An international prospective, randomised, multicentre trial that compared stenting using SE Astron Pulsar and Pulsar-18 (both from Biotronik) vs. angioplasty alone, failed to show statistically significant improved outcomes for stenting.
Ralf Langhoff, Vascular Center Berlin, Ev. Hospital Konigin, Elisabeth Herzberge, Berlin, Germany, presented the results at CIRSE 2013 (14–18 September, Barcelona, Spain).
“For the 92 subjects in our study there were no statistically significant signs of better clinical results in the stent group vs. the angioplasty group. Clinical success, as defined by improvement in Rutherford classification at 12 months, was met in 74.3% vs. 68.6% in the stent group and angioplasty group, respectively. Percutaneous transluminal angioplasty with bail-out stenting seems to be an acceptable primary approach for interventional therapy in peripheral arterial disease patients with below the knee lesions,” Langhoff noted.
The current clinical guidelines from the National Institute for Health and Care Excellence (NICE) and the European Society of Cardiology (ESC) recommend angioplasty with bailout stenting as the first choice therapy for critical limb ischaemia patients.
EXPAND is the first randomised controlled trial to show direct comparison of self-expanding stents vs. angioplasty in treating infrapopliteal lesions in patients with symptomatic critical limb ischaemia or severe intermittent claudication., Langhoff told delegates. The primary endpoint was upward shift of ≥+1 (for Rutherford 3) or ≥+2 (for Rutherford 4 and 5) on the Rutherford scale at 12 months. Secondary endpoints were freedom from target lesion revascularisation and amputation.
The investigators randomised 92 patients (71% men, mean age 73±9 years (51–89) between June 2009 and December 2011 at 11 sites. Forty seven of these were allocated to receive primary stenting and 45 to receive angioplasty. At baseline, almost all subjects presented the typical risk factors such as hypertension (96%) followed by diabetes (71%) and hyperlipidemia (68%). The majority of subjects (64%) were Rutherford 4 and 5, and 36% were Rutherford 3.
“Twelve-month clinical results were adjudicated by an independent clinical events committee. There was greater improvement in Rutherford stage classification (74.3% vs. 68.6%), greater freedom from target lesion revascularisation (75.6% vs. 78.6%), and reduced index limb amputation rates (9.8% vs. 14.3%) observed in the stent group vs. the angioplasty group. However, none of these differences achieved statistical significance,” Langhoff said.