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DRASTICO: Balloons, stents confer similar outcomes in complex PAD
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Drug-coated balloons were noninferior but not superior to drug-eluting stents for treatment of femoropopliteal lesions in high-risk patients with complex peripheral artery disease, according to the results of the DRASTICO study.
The researchers randomly assigned 192 patients with 240 lesions in 225 limbs to treatment with a DCB (IN.PACT Pacific, Medtronic; mean age, 75 years; 51% men) plus provisional bare-metal stenting or a DES (Zilver PTX, Cook Medical; mean age, 74 years; 76% men). Provisional bare-metal stenting was required in 21% of patients in the DCB group.
Both groups had more than a 50% rate of diabetes and critical limb ischemia, the mean lesion length was 14 cm and approximately 60% of patients had target lesion occlusion, according to the researchers.
The primary outcome was target lesion binary restenosis at 12 months as assessed by Doppler ultrasound. Secondary outcomes included freedom from target lesion revascularization and major amputation.
Compared with the DCB group, the DES group had larger mean lumen diameter after the procedure and less residual dissection, Francesco Liistro, MD, from the cardiovascular and neurologic department at San Donato Hospital in Arezzo, Italy, and colleagues wrote.
The primary outcome occurred in 22% of patients in the DCB group and 21% of patients in the DES group (P = .9), according to the researchers.
Clinically driven TLR occurred in 14% of the DCB group and 17% of the DES group (P = .5), whereas there were no major amputations in either group during the study period, the researchers wrote.
“Longer follow-up will give better understanding of whether there is a difference in patency and clinical outcomes between the two different drug elution technologies,” Liistro and colleagues wrote.
In a related editorial, John R. Laird, MD, medical director of the Adventist Heart and Vascular Institute in St. Helena, California, and a Cardiology Today’s Intervention Editorial Board Member, wrote that, “The fact that there were no major amputations in either treatment arm despite the high percentage of CLI patients was a great achievement.”
He noted, however, that paclitaxel-coated devices for treatment of PAD are under scrutiny due to a mortality signal observed in two long-term analyses.
“It will take time for questions regarding the safety of paclitaxel-eluting devices to be definitively answered. What is not in question is the effectiveness of paclitaxel-eluting stents and paclitaxel-coated balloons in reducing restenosis and lowering the need for additional interventions,” Laird wrote. – by Erik Swain
Disclosures: Liistro reports he is a consultant for Medtronic. The other authors report no relevant financial disclosures. Laird reports he serves as a consultant/advisory board member for Abbott Vascular, Bard/BD, Boston Scientific and Medtronic and is a board member of VIVA Physicians.
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