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Trial of Vascular Care Team vs. Education for PAD
Quick Takes
- Patients with peripheral artery disease (PAD) are largely undertreated with guideline-recommended lipid-lowering therapies.
- Use of a vascular care team model that includes a clinical pharmacist dramatically outperformed usual care in achieving and sustaining LDL-C reduction for 12 months.
- Implementation of clinical pharmacists and lipid management protocols has the potential to dramatically improve cardiovascular risk for patients with PAD.
Study Questions:
What is the difference in utilization of lipid management strategies when using a vascular care team including a clinical pharmacist versus usual care with provider education for patients with peripheral artery disease (PAD)?
Methods:
The authors conducted a single-center implementation trial, OPTIMIZE PAD-1 (Implementation of Vascular Care Team to Improve Medical Management of PAD Patients). The trial compared two strategies for lipid management in patients with noncoronary atherosclerotic disease (lower extremity PAD, cerebrovascular disease, and/or aortic aneurysm). Eligible patients with a baseline low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL were randomized to receive management either by: 1) a vascular care team including a clinical pharmacist with intensive lipid management protocol, or 2) usual care plus provider education. All medications were obtained through standard insurance means without trial-related financial support. The primary endpoint was a percent change in LDL-C at 12 months.
Results:
Among the 166 patients enrolled between July 2020 and April 2022, 74.2% did not have a baseline LDL-C level at goal (<70 mg/dL). Of the 114 patients who were randomized (mean age 66 years, 36.0% women, 15.8% Black race), 50.9% received high-intensity statins and 7.9% received ezetimibe at baseline. The mean 12-month LDL-C change from baseline was -49.1% (95% confidence interval [CI], -58.7% to -39.5%) in patients randomized to the vascular care team and -5.4% (95% CI, -15.3% to 4.6%) in patients randomized to usual care (p < 0.0001). At 12 months, patients randomized to vascular care team management were >3 times as likely to achieve a goal LDL-C <70 mg/dL and 8 times as likely to achieve an LDL-C <55 mg/dL as compared to patients randomized to usual care (p < 0.0001). At 12 months, the vascular care team and usual care arms had 75.4% and 61.4% use of high-intensity statins, 49.1% and 7.0% use of ezetimibe (p < 0.0001), and 43.9% and 0% use of PCSK9 inhibitors (p < 0.0001), respectively.
Conclusions:
The authors conclude that an interprofessional, algorithm-based program can achieve rapid and sustained LDL-C lowering in patients with PAD using commercial insurance mechanisms.
Perspective:
Lipid management is critical in patients with PAD and other noncoronary vascular diseases. However, clinicians have largely failed to achieve adequate lipid reduction in this very high-risk population. The OPTIMIZE PAD-1 study compared usual care combined with targeted clinician education about lipid-lowering strategies to an interprofessional management team approach that leveraged clinical pharmacists and a lipid optimization protocol. As has been demonstrated in several other clinical areas, the team-based care leveraging clinical pharmacists far outperformed the usual care arm, with a >3x odds of achieving LDL-C <70 mg/dL and 8x odds of achieving LDL-C <55 mg/dL. Most of this benefit was driven by high use of ezetimibe and PCSK9 inhibitors in the vascular care team arm as compared to the usual care arm.
Perhaps the most important part of this implementation study was that all patients used standard insurance programs to obtain medications; no medication support was provided by the trial. As such, this study provides high-quality evidence that a similar care model can be implemented and adopted nationally to drastically improve cardiovascular care for some of the highest-risk and most often undertreated population of patients.
Clinical Topics: Vascular Medicine, Atherosclerotic Disease (CAD/PAD)
Keywords: Dyslipidemia, Peripheral Arterial Disease
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