Peripheral DES superior to bare-metal stents for treatment of PAD
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A drug-eluting stent outperformed bare-metal stents for treatment of patients with lesions in the superficial femoral and proximal popliteal arteries, according to results of the EMINENT trial presented at VIVA 21.
The researchers randomly assigned 775 patients (mean age, 69 years; 70% men) with peripheral artery disease on a 2:1 basis to the DES (Eluvia, Boston Scientific) or a BMS. All patients had lesions in the superficial femoral or proximal popliteal arteries between 30 mm and 210 mm, had stenosis of at least 70% and were Rutherford category 2, 3 or 4.
“The Eluvia system is composed of the Innova stent, the Promus polymer and the drug paclitaxel,” Yann Gouëffic, MD, professor of vascular surgery at Paris Saint-Joseph Hospital, France, said during a presentation. “The main feature of the Eluvia DES is the long-term sustained release of the drug up to 1 year, at which point 90% of the drug is released.”
The primary effectiveness endpoint of primary patency at 1 year was achieved in 83.2% of the DES group compared with 74.3% of the BMS group (difference, 8.9 percentage points; 95% CI, 2.1-15.7; P = .0077), and a Kaplan-Meier analysis showed similar results (DES, 85.4%; BMS, 76.3%; log-rank P = .0087), Gouëffic said.
At 1 year, the safety endpoint of all-cause death, major amputation and target lesion revascularization occurred in 11.8% of both groups (P = .9912), he said, noting all-cause death did not differ between the groups at 1 year (DES, 2.7%; BMS, 1.1%; P = .1528).
“In 2021, we have more and more evidence about the safety of [paclitaxel-coated] devices,” he said.
On ultrasound, halo was observed in 26.1% of the DES group and 17.9% of the BMS group (P = .2067), and in the DES group there was no difference in clinically driven TLR between those who had halo and those who did not (6.7% vs. 6%, respectively; P = 1), according to the researchers.
Sustained clinical improvement was more common in the DES group than in the BMS group (83% vs. 76.6%; P = .045), Gouëffic said.
“Based on the EMINENT and IMPERIAL randomized controlled trials, the Eluvia DES should be considered as the stent of choice for treating [superficial femoral artery] and proximal popliteal artery lesions of intermediate length,” he said.
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Gouëffic Y, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).
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