Investigator: Peter Goverde (ZNA Stuivenberg, Antwerp, Belgium)

IDE: No

FDA approval: No

CE mark: Yes

Recruitment status: Recruiting

Phase: Post market

Study type: Interventional

Study design: Efficacy, open-label study. Randomised parallel assignment

Primary outcome measures: Efficacy measured by binary restenosis rate

Time frame – Primary outcome: 12 months

Target enrolment: 130 pts.

Start date: March 2016

Estimated primary completion date: September 2017

Estimated completion date: September 2017

Age (years): ≥18

Gender: Both

Last update: January 2017

Editor’s Summary: Early-generation Drug-coated Balloon randomised trials have produced encouraging results in preventing femoropopliteal restenosis following plain balloon angioplasty. However, the authors (Stabile et al) point out that these trials have mostly enrolled claudication (Rutherford class ≤4) patients, so do not provide any meaningful data for critical limb ischaemia patients. Further hampering clinical efficacy in challenging conditions, Stablile et al write, early Drug-coated Balloons “have several unsolved technical limitations such as inconsistent drug coating concentrations, significant drug loss prior to treatment, use of large paclitaxel particles which increases the risk of embolisation, and excessive initial balloon-artery drug transfer rates resulting in early drug-in-tissue concentrations which are too high.”
The LEG-DEB registry enrolled 123 consecutive patients at four European institutions between January 2014 and June 2015. All patients underwent LEGFLOW drug-coated balloon angioplasty treatment of the superficial femoral and/or popliteal artery. Of the treated patients, 79 (64.2%) were treated for claudication and 44 (35.8%) for critical limb ischaemia. Seventy-six patients (61.7%) were treated for de novo lesions (mean lesion length 95.1±57mm), 26 (21.1%) patients for restenosis (mean lesion length 96.1±32.1mm) and 21 (17.1%) for in-stent restenosis (mean lesion length 114.3±24.1mm).
Stabile and colleagues report that all procedures were successful in terms of angiographic and clinical success, and that technical and procedural success was achieved in all patients. Two patients (1.6%) had died at six months, both from non-cardiovascular causes. Freedom from target lesion revascularisation was achieved in 88.6% (n=109/123) of all patients. Freedom from target lesion revascularisation was achieved in 93.6% (n=74/79) of claudication patients, and in 79.5% (35/44) of critical limb ischaemia patients.
Analysis by lesion characteristics found an 88.2% (n=67/76) freedom from target lesion revascularisation rate for patients with de novo lesions, and 80.8% (n=21/26) for those with restenosis. No target lesion revascularisation was observed in the 21 in-stent restenosis patients. The authors also note that lesion length did not affect target lesion revascularisation rates—lesion lengths of 100mm. However, the presence of diabetes did affect target lesion revascularisation—diabetic patients had a rate of 86.7% (n=52/60) freedom from target lesion revascularisation versus 90.5% (n=57/63) for non-diabetics.