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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


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