CENTURY II: Bioresorbable-Polymer DES Safe, Effective at 2 Years

A new bioresorbable-polymer DES yields similar 2-year rates of target lesion failure and clinical outcomes compared with a commercially available DES with a durable polymer, according to results of the CENTURY II trial presented on Monday. 

The study enrolled patients slated for PCI with DES at 58 sites in Europe, Japan and Korea. Patients were randomized in a 1:1 fashion to receive Ultimaster (Terumo; n = 551), which releases sirolimus from an abluminal coating expected to resorb within 3 to 4 months, or Xience (Abbott Vascular; n = 557), which elutes everolimus from a permanent polymer.

The primary endpoint of CENTURY II — freedom from TLF (cardiac death, clinically indicated TLR and target vessel MI) at 9 months — was 4.26% with Ultimaster compared with 5.27% with Xience (P = .99). Shigeru Saito, MD, of Shonan Kamakura General Hospital, Kamakura, Japan, presented new 2-year results showing comparable TLF — 6.5% with Ultimaster and 6.6% with Xience — during longer-term follow-up (P = .66). Further, analysis of prespecified high-risk subgroups indicated no difference between the stents in 2-year TLF based on whether patients presented with high-risk ACS (P = .95) or had bifurcation lesions (P = .31), diabetes (P = .92), multivessel disease (P = .41), long lesions (P = .88) or small vessels (P = .98).

Other 2-year clinical outcomes also were comparable including death, cardiac death, clinically driven TLR, MI and target vessel MI. Saito noted a nonsignificant tendency toward lower rates of some clinical events in the Ultimaster group (Figure).

Additionally, the combined outcome of cardiac death and MI was 3.6% with Ultimaster and 4.7% with Xience (P = .66), and the incidence of a patient-oriented composite outcome of all-cause death, MI and revascularization was numerically but not significantly lower with Ultimaster at 2 years (13.3% vs. 16.9%; P = .16), Saito said.

“There was no very late stent thrombosis reported between 12 and 24 months for Ultimaster, which further demonstrated the good safety profile for this stent,” he said. Overall, the rate of definite or probable stent thrombosis at 2 years was 1.1% for each stent (P = .99).

Rates of bleeding (9.8% with Ultimaster vs. 11.5% with Xience; P = .37), angina (5.5% vs. 7.4%, respectively; P = .23) and dual antiplatelet therapy use (31.1% vs. 29.2%, respectively; P = .50) were also similar at 2 years.

“The long-term follow-up to 2 years of this large-scale global trial enrolling a patient population representing daily clinical practice, demonstrated good safety and efficacy of the Ultimaster stent,” Saito concluded. “The results were similar in both studied stents.”

Follow-up in the CENTURY II trial is planned through 5 years.

Disclosures: 

• Saito reports receiving grant/research support and consultant/honoraria fees from Terumo Corporation.