SORT OUT VI, NORBORI DES Vs RESOLUTE INTEGRITY

TCT ( Transcatheter Cardiovascular Therapeutics ) 2013 has just concluded in San Francisco. This annual event is probably the largest interventional meeting in the world. It showcases the latest in Interventional Cardiology for the last decade, I believe. We saw it grow from a very modest meeting in Washington, to become a giant of a meeting. The brain child of Dr Martin Leon and the Cardiovascular Research Foundation, it has grown from strength to strength.
Anyway, at this 2013 meeting, one of the interesting paper was SORT OUT VI, a head to head study comparing the Nobori DES against the Resolute Integrity. This study was part of the SORT OUT investigators research. This study was ld by Dr Bent Raungaard of the University of Talborg, Denmark. We all know that the Resolute Integrity is FDA approve, with a cobalt chromium platform and coated with Zotarolimus drug on a non degradable polymer, while the Nobori DES is coated with biolimus A9 drug on a biodegradable polymer.
This head to head comparison is to see which DES is better, or at least, in our Interventionist jargon, non-inferior.
Well about 3,000 patients with CAD, ( All-comers ) were enrolled, 1502 in the Reslute arm and 1497 in the Nobori arm. They were well matched. However there were only 18% diabetics in the study, whih was the community diabetic rate in Denmark but certainly a bit low for us. After 12 months of follow=up, the found that there was no difference in the primary endpoints. The MACE rates were 5.% in the Resolute arm and 5.1% in the Nobori arm.
Basically what that means is that the Nobori DES performed as well as the Resolute Integrity DES in this trial of all-comers with CAD. This is interesting, because the Nobori had a biodegradable polyer which was suppose to do better. Afterall, there was a prevailing thought, championed by non other than Renu Vermani that the polymer may be the cause of late stent thrombosis. Obviously, 12 months was not long enough to show this. We will need to ask Dr Bent to follow-up these patients for about 4-5 years to appreciate this difference.
For the moment, the Nobori DES is non inferior to the Resolute integrity of Medtronic International.