ADVERTISEMENT
Treatment of Coronary Artery Disease in Dialysis Patients with Sirolimus-eluting Stents: 1-year Clinical Follow-up of a Consecut
December 2004
In this preliminary series, sirolimus-eluting stent implantation appeared safe and effective for the treatment of dialysis patients with coronary artery disease. Dialysis patients are well known to be a high-risk population for cardiovascular morbidity and mortality, especially due to coronary atherosclerotic disease. However, the management of coronary disease in patients with end-stage renal failure is often problematic due to the presence of multiple co-morbidities and frequent limitations to drug prescription.1 Moreover, these patients have been reported to be at a higher risk for short- and long-term complications after invasive treatment compared to non-dialysis patients.2,3 The overall impact of invasive coronary treatment in dialysis patients is an ongoing debate. In a recent report, coronary bypass surgery was associated with superior outcomes compared to conventional stenting, with in-stent restenosis being suggested as a possible contributor to the impaired outcomes after percutaneous treatment.4
Sirolimus-eluting stents (SES) have been recently shown in randomized studies to markedly decrease neointimal growth and in-stent restenosis in comparison with conventional stents.5-7 However, all clinical trials conducted to date excluded patients with decreased renal function, and therefore the impact of SES implantation in patients with renal failure is currently unknown. The present study aimed to report on the 1-year clinical outcomes of a consecutive series of patients on chronic dialysis treated with SES.
Since April 2002, SES (Cypher; Johnson & Johnson-Cordis unit, Cordis Europa NV, Roden, the Netherlands) have been routinely utilized as the device of choice for all patients treated with percutaneous coronary intervention in our institution.8 During the first 6 months of this policy, SES implantation was performed in ten consecutive patients on chronic dialysis, who comprise the present study population. All patients on either chronic haemodialysis or peritoneal dialysis at the time of the procedure were included.
Methods
Percutaneous interventions were performed utilizing standard techniques, with the final strategy entirely left at the discretion of the operator aiming to achieve a residual stenosis 2,4,9–22 Although the present study did not include an angiographic re-evaluation, the uneventful late clinical outcomes observed were consistent with a marked reduction in the incidence of restenosis, as seen in non-dialysis patients.5–7
Coronary surgery has been associated with better clinical outcomes than percutaneous intervention in patients on chronic dialysis.4 However, the impact of restenosis as a contributor to the worse outcomes after angioplasty is still to be clarified.4 Five out of ten patients in the present series had undergone multivessel SES implantation. In all of these patients, the interventional treatment included stenting of lesions located in the left anterior descending artery or left main coronary, an anatomical scenario typically referred to surgical treatment. Whether SES constitutes an effective therapeutic option for dialysis patients with multivessel disease will have to be determined in further studies incorporating larger number of patients.
The SES decrease restenosis by locally delivering the antiproliferative drug, which eventually inhibits neointimal formation and prevents late lumen renarrowing. The interaction between the local administration of sirolimus and the systemic immunosuppression therapy in patients undergoing renal transplantation is currently unclear. In our series, renal transplantation was performed in 4 patients during the follow-up period. None of these patients presented any clinical complication that could be associated with increased drug toxicity. However, importantly, in all cases the transplantation was performed at least 3 months after the coronary procedure and, based on the known drug kinetics of SES, most of the drug should have been released by 1 month after the implantation.
1. Tozawa M, Iseki K, Iseki C, et al. Analysis of drug prescription in chronic hemodialysis patients. Nephrol Dial Transplant 2002;17:1819–1824.
2. Best PJ, Lennon R, Ting HH, et al The impact of renal insufficiency on clinical outcomes in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol 2002;39:1113–1119.
3. Rubenstein MH, Harrell LC, Sheynberg BV, et al. Are patients with renal failure good candidates for percutaneous coronary revascularization in the new device era? Circulation 2000;102:2966–2972.
4. Herzog CA, Ma JZ, Collins AJ. Comparative survival of dialysis patients in the United States after coronary angioplasty, coronary artery stenting, and coronary artery bypass surgery and impact of diabetes. Circulation 2002;106:2207–2211.
5. Moses JW, Leon MB, Popma JJ, et al. SES versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315–1323.
6. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a SES with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773–1780.
7. Schofer J, Schluter M, Gershlick AH, et al. SES for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093–1099.
8. Lemos PA, Lee C, Degertekin M, et al. Early outcome after SES implantation in patients with acute coronary syndromes. Insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol 2003;41:2093–2099.
9. Kahn JK, Rutherford BD, McConahay DR, et al. Short- and long-term outcome of percutaneous transluminal coronary angioplasty in chronic dialysis patients. Am Heart J 1990;119:484–489.
10. Ahmed WH, Shubrooks SJ, Gibson CM, et al. Complications and long-term outcome after percutaneous coronary angioplasty in chronic hemodialysis patients. Am Heart J 1994;128:252–255.
11. Rinehart AL, Herzog CA, Collins AJ, et al. A comparison of coronary angioplasty and coronary artery bypass grafting outcomes in chronic dialysis patients. Am J Kidney Dis 1995;25:281–290.
12. Koyanagi T, Nishida H, Kitamura M, et al. Comparison of clinical outcomes of coronary artery bypass grafting and percutaneous transluminal coronary angioplasty in renal dialysis patients. Ann Thorac Surg 1996;61:1793–1796.
13. Marso SP, Gimple LW, Philbrick JT, DiMarco JP. Effectiveness of percutaneous coronary interventions to prevent recurrent coronary events in patients on chronic hemodialysis. Am J Cardiol 1998;82:378–380.
14. Simsir SA, Kohlman-Trigoboff D, Flood R, et al. A comparison of coronary artery bypass grafting and percutaneous transluminal coronary angioplasty in patients on hemodialysis. Cardiovasc Surg 1998;6:500–6505.
15. Herzog CA, Ma JZ, Collins AJ. Long-term outcome of dialysis patients in the United States with coronary revascularization procedures. Kidney Int 1999;56:324–332.
16. Hang CL, Chen MC, Wu BJ, et al. Short- and long-term outcomes after percutaneous transluminal coronary angioplasty in chronic hemodialysis patients. Cathet Cardiovasc Interv 1999;47:430–433.
17. Le Feuvre C, Dambrin G, Helft G, et al. Comparison of clinical outcome following coronary stenting or balloon angioplasty in dialysis versus non-dialysis patients. Am J Cardiol 2000;85:1365–1368.
18. Agirbasli M, Weintraub WS, Chang GL, et al. Outcome of coronary revascularization in patients on renal dialysis. Am J Cardiol 2000;86:395–399.
19. Azar RR, Prpic R, Ho KK, et al. Impact of end-stage renal disease on clinical and angiographic outcomes after coronary stenting. Am J Cardiol 2000;86:485–489.
20. Malanuk RM, Nielsen CD, Theis P, et al. Treatment of coronary artery disease in hemodialysis patients: PTCA vs. stent. Cathet Cardiovasc Interv 2001;54:459–463.
21. Hase H, Nakamura M, Joki N, et al. Independent predictors of restenosis after percutaneous coronary revascularization in hemodialysis patients. Nephrol Dial Transplant 2001;16:2372–2377.
22. Le Feuvre C, Borentain M, Beygui F, et al. Comparison of short- and long-term outcomes of coronary angioplasty in patients with and without diabetes mellitus and with and without hemodialysis. Am J Cardiol 2003;92:721–725.