Comparison of sirolimus- and paclitaxel-eluting stents in patients with moderate renal insufficiency: results from the J-DESsERT trial.

BACKGROUND

It is unclear whether there are differences in clinical outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with moderate renal insufficiency (RI).

METHODS

The Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) was a prospective, randomized multicenter trial which compared 1:1 coronary stenting between SES and PES patients. Patient with serious RI (serum creatinine value 2mg/dL or higher) were excluded. Patients were classified into 2 arms according to renal function: a non-RI arm of 2220 patients (SES 1094 and PES 1126 patients with estimated glomerular filtration rate (eGFR) ≥60 mL min(-1) 1.73 m(-2)) and an RI arm of 1206 patients (SES 613, PES 593 with 30≤eGFR <60 mL min(-1) 1.73 m(-2)).

RESULTS

At 12 months, the primary endpoint of target vessel failure in the non-RI arm occurred in 6.0% in the SES group and 8.7% in the PES group (p=0.02). In the RI arm, this occurred in 5.7% and 8.1% (p=0.10). Mortality rates were 0.8% vs 0.7% (p=0.78) in the non-RI arm, and 2.2% vs 2.1% (p=0.90) in the RI arm. Cardiac death was 0.4% vs 0.1% (p=0.17) in the non-RI arm, and 1.0% vs 1.0% (p=0.96) in the RI arm. Mortality was higher in patients with RI than those without RI (2.1% vs 0.8%; p<0.01). Cardiac death rates increased in the RI arm compared with those in the non-RI arm (1.0% vs 0.2%; p<0.01).

CONCLUSIONS

Regardless of the presence or absence of moderate RI, differences in outcomes between SES and PES change little except mortality and cardiac death.