RESET: Similar rates of TLR in PCI with newer vs. older DES
SAN DIEGO — Patients who underwent PCI with a newer-generation everolimus-eluting stent had a similar risk for target lesion revascularization compared with those who underwent the procedure with a first-generation sirolimus-eluting stent, according to data presented at TCT 2018.
Hiroki Shiomi, MD, assistant professor in the department of cardiovascular medicine at Kyoto University Hospital in Japan, and colleagues analyzed 7-year data of 2,667 patients from the RESET trial. Patients were assigned a newer-generation EES (Xience, Abbott Vascular; n = 1,335; mean age, 69 years; 77% men) or a first-generation SES (Cypher, Cordis; n = 1,332; mean age, 69 years; 76% men). Seven-year clinical follow-up data were available for 2,441 patients.
In 3-year results published in Circulation: Cardiovascular Interventions in 2014, EES were noninferior to SES related to TLR and either death or MI.
The primary efficacy endpoint of TLR was not significantly different in the EES and SES groups at 7 years (10.2% vs. 11.7%, respectively; HR = 0.87; 95% CI, 0.68-1.1). Incidence of TLR was also not statistically different in the two groups in a landmark analysis of 1-year data (4.3% vs. 4.7%, respectively; HR = 0.93; 95% CI, 0.64-1.33).
The cumulative incidence of the primary safety endpoint, defined as death or MI, was lower in patients assigned EES vs. SES at 7 years (20.6% vs. 23.6%; HR = 0.85; 95% CI, 0.72-1.005). In a landmark analysis, the incidence of the primary safety endpoint was lower in the EES group vs. the SES group within 1 year (4.3% vs. 5.9%; HR = 0.71; 95% CI, 0.5-0.999), although this was not seen after 1 year (HR = 0.9; 95% CI, 0.75-1.09).
In a composite endpoint of target lesion failure, defined as cardiac death, clinically driven TLR or target vessel MI, the incidence was lower in the newer-generation EES vs. the SES (HR = 0.72; 95% CI, 0.59-0.88). The EES group also had a lower incidence of target vessel failure, defined as a composite of MI, cardiac death or clinically driven target vessel revascularization, compared with the SES group (HR = 0.8; 95% CI, 0.67-0.95).
“During 7 years of follow-up, the risk for the primary and composite endpoint of target lesion revascularization was not significantly different between new-generation everolimus-eluting stents and first-generation sirolimus-eluting stents,” Shiomi said during the press conference. – by Darlene Dobkowski
Shiomi H, et al. Late-Breaking Clinical Science 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Shiomi reports no relevant financial disclosures.