Impact of estimated glomerular filtration rate on the 24 – months outcomes after drug-eluting stents implantation in patients with coronary artery disease and insulin-treated diabetes mellitus

   In patients with coronary artery disease (CAD), renal failure which can result in hemodialysis use is seen during the percutaneous coronary intervention (PCI) performed with contrast agents with iodide. This injury is more particularly in patients with diabetes with lower estimated glomerular filtration rate (eGFR) compared to the patients who have not diabetes.
   Aims: The aim of this study is to investigate the alterations in the renal glomerular filtration rate after the implantation of the drug-eluting stents (DESs) in the patients with Type-2 insülin-treated diabetes mellitus (ITDM) and CAD.

   Study Design: Prospective study.
   Methods: In total, 463 patients with ITDM in which one or more drug-elution stents under PCI were inserted successively for last 5 years (last uptated to December 2015) were included into the study. Patients in both groups were followed with eGFR with laboratory tests and with other cardiologic parameters by the Departments of Cardiology and by the Department of Internal Medicine for 24 months with 3-month periods.
   Results: The patients being included into the study were separated into two groups according to the eGFR as Group 1 including 351 patients (75,8 %) with eGFR > 90 ml/min/1,73m² and Group 2 including 112 patients (24,2 %) with eGFR between 60 and 89 ml/min/1,73m². Patients in both groups were followed for 24 months with 3-month periods. At the end of the study, no statistically significant change was found in both groups in eGFRs. But, a tendency to decrease in the eGFR(s) in Group 2 was found. Furthermore, when three-month eGFR measurements were compared with the first eGFR before PCI, no significant difference was found.

   Besides, the frequency of contrast agent-induced nephropathy (CIN) was seen more common in significant level in Group 2 when compared to Group 1 (p < 0.01). In the 24-month cardiologic follow-up, the incidence of restenosis and revascularization, the incidence of major cardiac complications and the relative risk of death were seen more commonly significantly in Group 2 compared to Group 1 (p < 0.01).

1. International Diabetes Federation. Sixth edition, Diabetes Atlas. IDF Publ., Brussels, 2013.

2. World Health Organization. Definition, diagnosis and classification of diabetes mellitus and its complications: report of a WHO consultation. Part 1: Diagnosis and classification of diabetes mellitus. Geneva: World Health Organization, 1999.

3. Shaw J. E., Sicree R. A., Zimmet P. Z. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010; 87: 4-14.

4. Grundy S. M., Benjamin I. J., Burke G. L., Chait A., Eckel R. H., Howard B. V., Mitch W., Smith S. C. Jr., Sowers J. R. Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1999 Sep 7; 100 (10): 1134-46.

5. Smith Sidney C. Multiple Risk Factors for Cardiovascular Disease and Diabetes Mellitus. American Journal of Medicine, Mar 2007; Supplement 1, Vol. 120, pS3-S11.

6. Chiha M., Njeim M., Chedrawy E. G. Diabetes and сoronary heart disease: a risk factor for the global epidemic. Int J Hypertens. 2012; 2012: 697240.

7. Chillarón J. J., Roux J. A., Benaiges D., Pedro-Botet J. Subclinical cardiovascular disease in type 2 diabetes mellitus: To screen or not to screen. World J Clin Cases. 2014 Sep 16; 2 (9): 415-21.

8. Wilson P. W., D’Agostino R. B., Levy D., Belanger A. M., Silbershatz H., Kannel W. B. Prediction of coronary heart disease using risk factor categories. Circulation. 1998; 97: 1837–1847.

9. Luscher T. F., Creager M. A., Beckman J. A., Cosentino F. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part II. Circulation.2003; 108: 1655-61.

10. Melidonis A., Dimopoulos V., Lempidakis E., Hatzissavas J., Kouvaras G., Stefanidis A., et al. Angiographic study of coronary artery disease in diabetic patients in comparison with nondiabetic patients. Angiology 1999; 50: 997-1006.

11. Aronson D., Bloomgarden Z., Rayfield E. J. Potential mechanisms promoting restenosis in diabetic patients. J Am Coll Cardiol 1996; 27: 528 – 535.

12. Silva J. A., Escobar A., Collins T. J., Ramee S. R., White C. J. Unstable angina. A comparison of angioscopic findings between diabetic and nondiabetic patients. Circulation. 1995 Oct 1; 92 (7): 1731 - 6.

13. Vinik A. I., Erbas T., Casellini C. M. Diabetic cardiac autonomic neuropathy, inflammation and cardiovascular disease, J. Diabetes Investig. 2013 Jan;4 (1): 4-18. Epub 2013 Jan 29.

14. Stone G. W., Mehran R., Dangas G., Lansky A. J., Kornowski R., Leon M. B. Differential impact on survival of electrocardiographic Q-wave versus enzymatic myocardial infarction after percutaneous intervention: a device-specific analysis of 7147 patients. Circulation 2001; 104: 642-7.

15. Scheen A. J., Warzee F., Legrand V. M. Drug-eluting stents: metaanalysis in diabetic patients. Eur Heart J. 2004; 25: 2167 - 8.

16. Bangalore S., Kumar S., Fusaro M., Amoroso N., Kirtane A. J., Byrne R. A., Williams D. O., Slater J., Cutlip D. E., Feit F. Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22,844 patient years of follow-up from randomised trials. BMJ. 2012 Aug 10; 345: e5170.

17. Kumbhani D. J., Bavry A. A., Kamdar A. R., Helton T. J., Bhatt D. L. The effect of drug-eluting stents on intermediate angiographic and clinical outcomes in diabetic patients: insights from randomized clinical trials. Am Heart J. 2008 Apr; 155 (4): 640-7.

18. Mulukutla S. R., Vlachos H. A., Marroquin O. C., Selzer F., Holper E. M., Abbott J. D., Laskey W. K., Williams D. O., Smith C., Anderson W. D., Lee J. S., Srinivas V., Kelsey S. F., Kip K. E. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung and Blood Institute Dynamic Registry. JACC Cardiovasc Interv. 2008 Apr; 1 (2): 139-47.

19. Katsiki N., Athyros V. G., Karagiannis A., Mikhailidis D. P., Contrast-Induced Nephropathy: An "All or None" Phenomenon. Angiology. 2014 Sep 14.

20. Weisbord S., Palevsky P. Radiocontrast-induced acute renal failure. J Intensive Care Med. 2005; 20: 63-75.

21. Mehran R., Nikolsky E. Contrast-induced nephropathy: Definition, epidemiology, and patients at risk. Kidney Int Suppl. 2006: S11-S15.

22. Manske C., Sprafka J., Strony J., et al. Contrast nephropathy in azotemic diabetic patients undergoing coronary angiography. Am J. Med 1990; 89: 615-20.

23. Tajiri K., Maruyama H., Sato A., Shimojo N., Saito T., Endo M., Aihara H., Kawano S., Watanabe S., Sakai S., Aonuma K. Prediction of chronic renal insufficiency after coronary angiography by an early increase in oxidative stress and decrease in glomerular filtration rate. Circ J. 2011; 75 (2): 437-42. Epub 2010 Nov 16.

24. Marenzi G., Assanelli E., Marana I., et al. N-acetyl-cysteine and contrast-induced nephropathy in primary angioplasty. N Engl J. Med 2006; 354: 2773-82.

25. Stone G., McCullough P., Tumlin J., et al. Fenoldopam mesylate for the prevention of contrast-induced nephropathy: A randomized controlled trial. JAMA 2003; 290: 2284-91.

26. Liu Y. H., Liu Y., Duan C. Y., Tan N., Chen J. Y., Zhou Y. L., Li L. W., He P. C. Statins for the Prevention of Contrast-Induced Nephropathy After Coronary Angiography / Percutaneous Interventions: A Meta-analysis of Randomized Controlled Trials. J Cardiovasc Pharmacol Ther. 2014; Sep 5.

27. Rey J. R., Iglesias D., López De Sá E, Armada E., Moreno R., Salvador O., Monedero Mdel C., Blas S. G., Iniesta A. M., López- Sendon J. L. Prevention of contrast-induced nephropathy with haemofiltration in high-risk patients after percutaneous coronary intervention. Acute Card Care. 2011 Sep; 13 (3):164-9.

28. Au T. H., Bruckner A., Mohiuddin S. M., Hilleman D. E. The Prevention of Contrast-Induced Nephropathy. Ann Pharmacother. 2014 Oct; 48 (10): 1332-1342.

29. Moos S. I., Nagan G., de Weijert R. S., van Vemde D. N., Stoker J., Bipat S. Patients at risk for contrast-induced nephropathy and mid-term effects after contrast administration: a prospective cohort study. Neth J. Med. 2014 Sep; 72 (7): 363-71.

30. Roumie C. L., Hung A. M., Greevy R. A., Grijalva C. G., Liu X., Murff H. J., Elasy T. A., Griffin M. R. Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: a cohort study. Ann Intern Med. 2012 Nov 6; 157 (9): 601-10.

31. Forst T., Hanefeld M., Jacob S., Moeser G., Schwenk G., Pfützner A., Haupt A. Association of sulphonylurea treatment with all-cause and cardiovascular mortality: a systematic review and meta-analysis of observational studies. Diab Vasc Dis Res. 2013 Jul;10 (4): 302-14.

32. Monami M., Genovese S., Mannucci E. Cardio-vascular safety of sulfonylureas: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2013 Oct; 15 (10): 938-53.

33. Phung O. J., Schwartzman E., Allen R. W., Engel S. S., Rajpathak S. N. Sulphonylureas and risk of cardiovascular disease: systematic review and meta-analysis. Diabet Med. 2013 Oct; 30 (10): 1160 - 71.

34. Rensing K. L., Reuwer A. Q., Arsenault B. J., von der Thüsen J. H., Hoekstra J. B., Kastelein J. J., Twickler T. B. Reducing cardiovascular disease risk in patients with type 2 diabetes and concomitant macrovascular disease: can insulin be too much of a good thing? Diabetes Obes Metab. 2011 Dec; 13 (12): 1073-87.

35. Smith E. R. The angina grading system of the Canadian Cardiovascular Society. Can J Cardiol. 2002 Apr;18 (4): 439, 442.

36. National Kidney Foundation. K/DOQI Clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis 2002; 39 (Suppl 1): Sl-266.

37. Cockcroft D. W., Gault M. H. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16 (1): 31-41.

38. Van Belle E., Bauters C., Hubert E., Bodart J. C., Abolmaali K., Meurice T., et al. Restenosis rates in diabetic patients: a comparison of coronary stenting and balloon angioplasty in native coronary vessels. Circulation 1997; 96: 1454-60.

39. Savage M. P., Fischman D. L., Rake R., Leon M. B., Schatz R. A., Penn I., et al. Efficacy of coronary stenting versus balloon angioplasty in small coronary arteries. Stent Restenosis Study (STRESS) Investigators. J. Am Coll Cardiol 1998; 31: 307-11.

40. Geng D. F., Meng Z., Yan H. Y., Nie R. Q., Deng J., Wang J. F. Bare- metal stent versus drug-eluting stent in large coronary arteries: meta-analysis of randomized controlled trials. Catheter Cardiovasc Interv. 2013 Jun 1; 81 (7): 1087-94.

41. Iijima R., Byrne R. A., Dibra A., Ndrepepa G., Spaulding C., Laarman G. J., Menichelli M., Valgimigli M., Di Lorenzo E., Kaiser C., Tierala I., Mehilli J., Suttorp M. J., Violini R., Schömig A., Kastrati A. Drug-eluting stents versus bare-metal stents in diabetic patients with ST-segment elevation acute myocardial infarction: a pooled analysis of individual patient data from seven randomized trials. Rev Esp Cardiol. 2009 Apr; 62 (4): 354- 64.

42. Qin S. Y., Zhou Y., Jiang H. X., et al. The association of diabetes mellitus with clinical outcomes after coronary stenting: a meta-analysis. PLoS One. 2013 Sep 16; 8 (9): e72710.

43. Vogt A., Schoelmerich A., Pollner F., et al. Comparison of outcome in 1809 patients treated with drug-eluting stents or bare-metal stents in a real-world setting. Vasc Health Risk Manag. 2011; 7: 693-9.

44. Heyman S. N., Rosenberger C., Rosen S., Khamaisi M. Why is diabetes mellitus a risk factor for contrast-induced nephropathy? Biomed Res Int. 2013; 2013: 123589.

45. Shul'zhenko L. V., Pershukov I. V., Batyraliev T. A., Fettser D. V., Sidorenko B. A. The role of reduction of glomerular filtration rate in outcomes of drug-eluting stents implantation in patients with ischemic heart disease and chronic kidney disease. Kardiologiia.2010; 50 (4): 4-11.

46. Friedman E. A. Advanced glycation end-products in diabetic nephropathy. Nephrol Dial Transplant. 1999; 14 Suppl 3: 1-9.

47. Eui-Young Choi, Hyuck Moon Kwon, Chul-Woo Ahn, et al. Serum levels of advanced glycation end products are associated with in-stent restenosis in diabetic patients. Yonsei Med J. 2005 Feb 28; 46 (1): 78-85. doi: 10.3349/ymj.2005.46.1.78. PMID: 15744809 PMCID: PMC2823061 glycation end products are associated with in-stent restenosis in diabetic patients. Yonsei Med J. 2005 Feb 28; 46 (1):78-85.

48. Shen Y., Pu L.J., Lu L., Zhang Q., Zhang R. Y., Shen W. F. Serum advanced glycation end-products and receptors as prognostic biomarkers in diabetics undergoing coronary artery stent implantation. Can J. Cardiol. 2012 Nov-Dec; 28 (6):737-43.

49. Schrijvers B. F., Flyvbjerg A., De Vriese A. S. The role of vascular endothelial growth factor (VEGF) in renal pathophysiology. Kidney Int. 2004 Jun; 65 (6): 2003-17.

50. Stratmann B., Tschoepe D. Atherogenesis and atherothrombosis-focus on diabetes mellitus. Best Pract Res, Clin Endocrinol Metab. 2009 Jun; 23 (3): 291-303.

51. Nishio K., Fukui T., Tsunoda F., Kawamura K., Itoh S., Konno N., Ozawa K., Katagiri T. Insulin resistance as a predictor for restenosis after coronary stenting. Int J Cardiol. 2005 Aug 18; 103 (2): 128-34.

52. Dahm J. B. Feldrappe A. Hummel A. Moex B. Staudt A. Voelzke H. Vogelgesang D. Insulin resistance and hyperglycaemia are associated with recurrent stenosis in diabetic patients after percutaneous coronary intervention. Journal of Clinical and Basic Cardiology 2002; 5 (3), 241-246.

53. Zhang Z., Zhu M., Wang Z., Zhang H. Associations between different eGFR estimating equations and mortality for CVD patients: A retrospective cohort study based on the NHANES database. Medicine (Baltimore). 2022 Sep 23; 101 (38): e30726. doi: 10.1097/MD.0000000000030726. PMID: 36197188.