Commentary: When Bailout Stenting Is the Only Option,the Difference Lies in the Details

Endovascular treatment of superficial femoral artery (SFA) disease has been attracting increasing attention from physicians, investigators, and companies over the past few years. In fact, we are experiencing the era of endovascular SFA treatment as the majority of endovascular devices can be used, deployed, or implemented in this specific vascular area.^1–4 In parallel, there is an increasing interest in the “leave nothing behind” principle using a drug-coated balloon (DCB), provided that proper vessel preparation takes place.^5,6 However, the majority of studies in the SFA, even those investigating the newer paclitaxel-eluting stents, limit their focus to lesions <15 cm long. This does not reflect everyday life, where lesions as long as 30 cm may even extend to the popliteal artery.^7,8 Additionally, the variability of peripheral artery disease expression in the SFA, ranging from intermittent claudication to critical limb ischemia (CLI), is such that no optimal and definitive treatment is available, which has made the use of a metallic scaffold inevitable in many cases.

Tatters of endothelium following balloon inflation and >30% residual stenosis due mainly to recoil or persistent “malignant” atheromatosis are the main reasons for bailout stenting, together with the presence of CLI, in which the need for immediate lumen and hemodynamic gain is of utmost importance. Nonetheless, stenting remains a “bailout” option rather than a mainstream therapy because of in-stent restenosis, thrombotic occlusion, and stent fracture. ⁶ The latter makes revisiting the lesion intraluminally extremely challenging if not impossible in certain cases.

In the February 2018 issue of the JEVT, Laird et al ⁹ reported a multicenter randomized controlled trial to assess the safety and effectiveness of the TIGRIS stent (W.L. Gore & Associates, Flagstaff, AZ, USA) vs the LifeStent (Bard Peripheral Vascular, Tempe, AZ, USA) for the treatment of long (up to 24 cm) lesions in the SFA. Approximately half of the 267 lesions were moderately or severely calcified and 40% were occlusions. The study met its primary endpoints of noninferiority of TIGRIS compared with LifeStent, while the TIGRIS stent had no fractures. This is the most important finding of the current study, especially in the frame of long lesion treatment (129.0±73.3 mm of stented segment in 197 lesions). In the control arm, significantly more fractures were noted (32.7% at 24 months; p<0.001), the majority being high grade.

In-stent restenosis/occlusion is a separate entity in terms of both lesion approach and treatment. Stent fracture is a negative predictor of successful lesion crossing. What is more, atherectomy devices, scoring balloons, and DCBs could show promising benefit in the treatment of intrastent restenosis. These technologies cannot be used when there is no in-stent navigation through the lesion. A “substent” approach ¹⁰ requires more stenting, leading to a vicious cycle of recurrent restenotic events. Interestingly, although the TIGRIS stent resulted in similar patency, reintervention rates and quality of life measures at 1 and 2 years’ follow-up compared with the LifeStent; Cox multivariate analysis of the TIGRIS arm demonstrated a significant positive impact between the number of stents and primary patency, while the LifeStent, on the other hand, had lower primary patency when 2 stents were deployed vs 1.

Although new technologies have been used in the endovascular treatment of the SFA, bailout stenting remains a necessity. Of equal importance to prolonged patency rates is the fact of the absence of stent fractures makes the lesion easier to approach in the future.