Safety of routine protamine in the reversal of heparin in percutaneous coronary intervention: A systematic review and meta-analysis.

OBJECTIVES: To determine the safety and efficacy of protamine in the reversal of heparin in percutaneous coronary intervention (PCI). BACKGROUND: Heparin is routinely used for anticoagulation in PCI. Protamine is not used routinely to reverse heparin's effects in PCI, partly due to the perceived risk of stent thrombosis. METHODS: Relevant studies published in English were searched for in PubMed, Embase, and Cochrane databases from inception to April 26th, 2023. Our primary outcome of interest was stent thrombosis in patients receiving PCI for all indications. Secondary outcomes included mortality, major bleeding complications, and hospitalization length. Dichotomous outcomes were analyzed using a Mantel-Haenszel random-effects model and expressed as odds ratios (OR) with their 95% confidence intervals (CI), while continuous outcomes were analyzed using an inverse variance random-effects model expressed as mean differences (MD) with their 95% CI. RESULTS: 11 studies were included in our analysis. Protamine use was not associated with stent thrombosis: OR 0.58, 95% CI: 0.33, 1.01 (p = 0.05) nor with mortality (p = 0.89). Protamine administration was associated with a decreased incidence of major bleeding complications: OR 0.48; 95% CI: 0.25, 0.95 (p = 0.03) and decreased length of hospitalization (p < 0.0001). CONCLUSIONS: In patients pre-treated with dual antiplatelet therapy (DAPT), protamine may be a safe and efficacious option to facilitate earlier sheath removal, reduce major bleeding complications, and reduce length of hospitalization without increased risk of stent thrombosis.

Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy.

BACKGROUND: Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomize hospitalized smokers to receive usual smoking cessation care alone or usual smoking care augmented with financial incentives. We aim to compare the impact of these two strategies on 1) smoking abstinence, 2) use of counseling and nicotine replacement therapy, and 3) quality of life of participants. We also will evaluate the short-term and long-term return on the investment of incentives. The FIESTA Oral Microbiome Substudy will compare the oral microbiome of smokers and nonsmokers to longitudinally assess whether smoking cessation changes oral microbiome composition. METHODS: We will enroll 182 inpatient participants from the Manhattan campus of the Veterans Affairs New York Harbor Healthcare System. All participants receive enhanced usual care, including screening for tobacco use, counseling while hospitalized, access to nicotine replacement therapy, and referral to a state Quitline. Patients in the financial incentive arm receive enhanced usual care and up to $550 for participating in the New York Smoker's Quitline, using nicotine replacement therapy (NRT), and achieving biochemically confirmed smoking cessation at 2 months and 6 months. In the microbiome substudy, we enroll nonsmoking control participants matched to each recruited smoker's hospital ward, sex, age, diabetes status, and antibiotic use. After discharge, participants are asked to complete periodic phone interviews at 2 weeks, 2 months, 6 months, and 12 months and provide expired carbon monoxide and saliva samples at 2 months, 6 months, and 12 months for cotinine testing and oral microbiome analysis. DISCUSSION: The incentive interventions of FIESTA may benefit hospitalized smokers, an objective made all the more critical because smoking rates among hospitalized patients are higher than those in the general population. Moreover, the focus of FIESTA on evidence-based therapy and bioconfirmed smoking cessation can help guide policy efforts to reduce smoking-related healthcare costs in populations with high rates of tobacco use and costly illnesses. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02506829 . Registered on 1 July 2014.

Quality of health economic evaluations for the ACC/AHA stable ischemic heart disease practice guideline: A systematic review.

BACKGROUND: The American College of Cardiology/American Heart Association (ACC/AHA) recently published a rigorous framework to guide integration of economic data into clinical guidelines. We assessed the quality of economic evaluations in a major ACC/AHA clinical guidance report. METHODS: We systematically identified cost-effectiveness analyses (CEAs) of RCTs cited in the ACC/AHA 2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease. We extracted: (1) study identifiers; (2) parent RCT information; (3) economic analysis characteristics; and (4) study quality using the Quality of Health Economic Studies instrument (QHES). RESULTS: Quality scores were categorized as high (≥75 points) or low (<75 points). Of 1,266 citations in the guideline, 219 were RCTs associated with 77 CEAs. Mean quality score was 81 (out of 100) and improved over time, though 29.9% of studies were low-quality. Cost-per-QALY was the most commonly reported primary outcome (39.0%). Low-quality studies were less likely to report study perspective, use appropriate time horizons, or address statistical and clinical uncertainty. Funding was overwhelmingly private (83%). A detailed methodological assessment of high-quality studies revealed domains of additional methodological issues not identified by the QHES. CONCLUSIONS: Economic evaluations of RCTs in the 2012 ACC/AHA ischemic heart disease guideline largely had high QHES scores but methodological issues existed among "high-quality" studies. Because the ACC/AHA has generally been more systematic in its integration of scientific evidence compared to other professional societies, it is likely that most societies will need to proceed more cautiously in their integration of economic evidence.

Appropriate Use of Cardiac Stress Testing with Imaging: A Systematic Review and Meta-Analysis.

BACKGROUND: Appropriate use criteria (AUC) for cardiac stress tests address concerns about utilization growth and patient safety. We systematically reviewed studies of appropriateness, including within physician specialties; evaluated trends over time and in response to AUC updates; and characterized leading indications for inappropriate/rarely appropriate testing. METHODS: We searched PubMed (2005-2015) for English-language articles reporting stress echocardiography or myocardial perfusion imaging (MPI) appropriateness. Data were pooled using random-effects meta-analysis and meta-regression. RESULTS: Thirty-four publications of 41,578 patients were included, primarily from academic centers. Stress echocardiography appropriate testing rates were 53.0% (95% CI, 45.3%-60.7%) and 50.9% (42.6%-59.2%) and inappropriate/rarely appropriate rates were 19.1% (11.4%-26.8%) and 28.4% (23.9%-32.8%) using 2008 and 2011 AUC, respectively. Stress MPI appropriate testing rates were 71.1% (64.5%-77.7%) and 72.0% (67.6%-76.3%) and inappropriate/rarely appropriate rates were 10.7% (7.2%-14.2%) and 15.7% (12.4%-19.1%) using 2005 and 2009 AUC, respectively. There was no significant temporal trend toward rising rates of appropriateness for stress echocardiography or MPI. Unclassified stress echocardiograms fell by 79% (p = 0.04) with updated AUC. There were no differences between cardiac specialists and internists. CONCLUSIONS: Rates of appropriate use tend to be lower for stress echocardiography compared to MPI, and updated AUC reduced unclassified stress echocardiograms. There is no conclusive evidence that AUC improved appropriate use over time. Further research is needed to determine if integration of appropriateness guidelines in academic and community settings is an effective approach to optimizing inappropriate/rarely appropriate use of stress testing and its associated costs and patient harms.