Mixed Bag: New Performance Data on Fem-Pop Revascularization

Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, researchers say, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.

In their analysis, the “persistent and not insignificant risk” of treated-limb amputation in such patients who underwent femoropopliteal PVI was 4.3% over 4 years. The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.

The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1100 US hospitals. The study was published online July 10 in JACC: Cardiovascular Interventions.

The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University School of Medicine in New Haven, Connecticut, told theheart.org/Medscape Cardiology. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”

Of particular concern in the study, agrees the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”

Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” writes Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”

Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.

Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.

The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.

The multivariable-adjusted treated-limb amputation hazard ratio (HR) for popliteal vs SFA procedures was for 2.10 (95% CI, 1.52 – 2.92) for any amputation and 1.98 (95% CI, 1.32 – 2.95) for major amputation.

The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report states.

The overall lower-than-expected revascularization rates, the authors propose, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.

“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they write.

The study’s revascularization rates could have been underestimated because “[s]ome of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Virginia.

“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’

Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early vs delayed invasive management.

In his editorial, Mukherjee says that for patients with PAD and claudication, a PCSK9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.

“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”

Altin has disclosed no relevant relationships; disclosures for the other authors are in the report. Mukherjee and Bolorunduro have no relevant disclosures.

JACC Cardiovasc Interv. Published online July 10, 2023. Full text, Editorial

Follow Marilynn Larkin on Twitter: @MarilynnL.

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