The best devices for superficial femoral artery, with “limited” cases and vessel preparations

In endovascular treatment (EVT) of femoropopliteal lesions, advancements in drug technology have led to better outcomes compared to balloon angioplasty or bare-metal stents (1). However, it remains uncertain whether drug-coated balloons (DCBs) or drug-eluting stents (DESs) are more effective for treating femoropopliteal artery lesions (2). Stent thrombosis remains a challenge with DES (3), while DCB, although it leaves nothing behind, may cause problems like recoil and dissection after balloon dilation (4). In this context, the BEST SFA (Best Endovascular STrategy for complex lesions of the Superficial Femoral Artery) trial conducted by Wittig et al. and published in JACC: Cardiovascular Interventions (5), was carefully designed to explore these problems. In the stent-avoiding (SA) group, provisional stenting was performed only when there was more than 50% residual stenosis or flow-limiting dissection following DCB dilation. By comparing the outcomes of the SA group with those of the stent-preferred (SP) group, which involved DES implantation, this trial addresses a critical issue frequently encountered in daily clinical practice. This study is especially relevant because it included patients with more complex lesions than in previous randomized controlled trials (6). For instance, over two-thirds of the patients had lesions longer than 15 cm, and more than 80% had total occlusions with moderate to severe calcification. Despite this complexity, the results indicated no significant difference in patency between the two groups.

While the study’s approach is promising, the relatively small sample size of 120 patients might limit the impact on clinical decision-making for femoropopliteal lesions. In contrast, the BEST CLI trial (7), which also included ‘BEST’ in its title and enrolled 1,800 patients, significantly impacted clinical decision-making by demonstrating the superiority of saphenous vein grafts over EVT in patients with critical limb ischemia. Additionally, previous DCB trials have shown that patency rates tend to decline over time compared to scaffold devices (8,9). Therefore, longer-term follow-up is needed to fully understand the durability of the study’s results. Although the BEST SFA trial provides valuable insights, the smaller number of patients and the shorter period of follow-up might require careful interpretation of its results.

Another aspect worth noting is the higher prevalence of bailout stenting in the SA group, which 48% of patients required this intervention. This raises a question about whether the vessel preparation before using DCB was sufficient. Although vessel preparation strategies were determined angiographically at the operators’ discretion, the SA and SP groups performed vessel preparation in 72% and 52% of cases, respectively, even though the lesions treated were complex. In a previous report, the stent patency rate following vessel preparation in all patients was 87% (3). In the current study, where only 52% of patients underwent vessel preparation, it was 78%. While simple comparisons cannot be made, appropriate vessel preparation may lead to improved outcomes.

Consequently, 45% of the SA group had more than 30% residual stenosis, which is considerably higher than the rates reported in previous randomized controlled trials (2.9–8.5%, Table 1). Vessel preparation with balloon dilatation may play a critical role in achieving optimal primary patency (12). Recent studies have highlighted the potential benefits of intravascular ultrasound (IVUS) in optimizing vessel preparation by accurately measuring vessel size (13,14). Additionally, several IVUS findings have identified predictors of restenosis in both DCB and DES usage for femoropopliteal lesions (4,15). Despite the possibility of inadequate lesion preparation even with IVUS usage (12), it remains one of the best strategies for EVT in femoropopliteal lesions.

Reducing the percentage of bailout stenting is also important from a cost perspective. Although an atherectomy device was used in this study, previous reports indicate that only 15–25% of patients underwent bailout stenting after use of an atherectomy device (16), which is less than the 48% in this study. IVUS may be useful in the appropriate use of atherectomy devices (17).

It is also important to mention that the DCBs used in the SA group included five different types of paclitaxel-coated balloons (PCBs). Although animal studies report differences in the safety and efficacy of various PCBs (18-20), retrospective observational clinical studies have shown comparable results (10,21). Nevertheless, it would have been ideal to standardize the types of PCBs used. Type of bailout stenting in the SA group also varied with bare metal stents used in 26 cases, DES in 1 case, and Supera stent in 2 cases. Although a previous animal study has demonstrated that safety of additional DES implantation following DCB usage was acceptable (22), the type of stents used in bail out stenting should also have been standardized.

Lastly, the inconsistency in antiplatelet and anticoagulant therapies might have affected the study outcomes. While the study required at least 4 weeks of dual antiplatelet therapy (DAPT), there was no standard approach to antithrombotic therapy beyond that period. Furthermore, recent guidelines indicate the use of low-dose oral anticoagulants (OAC) after EVT as a Class IIa indication (23,24), OAC usage was relatively low in this study (10%). As a previous animal study has reported that organizing or organized thrombus may cause in-stent restenosis in poor below-the-knee runoff, additional OAC may be a more effective option especially in the SP group with chronic limb threatening ischaemia (25).

In summary, while this study presents an attractive concept, it may not be immediately practice-changing. To achieve the ‘BEST’ patient outcomes for femoropopliteal lesions, further research with a larger number of patients, sufficient vessel preparation, standardized strategies in both the DCB and DES groups, and a clear postoperative antiplatelet and OAC strategy would be beneficial.

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Cardiovascular Diagnosis and Therapy. The article has undergone external peer review.

Peer Review File: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-24-418/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-24-418/coif). S.T. received research grants from Abbot Vascular Japan, Boston Scientific Japan, Medtronic; honoraria from Abbot Vascular Japan, Boston Scientific Japan, Medtronic, Asahi Intecc, Terumo, Phillips, Shockwave Medical, Bayer. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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