Coronary artery disease
Comparison of Bivalirudin Monotherapy Versus Unfractionated Heparin Plus Tirofiban in Patients With Diabetes Mellitus Undergoing Elective Percutaneous Coronary Intervention

https://doi.org/10.1016/j.amjcard.2009.06.035Get rights and content

Bivalirudin demonstrated similar efficacy but resulted in a lower rate of bleeding compared to unfractionated heparin (UFH) plus platelet glycoprotein IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention. It has not been clearly evaluated whether this can also be applied to patients with diabetes mellitus. A total of 335 consecutive patients with diabetes mellitus referred for elective percutaneous coronary intervention were randomized in the Novel Approaches for Preventing or Limiting EventS (NAPLES) trial to receive bivalirudin monotherapy or UFH plus routine tirofiban. The primary composite end point (30-day composite incidence of death, urgent repeat revascularization, myocardial infarction, and all bleeding) was lower in the bivalirudin group than in the UFH plus tirofiban group (18.0% vs 31.5%, odds ratio 0.47, 95% confidence interval 0.28 to 0.79, p = 0.004). No death, urgent revascularization, or Q-wave myocardial infarction occurred. The rate of non–Q-wave myocardial infarction was similar in the 2 groups (10.2% in the bivalirudin group vs 12.5% in the UFH plus tirofiban group, p = 0.606). In contrast, fewer patients in the bivalirudin group experienced bleeding (8.4% vs 20.8%, odds ratio 0.34, 95% confidence interval 0.18 to 0.67, p = 0.002). This difference was mainly ascribed to the lower rate of minor bleeding (7.8% in the bivalirudin group vs 18.5% in the UFH plus tirofiban group, odds ratio 0.37, 95% confidence interval 0.19 to 0.74, p = 0.005), although the rate of major bleeding in the 2 groups was comparable (0.6% vs 2.4%, respectively; p = 0.371). In conclusion, in patients with diabetes mellitus undergoing elective percutaneous coronary intervention, the strategy of bivalirudin monotherapy compared to UFH plus routine tirofiban is safe and feasible and associated with a significant reduction of in-hospital bleeding.

Section snippets

Methods

From October 2005 to February 2008, all consecutive eligible patients undergoing PCI at the Clinica Mediterranea, Naples, Italy were considered for enrollment in the Novel Approaches for Preventing or Limiting EventS (NAPLES) trial. The inclusion criteria were age ≥18 years old, DM treated with insulin and/or oral agents, de novo coronary lesion in a native coronary artery, and elective PCI. The exclusion criteria were (1) PCI performed as reperfusion therapy for acute myocardial infarction

Results

Of 366 patients considered for eligibility, 335 were enrolled from October 4, 2005 to February 14, 2008. Of the 366 patients, 31 were not enrolled because they did not meet the inclusion criteria (n = 25) or refused participation (n = 6; Figure 1). The baseline clinical and biochemical characteristics were balanced between the 2 treatment groups (Table 1), and no statistically significant differences between groups in the most important procedural characteristics were present (Table 2). In the

Discussion

The results of the present prospective, randomized study suggest that in patients with DM undergoing elective PCI after clopidogrel preloading, an antithrombotic strategy of bivalirudin monotherapy, compared to UFH plus routine tirofiban administration, is effective in reducing the composite end point of 30-day death, MI, urgent revascularization, and bleeding. Bivalirudin administration resulted in a similar protection against the 30-day ischemic events after PCI, and the difference in the

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