SORT OUT V randomized trial (Odense University Hospital, Denmark) compared Nobori stent, a drug-eluting stent with biodegradable polymer eluting biolimus, versus CYPHER a drug-eluting stent with permanent polymer in the real world. Danish researchers used a non-inferiority design, by means of a primary objective of the study, the combined rate of major cardiac events (cardiac death, myocardial infarction and definite in-stent thrombosis and reintervention in treated vessel) at nine months follow up. A total of 2400 patients from July 2009 to January 2011 were included (1:1 randomization). The primary endpoint was 4.1% for degradable polymer and 3.2% for the group with permanent polymer and inferiority hypothesis cannot be ruled out but without statistical power to infer superiority of permanent polymer stent. At 12 months, the major cardiac events rate was 5.4% and 4.5% for degradable polymer stent and permanent polymer stent, respectively (p = 0.28). The annual rate of thrombosis was very low (0.8% with degradable polymer and 0.2% with permanent polymer, p = 0.07). The annual vessel reintervention observed in both groups was very encouraging, (4.2% with degradable polymer and 3.1% with permanent polymer). No rate differences were observed in heart attack or cardiac death.
Dr. Spencer King (Atlanta, Georgia, USA) commented: “First of all, these results are spectacular, regardless of used stent. It is likely that the true test of any degradable polymer stent is the reduction of events the year after discontinuation of clopidogrel. “We will wait to test their long-term behavior.”
E. H. Christiansen