At 2 years, superiority not confirmed for amphilimus-eluting stent in diabetes
BOSTON — After 2 years, PCI with amphilimus-eluting stents was noninferior to PCI with zotarolimus-eluting stents in patients with diabetes, not confirming the potential superiority signal observed at 1 year.
The 2-year results of the second-generation drug-eluting stents in diabetes randomized (SUGAR) trial were presented at TCT 2022.
The 1-year findings, presented at TCT 2021 and published in the European Heart Journal, indicated that the amphilimus-eluting stents (Cre8 Evo, Alvimedica) may be superior to zotarolimus-eluting stents (Resolute Onyx, Medtronic) in patients with diabetes at 1 year for the primary endpoint of target lesion failure, defined as cardiac death, target vessel MI or target lesion revascularization (HR = 0.65; 95% CI, 0.44-0.96; P = .03). That analysis was powered for noninferiority.
When the researchers conducted an analysis of the 2-year outcomes, the same primary endpoint was powered for superiority.
“SUGAR is the first randomized trial to compare second-generation drug-eluting stents in patients with diabetes in an all-comers pragmatic design,” Pablo Salinas, MD, PhD, of the San Carlos Clinical Hospital and San Carlos Clinical Hospital Institute of Health Research in Madrid, said during a press conference. “At 2 years, there is insufficient evidence that amphilimus-eluting stents are superior to zotarolimus-eluting stents with regard to target lesion failure in patients with diabetes undergoing PCI.”
SUGAR was a randomized trial in which 1,175 all-comer patients with diabetes indicated for PCI were assigned to undergo the procedure with a polymer-free stent eluting amphilimus or a durable polymer stent eluting zotarolimus.
Salinas and colleagues reported that, at 2 years, the SUGAR trial did not meet its primary endpoint and the outcome of TLF was not significantly different between patients treated with the amphilimus-eluting stent (10.4%) compared with zotarolimus-eluting stent (12.1%; HR = 0.84; 95% CI, 0.6-1.19; P = .331).
There was no significant difference between the two stents for the individual secondary outcomes of cardiac death (HR = 0.81; 95% CI, 0.42-1.55; P = .519), target vessel MI (HR = 0.89; 95% CI, 0.56-1.42; P = .627) and target vessel revascularization (HR = 0.93; 95% CI, 0.54-1.6; P = .782).
Moreover, researchers also observed no significant difference between the groups for all-cause mortality (HR = 1.03; 95% CI, 0.67-1.59; P = .89), all subsequent revascularizations (HR = 0.79; 95% CI, 0.54-1.19; P =.265) and MACE (HR = 0.88; 95% CI, 0.68-1.19; P = .371).
“It is important to remind everyone that a 7% all-cause mortality in a STEMI trial is quite high. These patients have the same chance of dying from cardiac causes as noncardiac causes,” Salinas said during the press conference. “We need a more comprehensive approach to patients with diabetes. Also ... roughly 50% of new revascularizations were of [the initial target vessel], so there is disease progression in these patients in just 2 years.”
Reference:
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Salinas P, et al. Late-Breaking Clinical Science in Coronary Artery Disease: Session VI, in Collaboration With Circulation. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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