Insulin may not be the culprit in poorer outcomes, according to TUXEDO sub-study.
Researchers examined the after-risk adjustment for insulin-treated type 2 diabetes patients who underwent stenting, looking at the rate of combined cardiac death, target vessel myocardial infarction or target vessel revascularization, compared with patients on other anti-diabetes drugs.
The analysis determined that patients with insulin-treated diabetes mellitus (ITDM) had similar outcomes when compared with those with non-ITDM after-risk adjustment, and use of everolimus-eluting stents was superior to paclitaxel-eluting stents in such patients.
Prior studies have shown that patients with ITDM have a higher risk of cardiovascular events. However, this finding is controversial, as other studies have shown that the increased risk of cardiovascular events disappears after risk adjustment. In addition, the choice of a drug-eluting stent (limus- vs taxol-eluting) in ITDM is controversial, with studies showing worse outcomes with an everolimus-eluting stent compared with a paclitaxel-eluting stent.
This study was done to compare those on insulin with those not on insulin and on the use of stents, who underwent percutaneous coronary intervention and to assess the efficacy and safety of an everolimus-eluting stent vs a paclitaxel-eluting stent based on insulin use status.
So, a prespecified analysis was conducted of the Taxus Element vs Xience Prime in a Diabetic Population (TUXEDO) clinical trial, which enrolled 1,830 patients with ITDM and non-ITDM from June 23, 2011 to March 12, 2014. Patients were randomized 1:1 to receive either a paclitaxel-eluting stent or an everolimus-eluting stent.
The primary endpoint was target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization at 1 year after the intervention.
The results showed that, among the 1,830 patients (1,377 male) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). Compared with the 1,083 patients with non-ITDM, those with ITDM had a significant increase in target vessel failure (42 vs 36; P = .02), death or myocardial infarction (43 vs 35; P = .009), death (26 vs 18; P = .01), and subacute stent thrombosis (8 vs 3; P = .03). The combined rate of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target vessel revascularization 1 year after stenting was higher for diabetes patients on insulin than their peers on other antidiabetic medications (5.6% versus 3.3%, P=0.02).
This arm also showed more deaths (3.5% versus 1.7%, P=0.01), more death or MI (5.8% versus 3.2%, P=0.009), and more subacute stent thrombosis (1.1% versus 0.3%, P=0.03) over the same period.
- In patients with DM enrolled in the TUXEDO trial, those with ITDM had significantly worse outcomes when compared with patients with non-ITDM.
- Compared with paclitaxel-eluting stents, everolimus-eluting stents reduced the rates of target vessel failure, MACE, MI, any stent thrombosis, definite stent thrombosis, target lesion revascularization, and target vessel revascularization in patients with ITDM.
- The absolute risk reduction of everolimus-eluting stents vs paclitaxel-eluting stents was greater for patients with ITDM when compared with those with non-ITDM.
JAMA Cardiology, April 20, 2016
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