The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Impact of obesity on revascularization and restenosis rates after bare-metal and drug-eluting stent implantation (from the TAXUS-IV trial).
The effect of obesity on repeat coronary revascularization and restenosis in patients who undergo stent implantation has not been reported. We therefore examined the database from the multicenter randomized TAXUS-IV trial to determine the effect of body mass index (BMI) on outcomes after bare-metal and drug-eluting stent implantation. In TAXUS-IV, patients were randomized to receive a slow-release, polymer-based, paclitaxel-eluting stent or a bare-metal stent. ⋯ By multivariate analysis, BMI > or =30.0 kg/m2 independently predicted binary restenosis (hazard ratio 4.26, p = 0.005), 1-year target vessel revascularization (hazard ratio 1.95, p = 0.04), and major adverse cardiac events (hazard ratio 1.95, p = 0.004) in patients who received bare-metal stents but not paclitaxel-eluting stents. In conclusion, obesity is an important risk factor for clinical and angiographic restenosis and for composite major adverse cardiac events in patients who receive bare-metal stents. Paclitaxel-eluting stents attenuate the increased risk associated with obesity, such that the intermediate-term prognosis after percutaneous coronary intervention is independent of weight.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Bivalirudin versus heparin and glycoprotein IIb/IIIa inhibition among patients with renal impairment undergoing percutaneous coronary intervention (a subanalysis of the REPLACE-2 trial).
Among patients who undergo percutaneous coronary intervention, renal impairment is associated with an excessive risk of bleeding and ischemic events. Bivalirudin provides comparable suppression of ischemic events with a decrease in bleeding events compared with heparin and glycoprotein IIb/IIIa inhibition. We examined the relation between adverse events, renal impairment, and antithrombotic therapy within a randomized comparison. ⋯ Fewer bleeding events with bivalirudin were also evident irrespective of renal dysfunction. No interaction between treatment assignment, bleeding or ischemic complications, and renal impairment was observed. The safety and efficacy of bivalirudin compared with heparin and planned glycoprotein IIb/IIIa inhibition in this high-risk group are comparable and consistent with the results of the overall trial.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Predictors of and outcomes of early thrombosis following balloon angioplasty versus primary stenting in acute myocardial infarction and usefulness of abciximab (the CADILLAC trial).
We sought to identify the predictors and clinical outcomes of early thrombosis after primary angioplasty and stenting for acute myocardial infarction (AMI). Little is known about the correlates and prognosis of acute and subacute thromboses after percutaneous coronary intervention (PCI) for AMI. We therefore studied the frequency, clinical determinants, and implications of early thrombosis in a large trial of patients who had primary PCI. ⋯ Patients who develop early thrombosis after primary PCI have a very high rate of major adverse cardiac events, including death and reinfarction, and usually require repeat coronary angioplasty or surgery for management. Complex baseline angiographic morphology and smaller maximal balloon diameter are predictors of early thrombosis after primary PCI for AMI. The incidence of early thrombosis after primary angioplasty and stenting is decreased by abciximab use.
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Multicenter Study Comparative Study
Comparability of quality-of-care indicators for emergency coronary angioplasty in patients with acute myocardial infarction regardless of on-site cardiac surgery (report from the National Registry of Myocardial Infarction).
Initial reports have suggested that primary percutaneous coronary intervention (PCI) can be performed safely in selected hospitals without on-site cardiac surgery; however, quality-of-care indicators for primary PCI in these institutions is unknown. Therefore, symptom onset-to-door intervals, door-to-balloon times, compliance with American College of Cardiology/American Heart Association (ACC/AHA) management guidelines, and in-hospital mortality were evaluated in 108,132 patients in 3 hospital settings in the National Registry of Myocardial Infarction: (1) diagnostic laboratories only (n = 47), (2) elective PCI only (n = 50), and (3) elective PCI and cardiac surgery (n = 562). Mean symptom onset-to-door intervals (127 minutes, 95% confidence interval 118 to135; 134 minutes, 95% confidence interval 125 to 142; and 140 minutes, 95% confidence intervals 138 to 141; p = 0.01) and door-to-balloon intervals (104 minutes, 95% confidence interval 101 to 108; 116 minutes, 95% confidence interval 112 to 119; and 119 minutes, 95% confidence interval 118 to 120; p <0.0001) were shorter in hospitals without cardiac surgery. ⋯ There were comparable in-hospital mortality rates (3.2%, 4.2%, and 4.8%, respectively; p = 0.07) for patients with similar Thrombolysis In Myocardial Infarction risk scores; however, 4.7% of patients treated with primary PCI in hospitals without cardiac surgery were transferred to another institution. Thus, hospitals performing primary PCI without on-site cardiac surgery that participated in this registry have quality-of-care indicators and adherence to ACC/AHA management guidelines that are comparable to hospitals with on-site cardiac surgery. The lack of on-site cardiac surgery does not appear to adversely affect quality-of-care indicators in primary PCI.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Usefulness and safety of percutaneous myocardial laser revascularization for refractory angina pectoris.
This prospective, double-blind, randomized, sham-controlled trial was designed to control for patient and investigator bias in assessing symptomatic improvement after percutaneous myocardial laser revascularization (PMLR) therapy. Eighty-two patients with stable angina pectoris (class III or IV) not amenable to conventional revascularization and with evidence of reversible ischemia, ejection fraction >/=25%, and myocardial wall thickness >/=8 mm were randomized to either PMLR with optimal medical therapy (n = 40) or to a sham procedure with optimal medical therapy (n = 42). With the exception of 1 laser technician, all patients, investigators, and assessors were blinded to treatment through the 12-month follow-up. ⋯ Angina-specific quality-of-life measures were significantly higher in the PMLR group at each follow-up (p <0.05). Exercise and medication usage was similar between groups at 12 months. We conclude that PMLR therapy is reasonably safe and effective as symptomatic improvement in patients refractory to medical therapy, and that the clinical benefit is not attributable to placebo effect or investigator bias.