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

• Published in: Cardiovascular revascularization medicine 2014-09, Vol.15 (6), p.323-328
• Main Authors: Otsuka, Masaya, Yokoi, Hiroyoshi, Matsuyama, Yutaka, Hayashi, Yasuhiko, Shiode, Nobuo, Masaoka, Yoshiko, Okimoto, Tomokazu, Tamekiyo, Hiromichi, Kawase, Tomoharu, Yamane, Kenichi, Kagawa, Yuzo, Nakamura, Masato, Muramatsu, Toshiya, Nanto, Shinsuke
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary - methods; Cardiovascular; Coronary Restenosis - therapy; Drug-Eluting Stents; Female; Humans; Japan-Drug Eluting Stents Evaluation: a Randomized Trial (J-DESsERT); Male; Middle Aged; Paclitaxel - therapeutic use; Paclitaxel-eluting stents; Prospective Studies; Renal insufficiency; Renal Insufficiency - therapy; Risk Assessment; Sirolimus - therapeutic use; Sirolimus-eluting stents; Treatment Outcome
• ISSN: 1553-8389; 1878-0938
• DOI: 10.1016/j.carrev.2014.09.003

Abstract 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 J apan- D rug E luting S tent s E valuation; a R andomized T rial (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 2 mg/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.