In the first all-diabetic trial of a drug-eluting stent, the CYPHER sirolimus-eluting stent significantly reduced in-segment late lumen loss and restenosis compared to a bare metal stent..
The DIABETES (DIABETes and sirolimus-Eluting Stent trial) trial is a randomized, prospective, placebo-controlled trial of the sirolimus-eluting stent (SES) in diabetic patients with de novo coronary stenoses. A total of 160 patients (221 lesions) treated at four university hospitals in Spain were randomly assigned to either a SES or bare metal stent. Eligible patients were either non-insulin dependent (but not managed on diet alone) or insulin dependent and had symptoms or subjective evidence of ischemia. The primary endpoint was in-segment (in-stent + 5mm distal and proximal) late lumen loss as assessed by QCA at nine-month follow-up.
Similar to the SIRIUS trial, mean lesion length was 15.0mm, but in keeping with common diabetic presentation and dissimilar to any previously completed DES study, mean reference vessel diameter was rather small at 2.34mm. Thirteen percent of all lesions treated were total occlusions.
At one month, there were no deaths, Q-wave or non-Q-wave MIs, or target lesion or vessel revascularizations in the SES arm, compared to 2 deaths and 3 non-Q-wave MIs in the control arm (MACE = 6.3%; p=0.1 compared to SES).
There was a highly significant 82% reduction in in-segment late lumen loss at nine months in the SES arm (0.8mm versus 0.44mm for controls; p<0.0001), which corresponded with a 76% reduction in in-segment restenosis (from 33% to 7%; p<0.001) and a 84% drop in in-stent restenosis (from 31% to 4.9%; p<0.0001). Nine-month MACE was also significantly reduced by the SES, from 36.3% to 11.3%. (See Table 1) Commenting on these results, session moderator and TCT co-director, Dr. Martin Leon, “The fact that this study was non-sponsored I think adds important credibility. We had angiographic follow-up on more insulin-dependent diabetics here than in the whole SIRIUS trial, so the insights are very important.” He went on to say: “These results are staggering.” More data on patients with diabetes
Data presented at TCT 2004 from two registries serve to expand the burgeoning database on the safety and efficacy of the CYPHER stent in the treatment of patients with diabetes. Presenting the one-year follow-up on 642 patients enrolled into the BRIDGE registry (French study), Dr Philippe Commeau, Beauregard Hospital, Marseille, France, reported a TLR rate of 6.2% and MACE rate of 10.2% in this highly challenging patient population in whom 73% had multi-vessel disease and >30% were IDDM. In a separate presentation, Dr Giulio Guagliumi, Bergamo, Italy, reported a TLR of 1.7% and MACE rate of 4.6% in 4,149 diabetic patients followed-up out to six months.