Long-term results of coronary endovascular revascularisation with eluting sirolimus-stents in patients with coronary heart disease comorbid with type-2 diabetes mellitus: evidence from 18-month prospective study

Abstract

Aim. To study long-term results of 3-42-month (mean 18.1 ± 1.2 month) of a prospective clinically and angiologically controlled follow-up after coronary endovascular revascularisation with sirolimus-eluting stents (SES) in patients with coronary heart disease (CHD) comorbid with type 2 diabetes mellitus (DM).
Material and methods. A total of 108 CHD patients with angina pectoris resistant to antianginal therapy were divided into 2 groups: 51 CHD patients with mild and moderate type-2 DM (group 1); 57 CHD patients free of diabetus (group 2). All the patients have undergone successful coronary endovascular revascularisation with SES. Anti-ischemic efficacy and safety of stenting were studied in the course of 18-month prospective follow-up.
Results. An anti-ischemic effect of stenting in hospital setting was achieved in all the patients. 18 months after stenting frequency and severity of anginal attacks reduced in group 1 by 70.6%, daily need in nitroglicerine - by 71.9%, in group 2 - by 87.1 and 93.1%, respectively. As a result, exercise tolerance improved in group 1 by 38.3%, in group 2 - by 40.8%. Quality of life improved by 22.7 and 25.1%, respectively. Most of the patients showed no deterioration of carbohydrate and lipid metabolism compensation. Recurrent angina and symptoms of painless myocardial ischemia occurred in 39.3 and 14% patients of group 1 and 2, respectively. More frequent causes of the recurrence were progression of coronary artery atherosclerosis de novo and Cypher stent restenosis (11.8 and 3.5% in group 1 and 2, respectively).
Conclusion. SES implantation provided good anti-ischemic efficacy in 60.7 and 86% CHD patients with and without DM, respectively. It significantly improved exercise tolerance and quality of life.

References

  1. Дедов И. И., Александров Ан. А. Сахарный диабет и ишемическая болезнь сердца: необходимость совместных действий. В кн.: Ишемическая болезнь сердца. Форум. М.; 2002. 1-5.
  2. Kip K. E., Faxon D. R., Detre K. M. et al. Coronary angioplasty in diabetic patients: The National Heart, Lung and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1996; 94: 1818-1825.
  3. Stein B., Weintraub W. S., Gebhart S. S. P. et al. Influence of diabetes mellitus on early and late outcome after percutaneous transluminal coronary angioplasty. Circulation 1995; 91: 979-989.
  4. Van Belle E., Bauters C., Hubert E. et al. Restenosis rates in diabetic patients: A comparison of coronary stenting and balloon angioplasty in native coronary vessel. Circulation 1997; 96: 1454-1460.
  5. Savage M. P., Fischman D. L., Schatz R. A. et al. Coronary intervention in the diabetic patient: improved outcome after percutaneous transluminal coronary angioplasty. Circulation 1995; 91: 979-989.
  6. Козлов С. Г., Петрова К. Н. Эндоваскулярная реваскуляризация миокарда у больных сахарным диабетом. Кардиология 2006:; 9: 57-66.
  7. Kurbaan A. S., Bowker T. J., Ilsley C. D. et al. Difference in mortality of the CABRI diabetic and nondiabetic populations and its relation to coronary artery disease and the revascularization mode. Am. J. Cardiol. 2001; 87: 947-950.
  8. Detre K. M., Guo P., Holubkov R. et al. Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the bypass angioplasty revascularization investigation (BARI). Circulation 1999; 99: 633-640.
  9. Holmes D. R., Hirshfeld J., Faxon D. et al. ACC Expert consensus document on coronary artery stents. Document of the American College of Cardiology. J. Am. Coll. Cardiol. 1998; 32: 1471-1482.
  10. Van Belle E., Abolmaali K., Banters C. et al. Restenosis, late vessel occlusion and left ventricular function 6 months after balloon angioplasty in diabetic patients. J. Am. Coll. Cardiol. 1999; 34: 476-485.
  11. Rozenman Y., Sapoznikov D., Gotsman M. S. Restenosis and progression of coronary disease after balloon angioplasty in patients with diabetes mellitus. Clin. Cardiol. 2000; 23: 890-894.
  12. Van Belle E., Perie M., Braune D. et al. Effects of coronary stenting on vessel patency and long-term clinical outcome after percutaneous coronary revascularization in diabetic patients. J. Am. Coll. Cardiol. 2002; 40: 410-417.
  13. Morice M. C., Serruys P. W., Sousa J. E. et al. RAVEL Study Group. Randomized study with the sirolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesion. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 2002; 346: 1773-1780.
  14. Moses J. W., Leon M. B., Popma J. J. et al. SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. 2003; 349: 1315-1323.
  15. Colombo A., Drzewieki J., Banning A. et al. Taxus II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003; 108: 788-794.
  16. Moussa I., Leon M. B., Baim D. S. et al. Impact of sirilimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) study. Circulation 2004; 109: 2273-2278.
  17. Abizaid A., Costa M. A., Blanchard D. et al. Ravel Investigators. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur. Head J. 2004; 25: 107-112.
  18. Holmes D. R., Leon M. B., Moses J. W. et al. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in a patients at high risk for coronary restenosis. Circulation 2004; 109: 634-640.
  19. Sabate M., Jimenez-Quevedo P., Angiolillo D. J. et al. A randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the DIABETES trial. Circulation 2005; 112: 2175-2183.
  20. Jimenez-Quevedo P., Sabate M., Angiolillo D. J. et al. DIABETES Investigators. Vascular effects of sirolimus-eluting versus bare metal stents in diabetic patients: three-dimensional ultrasound results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) trial. J. Am. Coll. Cardiol. 2006; 47: 2172-2179.
  21. Alberty K. G., Zimmet P. Z. for the WHO Consultation Group Defenition, Diagnosis and Classification of Diabetes Mellitus. Provisional report of a WHO consultation. Diabet. Med. 1998; 15: 1-11.
  22. Rodriguez A. E., Maree A. O., Mieres J. et al. Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry. Eur. Heart J. 2007; 28: 2118-2125.
  23. RITA Trial participants. Coronary angioplasty versus coronary artery bypass surgery: the Randomized Intervention Treatment of Angina (RITA) trial. Lancet 1993; 341: 573-580.
  24. King S. B. III, Lembo N. J., Weintraub W. S. et al. A randomized trial comparing coronary angioplasty with coronary bypass surgery Emory Angioplasty versus Surgery Trial (EAST). N. Engl. J. Med. 1994; 321: 1044-1050.
  25. Rodriguez A. E., Mieres J., Fernandez-Pereira C. et al. Coronary stent thrombosis in drug-eluting stent erea: insights from ERACI III trial. J. Am. Coll. Cardiol. 2006; 47: 205-207.
  26. Spaulding C., Daemen J., Boersma E. et al. Pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N. Engl. J. Med. 2007; 356: 989-997.
  27. CARBI Trial Participants. First-year results of CABRI (Coronary Angioplasty versus Bypass Revascularization Investigation). Lancet 1995; 346: 1179-1184.
  28. Pocock S. J., Henderson R. A., Rickards A. F. et al. Meta-analysis of randomized trials comparing coronary angioplasty with bypass surgery. Lancet 1995; 346: 1184-1189.
  29. The Bypass Angioplasty Revascularization investigation (BARI) Investigators, Comparison of coronary bypass surgery with angioplasty in patients multivessel disease. N. Engl. J. Med. 1996; 335: 217-225.
  30. Smith S. C. Jr., Dove J. T., Jacobs A. K. et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA College of Cardiology / American Heart Association task force for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation 2001; 103: 3013-3041.
  31. Serruys P. W., Ong A. T., van Herwerden L. A. et al. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J. Am. Coll. Cardio1. 2005; 46: 575-581.
  32. Lemors P. A., Serruys P. W., van Domburg R. T. et al. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation 2004; 109; 190-195.
  33. Rodriguez A., Bernardi V., Navia J. et al. Argentine randomized study: Coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II): 30-day and one-year follow-up results. ERACI II Investigators. J. Am. Coll. Cardiol. 2001; 37: 51-58.
  34. The SOS Investigators. Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomized controlled trial. Lancet 2002; 360: 965-970.
  35. Hermiller J. B., Raizner A., Cannon L. et al. TAXUS-IV Investigators. Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial. J. Am. Coll. Cardiol. 2005; 45: 1172-1179.
  36. Suselbeck T., Latsch A., Siri H. et al. Role vessel size as a predictor for the occurrence of in-stent restenosis in patients with diabetes mellitus. Am. J. Cardiol. 2001; 88: 243-247.
  37. Gilbert J., Rabound J., Zinman B. Meta-analysis of the effect of diabetes on restenosis rates among patients receiving coronary angioplasty stenting. Diabet. Care 2004; 27: 990-994.
  38. Сумароков А. Б., Самко А. Н., Наумов В. Г. Проблема предотвращения рестенозирования сосуда после имплантации коронарного стента. Тер. арх. 2004; 8: 82-85.
  39. Кипшидзе Н., Мосес Дж. В., Сирраиус Р. В. и др. Новые направления в интервенционной кардиологии - содержащие лекарство стенты. Обзор. Тер. арх. 2003; 9: 89-94.
  40. Jakovou I., Schmidt T., Bonizzoni E. et al. Incedence, predictors and outcome of thrombosis after successful implantation of drugeluting stents. J. A. M. A. 2005; 293(17): 2126-2130.
  41. Nasser M., Kapeliovich M., Markiewicz W. Late thrombosis of sirolimus-eluting stents following noncardiac surgery. Catheter. Cardiovasc. Interv. 2005; 65(4): 516-519.

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Copyright (c) 2009 Teplyakov A.T., Torim Y.Y., Kuznetsova A.V., Rybal'chenko E.V., Krylov A.L., Karpov R.S., Teplyakov A.T., Torim Y.Y., Kuznetsova A.V., Rybalchenko E.V., Krylov A.L., Karpov R.S.

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