A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 205-205 ◽  
Author(s):  
Sam Schulman ◽  
Ajay K Kakkar ◽  
Sebastian M Schellong ◽  
Samuel Z. Goldhaber ◽  
Eriksson Henry ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adverse Events ◽  
Primary Outcome ◽  
Warfarin Dose ◽  
Hazard Ratio ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Coronary Syndrome ◽  
Recurrent Vte ◽  
Acute Venous Thromboembolism

Abstract Abstract 205 Background: Dabigatran has been compared with warfarin for treatment of acute venous thromboembolism in one previous trial (RE-COVER). Based on the low rate of the primary outcome as the RE-COVER study was running, we undertook this replica study to confirm the results of RE-COVER, and to allow for more rigorous sub-group analyses. Methods: In a randomized, double-blind, double-dummy trial of 2568 patients with acute VTE, treated with low molecular weight or unfractionated heparin for 5 to 11 days, we compared dabigatran, 150 mg twice daily, with warfarin, dose-adjusted to an International Normalized Ratio of 2.0 and 3.0, each given for 6 months. Primary outcome was recurrent symptomatic, objectively confirmed venous thromboembolism and deaths related to venous thromboembolism during 6 months. Safety endpoints included bleeding events, acute coronary syndrome, elevated liver function tests, and adverse events. Results: Of 1279 patients randomized to dabigatran, 30 (2.4%) had recurrent VTE compared with 28 (2.2%) of 1289 patients randomized to warfarin; risk difference 0.2% (95% confidence interval [CI], −1.0 to 1.5); p<0.0001 for the pre-specified non-inferiority margin. The hazard ratio for dabigatran was 1.08 (95% CI, 0.64 to 1.80). Major bleeding occurred in 15 patients treated with dabigatran and 22 patients treated with warfarin (hazard ratio 0.69; 95% CI, 0.36 to 1.32) and any bleeding occurred in 200 versus 285 patients, respectively (hazard ratio 0.67, 95% CI, 0.56 to 0.81). The frequency of reported ACS events was less than 1% in the trial, with more cases in the dabigatran treatment group than those treated with warfarin. There were 25 deaths during each treatment, and serious adverse events were similar in the two groups. Analysis of outcomes based on demographic characteristics showed consistency of effects for both safety and efficacy. This included the analysis based on Asian race, which had been limited in RE-COVER. There were 537 Asian patients in RE-COVER II compared to only 65 in RE-COVER. The event rates of recurrent VTE and of any bleeding were similar in Asians and non-Asians. Conclusion: The study confirms that the efficacy of dabigatran is non-inferior to warfarin in the treatment of acute VTE and with a lower risk for bleeding. The safety of dabigatran is similar in the Asian population compared with non-Asians. Disclosures: Off Label Use: dabigatran for treatment of venous thromboembolism. Christiansen:Boehringer Ingelheim: Employment. Schnee:Boehringer Ingelheim: Employment.

scholarly journals Predicting the Risk of Recurrent Venous Thromboembolism: Current Challenges and Future Opportunities

2020 ◽  
Vol 9 (5) ◽  
pp. 1582 ◽  
Author(s):  
Hannah Stevens ◽  
Karlheinz Peter ◽  
Huyen Tran ◽  
James McFadyen
Keyword(s):  
Venous Thromboembolism ◽  
Prediction Models ◽  
Clinical Prediction ◽  
Bleeding Events ◽  
Clinical Prediction Models ◽  
Disease Pathogenesis ◽  
Recurrent Venous Thromboembolism ◽  
Novel Biomarkers ◽  
Recurrent Vte ◽  
Acute Venous Thromboembolism

Acute venous thromboembolism (VTE) is a commonly diagnosed condition and requires treatment with anticoagulation to reduce the risk of embolisation as well as recurrent venous thrombotic events. In many cases, cessation of anticoagulation is associated with an unacceptably high risk of recurrent VTE, precipitating the use of indefinite anticoagulation. In contrast, however, continuing anticoagulation is associated with increased major bleeding events. As a consequence, it is essential to accurately predict the subgroup of patients who have the highest probability of experiencing recurrent VTE, so that treatment can be appropriately tailored to each individual. To this end, the development of clinical prediction models has aided in calculating the risk of recurrent thrombotic events; however, there are several limitations with regards to routine use for all patients with acute VTE. More recently, focus has shifted towards the utility of novel biomarkers in the understanding of disease pathogenesis as well as their application in predicting recurrent VTE. Below, we review the current strategies used to predict the development of recurrent VTE, with emphasis on the application of several promising novel biomarkers in this field.

Association of Hyper-Polypharmacy With Clinical Outcomes in Heart Failure With Preserved Ejection Fraction

2021 ◽  
Author(s):  
Masatoshi Minamisawa ◽  
Brian Claggett ◽  
Kota Suzuki ◽  
Sheila M. Hegde ◽  
Amil M. Shah ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Ejection Fraction ◽  
Primary Outcome ◽  
Hazard Ratio ◽  
Preserved Ejection Fraction ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Patients With Heart Failure ◽  
The Relationship

Background: Polypharmacy is associated with a poor prognosis in the elderly, however, information on the association of polypharmacy with cardiovascular outcomes in heart failure with preserved ejection fraction is sparse. This study sought to investigate the relationship between polypharmacy and adverse cardiovascular events in patients with heart failure with preserved ejection fraction. Methods: Baseline total number of medications was determined in 1758 patients with heart failure with preserved ejection fraction enrolled in the Americas regions of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist), by 3 categories: nonpolypharmacy (<5 medications), polypharmacy (5–9), and hyper-polypharmacy (≥10). We examined the relationship of polypharmacy status with the primary outcome (cardiovascular death, HF hospitalization, or aborted cardiac arrest), hospitalizations for any reason, and serious adverse events. Results: The proportion of patients taking 5 or more medications was 92.5% (inclusive of polypharmacy [38.7%] and hyper-polypharmacy [53.8%]). Over a 2.9-year median follow-up, compared with patients with polypharmacy, hyper-polypharmacy was associated with an increased risk for the primary outcome, hospitalization for any reason and any serious adverse events in the univariable analysis, but not significantly associated with mortality. After multivariable adjustment for demographic and comorbidities, hyper-polypharmacy remained significantly associated with an increased risk for hospitalization for any reason (hazard ratio, 1.22 [95% CI, 1.05–1.41]; P =0.009) and any serious adverse events (hazard ratio, 1.23 [95% CI, 1.07–1.42]; P =0.005), whereas the primary outcome was no longer statistically significant. Conclusions: Hyper-polypharmacy was common and associated with an elevated risk of hospitalization for any reason and any serious adverse events in patients with heart failure with preserved ejection fraction. There were no significant associations between polypharmacy status and mortality.

scholarly journals Utility of a Nurse-Led Pathway for Patients with Acute Venous Thromboembolism Discharged on Rivaroxaban: A Prospective Cohort Study

2018 ◽  
Vol 45 (02) ◽  
pp. 187-195 ◽  
Author(s):  
Tishya Indran ◽  
Anita Cummins ◽  
Ashwini Bennett ◽  
Erica Wood ◽  
Susan Brown ◽  
...  
Keyword(s):  
Cohort Study ◽  
Venous Thromboembolism ◽  
Adverse Events ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Oral Anticoagulants ◽  
All Cause Mortality ◽  
Clinical Surveillance ◽  
Recurrent Vte ◽  
Acute Venous Thromboembolism

AbstractThe highest risk of adverse events for patients with acute venous thromboembolism (VTE) is during the early anticoagulation period. However, no established model exists for early clinical monitoring of patients treated with non–vitamin K antagonist oral anticoagulants (NOACs). The authors' aim was to evaluate the utility of a nurse-led pathway to minimize adverse events in acute VTE patients starting on rivaroxaban. The rivaroxaban VTE treatment pathway is a prospective cohort study of consecutive patients with objectively confirmed VTE between July 2015 and May 2017. Primary outcome was the proportion of patients identified at major risk of adverse events (bleeding or recurrent VTE). Secondary outcomes were rates of interventions, major or clinically relevant nonmajor bleeding (CRNMB), recurrent VTE, and all-cause mortality at 90 days. Among 304 participants, 5% (n = 15) were identified to be at major and 9% (n = 28) at possible risk for adverse events. Appropriate interventions to prevent harm were required in 40 patients. Rates of major bleeding, CRNMB, recurrence, and all-cause mortality were 0.3% (95% confidence interval [CI]: 0.1–1.8), 7.2% (95% CI: 4.8–10.7), 1.0 (95% CI: 0.3–2.9), and 1.6% (95% CI: 0.7–3.8), respectively. In conclusion, following discharge of acute VTE patients, a nurse-led pathway identified one in seven (14%) patients at major or possible risk of adverse events. Preemptive interventions to reduce harm translated into the low rates of bleeding and recurrence. The authors' experience highlights the feasibility and importance of a structured clinical surveillance pathway for acute VTE patients initiating NOAC therapy.

scholarly journals SAMe-TT2R2 predicts quality of anticoagulation in patients with acute venous thromboembolism: The MAQI2 experience

2017 ◽  
Vol 22 (3) ◽  
pp. 197-203 ◽  
Author(s):  
Akash Kataruka ◽  
Xiaowen Kong ◽  
Brian Haymart ◽  
Eva Kline-Rogers ◽  
Steve Almany ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adverse Events ◽  
Clinical Decision Making ◽  
Predictive Ability ◽  
Clinical Decision ◽  
International Normalized Ratio ◽  
Clinical Events ◽  
Recurrent Vte ◽  
Acute Venous Thromboembolism

A high SAMe-TT2R2 score predicted poor warfarin control and adverse events among atrial fibrillation patients. However, the SAMe-TT2R2 score has not been well validated in venous thromboembolism (VTE) patients. A cohort of 1943 warfarin-treated patients with acute VTE was analyzed to correlate the SAMe-TT2R2 score with time in therapeutic range (TTR) and clinical adverse events. A TTR <60% was more frequent among patients with a high (>2) versus low (0–1) SAMe-TT2R2 score (63.4% vs 52.3%, p<0.0001). A high SAMe-TT2R2 score (>2) correlated with increased overall adverse events (7.9 vs 4.5 overall adverse events/100 patient years, p=0.002), driven primarily by increased recurrent VTE rates (4.2 vs 1.5 recurrent VTE/100 patient years, p=0.0003). The SAMe-TT2R2 score had a modest predictive ability for international normalized ratio (INR) quality and adverse clinical events among warfarin-treated VTE patients. The utility of the SAMe-TT2R2 score to guide clinical decision-making remains to be investigated.

scholarly journals Fondaparinux Pre-, Peri-, and/or Postpartum for the Prophylaxis/Treatment of Venous Thromboembolism (FondaPPP)

2021 ◽  
Vol 27 ◽  
pp. 107602962110145
Author(s):  
Carl-Erik Dempfle ◽  
Jürgen Koscielny ◽  
Edelgard Lindhoff-Last ◽  
Birgit Linnemann ◽  
Irene Bux-Gewehr ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adverse Events ◽  
Drug Hypersensitivity ◽  
Low Molecular Weight ◽  
Premature Births ◽  
First Line ◽  
Bleeding Events ◽  
Heparin Induced Thrombocytopenia ◽  
First Line Therapy ◽  
Heparin Allergy

We analyzed data for women who received fondaparinux for ≥7 days during pregnancy. The study retrospectively included women who received fondaparinux pre-, peri- and/or postpartum for ≥7 days for prophylaxis/venous thromboembolism (VTE) treatment at German specialist centers (2004-2010). Data on pregnancy, VTE risk factors, anticoagulant treatment, pregnancy outcome and adverse events were extracted from medical records. 120 women (mean age 31.5 years) were included. Among 84 women with prior pregnancies, 41.0% had ≥1 abortion. Anticoagulation was indicated for prophylaxis in 92.5% cases, including 82.5% women with an elevated VTE risk (82.8% thrombophilia, 34.2% VTE history). All women received low-molecular-weight heparin (LMWH) as first-line therapy; 3 also unfractionated heparin. Treatment changed to fondaparinux, due to heparin allergy (41.7%) or heparin-induced thrombocytopenia (10.0%). Fondaparinux was generally well tolerated. Adverse events included bleeding events (n = 5), abortion (n = 2), premature births (n = 2), stillbirth (n = 1), arrested labors (n = 2), injection site erythema (n = 4) and unspecified drug hypersensitivity (n = 6). No VTE events or increased liver enzymes occurred during treatment. In this retrospective study, fondaparinux was effective and well tolerated. Trial registration: ClinicalTrials.gov NCT01004939.

Successful Use of Intravenous Methylnaltrexone for Opioid-Induced Constipation in Critically Ill Pediatric Patients

2021 ◽  
Author(s):  
Kimberly P. Mills ◽  
Christopher C. McPherson ◽  
Ahmed S. Said ◽  
Michael A. Lahart
Keyword(s):  
Adverse Events ◽  
Critically Ill ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Case Series ◽  
Opioid Withdrawal ◽  
Limited Data ◽  
Serious Adverse Events ◽  
Patient Response ◽  
Hospital Patients

Abstract Objectives Methylnaltrexone is U.S. Food and Drug Administration (FDA) approved as a subcutaneous injection for adults with opioid-induced constipation (OIC). Case series have described the use of methylnaltrexone for OIC in the pediatric oncology population. There are limited data describing its intravenous use in critically ill pediatric patients. Methods We conducted a retrospective observational study at St. Louis Children's Hospital. Patients less than 18 years old who received at least one dose of intravenous methylnaltrexone while admitted to an intensive care unit between January 2016 and August 2019 were included. The primary outcome was documented laxation within 24 hours of methylnaltrexone administration. Results Sixteen patients received a total of 34 doses of intravenous methylnaltrexone. Patients received a median of 1.69 (interquartile range [IQR], 0.9–4.86) morphine milligram equivalents per kilogram per 24 hours, over a median of 14 days (IQR, 11–30), before methylnaltrexone administration. The median dose of methylnaltrexone was 0.15 mg/kg (IQR, 0.15–0.16). Ten patients (63%) responded to the first dose of methylnaltrexone, and 14 patients (88%) responded to at least one dose. Overall, 26 doses (76%) led to patient response. Four patients (25%) experienced adverse events (emesis, abdominal pain) after methylnaltrexone administration. No signs or symptoms of opioid withdrawal were documented. Conclusions Intravenous methylnaltrexone appears to be safe and effective in treating OIC in critically ill pediatric patients. No serious adverse events or signs of opioid withdrawal were observed after single and repeat dosing. Patients responded to methylnaltrexone with varying opioid dosing and durations prior to administration.

Abstract 104: Disability After Minor Stroke and TIA in the POINT Trial

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Brett L Cucchiara ◽  
Jordan Elm ◽  
J Donald Easton ◽  
Shelagh Coutts ◽  
Joshua Willey ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Antiplatelet Therapy ◽  
Primary Outcome ◽  
Dual Antiplatelet Therapy ◽  
Recurrent Stroke ◽  
Primary Outcome Measure ◽  
Minor Stroke ◽  
Serious Adverse Events ◽  
Index Event

Background and Purpose: To assess the effect of combination antiplatelet therapy with aspirin and clopidogrel versus aspirin alone on disability following TIA or minor stroke and to identify factors associated with disability. Methods: The POINT trial randomized patients with TIA or minor stroke (NIHSS≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, MI, or vascular death. We performed a post-hoc exploratory analysis to examine the effect of treatment on overall disability (defined as mRS>1) at 90 days as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results: At 90 days, 188/1964 (9.6%) of patients enrolled with TIA and 471/2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% vs. 14.3%, OR 0.97, 95%CI 0.82-1.14, p=0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% vs. 4.0%, OR 0.73, 95%CI 0.53-1.01, p=0.06), and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% vs. 7.4%, OR 0.78, 95% CI 0.62-0.99, p=0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% vs. 6.0%, OR 0.74 95% CI 0.57-0.96, p=0.02). In multivariate analysis of patients enrolled with TIA, disability was significantly associated with age, subsequent ischemic stroke, serious adverse events, and major bleeding. In patients enrolled with stroke, disability was associated with female sex, hypertension, diabetes, NIHSS score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events. Conclusions: In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, dual antiplatelet therapy might reduce stroke-related disability.

scholarly journals Efficacy and safety of eltrombopag in the treatment of severe chronic immune thrombocytopenia in children of China: A single-center observational study

2019 ◽  
Vol 33 ◽  
pp. 205873841987212 ◽  
Author(s):  
Xiaoling Cheng ◽  
Kuo Yan ◽  
Jingyao Ma ◽  
Zhenping Chen ◽  
Libo Zhao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Immune Thrombocytopenia ◽  
Response Rates ◽  
Drug Dosage ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Durable Response ◽  
Chronic Immune Thrombocytopenia

The treatment of severe chronic immune thrombocytopenia (SCITP) in pediatric patients is challenging. We evaluated the clinical efficacy and safety of eltrombopag in children with SCITP in China. This observational study was carried out at the Hematology Oncology Center, Beijing Children’s Hospital between April 2017 and July 2018. Patients with SCITP who had at least 12 weeks of eltrombopag treatment and follow-up data were included. Baseline data, such as age, drug dosage, pre-study platelet count, concomitant medications, and bleeding severity, were collected. Treatment response rates, durable response rates, bleeding events, and adverse events were assessed during eltrombopag therapy for at least 12 weeks. The median duration of eltrombopag therapy was 16 (12–48) weeks. The overall, complete, and partial response rates were 75% (15/20), 35% (7/20), and 40% (8/20), respectively. The durable response rate was 70% (14/20). No serious bleeding events or serious adverse events occurred during the study period. Eltrombopag appears to be effective and safe in children with SCITP, although additional research is needed to confirm this.

P1731High-sensitivity troponin with sex-specific thresholds in suspected acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K K Lee ◽  
A V Ferry ◽  
A Anand ◽  
F E Strachan ◽  
A R Chapman ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Confidence Interval ◽  
Myocardial Injury ◽  
Primary Outcome ◽  
Hazard Ratio ◽  
Adjusted Hazard Ratio ◽  
Coronary Syndrome ◽  
Diagnostic Thresholds ◽  
The Impact

Abstract Background/Introduction Major disparities between women and men in the diagnosis, management and outcome of acute coronary syndrome are well recognised. Whether sex-specific diagnostic thresholds for myocardial infarction will address these differences is uncertain. Purpose To evaluate the impact of implementing a high-sensitivity cardiac troponin I (hs-cTnI) assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome. Methods In a stepped-wedge, cluster-randomized controlled trial across ten hospitals we evaluated the implementation of a hs-cTnI assay in 48,282 (47% women) consecutive patients with suspected acute coronary syndrome. During a validation phase the hs-cTnI assay results were suppressed and a contemporary cTnI assay with a single threshold was used to guide care. Myocardial injury was defined as any hs-cTnI concentration >99th centile of 16 ng/L in women and 34 ng/L in men. The primary outcome was myocardial infarction after the initial presentation or cardiovascular death at 1 year. In this prespecified analysis, we evaluated outcomes in men and women before and after implementation of the hs-cTnI assay. Results Use of the hs-cTnI assay with sex-specific thresholds increased myocardial injury in women by 42% (from 3,521 (16%) to 4,991 (22%)) and by 6% in men (from 5,068 (20%) to 5,369 (21%)). Whilst treatment increased in both sexes, women with myocardial injury remained less likely than men to undergo coronary revascularisation (15% versus34%), or to receive dual anti-platelet (26% versus43%), statin (16% versus26%) or other preventative therapies (P<0.001 for all). The primary outcome occurred in 18% (369/2,072) and 17% (488/2,919) of women with myocardial injury during the validation and implementation phase respectively (adjusted hazard ratio 1.11, 95% confidence interval 0.92 to 1.33), compared to 18% (370/2,044) and 15% (513/3,325) of men (adjusted hazard ratio 0.85, 95% confidence interval 0.71 to 1.01). Patient management Conclusion Use of sex-specific thresholds identified five-times more additional women than men with myocardial injury, such that the proportion of women and men with myocardial injury is now similar. Despite this increase, women received approximately half the number of treatments for coronary artery disease as men and their outcomes were not improved. Acknowledgement/Funding The British Heart Foundation

scholarly journals Early Dynamic Change in High-Sensitivity Cardiac Troponin T in the Investigation of Acute Myocardial Infarction

2011 ◽  
Vol 57 (8) ◽  
pp. 1154-1160 ◽  
Author(s):  
Sally J Aldous ◽  
A Mark Richards ◽  
Louise Cullen ◽  
Martin P Than
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Adverse Events ◽  
Troponin T ◽  
Dynamic Change ◽  
High Sensitivity ◽  
Hazard Ratio ◽  
Diagnostic Sensitivity ◽  
Diagnostic Specificity ◽  
Coronary Syndrome

BACKGROUND The definition of acute myocardial infarction (AMI) requires a rise and/or fall in troponin with 1 or more results ≥99th percentile of the reference range. How much troponin must change has not been specified. We ascertained whether dynamic changes (δ) in high-sensitivity troponin T (hs-TnT) improved diagnostic and prognostic test performance in the emergency department. METHODS We recruited 939 patients with symptoms suggestive of acute coronary syndrome (without ST elevation). hs-cTnT was measured at 0 h and 2 h after presentation. End-points were admission diagnosis of AMI and 1-year adverse events (composite of death, AMI, revascularization). RESULTS Diagnostic specificity of 0–2-h hs-cTnT for AMI (incurred by 200 patients) improved from 79.8% (78.8%–80.5%) by using the 99th percentile alone to 94.2% (92.9%–95.4%) when we also included a δ ≥20%, but diagnostic sensitivity decreased from 94.5% (90.7%–96.9%) to 49.5% (44.6%–53.9%). With the inclusion of those patients with a δ ≥20% when 0–2-h hs-cTnT was &lt;99th percentile, in addition to any with concentrations ≥99th percentile, diagnostic sensitivity increased to 97.5% (94.4%–98.9%). hs-cTnT ≥99th percentile predicted adverse events (incurred by 111 patients), adjusted hazard ratio 1.9 (1.2–2.8), whereas a δ ≥20% did not, hazard ratio 1.1 (0.7–1.7). CONCLUSIONS Diagnostic specificity of hs-cTnT improved with the use of a δ ≥20% in those patients with concentrations ≥99th percentile, but at a cost of a large reduction in sensitivity. Diagnostic sensitivity improved with the use of a δ ≥20% in patients with 0–2-h concentrations &lt;99th percentile. Both approaches may be required for optimum rule-in and rule-out strategies, respectively. The δ criteria seem to be less useful for medium-term risk stratification.

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