Drug-Coated Balloon Angioplasty in Femoropopliteal CTOs: Intraluminal or Subintimal?

Patients with peripheral vascular disease often experience femoropopliteal compromise. It is estimated that approximately 50% of lesions in this area are chronic total occlusions (CTO). Even though success rate has improved for peripheral CTO treatments, long term clinical and technical outcomes have not been fully determined yet. 

Angioplastia con balones liberadores en oclusiones totales crónicas femoropoplíteas

Prior research has looked into stenting outcomes in femoropopliteal territory, and has found comparable outcomes between intraluminal and subintimal approaches. However, evidence on treatments with drug coated balloons (DCB) in CTO is limited. Therefore, the aim of this study was to assess clinical safety of subintimal vs intraluminal DCB angioplasty in femoropopliteal CTO, with a low incidence of rescue stenting. 

The study looked at data from the POPCORN registry (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease), which included patients older than 20, treated with DCBs (IN.PACT Admiral and Lutonix) for femoropopliteal disease in 81 cardiovascular centers in Japan. They looked at a total 3165 lesions in femoropopliteal territory: 819 were CTO (they could use IVUS in 469 lesions).

Primary end point was freedom from restenosis. Secondary end points included freedom from target vessel revascularization, limb salvage index and average survival. Wire passage (intraluminal vs subintimal) was evaluated using IVUS, after passage, either intraluminal or subintimal.

Read also: SMART Trial: What is the Best Valve for Small Annuli?

Of 469 included patients, 198 were treated with the subintimal technique and 271 with intraluminal technique. During a mean followup of 14.2 months, restenosis was observed in 140 patients. The group treated with the intraluminal technique showed higher prevalence of male sex, chronic kidney disease, more severity according to Rutherford classification, and also longer CTO.

The proportion of patients with severe dissection (8.8% vs 9.9%; P= 0.77) and need for rescue stenting (10.5% vs 9.7%; P= 0.69) did not differ between techniques. The frequency of perioperative complications was similar in both groups. However, the group treated with the subintimal technique showed lower rate of freedom from restenosis (77.0%; IC95%: 70.7%-83.8%) vs. the intraluminal group (84.2%; IC95%:79.2%-89.6%; P= 0.024).

Independent factors increasing restenosis risk were smoking, severe calcification and type of DCB. 


In conclusion, this study suggests that intraluminal angioplasty with DCB presents better outcomes in terms of freedom from restenosis at one year vs. the subintimal technique. In addition, we highlight the importance of the correct assessment using IVUS. 

Dr. Omar Tupayachi

Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.

Original Title: Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions.

Source: Toyoshima T, Takahara M, Iida O, Tomoi Y, Kawasaki D, Tanaka A, Yamauchi Y, Tobita K, Kozuki A, Fujihara M, Higuchi Y, Soga Y; POPCORN Investigators. Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions. JACC Cardiovasc Interv. 2024 Mar 11;17(5):608-618. doi: 10.1016/j.jcin.2023.12.028. PMID: 38479962.

Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology