Drug eluting stents versus PTA with GP IIb/IIIa blockade below the knee in patients with current ulcers--The BELOW Study.

The study was designed as a feasibility trial to evaluate the use of GP IIb/IIIa blockade in connection with drug eluting stents, bare stents and PTA only. Sixty patients with current ulcers were randomly assigned to receive abciximab plus a sirolimus coated stent (N.=14), abciximab plus a bare stent (N.=16), abciximab plus PTA (N.=14) and PTA alone (N.=19). Angiographic control was performed at two and six months. Recanalization was successful in all cases. Two month restenosis rate was 9%, 45.5%, 67% and 46%. At six month follow-up restenosis rate was 9%, 67%, 75% and 58%, respectively; 14% of all patients had major amputations within six months. Adjunctive administration of abciximab during peripheral arterial intervention below the knee was found to be safe. Sirolimus coated stent administration was followed by a higher patency rate.

RCT Entities:   Population Interventions Outcomes