Analysis of the BARI 2D study – Revascularization and the use of anti-diabetic drugs in patients with Type 2 diabetes and coronary heart disease
Authors:
P. Neužil; P. Pavlíčková
Authors‘ workplace:
Primář: doc. MUDr. Petr Neužil, CSc. FESC.
; Kardiologické oddělení Nemocnice Na Homolce, Praha
Published in:
Prakt. Lék. 2010; 90(1): 34-39
Category:
Of different specialties
Overview
Backround:
A multicentric clinical BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) Study took place from 2001–2008. It compared early revascularization (ER-either PCI or CABG) to medical therapy (MT), together with intensive pharmacotherapy and lifestyle intervention in both groups. At the same time, 2 diabetes drug treatment strategies
- „insulin sensitizers“ – IS, and
- „insulin providers“ –IP
#were compared. The primary endpoint was all-cause mortality.
Methods:
2368 pts with 2 type DM and CAD suitable for revascularization were randomized to either ER or MT. Simultaneously, an independent randomisation to either IS or IP diabetes treatment was performed. The average follow-up period was 5.3 years.
Results:
Overall 5-year mortality was 13.2 % (n=155) in the ER vs. 13.5 % (n=161) in the MT group (p= 0.97, nonsignificant), and 13.2 % (n=156) in the IS group vs. 13.5 % (n=160) in the IP group, (p=0.89, nonsignificant). The secondary endpoint (death, nonfatal MI, stroke) findings were also not statistically significant.
- ER 22.
6 % (n=266) vs. MT 23.7 % (n=283), p=0.70, and
- IS 22.
1 % (n=261) vs. IP 24.3 % (n=288), p=0.13;
Conclusion:
None of the treatment strategies showed a clear benefit as a means of reducing mortality or major cardiovascular events. The only statistically relevant difference - less major CV events in the early revascularized patients designated to CABG – is probably related to the less severe CAD in these patients.
Key words:
ischaemic heart disease, diabetes mellitus, revascularization, conservative therapy
Sources
1. Shaw, J.E., Sicree, R.A., Zimmet, P.Z. Global estimates of the prevalence of diabetes mellitus for 2010 – 2030 Diabetes Res. Clin. Pract. 2009, 86, p. 94-102.
2. Magliano, D.J., Shaw, J.E., Shortreed, S.M., Nusseleder, W.J. et al. Lifetime risk and projected population provealence of diabetes. Diabetologia 2008, 51, p. 179-186.
3. Isomaa, B. A major health hazard: the metabolic syndrome. Life Sci. 2003, 73, p. 2395-2411.
4. Lenzen, M.J., Boersma, E., Bertrand, M.E. et al. Management and outcome of patients with estabilished coronary artery disease: the Euro Heart Survey on coronary revascularization. Eur. Heart. J. 2005, 26, p. 1169-1179.
5. Ústav zdravotnických informací a statistiky České republiky. Léčení diabetici podle druhu léčby s. 66 - 68 in: Zdravotnická ročenka České republiky 2008; ÚZIS ČR, Praha ISBN 978-80-7280-783-3.
6. O’Keefe, J.H., Carter, M.D., Lavie, C.J. Primary and secondary prevention of cardiovascular diseases: a practical evidence-based approach. Mayo Clin. Proc. 2009, 84(8), p. 741-757.
7. Mytas. D.Z., Stougiannos, P.N., Zairis, M.N. et al. Diabetic myocardial disease: patophysiology, early diagnosis and therapeutic options. J. Diabetes Complications 2009, 23(4), p. 273-282.
8. Špinar, J., Vítovec, J. Metabolický syndrom a kardiovaskulární onemocnění. Vnitř. Lék. 2009, 55(7-8), s. 653-658.
9. Geiss, L.S., Herman, W.H., Smith, P.J. Mortality in non-insulin-dependent diabetes. In: Aubert RE, Ballard DJ, Barrett-Connor E, eds. Diabetes in America. 2nd ed. Bethesda, MD; National Institute of Diabetes and Digestive and Kidney Diseases 1995; p. 233-257.
10. Mak, K.H., Moliterno, D.J., Granger, C.B. et al. Influence of diabetes mellitus on clinical outcome in the thrombolytic era of acute myocardial infarction. J. Am. Coll. Cardiol. 1997, 30, p. 171-179.
11. Malmberg, K., Yusuf, S., Gerstein, H.C. et. al. Impact of diabetes on long-term prognosis in patients with unstable angina and non-Q-wave myocardial infarction: results of the OASIS (Organization to Assess Strategies for Ischemic Syndromes) Registry. Circulation 2009, 102, p. 1014-1019.
12. Bonora, E., Targher, G., Formentini, F. et al. The metabolic syndrome is an independent predictor of cardiovascular disease in type 2 diabetic subjects. Prospective data from the Verona diabetes complication study. Diabet. Med. 2002, 21, p. 52.
13. Cífková, R., Býma, S., Češka, R. a kol. Prevence kardiovaskulárních onemocnění v dospělém věku. Společné doporučení českých odborných společností. Vnitř. lék. 2005, 51, s. 2021-2025.
14. Depres, J.P., Lamarche, B., Mauriege, P. et al. Hyperinsulinemia as an independent risk factor for ischemic heart disease. N. Engl. J. Med. 1996, 334, p. 952-957.
15. Gaede, P., Vedel, P., Larsen, N. et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N. Engl. J. Med. 2003, 348, p. 383-393.
16. Mannucci, E., Monami, M., Massotti, G., Marchionni, N. All-cause mortality in diabetic patients treated with combinations of sulfonylureas and biguanides. Diabetes Metab. Res. Rev. 2004, 20, p. 44-47.
17. BARI Investigators. Influence of diabetes on 5-year mortality and morbidity in a randomized trial comparing CABG and PTCA in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 1996, 96, p. 1761-1769.
18. The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. N. Engl. J. Med. 1996, 335(4), p. 275-277.
19. 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, p. 633-640.
20. UK Prospective Diabetes Study. Papers presenting major results of the study. UKPDS 33 + 34: Lancet 1998, 352, p. 837-865.
21. Annaswamy, R., Seely, E., Bekins, S. et al. Rosiglitazon improves insulin sensitivity and lowers blood pressure in hypertensive patients. Diabetes Care 2003, 26, p. 172-178.
22. Hafner, S.M., Mykkanen, L., Festa, A. et al. Insulin-resistant prediabetic subject have more atherogenic risc factors than insulin-sensitive prediabetic subjects: implications for preventing coronary heart disease during prediabetic state. Circulation 2000, 101, p. 975-980.
23. Zangenech, F., Kudva, Y., Basu, A. Insulin senzitizers. Mayo Clinic Proc. 2003, 78, p. 471-477.
24. Kronmal, R.A., Barzilay, J.I., Tracy, R.P. et al. The relationship of fasting serum radioimmune insulin levels to incident coronary heart disease in an insulin-treated diabetic cohort. J. Clin. Endocrinol. Metab. 2004, 89, p. 2852-2858.
25. Skyler, J.S., Bergenstal, R., Bonow, R.O. et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Circulation 2009, 119, p. 351-357.
26. Erdmann, E., Dormandy, J.A., Charbonnel, B. et al. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J. Am. Coll. Cardiol. 2007, 49, p.1772-1780.
27. Trikalinos,T.A., Alsheikh-Ali, A.A., Tatsioni, A. et al. Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis. Lancet 2009, 373, p. 911-918.
28. Roger, S., Blumenthal, R.S., Cohn, G., Schulman, S.P. Medical therapy versus coronary angioplasty in stable coronary artery disease: a critical review of the literature. J. Am. Coll. Cardiol. 2000, 36, p. 668-673.
29. Hoffman, S.N., TenBrook, J.A., Wolf, M.P. et al. A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty: one- to eight-year outcomes. J. Am. Coll. Cardiol. 2003, 41(8), p.1293-1304.
30. Lagerqvist, B., Husted, S., Kontny, F. et al. 5-Year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet 2006, 368, p. 998-1004.
31. RITA2 trial participants: Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina RITA-2 trial. Lancet 1997, 350, p. 46l-468.
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