomes between groups. RESULTS: Of 15,891 patients undergoing PVIs, 48.8% received GDMT and 6,120 patients in each group were matched. Median follow-up was 9.6 (IQR: 4.5-16.2) months for mortality and 8.4 (IQR: 3.5-15.4) for amputation. Mean age was 72.0 ± 9.9 years. Mortality risk was higher among patients who did not receive GDMT versus those on GDMT (31.2% vs 24.5%; HR: 1.37, 95% CI: 1.25-1.50; P < 0.001), as well as, risk of amputation (16.0% vs 13.2%; HR: 1.20; 95% CI: 1.08-1.35; P < 0.001). GDMT rates across sites and providers ranging from 0% to 100%, with lower performance translating into higher risk. CONCLUSIONS: Almost one-half of the patients receiving PVI in this national quality registry were not on GDMT, and this was associated with increased risk of mortality and major amputation. Quality improvement efforts in vascular care should focus on GDMT in patients undergoing PVI.

Variability in Antithrombotic Therapy after Infrainguinal Lower Extremity Bypass.

BACKGROUND: Antiplatelet monotherapy is recommended after infrainguinal lower extremity bypass (LEB). However, there is a paucity of high-quality data to guide therapy, and antiplatelet therapy is often prescribed in combination with anticoagulation. We therefore aimed to assess the variability in the use of antithrombotic therapy after infrainguinal LEB. METHODS: The Vascular Quality Initiative dataset (2015-2021) was retrospectively reviewed to determine discharge patterns of antithrombotic therapy for all patients undergoing infrainguinal LEB. Monotherapy on discharge was defined as either single antiplatelet therapy (SAPT) or single anticoagulant (SAC). Combination therapy was dual antiplatelet therapy (DAPT), anticoagulant + antiplatelet (ACAP), or triple therapy. Hierarchical multivariable logistic regression with random effects for physician and center was used to identify predictors of combination therapy. Median odds ratios (MOR) were derived to quantify degree of variability in antithrombotic therapy. RESULTS: There were 29,507 patients undergoing infrainguinal LEB (monotherapy = 10,634 vs. combination therapy = 18,873). SAPT (90.6%) was the most common form of monotherapy, while DAPT (57.7%) and ACAP (34.6%) were the most common combination therapies. Patients undergoing LEB to popliteal targets were more likely to be prescribed monotherapy (SAC or SAPT) than to infra-popliteal targets (60.6% vs. 56.6%, P < 0.001). Combination therapy (DAPT, ACAP, or triple therapy) was more often used in patients with tibial or plantar arteries as the bypass target. Patients undergoing bypass using autogenous vein were more likely to receive monotherapy compared with those receiving other conduits (64.8% vs. 52.9%, P < 0.001), while patients with prosthetic grafts were more likely to receive combination therapy (37.9% vs. 28.2%, P < 0.001). There were no significant differences in postoperative bleeding (P = 0.491) or 30-day mortality (P = 0.302) between the two groups. Prior peripheral vascular interventions (PVI) (odds ratio [OR]: 1.89, 95% confidence interval [CI]: 1.79-1.99), concomitant PVI (OR: 1.83, 95% CI: 1.66-2.02), prosthetic graft use (OR: 1.74, 95% CI: 1.64-1.85), prior percutaneous coronary intervention (OR: 1.53, 95% CI: 1.43-1.65), plantar distal target (OR: 1.46, 95% CI: 1.29-1.65), alternative conduits (OR: 1.39, 95% CI: 1.25-1.53), and tibial distal targets (OR: 1.36, 95% CI: 1.28-1.44) were independent predictors of combination therapy in a multivariable regression model. Upon adjusting for patient-level factors, there was significant physician-level (MOR: 1.65, 95% CI 1.61-1.67) and center-level (MOR: 1.64, 95% CI 1.57-1.69) variability in the selection of antithrombotic therapy. CONCLUSIONS: Significant physician- and center-level variability in the use of antithrombotic regimens after infrainguinal bypass reflects the paucity of available evidence to guide therapy. Pragmatic trials are needed to assess antithrombotic strategies and guide recommendations aimed at optimizing cardiovascular and graft-specific outcomes after LEB.

Variability in 30-day major amputation rates following endovascular peripheral vascular intervention for critical limb ischemia.

Introduction: Patients with critical limb ischemia (CLI) can undergo endovascular peripheral vascular intervention (PVI) to restore blood flow and decrease risk of amputation. As a potential indicator of quality for CLI care, we sought to describe 30-day major amputation rates following PVI. We also examined rate variability, and patient-level and site-level factors predicting amputations, using a national electronic health record (EHR) database. Methods: Using the Cerner Health Facts de-identified EHR database, patients with CLI diagnosis codes undergoing PVI were identified. The rate of amputation within 30 days of PVI was calculated. Risk ratios predicting amputation were derived using a mixed effects Poisson regression model adjusting for 16 patient and clinical factors. Median risk ratios (MRRs) were calculated to quantify site-level variability in amputations. Results: A total of 20,204 PVI procedures for CLI from 179 healthcare sites were identified. Mean age at procedure was 69.0 ± 12.6 years, 58.0% were male, and 29.6% were persons of color. Amputation within 30 days of PVI occurred after 570 (2.8%) procedures. Malnutrition, previous amputation, diabetes, and being of Black race were predictors of amputation. Amputation rates across sites ranged from 0.0% to 10.0%. The unadjusted MRR was 1.40 (95% CI 1.35-1.46), which was attenuated after adjusting for patient-level factors (MRR 1.30, 95% CI 1.26-1.34) and site characteristics (MRR 1.11, 95% CI 1.09-1.13). Conclusions: Among PVI procedures for CLI treatment, 30-day amputation rates varied across institutions. Although patient-level factors explained some variability, site-level factors explained most variation in the rates of these outcomes.

Guideline-Directed Medical Therapy in Patients with Chronic Kidney Disease Undergoing Peripheral Vascular Intervention.

INTRODUCTION: Guideline-directed medical therapy (GDMT) is imperative to improve cardiovascular and limb outcomes for patients with critical limb ischemia (CLI), especially amongst those at highest risk for poor outcomes, including those with comorbid chronic kidney disease (CKD). Our objective was to examine GDMT prescription rates and their variation across individual sites for patients with CLI undergoing peripheral vascular interventions (PVIs), by their comorbid CKD status. METHODS: Patients with CLI who underwent PVI (October 2016-April 2019) were included from the Vascular Quality Initiative (VQI) database. CKD was defined as GFR <60 mL/min/1.73 m2. GDMT included the composite use of antiplatelet therapy and a statin, as well as an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker if hypertension was present. The use of GDMT before and after the index procedure was summarized in those with and without CKD. Adjusted median odds ratios (MORs) for site variability were calculated. RESULTS: The study included 28,652 patients, with a mean age of 69.4 ± 11.7 years, and 40.8% were females. A total of 47.5% had CKD. Patients with CKD versus those without CKD had lower prescription rates both before (31.7% vs. 38.9%) and after (36.5% vs. 48.8%) PVI (p < 0.0001). Significant site variability was observed in the delivery of GDMT in both the non-CKD and CKD groups before and after PVI (adjusted MORs: 1.31-1.41). DISCUSSION/CONCLUSION: In patients with CLI undergoing PVI, patients with comorbid CKD were less likely to receive GDMT. Significant variability of GDMT was observed across sites. These findings indicate that significant improvements must be made in the medical management of patients with CLI, particularly in patients at high risk for poor clinical outcomes.

Association of Perceived Stress Levels With Long-term Mortality in Patients With Peripheral Artery Disease.

Importance: Identifying modifiable risk factors, such as stress, that could inform the design of peripheral artery disease (PAD) management strategies is critical for reducing the risk of mortality. Few studies have examined the association of self-perceived stress with outcomes in patients with PAD. Objective: To examine the association of high levels of self-perceived stress with mortality in patients with PAD. Design, Setting, and Participants: This cohort study analyzed data from the registry of the Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a multicenter study that enrolled patients with new or worsening symptoms of PAD who presented to 16 subspecialty clinics across the US, the Netherlands, and Australia from June 2, 2011, to December 3, 2015. However, the present study included only patients in the US sites because assessments of mortality for patients in the Netherlands and Australia were not available. Data analysis was conducted from July 2019 to March 2020. Exposure: Self-perceived stress was quantified using the 4-item Perceived Stress Scale (PSS-4), with a score range of 0 to 16. A score of 6 or higher indicated high stress in this cohort. Missing scores were imputed using multiple imputation by chained equations with predictive mean matching. Stress was assessed at baseline and at 3-, 6-, and 12-month follow-up. Patients who reported high levels of stress at 2 or more follow-up assessments were categorized as having chronic stress. Main Outcomes and Measures: All-cause mortality was the primary study outcome. Such data for the subsequent 4 years after the 12-month follow-up were obtained from the National Death Index. Results: The final cohort included 765 patients, with a mean (SD) age of 68.4 (9.7) years. Of these patients, 57.8% were men and 71.6% were white individuals. High stress levels were reported in 65% of patients at baseline and in 20% at the 12-month follow-up. In an adjusted Cox proportional hazards regression model accounting for demographics, comorbidities, disease severity, treatment type, and socioeconomic status, exposure to chronic stress during the 12 months of follow-up was independently associated with increased risk of all-cause mortality in the subsequent 4 years (hazard ratio, 2.12; 95% CI, 1.14-3.94; P = .02). Conclusions and Relevance: In thie cohort study of patients with PAD, higher stress levels in the year after diagnosis appeared to be associated with greater long-term mortality risk, even after adjustment for confounding factors. These findings suggest that, given that stress is a modifiable risk factor for which evidence-based management strategies exist, a holistic approach that includes assessment of chronic stress has the potential to improve survival in patients with PAD.