This article is more than 5 years old. Information may no longer be current.
Peripheral DES effective in real-world cohort, with caveat
Click Here to Manage Email Alerts
A novel fluoropolymer-based paclitaxel-eluting stent was effective in treating long femoropopliteal lesions in an all-comers population, but conferred a signal of aneurysm formation, researchers reported.
The researchers retrospectively analyzed 62 patients with longer femoropopliteal lesions (mean length, 20 cm; 79% chronic total occlusions; 42% with moderate to severe calcification) who failed treatment with plain old balloon angioplasty and were subsequently treated with the PES (Eluvia, Boston Scientific).
Outcomes of interest were primary patency, freedom from target lesion revascularization, amputation-free survival and paclitaxel-related adverse events at 1 year.
Mean age of the patients was 71 years, 63% were men, 84% had de novo lesions, 76% had a PES implanted in the distal superficial femoral artery and 44% had a PES implanted in the proximal popliteal artery.
Primary patency and freedom from TLR were both 87% at 1 year, Theodosios Bisdas, MD, from the Clinic for Vascular Surgery, St. Franziskus Hospital and University Clinic of Muenster, Germany, and colleagues wrote.
Among patients with claudication, 1-year amputation-free survival was 100%, whereas in patients with critical limb ischemia, it was 87% (HR = 6.3; 95% CI, 1.25-31.54), according to the researchers.
Aneurysm formations
Eight percent of patients had aneurysm formations in the treated segment, believed to be attributable to paclitaxel, Bisdas and colleagues wrote, noting that of these patients, “All but [one] were asymptomatic and received dual antiplatelet therapy for 6 months and re-evaluation with duplex ultrasound every 6 months. No peripheral embolization or aneurysm rupture was observed. Of note, all cases were de novo chronic total occlusions without any previous treatment with paclitaxel-eluting technologies.
“In this study, the use of a polymer-based PES platform led to encouraging outcomes
at 12 months. Nonetheless, aneurysmal degeneration of the treated vessels might compromise the performance of this treatment modality,” they concluded. “Larger multicenter prospective trials are needed to confirm the theoretical advantages of this approach, especially in comparison with a combined treatment strategy with DCBs and bare-metal stents or vessel preparation techniques and antirestenotic therapy. Moreover, an evidence-based reassessment of the current recommendations regarding the duration of dual antiplatelet treatment after PES implantation remains mandatory.”
Warning signs
In a related editorial, Bernardo Cortese, MD, from the Interventional Cardiology Unit, ASST Fatebenefratelli-Sacco, Milan; and Fondazione Monasterio-Regione Toscana-CNR, Pisa and Massa, Italy, questioned “why we should proceed with a technology that has been associated with warning signs?”
“The present study brings an important piece to the puzzle of how to treat complex SFA lesions, although my conclusions are different from the ones outlined in this paper,” he wrote. “Paclitaxel-eluting stents should have a limited role in this setting; in fact, it is undesirable to transform patients in stable condition into patients requiring closer surveillance and at higher thrombotic and bleeding risk because we have chosen one device instead of another. Complex SFA lesions, including total occlusions, should be treated with either surgery or endovascular treatment with older or newer therapeutic options with adequate safety profiles.” – by Erik Swain
Disclosures: Bisdas reports he consults for Bard, Boston Scientific, Cook Medical and Medtronic. Another researcher reports he received honoraria from Boston Scientific and Medtronic. Cortese reports no relevant financial disclosures.
Click Here to Manage Email Alerts