Endovascular treatment of femoropopliteal lesions has become the first-line treatment due to the development of devices that decrease the restenosis rate. Recently, the IMPERIAL study showed greater patency at 1 year and greater freedom from clinically guided revascularization at 2 years in favor of the ELUVIA stent (paclitaxel-eluting fluoropolymer, FP-DES) compared with the ZILVER PTX stent (polymer-free paclitaxel-coated stent).
These studies were conducted under angiographic guidance. Currently, the use of intravascular ultrasound (IVUS) has become a popular practice as it provides greater detail on arterial architecture and pathology. A randomized controlled study demonstrated that using IVUS significantly decreased the rate of restenosis after endovascular treatment, particularly when using drug-eluting balloons.
The aim of this subanalysis of the CAPSICUM (Contemporary Outcomes Achieved With Paclitaxel-Eluting Peripheral Stents to Treat Symptomatic Lower Limb Ischemia and Lesions in the Superficial Femoral Artery or Proximal Popliteal Artery) study was to evaluate the impact of IVUS on clinical outcomes after DES-PF implantation in femoropopliteal lesions in patients with symptomatic peripheral disease.
The primary endpoint (PEP) was 1-year Doppler-defined restenosis. The secondary endpoint (SEP) included residual stenosis after the procedure, peri-procedural complications, occlusive restenosis at 1 year, stent thrombosis, revascularization of the treated vessel, major amputation, need for peripheral bypass, major limb-related adverse events, death, and aneurysmal degeneration.
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A total of 843 patients underwent IVUS-guided DES-PF implantation and, after propensity score matching (PSM) to homogenize the groups, researchers analyzed 820 patients in the IVUS group vs. 244 patients in the non-IVUS group. Mean patient age was 74 years old, and most subjects were male. Most patients were in Rutherford classification category 3. Patients in the IVUS group had a lower prevalence of diabetes, there were less cases of history of peripheral angioplasty and a higher prevalence of chronic total occlusions. Further, the IVUS group had smaller reference vessel diameter, longer lesions, and a higher percentage of chronic occlusions.
There were no differences in the PEP, with a 1-year restenosis rate of 11.5% in the IVUS group vs. 15.5% in the non-IVUS group (p = 0.22). The frequency of aneurysmal degeneration at 1 year was higher in the IVUS group (p < 0.001).
Conclusion
This study proved that clinical outcomes at 1 year after DES-PF implantation showed no significant differences between the use of IVUS vs. angiography. The only exception was the incidence of aneurysmal degeneration, which was higher in the IVUS group.
Dr. Andrés Rodríguez.
Member of the editorial board of SOLACI.org.
Original Title: Clinical Impact of Intravascular Ultrasound–Guided Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Lesions
Reference: Takuya Tsujimura, MD et al J Am Coll Cardiol Intv 2022;15:1569–1578.
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