The American journal of cardiology
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Multicenter Study Comparative Study
Comparison of event and procedure rates following percutaneous transluminal coronary angioplasty in patients with and without previous coronary artery bypass graft surgery [the ROSETTA (Routine versus Selective Exercise Treadmill Testing after Angioplasty) Registry].
To compare 6-month post-percutaneous transluminal coronary angioplasty (PTCA) outcomes and cardiac procedure use among patients with and without prior coronary artery bypass graft (CABG) surgery, we examined 791 patients who were enrolled in the Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) Registry. The ROSETTA Registry is a prospective, multicenter registry that examines the use of functional testing after successful PTCA. Most patients were men (76%, mean age 61 +/- 11 years) who underwent single-vessel PTCA (85%) with stent implantation (58%). ⋯ Within the prior CABG group, patients with a PTCA of a bypass graft had a higher composite clinical event rate than patients with a PTCA of a native vessel (32% vs 17%, p = 0.05). In contrast, patients with a PTCA of a native vessel had event rates similar to those of patients with no prior CABG (17% vs 12%, p = 0.2). Thus, post-CABG patients have an increased risk of developing a cardiac event or needing a follow-up cardiac procedure during the 6 months after PTCA.
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Multicenter Study
Development and validation of a clinical prediction rule for major adverse outcomes in coronary bypass grafting.
In this study, we develop and internally validate a clinical prediction rule for in-hospital major adverse outcomes, defined as death, renal failure, reinfarction, cardiac arrest, cerebrovascular accident, or coma, in patients who underwent coronary artery bypass grafting (CABG). All adult patients (n = 9,498) who underwent a CABG and no other concomitant surgery at 12 academic medical centers from August 1993 to October 1995 were included in the study. We assessed in-hospital major adverse outcomes and their predictors using information on admission, coronary angiography, and postoperative hospital course. ⋯ The spread in probability between the lowest and highest risk groups of having a major adverse outcome was 1.7% to 32.3% in the derivation set and 2.2% to 22.3% in the validation set. The prediction model performed well in both outcome discrimination and calibration. Thus, this clinical prediction rule allows accurate stratification of potential CABG candidates before surgery according to the risk of experiencing a major adverse outcome postoperatively.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effects of omapatrilat on hemodynamics and safety in patients with heart failure.
Omapatrilat, a novel vasopeptidase inhibitor, is a highly potent and selective inhibitor of neutral endopeptidase and angiotensin-converting enzyme; its therapeutic potential is being investigated for treatment of hypertension and heart failure. In the present study, the safety, tolerability, and hemodynamic effects of single oral doses of omapatrilat (1 to 50 mg) are compared with placebo in patients with heart failure. Patients with heart failure (New York Heart Association functional class II to IV) and a resting left ventricular ejection fraction < or = 40% were enrolled in a double-blind, placebo-controlled, sequential-panel study of single doses of omapatrilat of 1, 2.5, 5, 10, 25, or 50 mg, followed by hemodynamic assessment for 24 hours. ⋯ Additionally, by 2 hours after dosing with omapatrilat 25 and 50 mg, a trend in peak increases from baseline in plasma atrial natriuretic peptide (twofold) and cyclic guanosine monophosphate (nearly twofold) was observed. Moreover, omapatrilat was well tolerated. Thus, omapatrilat administered orally to patients with heart failure was safe and well tolerated and resulted in improved hemodynamic performance.
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Multicenter Study
Precipitating factors and decision-making processes of short-term worsening heart failure despite "optimal" treatment (from the IN-CHF Registry).
This study sought to prospectively assess which factors were related to short-term worsening heart failure (HF) leading to or not to hospital admission, in long-term outpatients followed by cardiologists. The subsequent decision-making process was also analyzed. The study population consisted of 2,701 outpatients enrolled in the registry of the Italian Network on Congestive Heart Failure (IN-CHF) and followed by 133 cardiology centers (19% of all existing Italian cardiology centers). ⋯ Thus, in ambulatory HF patients, short-term worsening HF can be predicted according to the clinical characteristics on an outpatient basis. Nearly 1/3 of precipitating factors can be prevented. Patient education and avoidance of inappropriate treatment may reduce the number of relapses.
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Multicenter Study Clinical Trial
Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators.
The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. ⋯ At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 +/- 0.69 mm and a loss index of 0.48 +/- 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent.