The American journal of cardiology
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Randomized Controlled Trial
Comparison of bivalirudin monotherapy versus unfractionated heparin plus tirofiban in patients with diabetes mellitus undergoing elective percutaneous coronary intervention.
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. ⋯ 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.
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Randomized Controlled Trial
Impact of final activated clotting time after transradial coronary stenting with maximal antiplatelet therapy.
The optimal value of activated clotting time (ACT) during percutaneous coronary intervention (PCI) with unfractionated heparin remains controversial. No data are available on the relation between the ACT at the end of the procedure (final ACT) and the clinical outcomes after transradial PCI and maximal antiplatelet therapy. By dividing the final ACT values in tertiles, we analyzed the ischemic and bleeding events in 1,234 consecutive patients with acute coronary syndrome recruited in the EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) trial. ⋯ Death and target vessel revascularization remained similar in all tertiles for < or =3 years. In conclusion, with the combination of aspirin, clopidogrel pretreatment, and abciximab, a final ACT value of >330 seconds appears protective against peri-PCI myonecrosis, and this benefit was maintained for < or =3 years. With a transradial approach and maximal antiplatelet therapy, greater ACT values did not correlate with an increased risk of bleeding.
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Randomized Controlled Trial Multicenter Study Comparative Study
Impact of an initial strategy of medical therapy without percutaneous coronary intervention in high-risk patients from the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial.
We explored the safety and quality-of-life consequences of treating patients with stable coronary disease and high-risk features initially with optimal medical therapy (OMT) alone compared to OMT plus percutaneous coronary intervention. This was a post hoc analysis of Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial patients. We defined high risk as the onset of Canadian Cardiovascular Society class III angina within 2 months or stabilized acute coronary syndrome within 2 weeks of enrollment. ⋯ No significant difference was found in the prevalence of angina between the 2 groups at 1 year. During the first year of follow-up, 30% of the OMT patients crossed over to the revascularization group. In conclusion, an initial strategy of OMT alone for high-risk patients in the COURAGE trial did not result in increased death or myocardial infarction at 4.6 years or worse angina at 1 year, but it was associated with a high rate of crossover to revascularization.
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Randomized Controlled Trial Comparative Study
Efficacy of single-bolus administration of sodium bicarbonate to prevent contrast-induced nephropathy in patients with mild renal insufficiency undergoing an elective coronary procedure.
We sought to clarify whether a single-bolus intravenous administration of sodium bicarbonate in addition to hydration with sodium chloride prevents contrast-induced nephropathy (CIN). One hundred forty-four patients with mild renal insufficiency (serum creatinine >1.1 to <2.0 mg/dl) undergoing an elective coronary procedure were randomly assigned to the following 2 groups: standard hydration with sodium chloride plus single-bolus intravenous administration of sodium bicarbonate (20 mEq) immediately before contrast exposure (group A, n = 72) and standard hydration alone (group B, n = 72). ⋯ Incidence of adverse clinical events (acute pulmonary edema, acute renal failure requiring dialysis, and death within 7 days of procedure) did not differ between the 2 groups (0% vs 1.4%). In conclusion, single-bolus intravenous administration of sodium bicarbonate in addition to standard hydration can more effectively prevent CIN than standard hydration alone in patients with mild renal insufficiency undergoing an elective coronary procedure.
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Randomized Controlled Trial
Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study.
Both randomized and observational studies have suggested that pretreatment with statins may reduce the incidence of periprocedural myocardial infarction (PMI) in patients with stable angina during elective percutaneous coronary intervention (PCI). The purpose of this randomized study (Clinical Trial Registration No. NCT00469326) was to investigate the effect of 2-day atorvastatin therapy on the incidence of PMI in patients with stable angina pectoris undergoing elective PCI. ⋯ The median peak troponin I level after PCI was 0.100 ng/ml (0.096 to 0.385) in the atorvastatin group and 0.100 ng/ml (0.60 to 0.262) in the control group (p = 0.54). On multivariate analysis, the only independent predictor of PMI was patient age (odds ratio 1.09, 95% confidence interval 1.025 to 1.159, p = 0.006). In conclusion, in the present study 2-day pre-PCI therapy with atorvastatin did not reduce the occurrence of PMI in patients with stable angina pectoris undergoing elective PCI.