Endovascular Treatment and Outcomes for Femoropopliteal In-Stent Restenosis: Insights from the XLPAD Registry
Michael H. Vu, Glaiza-Mae Sande-Docor, Yulun Liu, Shirling Tsai, Mitul Patel, Chris Metzger, Mehdi H. Shishehbor, Emmanouil S. Brilakis, Nicolas W. Shammas, Peter Monteleone, Subhash Banerjee
Abstract
Background. There is limited “real-world” evidence examining treatment modalities and outcomes in patients with symptomatic peripheral arterial disease undergoing endovascular treatment of femoropopliteal (FP) in-stent restenosis (ISR). Materials and Methods. We compared outcomes in 2,895 patients from the XLPAD registry (NCT01904851) between 2006 and 2019 treated for FP ISR (n = 347) and non-ISR (n = 2,548) lesions. Primary endpoint included major adverse limb events (MALE) at 1 year, a composite of all-cause death, target limb repeat revascularization, or major amputation. Results. ISR patients were more frequently on antiplatelet (94.5% vs 89.4%, <a:math xmlns:a="http://www.w3.org/1998/Math/MathML" id="M1"> <a:mi>p</a:mi> <a:mo>=</a:mo> <a:mn>0.007</a:mn> </a:math> ) and statin (68.9% vs 60.3%, <c:math xmlns:c="http://www.w3.org/1998/Math/MathML" id="M2"> <c:mi>p</c:mi> <c:mo>=</c:mo> <c:mn>0.003</c:mn> </c:math> ) therapies. Lesion length was similar (ISR: 145 ± 99 mm vs. non-ISR: 142 ± 99 mm, <e:math xmlns:e="http://www.w3.org/1998/Math/MathML" id="M3"> <e:mi>p</e:mi> <e:mo>=</e:mo> <e:mn>0.55</e:mn> </e:math> ). Fewer treated ISR lesions were chronic total occlusions (47.3% vs. 53.7%, <g:math xmlns:g="http://www.w3.org/1998/Math/MathML" id="M4"> <g:mi>p</g:mi> <g:mo>=</g:mo> <g:mn>0.02</g:mn> </g:math> ) and severely calcified (22.4% vs. 44.7%, <i:math xmlns:i="http://www.w3.org/1998/Math/MathML" id="M5"> <i:mi>p</i:mi> <i:mo><</i:mo> <i:mn>0.001</i:mn> </i:math> ). Atherectomy (63.5% vs. 45.0%, <k:math xmlns:k="http://www.w3.org/1998/Math/MathML" id="M6"> <k:mi>p</k:mi> <k:mo><</k:mo> <k:mn>0.001</k:mn> </k:math> ) and drug-coated balloons (DCB; 4.7% vs. 1.7%, <m:math xmlns:m="http://www.w3.org/1998/Math/MathML" id="M7"> <m:mi>p</m:mi> <m:mo><</m:mo> <m:mn>0.001</m:mn> </m:math> ) were more frequently used in ISR lesions. The distal embolization rate was higher in ISR lesions (2.4% vs. 0.9%, <o:math xmlns:o="http://www.w3.org/1998/Math/MathML" id="M8"> <o:mi>p</o:mi> <o:mo>=</o:mo> <o:mn>0.02</o:mn> </o:math> ). Repeat revascularization (21.5% vs. 16.7%, <q:math xmlns:q="http://www.w3.org/1998/Math/MathML" id="M9"> <q:mi>p</q:mi> <q:mo>=</q:mo> <q:mn>0.04</q:mn> </q:math> ; Figure) was higher and freedom from MALE at 1 year was significantly lower (87% vs. 92.5%, <s:math xmlns:s="http://www.w3.org/1998/Math/MathML" id="M10"> <s:mi>p</s:mi> <s:mo><</s:mo> <s:mn>0.001</s:mn> </s:math> ) in the ISR group. Conclusion. Atherectomy and DCB are more frequently used to treat FP ISR lesions. Patients with FP ISR have more intraprocedural distal embolization, higher repeat revascularization procedures, and lower freedom from MALE at 1 year.