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RESERVOIR: Amphilimus-eluting stent noninferior to EES in patients with diabetes
In patients with diabetes undergoing coronary revascularization, polymer-free amphilimus-eluting stents appear to be noninferior to everolimus-eluting stents, according to results of the RESERVOIR clinical trial.
In the multicenter, prospective, open-label, assessor-masked, active treatment-controlled, randomized clinical trial, researchers evaluated 112 patients with diabetes and confirmed silent ischemia, stable/unstable angina or non-STEMI. Eligible patients were being treated with glucose-lowering agents and had a single de novo coronary lesion per artery (in a maximum of two major coronary arteries) with length between 12 mm and 25 mm and an estimated reference diameter of 2.5 mm to 3.5 mm. After successful predilation, patients were randomly assigned to undergo revascularization with an amphilimus-eluting stent (AES; Cre8, Alvimedica; n = 56; 58 lesions) or an everolimus-eluting stent (EES; Xience Prime/Xience Expedition, Abbott Vascular; n = 56; 58 lesions). The primary endpoint was neointimal volume obstruction at 9 months, as evaluated by OCT.
Forty percent of patients overall were treated with insulin. The baseline HbA1c was 7.3% and did not change at follow-up. LDL levels were significantly decreased from baseline to follow-up (mean change, –8.9 mg/dL; 95% CI, –1.5 to –16.4), with no disparities between groups.
In the AES group, the primary endpoint of neointimal volume obstruction was 11.97 ± 5.94%, whereas in the EES group, the primary endpoint was 16.11 ± 18.18%, fulfilling the noninferiority criteria (P = .0003). In analyses of six prespecified subgroups, the researchers found no specific interactions between treatment allocation and OCT outcomes, except for patients with HbA1c levels greater than the median. Among patients in this subgroup, treatment with AES yielded a significantly lower neointimal volume obstruction vs. EES (mean difference, 10.62%; 95% CI, –22.68 to –1.69). In-stent late lumen loss in the AES group was 0.14 ± 0.24 mm vs. 0.24 ± 0.57 mm in the EES group (P = .27). In-segment late lumen loss was 0.06 ± 0.3 mm in the AES group vs. 0.21 ± 0.61 mm in the EES group (P = .34). The AES group demonstrated a larger minimal lumen diameter at follow-up (P = .02), owing primarily to two cases of occlusive restenosis in the EES group.
“The present study is the first to show the noninferiority of a polymer-free AES compared with the EES in patients with [diabetes], and it demonstrates that formulation of the drug with an amphiphilic carrier results in noninferior efficacy compared with the classic elution from SPIRIT III durable polymers,” the researchers wrote. “Results suggest a high efficacy of AES in patients with [diabetes], which must be confirmed by a large randomized clinical trial.” – by Jennifer Byrne
Disclosure: One researcher reports receiving speaker fees from Abbott, AstraZeneca, BioVentrix and Boston Scientific. Another researcher reports receiving a research grant and speaker fees from Abbott.