Safety and Efficacy of Sirolimus-Eluting Stent in Diabetic Patients Compared with Non-Diabetic Patients Undergoing Percutaneous Coronary Intervention
DOI:
https://doi.org/10.12970/2311-052X.2014.02.01.5Keywords:
Percutaneous coronary intervention, Diabetes, Drug eluting stentAbstract
Background: The research has been shown that the clinical outcomes of diabetic patients undergoing revascularization either coronary artery bypass grafting or percutaneous coronary intervention (PCI) are inferior to that of non-diabetic patients.
Objectives: We have carried out the registry to assess the clinical outcomes of the patients with diabetes mellitus (DM) compared to the patients without DM after the PCI with sirolimus-eluting stent.
Methods: Indolimus Diabetic registry is a single-centre; single-armed, retrospective registry that enrolled 530 patients who underwent PCI with Indolimus® stent at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India during the study period. The endpoint of the registry was a major adverse cardiac event (MACE) defined as a composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave not clearly attributable to a non-target vessel), target lesion revascularization (TLR) and target vessel revascularization (TVR) and that were observed at 30-days and at 6-monthsfollow-up.
Results: Among 530 patients, 169 patients were having DM. It is noteworthy that the patients with DM were more often women (29.6% vs. 18.0%), hypertensive (54.4% vs. 34.1%) and higher incidence of revascularization (4.2% vs. 2.5%). Double vessel disease was more prevalent in diabetic population as compared to non-diabetics (37.9% vs. 24.9%). Total 617 lesions were encountered in 530 patients (202 in diabetic patients and 415 in non-diabetic patients). There was no significant difference observed in the lesion class. There was no statistical significant difference observed for cardiac death (1.8% vs. 1.7%, p=1.00) and MACE (1.8% vs. 1.9%, p=1.00) in diabetic and non-diabetic patients at 30-days follow-up. However, at 6-month follow-up, it has been observed that the occurrence of MACE was higher but not statistically significant in diabetic patients as compared to non-diabetic patients (4.1% vs. 2.5%, p=0.29).
Conclusions: In this Indolimus Diabetic registry, MACE rate did not significantly differ between diabetic and non-diabetic population at 30-days and at 6-months follow-up. However, long term follow-up is needed to determine whether a similar safety profile is maintained.
References
Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA 1979; 241: 2035-8. http://dx.doi.org/10.1001/jama.1979.03290450033020
Stein B, Weintraub WS, Gebhart SP, et al. Influence of diabetes mellitus on early and late outcome after percutaneous transluminal coronary angioplasty. Circulation 1995; 91: 979-89. http://dx.doi.org/10.1161/01.CIR.91.4.979
Niles NW, McGrath PD, Malenka D, et al. Survival of patients with diabetes and multivessel coronary artery disease after surgical or percutaneous coronary revascularization: results of a large regional prospective study. Northern New England Cardiovascular Disease Study Group. J Am Coll Cardiol 2001; 37: 1008-15. http://dx.doi.org/10.1016/S0735-1097(00)01205-5
Aronson D, Edelman ER. Revascularization for coronary artery disease in diabetes mellitus: angioplasty, stents and coronary artery bypass grafting. Rev Endocr Metab Disord 2010; 11: 75-86. http://dx.doi.org/10.1007/s11154-010-9135-3
Mosseri M, Nahir M, Rozenman Y, et al. Diffuse narrowing of coronary arteries in diabetic patients: the earliest phase of coronary artery disease. Cardiology 1998; 89: 103-10. http://dx.doi.org/10.1159/000006764
Elezi S, Kastrati A, Pache J, et al. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol 1998; 32: 1866-73. http://dx.doi.org/10.1016/S0735-1097(98)00467-7
Kornowski R, Mintz GS, Kent KM, et al. Increased restenosis in diabetes mellitus after coronary interventions is due to exaggerated intimal hyperplasia. A serial intravascular ultrasound study. Circulation 1997; 95: 1366-9. http://dx.doi.org/10.1161/01.CIR.95.6.1366
Stenestrand U, James SK, Lindback J, et al. Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 2010; 31: 177-86. http://dx.doi.org/10.1093/eurheartj/ehp424
Rajasekhar D, Vanajakshamma V, Shashank C, Srinivasakumar ML, Sivasankara C. The real world experience of the biodegradable polymer-coated sirolimuseluting coronary stent system. Cathet Cardiovasc Intervent 2013 Oct 15.
[Epub ahead of print]. http://dx.doi.org/10.1002/ccd.25246
Goraya TY, Leibson CL, Palumbo PJ, et al. Coronary atherosclerosis in diabetes mellitus: a population-based autopsy study. J Am Coll Cardiol 2002; 40: 946-53. http://dx.doi.org/10.1016/S0735-1097(02)02065-X
Moreno PR, Fuster V. New aspects in the pathogenesis of diabetic atherothrombosis. J Am Coll Cardiol 2004; 44: 2293- 300. http://dx.doi.org/10.1016/j.jacc.2004.07.060
Creager MA, Luscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part I. Circulation 2003; 108: 1527-32. http://dx.doi.org/10.1161/01.CIR.0000091257.27563.32
Kip KE, Faxon DP, Detre KM, Yeh W, Kelsey SF, Currier JW. Coronary angioplasty in diabetic patients. The National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1996; 94: 1818- 25. http://dx.doi.org/10.1161/01.CIR.94.8.1818
Deligonul U, Vandormael M, Kern MJ, Galan K. Repeat coronary angioplasty for restenosis: results and predictors of follow-up clinical events. Am Heart J 1989; 117: 997-1002. http://dx.doi.org/10.1016/0002-8703(89)90852-1
Weintraub WS, Kosinski AS, Brown CL, 3rd, King SB, 3rd. Can restenosis after coronary angioplasty be predicted from clinical variables? J Am Coll Cardiol 1993; 21: 6-14. http://dx.doi.org/10.1016/0735-1097(93)90711-9
Hollman J, Badhwar K, Beck GJ, Franco I, Simpfendorfer C. Risk factors for recurrent stenosis following successful coronary angioplasty. Cleve Clin J Med 1989; 56: 517-23. http://dx.doi.org/10.3949/ccjm.56.5.517
Zhang Q, Zhang RY, Zhang JS, et al. One-year clinical outcomes of Chinese sirolimus-eluting stent in the treatment of unselected patients with coronary artery disease. Chin Med J (Engl) 2006; 119: 165-8.
Slavin L, Chhabra A, Tobis JM. Drug-eluting stents: preventing restenosis. Cardiol Rev 2007; 15: 1-12. http://dx.doi.org/10.1097/01.crd.0000200844.16899.fc
Finn AV, Palacios IF, Kastrati A, Gold HK. Drug-eluting stents for diabetes mellitus: a rush to judgment? J Am Coll Cardiol 2005; 45: 479-83. http://dx.doi.org/10.1016/j.jacc.2004.10.060
Jimenez-Quevedo P, Sabate M, Angiolillo DJ, et al. Longterm clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial. Eur Heart J 2007; 28: 1946-52. http://dx.doi.org/10.1093/eurheartj/ehm197
Lee SW, Park SW, Kim YH, et al. A randomized comparison of sirolimus- versus Paclitaxel-eluting stent implantation in patients with diabetes mellitus. J Am Coll Cardiol 2008; 52: 727-33. http://dx.doi.org/10.1016/j.jacc.2008.04.056
Lee SW, Park SW, Kim YH, et al. A randomized comparison of sirolimus- versus paclitaxel-eluting stent implantation in patients with diabetes mellitus: 4-year clinical outcomes of DES-DIABETES (drug-eluting stent in patients with DIABETES mellitus) trial. JACC Cardiovasc Interv 2011; 4: 310-6. http://dx.doi.org/10.1016/j.jcin.2010.12.006
