Journal of the American College of Cardiology
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J. Am. Coll. Cardiol. · Jun 2012
Randomized Controlled Trial Multicenter Study Comparative StudyFirst results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes.
The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). ⋯ In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).
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J. Am. Coll. Cardiol. · Jun 2012
Meta AnalysisClinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies.
This study sought to perform a weighted meta-analysis to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature. ⋯ VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes. Future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.
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J. Am. Coll. Cardiol. · Jun 2012
Randomized Controlled TrialSafety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy.
The primary objective of this study was to evaluate the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy of 5 SAR236553/REGN727 (SAR236553) dosing regimens versus placebo at week 12 in patients with LDL-C ≥100 mg/dl on stable atorvastatin therapy. Secondary objectives included evaluation of effects on other lipid parameters and the attainment of LDL-C treatment goals of <100 mg/dl (2.59 mmol/l) and <70 mg/dl (1.81 mmol/l). ⋯ When added to atorvastatin, PCSK9 inhibition with SAR236553 further reduces LDL-C by 40% to 72%. These additional reductions are both dose- and dosing frequency-dependent. (Efficacy and Safety Evaluation of SAR236553 [REGN727] in Patients With Primary Hypercholesterolemia and LDL-cholesterol on Stable Atorvastatin Therapy; NCT01288443).
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J. Am. Coll. Cardiol. · Jun 2012
Review Historical ArticleThe New York State cardiac registries: history, contributions, limitations, and lessons for future efforts to assess and publicly report healthcare outcomes.
In 1988, the New York State Health Commissioner was confronted with hospital-level data demonstrating very large, multiple-year, interhospital variations in short-term mortality and complications for cardiac surgery. The concern with the extent to which these differences were due to variations in patients' pre-surgical severity of illness versus hospitals' quality of care led to the development of clinical registries for cardiac surgery in 1989 and for percutaneous coronary interventions in 1992 in New York. In 1990, the Department of Health released hospitals' risk-adjusted cardiac surgery mortality rates for the first time, and shortly thereafter, similar data were released for hospitals and physicians for percutaneous coronary interventions, cardiac valve surgery, and pediatric cardiac surgery (only hospital data). ⋯ These changes include decreases in risk-adjusted mortality, cessation of cardiac surgery in New York by low-volume and high-mortality surgeons, out-of-state referral or avoidance of cardiac surgery/angioplasty for high-risk patients, alteration of contracting choices by insurance companies, and modifications in market share of cardiac hospitals. Evidence related to these impacts is reviewed and critiqued. This communication also includes a summary of numerous studies that used New York's cardiac registries to examine a variety of policy issues regarding the choice and use of cardiac procedures, the comparative effectiveness of competing treatment options, and the examination of the relationship among processes, structures, and outcomes of cardiac care.