Drug-eluting stents in patients with stage 5 chronic kidney disease and dialysis replacement therapy: are they safe?

s / Cardiovascular Revasculariza mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis as compared to bare metal stents (BMS) but in patients with CKD data on efficacy and safety of DES is limited. Methods: This is a subanalysis of a registry of 611 consecutive patients who underwent percutaneous coronary intervention with DES between June 2002 and June 2006. A total of 504 patients had serum creatinine available and were included in this analysis. Outcomes were stratified on the basis of the presence of CKD, defined as a baseline glomerular filtration rate b60 ml/min per 1.73 m. Results: CKD was present in 165 patients (32.7%). Patients with CKD were older, had more hypertension and diabetes. The mean follow-up was 22.7 months (maximal, 63.5 months). Patients with CKD presented higher incidence of death (12.3% vs. 2.4%, Pb.001) and myocardial infarction (MI) (7.4% vs. 3.3%, P=.04) when compared to patients without CKD. However, the toll-like receptor rates were similar between groups (4.8% vs. 5.6%, P=.7, patients with CKD and without CKD, respectively). Conclusion: In this real-world registry, coronary intervention with DES in patients with CKD was associated with similar target lesion revascularization, as compared to patients without CKD, indicating the efficacy of DES in preventing in-stent restenosis in this population. Nevertheless, CKD was associated with higher MI and mortality rates. doi:10.1016/j.carrev.2009.04.026 Drug-eluting stents in patients with stage 5 chronic kidney disease and dialysis replacement therapy: are they safe? Luis Gruberg, William E Lawson, Allen Jeremias, Anil Mani, Joseph Chernilas, Lisa Wilbert, David L Brown Stony Brook University Medical Center, Stony Brook, NY Background: Patients with Stage 5 chronic kidney disease (CKD) on dialysis replacement therapy who undergo coronary revascularization are at a higher risk for poor outcomes and repeat interventions. These patients have been con -sistently excluded from contemporary studies with drug-eluting stents (DES). Methods: Between June 2003 and December 2007, a total of 74 end-stage renal disease patients underwent coronary revascularization with a DES. These patients were compared to 77 Stage 5 CKD patients treated with bare metal stents (BMS) in a similar time period between January 2000 and May 2003. Results: Baseline clinical characteristics were similar between the two groups, except for a higher percentage of male patients in the DES arm. Inhospital outcomes were similar in both groups, and at 6-months of followup, the incidence of clinical restenosis and the need for repeat revascularization procedures were similar in both groups. DES (n=74) BMS (n=77) P Age (years) 64.3 62.8 NS Male gender (%) 74.3 51.9 P≤.01 Diabetes (%) 56.8 57.1 NS Three-vessel disease (%) 35.1 26.0 NS Ejection fraction (%) 48 44 NS Revascularization (%) 17.6 14.3 NS Restenosis (%) 8.1 10.4 NS Stent thrombosis (%) 0 0 NS Death (%) 4.1 2.6 NS Conclusions: The use of DES in Stage 5 CKD patients on dialysis replacement therapy seems to be safe and effective, with low rates of revascularization procedures, stent thrombosis, and major cardiac events when compared to similar patients treated with bare metal stents. doi:10.1016/j.carrev.2009.04.027 Predictors of major adverse cardiac events in patients undergoing percutaneous coronary intervention with drug-eluting stents for the treatment of saphenous vein graft disease Nicholas J Ruggiero II , Stuart Gould, Heath Saltzman, Deborah DeEugenio, Abhijit DasGupta, Thomas Kiernan , Bryan P Yan, Paul Walinsky, David Fischman, Michael Savage Massachusetts General Hospital, Boston, MA Thomas Jefferson University Hospital, Philadelphia, PA Temple University School of Pharmacy, Philadelphia, PA Background: In our prior study, we illustrated that diffuse disease (defined as N30 mm of disease or more than three lesions in one vessel) in comparison to focal disease was associated with a statistically significant increase in major adverse cardiac events (MACE) events. Building on that premise, we performed a multivariate analysis on the study population to evaluate if other risk factors imparted an increased risk of MACE. Methods: Seventy consecutive patients [75 saphenous vein grafts (SVG)] treated with DES were evaluated. Procedural outcomes and MACE were assessed at a mean follow-up of 17±9 months. MACE was defined as death, myocardial infarction (MI), stent thrombosis, or target vessel revascularization (TVR). Results: The study population consisted of 61 men and nine women with a mean age of 70±8 years. Twenty-eight (40%) patients had diabetes. Fortythree (61%) patients had an acute coronary syndrome.Mean SVG age was 12 ±6 years. Diffuse disease was present in 29 grafts (39%). A total of 94 lesions were treatedwith 114 stents, including 104 (91%)Cypher and 10 (9%) Taxus. Total stent length was 31±20 mm. Distal protection was utilized in 55% of interventions. PCI was successful in all patients, with no periprocedural deaths, coronary artery bypass graft or stent thromboses. There was one acute non-Q-wave MI (1.3%) and one death at late follow-up. At 1 year, actuarial TVR-free survival was 84% in all patients. TVR-free survival was 97% in focal disease versus 64% in diffuse disease (Pb.01). At 1 year, freedom from any MACE was 95% in focal disease versus 61% in diffuse disease. Conclusion: Cox regression analysis illustrated that diffuse disease, hyperlipidemia, tobacco use, peripheral arterial disease, graft age N8 years, and acute coronary syndrome at the time of procedure all impart a statistically significant increase in MACE events. doi:10.1016/j.carrev.2009.04.028 Normal vasomotor function with minimal inflammatory response to cerivastatin-eluting stent in a rabbit iliac model Lakshmana K Pendyala, Traci Goodchild, Xinhua Yin, Jinsheng Li , Toshiro Shinke, Sarah Geva , Anna Venegoni, Kenneth Colley, Nicolos Chronos , Keith Robinson, Dongming Hou c Saint Joseph's Research Institute, Madison, GA Medlogics Device Corporation, Santa Rosa, CA Saint Joseph's Research Institute, Atlanta, GA Background: We evaluated cytotoxicity of cerivastatin on vascular cells in vitro along with endothelial structure and function following implantation of cerivastatin-eluting stent (CES) in rabbit iliac arteries in vivo. Methods: Human aortic smooth muscle and endothelial cells (hAEC), as well as rabbit aortic smooth muscle were cultured and IC50 curves were generated using cerivastatin (0.4–6.4 μM). A total 36 stents (bare metal, sham with coating only and CES, n=12/group) were implanted in 18 rabbits. Animals were terminated at 28 days post implant for vasomotor function and histological assessment. Results: IC50 of cerivastatin on smooth muscle cells from human and rabbit were similar (−5.9 and −5.0 M, respectively). Cerivastatin did not have any cytotoxic effects on hAEC. Vasodilation response to incremental doses of acetylcholine and NTG was demonstrated in all three groups, P=NS (Fig). Histopathology scoring for re-endothelialization, inflammatory cell infiltration, intramural thrombi, and luminal endothelial cell coverage were not different in all groups. There was also no difference in the number of adherent inflammatory cells among stented arms. 201 tion Medicine 10 (2009) 195–212