Large Study Finds Comparable 8-Month TVF for PES, SES

MIAMI BEACH, FLA.—Eight-month results from the largest prospective randomized trial to date comparing sirolimus-eluting (SES) and paclitaxel-eluting stents show similar rates of target vessel failure among all patients, including those with diabetes. However, at 12 months, the risk of TVF and MACCE was greater with PES.

Masato Nakamura, MD, of the Toho University Ohashi Medical Center in Japan, presented interim results from the J-DESsERT trial, a randomized comparison of PES and SES in an overall population including a subset of diabetics. The trial included a total of 3,553 patients at 123 sites. Patients were randomly assigned to SES (n=1,766) or PES (n=1,767), with randomization stratified based on the presence or absence of diabetes. 

“In a specific disease condition, such as in diabetic patients, it has been reported that PES are more suitable than SES, due to the difference in the mechanism of action of the drugs,” Nakamura said. “But there has been no conclusion yet stating which one of the stents is superior to the other.”

Nakamura noted there was no difference in the primary endpoint of TVF at 8 months for both the overall cohort and the diabetic subset, but at 12 months a difference emerged (see Figures 1-2). Additionally, rates of MACCE at 8 months were similar for all patient populations; however, at 12 months, rates of MACCE were lower with SES for the overall population (6.9% vs. 10%; P=.0018), which he said was due to a lower rate of TLR with SES vs. PES (2.9% vs. 6.8%; P<.0001).

Both stents demonstrated comparable outcomes with respect to the risk of MI (SES, 1.7% vs. PES, 1.2%; P=.23) or death (SES, 1.1% vs. PES, 1.3%; P=.54) at 1 year.

Nakamura said the study worked from the hypothesis that PES are non-inferior to SES in the overall study population in terms of TVF at 8 months post-procedure. Once that was confirmed, the aim was to compare the TVF rate at 8 months between PES and SES in the diabetic group.

Study details

Definitions for allocation into the diabetic group were a previous diabetes diagnosis, patients currently on diabetes medications, and HbA1c ≥ 6.5% within 30 days before the procedure. At baseline, unstable angina was more frequent in the PES group; a Type B2/C lesion was found in 65% of cases; and IVUS was used in more than 75% of cases.