Impact of postprocedural minimum lumen area on clinical outcome after femoropopliteal drug-eluting stent implantation

Abstract

Introduction: Although favorable results of fluoropolymer-based drug-eluting stent (FP-DES) treatment for femoropopliteal lesions have been reported, it is unclear whether minimal lumen area (MLA) after FP-DES implantation affects clinical outcomes. This study aimed to reveal the association between intravascular ultrasound (IVUS)-evaluated MLA and the 1-year risk of restenosis and aneurysmal degeneration after FP-DES implantation for femoropopliteal lesions. Methods: A subanalysis of the CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study analyzed 718 limbs in 686 patients with available IVUS-evaluated MLA data. The association of MLA with the 1-year risk of restenosis and aneurysmal degeneration was analyzed using the generalized propensity score method. Results: The 1-year incidence rate of restenosis was estimated to be 8.8% (95% CI, 6.1% to 12.5%) for the upper quartile of MLA (21.1 mm2) versus 14.3% (95% CI, 10.7% to 18.7%) for the lower quartile of MLA (15.2 mm2), with an odds ratio of 0.58 (95% CI, 0.36 to 0.93; p = 0.024), whereas the 1-year incidence rate of aneurysmal degeneration was 23.8% (95% CI, 19.5% to 28.8%) for the upper quartile versus 16.8% (95% CI, 12.6% to 22.0%) for the lower quartile, with an odds ratio of 1.55 (95% CI, 1.04 to 2.32; p = 0.031). Conclusion: A large MLA after FP-DES implantation for femoropopliteal lesions was associated with decreased restenosis risk but increased aneurysmal degeneration risk. These findings suggest that MLA is a valuable predictor of clinical outcomes.

Pathological evaluation of a fluoropolymer-based drug-eluting stent in an arteriovenous graft outflow venous stenosis

“… 6 However, other reports have raised clinical concerns regarding aneurysmal changes. 7 Therefore, understanding the vascular changes after FP-DES implantation for dysfunctional AVGs is of significant clinical interest.…”

Looking into the future: Endovascular intervention with intravascular ultrasound

“…In this edition of Vascular Medicine, Haraguchi and colleagues bolster the evidence for IVUS during endovascular treatment of femoropopliteal PAD. 4 The authors evaluated the association between IVUS-assessed minimal luminal area (MLA) and the likelihood of in-stent restenosis or aneurysmal degeneration within a subanalysis of the CAPSICUM study. 5 CAPSICUM was a prospective, observational study across 60 centers in Japan that included patients who received a fluoropolymer-based drug-eluting stent (FP-DES) for symptomatic femoropopliteal PAD.…”

“…The report by Haraguchi and colleagues evaluated IVUS-derived MLA as a predictor of late outcomes, demonstrating that a larger poststent MLA was associated with a reduced risk of restenosis. 4 Regardless of IVUS use, other research has established that small reference vessel diameter is a predictor for restenosis. 5 Interestingly, in Haraguchi et al's work, it is notable that the lowest rate of restenosis was within the third MLA quartile, and not the largest quartile, as might have been expected.…”

“…5 Interestingly, in Haraguchi et al's work, it is notable that the lowest rate of restenosis was within the third MLA quartile, and not the largest quartile, as might have been expected. 4 Therefore, additional prospective study is required to demonstrate the value of IVUS on optimizing MLA as a characteristic distinct from the reference vessel diameter. Furthermore, MLA indexed to distal lumen vessel or MLA indexed to target lesion area may provide more actionable intraprocedural targets that deserve rigorous evaluation.…”

“…Haraguchi and colleagues 4 are commended for a rigorous analysis of observational data to refine the potential utility of IVUS on endovascular care of femoropopliteal PAD by asking a focused question about IVUS use in PAD therapies that was appropriately specific. Future studies evaluating the utility of IVUS should take care to test relevant hypotheses while rigorously controlling how IVUS is used and applied to unique patient subgroups where the benefits of the technology may be particularly relevant.…”