The American journal of cardiology
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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
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.