scholarly journals Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Roubi Kilo ◽  
Silvy Laporte ◽  
Rama Arab ◽  
Sabine Mainbourg ◽  
Steeve Provencher ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Surrogate Endpoint ◽  
Weak Correlation ◽  
Surrogate Outcome ◽  
Randomized Controlled ◽  
Relative Risks ◽  
All Cause Mortality ◽  
Prevention Studies ◽  
Randomized Control ◽  
Net Clinical Benefit

AbstractThis study aimed to explore the validity of the use of the net clinical benefit (NCB), i.e. the sum of major bleeding and thrombotic events, as a potential surrogate for all-cause mortality in clinical trials assessing antithrombotics. Published randomized controlled trials testing anticoagulants in the prevention or treatment of venous thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) were systematically reviewed. The validity of NCB as a surrogate endpoint was estimated by calculating the strength of correlation of determination (R2) and its 95% confidence interval (CI) between the relative risks of NCB and all-cause mortality. Amongst the 125 trials retrieved, the highest R2trial values were estimated for NVAF (R2trial = 0.41, 95% CI [0.03; 0.48]), and acute VTE (R2trial = 0.30, 95% CI [0.04; 0.84]). Conversely, the NCB did not correlate with all-cause mortality in prevention studies with medical (R2trial = 0.12, 95% CI [0.00; 0.36]), surgical (R2trial = 0.05, 95% CI [0.00; 0.23]), and cancer patients (R2trial = 0.006, 95% CI [0.00; 1.00]). A weak correlation between NCB and all cause-mortality was found in NVAF and acute VTE, whereas no correlation was observed in clinical situations where the mortality rate was low. Consequently, NCB should not be considered a surrogate outcome for all cause-mortality in anticoagulation trials.

scholarly journals Influence of Epidemiologic and Clinical Trends on Risk Stratification and Net Clinical Benefit of Long-term Oral Anticoagulation for Nonvalvular Atrial Fibrillation

2018 ◽  
Vol 2 (2) ◽  
pp. 22-25
Author(s):  
Richard W. Asinger ◽  
Gautam R. Shroff
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulation ◽  
Clinical Benefit ◽  
Controlled Trial ◽  
Systemic Embolism ◽  
Net Benefit ◽  
Nonvalvular Atrial Fibrillation ◽  
Randomized Controlled ◽  
Net Clinical Benefit

The prevalence of atrial fibrillation without rheumatic valvular disease, nonvalvular atrial fibrillation (NVAF), increases with age and independently predicts future stroke and systemic embolism. Randomized controlled trials of long-term oral anticoagulation for NVAF since the 1980s report a 67% risk reduction in stroke and systemic embolism. Data from these trials are used in risk calculators to predict stroke and bleeding; clinicians use these calculators to determine individualized net clinical benefit of oral anticoagulation. Over the past three decades, NVAF stroke rates have declined independent of oral anticoagulation. Newer asymptomatic (subclinical) NVAF populations are being identified, and clinical practice has changed with increasingly older patients (with higher fall and bleeding risk) receiving oral anticoagulation. These trends suggest contemporary patients with NVAF may derive a lower net benefit from oral anticoagulation compared with those in the original randomized controlled trial. Methods that evaluate for and continuously monitor net clinical benefit of oral anticoagulation for contemporary NVAF are necessary.

The Effects of Smoking on Mood, Rapport, and Satisfaction in Conversation among Japanese Smokers in A First Meeting: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Kengo Yokomitsu ◽  
Keita Somatori ◽  
Tomonari Irie
Keyword(s):  
Interpersonal Communication ◽  
Controlled Trial ◽  
Tobacco Consumption ◽  
Cigarette Use ◽  
Intrapersonal Communication ◽  
Face To Face ◽  
Water Group ◽  
Randomized Controlled ◽  
Randomized Control ◽  
The Difference

Through a randomized control design, this study examines whether tobacco consumption contributes to mood change and social enhancement in dyadic conversation. In addition, we would like to focus on the difference between smoking device and cigarette use. Specifically, we compare the intrapersonal and interpersonal communication in dyadic conversation among the cigarette group, the smoking device cigarette group, the water group, and the nothing consumption group. In the present study, 80 participants engaged in a dyadic, face-to-face, unstructured conversation with a stranger of the same gender. Regarding intrapersonal communication, no significant differences were found between the groups’ POMS 2 subscale scores (anger-hostility, confusion-bewilderment, depression-dejection, tension-anxiety, fatigue-inertia, vigour-activity, and friendliness). The smoking device and cigarette groups had greater rapport than the water group. Moreover, the smoking device group were more satisfied with dyadic conversation than the water group. Finally, there were no significant differences in verbal communication among the groups.

scholarly journals A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Hang Ouyang ◽  
Xuehui Zeng ◽  
Chunlei Zhang ◽  
Linli Song ◽  
Jiarui Xu ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Controlled Trials ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Late Luminal Loss

Abstract Objective We performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients. Methods A systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality. Results EES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52–0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26–0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28–0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07–0.51, p = 0.001). Conclusion Among those three types of stents, EES should be the first recommended stent for DM patients.

scholarly journals Ischemic and bleeding risk stratification in diabetic patients after acute coronary syndrome based on insulin requirement

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Cavallari ◽  
E Sagazio ◽  
E Antonucci ◽  
P Calabro' ◽  
F Gragnano ◽  
...  
Keyword(s):  
Insulin Therapy ◽  
Antiplatelet Therapy ◽  
Clinical Benefit ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Diabetic Patients ◽  
Coronary Syndrome ◽  
Diabetes Status ◽  
Increased Risk ◽  
Net Clinical Benefit

Abstract Background Diabetes is a known risk factor for a first or recurrent cardiovascular event, however, its association with an increased risk of bleeding is controversial. To date, no study has explored the prognostic weight of insulin therapy in the setting of ACS. Purpose To investigate the differential role of insulin versus no insulin therapy on ischemic and bleeding risks in patients with diabetes and ACS. Methods START-ANTIPLATELET is a prospective, real-world multicenter registry including consecutive patients admitted for ACS. For the purpose of this analysis, patients were stratified according to diabetes status and insulin therapy. We compared 1-year rates of major adverse cardiovascular events, a composite of cardiovascular death, myocardial infarction and stroke, and of any bleeding, according to diabetes status (no diabetes, diabetes not on insulin therapy, diabetes on insulin therapy). In addition, we evaluated the net clinical benefit of dual antiplatelet therapy with the newer P2Y12 inhibitors (ticagrelor or prasugrel) vs dual antiplatelet therapy with clopidogrel according to diabetes status. Results In an overall population of 907 patients, 198 had diabetes, 10.6% of whom were on insulin. From non-diabetic patients to diabetic patients not on insulin and diabetic patients on insulin there was a stepwise decrease of MACE-free survival (log-rank p 0.039) with incidence of events at 1 year being 3.8%, 6.8% (adjusted p vs no diabetes 0.49) and 12.5% (adjusted p vs no diabetes 0.047), respectively (Figure, panel A). The rates of any bleeding were higher in patients on insulin (20.8% vs 8.8% in those without diabetes and 5.8% in diabetic patients not receiving insulin; log-rank p 0.028; Figure, panel B). Multivariable analysis demonstrated an almost 5-fold increase of any bleeding in diabetic patients with vs without insulin (OR 4.98, 95% CI 1.46–16.92; p=0.010). In the overall population, the incidence of the net composite endpoint including MACE or major bleeding with the use of ticagrelor/prasugrel on top of aspirin was significantly lower compared to use of clopidogrel (4.7% vs 8.4%; OR 0.54, 95% CI 0.30–0.94, p=0.031). This net clinical benefit in patients receiving a newer P2Y12 inhibitor was regardless of the diabetes status (p for interaction 0.48). Conclusions In this cohort of ACS patients, the presence of diabetes stratified by insulin therapy was associated with a graded increase in the 1-year rates of MACE. Conversely, insulin therapy significantly contributed to the overall increase of bleeding risk in diabetes. Funding Acknowledgement Type of funding source: None

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