Short‐ and long‐term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta‐analysis of randomized trials

Abstract

Background: Diabetes patients undergoing percutaneous coronary intervention (PCI) have more complications than nondiabetes patients, including increased long-term mortality. Use of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitors (GPI) in diabetes patients undergoing PCI and its effect on long-term mortality were evaluated in few randomized trials, but with conflicting results. Methods: We searched the literature for randomized controlled trials that compared heparin and GPI therapy with bivalirudin in diabetes patients undergoing PCI. The incidence of major adverse cardiovascular events (MACE), death from any cause, myocardial infarction (MI), urgent revascularization, major and minor bleeding (at 30 days), as well as all-cause mortality at 1 year were included, and meta-analysis was performed. Results: A total of 5,137 patients with diabetes were included in four randomized trials. At 30 days, bivalirudin, compared with heparin and GPI, caused less major bleeding (odds ratio (OR), 0.68; 95% confidence interval (CI), 0.52-0.89; P 5 0.005) and less minor bleeding (OR, 0.48; 95% CI, 0.41-0.57; P < 0.00001) and similar rates of MACE (OR, 0.87; 95% CI, 0.70-1.08; P 5 0.21), MI (OR, 0.87; 95% CI, 0.68-1.10; P 5 0.25), and urgent revascularization (OR, 1.12; 95% CI, 0.76-1.65; P 5 0.57). Death from any cause at 30 day was numerically lower with bivalirudin use but not statistically significant (OR, 0.72; 95% CI, 0.46-1.13; P 5 0.15). Mortality at 1 year was significantly lower in diabetes patients treated with bivalirudin compared with heparin and GPI (OR, 0.72; 95% CI, 0.52-0.99; P 5 0.04). A secondary analysis suggests that the major bleeding benefit with bivalirudin may be driven by mandated use Catheterization and Cardiovascular Interventions 86: 364-375 (2015) of GPI in heparin arm. Conclusion: Among patients with diabetes undergoing PCI, bivalirudin caused less major and minor bleeding compared with heparin and GPI, with similar rates of MACE, death, MI, and urgent revascularization at 30 days, but significantly lower mortality rates at 1 year. V C 2015 Wiley Periodicals, Inc.

Safety and Effectiveness of Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

“…These results were comparable with a number of meta-analyses conducted recently (Cavender and Sabatine, 2014; Cassese et al, 2015; Nairooz et al, 2015). However, in another meta-analysis conducted by Navarese et al (2015), no significant difference was found in the risk for major bleeding (based on the primary study definition) between bivalirudin-based regimens and heparin-based regimens with provisional GPI use (Navarese et al, 2015).…”

“…A meta-analysis conducted by Nairooz et al (2015) suggested that the lower risk of major bleeding offered by bivalirudin-based regimens may be driven by mandating the use of a GPI (Nairooz et al, 2015). The improved safety of bivalirudin-based regimens could be largely attributed to the more frequent co-administration of GPIs with heparin.…”

Efficacy and safety of bivalirudin versus heparin in patients with diabetes mellitus undergoing percutaneous coronary intervention

“…There was a meta-analysis published in 2015 by Nairooz et al, [18] in which they reported that the application of Biva significantly lower levels of major bleeding and mortality compared with that resulting from heparin and GPI use in diabetes patients undergoing PCI. However, our findings are not consistent with these results.…”

Diabetes is not sufficient justification for IIb/IIIa use in percutaneous coronary intervention

“…The diabetic prothrombotic state differentially increases ischemic more than bleeding risk particularly in individuals requiring insulin treatment . Nairooz et al's and other meta‐analyses, as most precise available estimates, demonstrate that bivalirudin with provisional IIb/IIIa use is superior to routine IIb/IIIa therapy due to less bleeding and lower one‐year mortality in diabetics . Except for the mortality benefit of bivalirudin, this subgroup result is consistent with the outcome in all PCI patients: less bleeding and equivalent ischemic outcomes between bivalirudin and routine IIb/IIIa use.…”