EXPAND Compares Treatments of Infrapopliteal Lesions

September 14, 2015—Karl-Ludwig Schulte, MD, et al published findings from the EXPAND study online ahead of print in the Journal of Endovascular Therapy (JEVT). The purpose of the study was to compare primary placement of an Astron Pulsar SE or Pulsar-18 self-expanding nitinol stent (Biotronik) to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). 

The investigators concluded that primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

As summarized in JEVT, the EXPAND trial was composed of 92 patients (mean age, 72.9 ± 9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers. Patients were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a one-category or greater increase for Rutherford category 3 patients, or a two-category or greater increase for CLI patients (Rutherford categories 4/5) compared with baseline. The study also assessed target lesion revascularization (TLR), mortality, and amputation after 12 months. 

Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting. There were no significant differences in Kaplan-Meier estimates of freedom from TLR (76.6% vs 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year, reported the investigators in JEVT.