Coronary artery diseaseComparison of Bivalirudin Monotherapy Versus Unfractionated Heparin Plus Tirofiban in Patients With Diabetes Mellitus Undergoing Elective Percutaneous Coronary Intervention
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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One-year clinical outcomes of bivalirudin versus unfractionated heparin in patients with type 2 diabetes undergoing elective percutaneous coronary intervention
2023, Diabetes and Metabolic Syndrome: Clinical Research and ReviewsEfficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials
2016, International Journal of CardiologyCitation Excerpt :The quality assessment is detailed in Supplementary Table 2, Supplementary Fig. 1 and Supplementary Fig. 2. We identified 1578 articles and included 17 trials [6–22] that satisfied our inclusion criteria. The selected procedure is shown in Fig. 1.
Risk of Stent Thrombosis and Major Bleeding with Bivalirudin Compared with Active Control: A Systematic Review and Meta-analysis of Randomized Trials
2015, Thrombosis ResearchCitation Excerpt :Aspirin was used in all trials in the bivalirudin and heparin groups as the background treatment. Clopidogrel was used in most trials in both groups [2,5,6,8,9,13,23–32,34–37] but was administered only to the heparin group in the BRAVE 4 trial [10]. Prasugrel was administered as the background treatment in EUROMAX [23] and HEAT-PPCI [8].
Bivalirudin in stable angina and acute coronary syndromes
2015, Pharmacology and TherapeuticsBivalirudin versus heparin for percutaneous coronary intervention: An updated meta-analysis of randomized controlled trials
2014, Cardiovascular Revascularization MedicineCitation Excerpt :Our search flow diagram can be found in Fig. 1. For our meta-analysis, we included 14 RCTs [7–10,29–40] with 30,446 patients that were randomized to either bivalirudin with provisional GPI use (n = 14,869) or heparin with provisional GPI use (n = 6451) [7–10,29–33] or heparin with routine GPI use (n = 9126) [9,34–38]. Baseline study characteristics can be found in Table 1.