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Insulin treatment may affect outcomes after PCI in patients with diabetes
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In a secondary analysis of the TUXEDO trial, patients with insulin-treated diabetes had a significantly increased risk for adverse CV events after PCI, but this finding was attenuated after adjustment for baseline risk factors, diabetes duration and diabetes control.
Moreover, use of everolimus-eluting stents (EES) appears to mitigate the risk for adverse CV events, including stent thrombosis, compared with paclitaxel-eluting stents (PES) in patients with insulin-treated diabetes.
For the prespecified secondary analysis, Sripal Bangalore, MD, MHA, and colleagues evaluated 1,830 participants (1,377 men) of the TUXEDO trial who were randomly assigned to PCI with PES or EES from June 2011 to March 2014. Participants were further classified as insulin-treated (n = 747; 40.8%) or non-insulin-treated (n = 1,083; 59.2%). All participants also received dual antiplatelet therapy before PCI and for at least 12 months after stent implantation. Follow-up took place at 30 days, 180 days and 1 year after the index procedure.
Sripal Bangalore
The primary endpoint, which was also the primary endpoint of the TUXEDO trial, was target vessel failure at 1 year. This outcome was a composite of cardiac death, target vessel MI or ischemia-driven target vessel revascularization.
Compared with non-insulin-treated diabetes, those treated with insulin had a higher prevalence of TVF (5.6% vs. 3.3%; P = .02), MACE (6% vs. 3.7%; P = .02), death or MI (5.8% vs. 3.2%; P = .009) and cardiac death or MI (4.7% vs. 2.9%; P = .04). Moreover, insulin treatment was associated with increased rates of mortality (3.5% vs. 1.7%; P = .01), Q-wave MI (0.9% vs. 0.2%; P = .04) and subacute stent thrombosis (1.1% vs. 0.3%; P = .03). Nonsignificantly higher rates of cardiac death, target lesion revascularization and TVR were also seen in the insulin-treated diabetes group. Participants with an HbA1c of at least 7% had higher rates of TVF compared with those with an HbA1c less than 7% in both insulin-treated (5.7% vs. 4.8%) and non-insulin-treated participants with diabetes (3.2% vs. 2.9%).
In the regression adjustment to a propensity score model, which accounted for baseline variations between the groups, all of the aforementioned CV risks were attenuated to the point of no longer retaining statistical significance, according to the researchers.
Additional analyses of the insulin-treated group revealed that EES decreased the prevalence of TVF (3.4% vs. 7.9%; P = .007), MACE (3.9% vs. 8.2%; P = .01), MI (1.3% vs. 4.4%; P = .01), stent thrombosis (0.5% vs. 3%; P = .009), TLR (1% vs. 5.2%; P = .001) and TVR (1% vs. 5.2%; P = .001) compared with PES.
In non-insulin-treated participants, EES yielded a decrease in target vessel-related MI vs. PES (0.6% vs. 2%) and showed a trend toward results comparable to the insulin-treated group in terms of other outcomes (P > .05 for interaction).
According to the researchers, the increased risk for CV events in insulin-treated patients appears to be largely attributable to baseline variations between treatment with or without insulin.
“In patients with [diabetes] enrolled in the TUXEDO trial, those with [insulin-treated diabetes] had significantly worse outcomes compared with patients with non-[insulin-treated diabetes] in the unadjusted analysis,” Bangalore, associate professor of medicine at New York University School of Medicine, and colleagues wrote in JAMA Cardiology
“However, this finding was largely attenuated in the propensity score-adjusted analysis, implying that the increased possibility of adverse [CV] events in patients with [insulin-treated diabetes] is accounted for by the differences in baseline risk factors, diabetes duration and [diabetes] control.” – by Jennifer Byrne
Disclosure: One researcher reports receiving an honorarium from Abbott Vascular. Another researcher reports receiving grants/personal fees from Boston Scientific Corp. and grants from Abbott Vascular.
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