TY - JOUR
T1 - Impact of moderate renal insufficiency on restenosis and adverse clinical events after sirolimus-eluting and bare metal stent implantation (from the SIRIUS trials)
AU - Garg, Pallav
AU - Charytan, David M.
AU - Novack, Lena
AU - Cutlip, Donald E.
AU - Popma, Jeffrey J.
AU - Moses, Jeffrey
AU - Leon, Martin B.
AU - Schofer, Joachim
AU - Breithardt, Guenter
AU - Schampaert, Erick
AU - Mauri, Laura
N1 - Funding Information:
Dr. Popma has been a member of Cordis/Johnson & Johnson Science Advisory Board, Miami, Florida, and has received research grant from Cordis/Johnson & Johnson . Dr. Leon was previously a member of Cordis/Johnson & Johnson Science Advisory Board. Dr. Moses has served as a speaker for Cordis/Johnson & Johnson. Dr. Schampaert has received a research grant from Cordis/Johnson & Johnson (honoraria <$10,000) and served as a consultant and speaker with Cordis/Johnson & Johnson, Boston Scientific, Natick, Massachusetts, Eli Lilly, Indianapolis, Indiana, Sanofi-Aventis, Bridgewater, New Jersey, and GlaxoSmithKline, Brentford, Middlesex, United Kingdom (all honoraria <$10,000). Drs. Schofer and Breithardt have received compensation for travel expenses and accommodation as co-PI for participation in meetings of the Steering Committee of E-SIRIUS. Dr. Mauri has served as a consultant with Cordis/Johnson & Johnson and Medtronic, Minneapolis, Minnesota, (honoraria <$10,000). The other authors have no disclosures.
PY - 2010/11/15
Y1 - 2010/11/15
N2 - Whether drug-eluting stents are effective and safe in patients with moderate renal insufficiency (RI) is unknown. We performed a pooled analysis of data from 3 blinded randomized trials of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs; SIRIUS, C-SIRIUS, E-SIRIUS) that included 1,510 patients. Clinical and angiographic outcomes were stratified by the presence of RI defined by creatinine clearance calculated by the Cockcroft-Gault formula (normal ≥90, mild 60 to 89, moderate <60 ml/min). Patients with baseline creatinine >3.0 mg/dl were excluded from these trials. Baseline mild RI was present in 517 patients (34.7%, mean creatinine clearance 75.7 ml/min) and moderate RI in 228 patients (15.3%, mean creatinine clearance 47.2 ml/min). Treatment with SESs resulted in lower rates of 8-month angiographic restenosis rates in patients with RI (mild RI 6.7% vs 42.6%, p <0.001; moderate RI 9.7% vs 39.7%, p <0.001) and without baseline RI (7.7% vs 37.2%, p <0.001). One-year target vessel revascularization rates were similarly decreased with SESs in patients with (mild RI 4.7% vs 24.2%, p <0.001; moderate RI 5.5% vs 26.9%, p <0.001) and without (8.1% vs 22.4%, p <0.001) RI, and this benefit was maintained at 5 years. Compared to patients with normal or mild RI, patients with moderate RI had higher rates of overall mortality and cardiac death at 1 year and 5 years (death 2.6% vs 0.6%, p <0.01, and 17.5% vs 6.3%, p <0.01, at 1 year and 5 years, respectively; cardiac death 1.3% vs 0.2%, p = 0.05, and 6.6% vs 3.4%, p = 0.04, at 1 year and 5 years, respectively). However, there was no differential effect of SESs versus BMSs on any safety end point. In conclusion, patients with moderate RI have a nearly threefold increase in 5-year mortality after percutaneous coronary intervention compared to patients without RI. The effectiveness of SESs in decreasing restenosis compared to BMSs in patients with moderate RI was preserved and rates of death and myocardial infarction were not adversely affected.
AB - Whether drug-eluting stents are effective and safe in patients with moderate renal insufficiency (RI) is unknown. We performed a pooled analysis of data from 3 blinded randomized trials of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs; SIRIUS, C-SIRIUS, E-SIRIUS) that included 1,510 patients. Clinical and angiographic outcomes were stratified by the presence of RI defined by creatinine clearance calculated by the Cockcroft-Gault formula (normal ≥90, mild 60 to 89, moderate <60 ml/min). Patients with baseline creatinine >3.0 mg/dl were excluded from these trials. Baseline mild RI was present in 517 patients (34.7%, mean creatinine clearance 75.7 ml/min) and moderate RI in 228 patients (15.3%, mean creatinine clearance 47.2 ml/min). Treatment with SESs resulted in lower rates of 8-month angiographic restenosis rates in patients with RI (mild RI 6.7% vs 42.6%, p <0.001; moderate RI 9.7% vs 39.7%, p <0.001) and without baseline RI (7.7% vs 37.2%, p <0.001). One-year target vessel revascularization rates were similarly decreased with SESs in patients with (mild RI 4.7% vs 24.2%, p <0.001; moderate RI 5.5% vs 26.9%, p <0.001) and without (8.1% vs 22.4%, p <0.001) RI, and this benefit was maintained at 5 years. Compared to patients with normal or mild RI, patients with moderate RI had higher rates of overall mortality and cardiac death at 1 year and 5 years (death 2.6% vs 0.6%, p <0.01, and 17.5% vs 6.3%, p <0.01, at 1 year and 5 years, respectively; cardiac death 1.3% vs 0.2%, p = 0.05, and 6.6% vs 3.4%, p = 0.04, at 1 year and 5 years, respectively). However, there was no differential effect of SESs versus BMSs on any safety end point. In conclusion, patients with moderate RI have a nearly threefold increase in 5-year mortality after percutaneous coronary intervention compared to patients without RI. The effectiveness of SESs in decreasing restenosis compared to BMSs in patients with moderate RI was preserved and rates of death and myocardial infarction were not adversely affected.
UR - http://www.scopus.com/inward/record.url?scp=78149439662&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2010.07.011
DO - 10.1016/j.amjcard.2010.07.011
M3 - Article
C2 - 21059433
AN - SCOPUS:78149439662
SN - 0002-9149
VL - 106
SP - 1436
EP - 1442
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 10
ER -