Peripheral Artery Disease

FDA Approves Eluvia Paclitaxel-Polymer Stent for PAD

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Regulators in the United States have approved the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) for the treatment of peripheral artery disease (PAD), based on the paclitaxel-polymer-based stent’s showing in the IMPERIAL trial, the company announced today.

The US Food and Drug Administration approval follows IMPERIAL’s presentation at Transcatheter Cardiovascular Therapeutics 2018 and its publication in the Lancet released at about the same time, both covered by theheart.org | Medscape Cardiology.

Patency rates at one year for the treated femoropopliteal arteries in the trial were noninferior for the Eluvia stent compared with stenting with the paclitaxel-eluting Zilver PTX (Cook Medical). The actual 12-month patency rate difference between the two stents emerged as significantly greater for Eluvia in a prespecified post hoc analysis (P < .001).

In contrast to the Zilver, the Eluvia system is designed to delivery a polymer vehicle for paclitaxel that delivers the drug gradually over the course of a year. It received CE-Mark approval in Europe about 2 years ago, Boston Scientific says in their press release.

Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease

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Abstract

Background  Peripheral artery disease (PAD) is associated with heightened ischemic and bleeding risk in patients with prior myocardial infarction (MI).

Objectives  This study evaluated the efficacy and safety of ticagrelor on major cardiovascular (CV) events and major adverse limb events in patients with PAD and a prior MI.

Methods  PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin—Thrombolysis In Myocardial Infarction 54) randomized 21,162 patients with prior MI (1 to 3 years) to ticagrelor 90 mg twice daily, ticagrelor 60 mg twice daily, or placebo, all on a background of low-dose aspirin. History of PAD was obtained at baseline. Occurrences of major adverse cardiovascular events (MACE) (defined as CV death, MI, or stroke) and major adverse limb events (MALE) (defined as acute limb ischemia or peripheral revascularization for ischemia) were recorded in follow-up.

Results  A total of 1,143 patients (5%) had known PAD. In the placebo arm, those with PAD (n = 404) had higher rates of MACE at 3 years than those without (n = 6,663; 19.3% vs. 8.4%; p < 0.001), which persisted after adjusting for baseline differences (adjusted hazard ratio: 1.60; 95% confidence interval: 1.20 to 2.13; p = 0.0013), and higher rates of acute limb ischemia (1.0% vs. 0.1%) and peripheral revascularization procedures (9.15% vs. 0.46%). Whereas the relative risk reduction in MACE with ticagrelor was consistent, regardless of PAD, patients with PAD had a greater absolute risk reduction of 4.1% (number needed to treat: 25) due to their higher absolute risk. The absolute excess of TIMI major bleeding was 0.12% (number needed to harm: 834). The 60-mg dose had particularly favorable outcomes for CV and all-cause mortality. Ticagrelor (pooled doses) reduced the risk of MALE (hazard ratio: 0.65; 95% confidence interval: 0.44 to 0.95; p = 0.026).

Conclusions  Among stable patients with prior MI, those with concomitant PAD have heightened ischemic risk. In these patients, ticagrelor reduced MACE, with a large absolute risk reduction, and MALE. (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS-TIMI 54]; NCT01225562)

Perspectives

COMPETENCY IN PATIENT CARE: Prolonged therapy with ticagrelor reduced ischemic risk and increased bleeding in patients with prior MI, and in a subgroup analysis, those with concomitant PAD appeared to derive greater absolute benefit than those without PAD.

TRANSLATIONAL OUTLOOK: An ongoing prospective trial of ticagrelor as antiplatelet monotherapy should provide more insight into the efficacy and safety of ticagrelor monotherapy versus clopidogrel monotherapy in a broad population of patients with PAD, including those without concomitant coronary disease.

The Development of Therapeutics for Peripheral Artery Disease

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Peripheral artery disease (PAD) primarily manifests as occlusive atherosclerosis in the peripheral circulation to the lower extremities (1). Symptomatic patients have either a profound exercise limitation or develop critical limb ischemia, and all of these patients are at heightened risk for major cardiovascular and ischemic limb events (2). Despite a severe morbidity and mortality risk, historically, little attention has been paid to developing targeted therapies to reduce this risk in patients with PAD (3). However, there were early signals that PAD may be responsive to potent antiplatelet therapy in the CAPRIE (Clopidogrel versus Aspirin in Patients at Risk for Ischemic Events) trial, where the PAD subgroup had a greater response to clopidogrel than aspirin to reduce major cardiovascular adverse events (MACE) (defined as myocardial infarction, stroke, and vascular death) (4). In contrast, there is moderate evidence that aspirin is less effective in PAD (5). These results demonstrate that antiplatelet drugs do not provide similar benefit across all vascular territories and that individualized therapies need to be considered in PAD.