SORT-OUT VI: 3-Year Outcomes Similar With BES, ZES

A biodegradable-polymer biolimus-eluting stent (BES) and a permanent-polymer zotarolimus-eluting stent (ZES) both offer low rates of MACE through 3 years, according to extended follow-up of the SORT-OUT VI trial presented in the Main Arena on Tuesday. 

For the SORT-OUT VI trial, Bent Raungaard, MD, of Aarhus University Hospital, Aarhus, Denmark, and colleagues enrolled 2,999 Scandinavian patients (mean age 65 years; approximately 75% men) with chronic stable CAD or ACS and at least one coronary lesion of ≥ 50% diameter stenosis in a vessel with a reference diameter of 2.25 mm to 4 mm. Patients were randomly assigned to PCI with the Resolute Integrity ZES (Medtronic; n = 1,502) or BioMatrix Flex BES (Biosensors; n = 1,497). Three-year follow-up data were available for 99.8% of the original cohort.  

Baseline characteristics were well-proportioned between the groups. In each group, 18% of patients had diabetes and 30.7% were current smokers. However, more patients assigned BES had prior PCI (P = .03) and more patients assigned ZES had prior CABG (P = .09). The percentage of patients with more than one lesion and the total stented length per patient were higher in the ZES group. Also, more patients had lesion type B2/C in the ZES group, though the difference did not reach statistical significance.

At 3 years, the occurrence of MACE including cardiac death, MI and target lesion revascularization (primary endpoint) was similar with BES and ZES (Figure).

When the researchers examined individual components of MACE, there were no differences in the 3-year rates of cardiac death (BES 3.4%, ZES 2.7%; OR 0.81; 95% CI 0.54-1.22; P = .31), MI not clearly attributable to non-target lesions (2.5% and 2.6%, respectively; OR 1.03; 95% CI 0.66-1.61; P =.89) or TLR (5.5% and 5.4%, respectively; OR 0.98; 95% CI 0.72-1.33; P = .36).

Definite stent thrombosis was 1.1% with BES and 1% with ZES (OR 0.89; 95% CI 0.44-1.77; P = .73). One-year landmark analysis revealed similar results for the 2 devices.   

“The 3-year results from the SORT-OUT VI all-comer randomized trial show that both [devices] have excellent long-term safety and efficacy profile,” Raungaard concluded, adding, “These data indicate that a durable polymer can be as safe and efficacious as a biodegradable polymer.”

Disclosures: 

• Raungaard reports no relevant conflicts of interest.