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1.
Thromb Haemost ; 2020 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-31940677

RESUMO

BACKGROUND: Western guidelines recommend an international normalized ratio (INR) range of 2 to 3 when using warfarin for stroke prevention in atrial fibrillation (AF), but lower INR ranges are frequently used in East Asia. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) in AF patients comparing the effect of lower versus standard INR targets on thromboembolism, major bleeding, and mortality. METHODS: We searched Western databases including Cochrane CENTRAL, Medline, and Embase as well as Chinese databases including SinoMed, CNKI, and Wanfang Data. We pooled risk ratios (RRs) using random-effects model. We grouped INR targets in two ways: (1) any study-specific lower versus standard targets and (2) INR ranges of approximately 1.5 to 2 versus 2 to 3. RESULTS: Seventy-nine RCTs (n = 12,928) met eligibility criteria: 74 (n = 11,322) from East Asia and 5 (n = 1,606) from Western countries. Compared with standard targets, lower INR ranges were associated with higher rates of thromboembolism (76 RCTs, n = 12,577: 7.1% vs. 4.4%, RR 1.50, 95% confidence interval [CI] 1.29-1.74, I 2 = 0%), lower rates of major bleeding (61 RCTs, n = 10,815: 2.2% vs. 4.4%, RR 0.54, 95% CI 0.44-0.67, I 2 = 0%), and similar mortality (32 RCTs, n = 7,327: 4.8% vs. 5.2%, RR 1.00, 95% CI 0.85-1.19, I 2 = 0%). Results were similar when comparing target ranges of approximately 1.5 to 2 versus 2 to 3. CONCLUSION: Moderate quality evidence suggests lower INR targets reduce bleeding but increase thromboembolism in AF. The data are dominated by East-Asian studies, limiting generalizability to Western populations. Until higher quality data demonstrate otherwise, an INR range of 2 to 3 should remain standard for thromboembolic prophylaxis in AF.

2.
Trials ; 21(1): 92, 2020 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-31941546

RESUMO

BACKGROUND: The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards. METHODS: We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients. RESULTS: A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1-4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients. CONCLUSION: It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02917551. Registered on September 28, 2016.

3.
J Cardiothorac Vasc Anesth ; 34(1): 99-105, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31401207

RESUMO

OBJECTIVE: Steroids suppress the inflammatory response to cardiopulmonary bypass, but the impact on death at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of intensive care unit (ICU) and hospital stays are uncertain. DESIGN: Patient-level data meta-analysis of 2 randomized trials. SETTING: Eighty-eight cardiac surgical centers in 19 countries. PARTICIPANTS: A total of 11,989 participants, from the Steroids in Cardiac Surgery trial and the Dexamethasone in Cardiac Surgery study, undergoing cardiac surgery with the use of cardiopulmonary bypass. INTERVENTIONS: Participants were randomly assigned to steroid or placebo. MEASURES AND MAIN RESULTS: Outcomes assessed were mortality at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of ICU and hospital stays. There was no significant difference in death at 30 days between the steroid and placebo groups (odds ratio [OR], 0.87; 95% confidence interval [CI], 0.72-1.07). Myocardial infarction did not differ significantly (OR, 1.17; 95% CI, 0.93-1.47); however, myocardial injury was higher in the steroid group (OR, 1.25; 95% CI, 1.12-1.40). There were no significant differences for the outcomes of stroke, renal failure, new atrial fibrillation, or transfusion. Steroids significantly reduced respiratory failure (OR, 0.83; 95% CI, 0.75-0.99), infection (OR, 0.80; 95% CI, 0.72-0.89), and length of ICU (p < 0.001) and hospital stays (p = 0.006). CONCLUSIONS: This patient-level meta-analysis does not support the routine use of steroids in cardiac surgery. Steroid administration did not decrease the risk of death, myocardial infarction, stroke, renal failure, new atrial fibrillation, or transfusion. Steroids increased the risk of myocardial injury in both the Steroids in Cardiac Surgery and Dexamethasone in Cardiac Surgery trials. Finally, steroids lowered the risk of respiratory failure and infection, and reduced length of ICU and hospital stay.

4.
Eur J Cardiothorac Surg ; 57(1): 168-175, 2020 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-31180497

RESUMO

OBJECTIVES: Using data from the CORONARY trial (n = 4752), we evaluated the incidence and prognostic significance of myocardial infarction (MI) applying different definitions based on peak postoperative creatine kinase-MB isoenzyme and cardiac troponin levels. We then aimed to identify the peak cardiac troponin during the first 3 postoperative days that was independently associated with a 2-fold increase in 30-day mortality. METHODS: To combine different assays, we analysed cardiac troponins in multiples of their respective upper limit of normal (ULN). We identified the lowest threshold with a hazard ratio (HR) >2 for 30-day mortality independent of EuroSCORE and on- versus off-pump surgery. RESULTS: Depending on the definition used based on creatine kinase-MB, the incidence of MI after coronary artery bypass grafting (CABG) ranged from 0.6% to 19% and the associated HRs for 30-day mortality ranged from 2.7 to 6.9. Using cardiac troponin (1528 patients), the incidence of MI ranged from 1.7% to 13% depending on the definition used with HRs for 30-day mortality ranging from 5.1 to 7.2. The first cardiac troponin threshold we evaluated, 180xULN, was associated with an adjusted HR for 30-day mortality of 7.6 [95% confidence interval (CI) 3.4-17.1] when compared to <130xULN. The next independent threshold was 130xULN with an adjusted HR for 30-day mortality of 7.8 (95% CI 2.3-26.1). The next cardiac troponin tested threshold (70xULN) did not meet criteria for significance. CONCLUSIONS: Our results illustrate that the incidence and prognosis of a post-CABG MI varies based on the definition used. Validated post-CABG MI diagnostic criteria formulated from their independent association with important clinical outcomes are needed.

5.
BMJ Open ; 9(12): e031895, 2019 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-31831540

RESUMO

INTRODUCTION: Perioperative benzodiazepines are used because of their anxiolytic, sedative and amnestic effects. Evidence has demonstrated an association of benzodiazepines with adverse neuropsychiatric effects. Nonetheless, because of their potential benefits, perioperative benzodiazepines continue to be used routinely. We seek to evaluate the body of evidence of the risks and benefits of benzodiazepine use during the perioperative period. METHODS AND ANALYSIS: We will search Cochrane CENTRAL, MEDLINE, EMBASE, PsychINFO, CINAHL and Web of Science from inception to March 2019 for randomised controlled trials (RCTs) and observational studies evaluating the administration of benzodiazepine medications as compared with all other medications (or nothing) in patients undergoing cardiac and non-cardiac surgery. We will exclude studies assessing the use of benzodiazepines for procedural sedation or day surgery. We will examine the impact of giving these medications before, during and after surgery. Outcomes of interest include the incidence of delirium, duration of delirium, postprocedure cognitive change, the incidence of intraoperative awareness, patient satisfaction/quality of life/quality of recovery, length-of-stay (LOS) in the intensive care unit (ICU), hospital LOS and in-hospital mortality.Reviewers will screen references and assess eligibility using predefined criteria independently and in duplicate. Two reviewers will independently collect data using prepiloted forms. We will present results separately for RCTs and observational studies. We will pool data using a random effect model and present results as relative risk with 95% CIs for dichotomous outcomes and mean difference with 95% CI for continuous outcomes. We will pool adjusted ORs for observational studies. We will assess risk of bias for individual studies using the Cochrane Collaboration tool for RCTs. For observational studies, we will use tools designed by the Clinical Advances through Research and Information Translation group. Quality of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: This systematic review involves no patient contact and no interaction with healthcare providers or systems. As such, we did not seek ethics board approval. We will disseminate the findings of our systematic review through the presentation at peer-reviewed conferences and by seeking publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42019128144.

6.
Cancers (Basel) ; 11(12)2019 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-31817219

RESUMO

Hepatoblastoma is the most common childhood liver malignancy. The management of hepatoblastoma requires multidisciplinary efforts. The five-year overall survival is approximately 80% in developed countries. Surgery remains the mainstay of treatment for hepatoblastoma, and meticulous techniques must be employed to ensure safe and effective local control surgeries. Additionally, there have been several advances from both pediatric and adult literature in the way liver tumor surgery is performed. In this review, we highlight important aspects of liver surgery for hepatoblastoma, the management of metastatic disease, and the most current technical advances in performing these procedures in a safe and effective manner.

7.
Circulation ; 140(23): 1933-1942, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31790297

RESUMO

Managing severe valvular heart disease with mechanical valve replacement necessitates lifelong anticoagulation with a vitamin K antagonist. Optimal anticoagulation intensity for patients with mechanical valves remains uncertain; current recommendations are inconsistent across guideline bodies and largely based on expert opinion. In this review, we outline the history of anticoagulation therapy in patients with mechanical heart valves and critically evaluate current antithrombotic guidelines for these patients. We conclude that randomized trials evaluating optimal anticoagulation intensity in patients with mechanical valves are needed, and that future guidelines must better justify antithrombotic treatment recommendations.

8.
J Am Coll Cardiol ; 74(25): 3164-3173, 2019 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-31856974

RESUMO

Repeat revascularization is a commonly used outcome measure in trials comparing percutaneous coronary intervention and coronary artery bypass graft surgery, and differences in this outcome often drive the relative risk for the primary endpoint. However, repeat revascularization as an outcome measure has important limitations that complicates its meaningful interpretation, including confounding by indication (driven by varying use of stress testing and thresholds for invasive angiography), differential likelihood of revascularization after graft versus stent failure, uncertainty of the prognostic impact of repeat revascularization, and patient preferences and appraisal of the import of repeat revascularization. Knowledge of these issues will result in better appreciation of the utility of repeat revascularization as a clinically meaningful outcome measure. The authors describe these issues and provide recommendations for the use and assessment of repeat revascularization as an endpoint when comparing different revascularization modalities.

9.
Ann Intern Med ; 2019 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-31869834

RESUMO

Background: Preliminary data suggest that preoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) may improve risk prediction in patients undergoing noncardiac surgery. Objective: To determine whether preoperative NT-proBNP has additional predictive value beyond a clinical risk score for the composite of vascular death and myocardial injury after noncardiac surgery (MINS) within 30 days after surgery. Design: Prospective cohort study. Setting: 16 hospitals in 9 countries. Patients: 10 402 patients aged 45 years or older having inpatient noncardiac surgery. Measurements: All patients had NT-proBNP levels measured before surgery and troponin T levels measured daily for up to 3 days after surgery. Results: In multivariable analyses, compared with preoperative NT-proBNP values less than 100 pg/mL (the reference group), those of 100 to less than 200 pg/mL, 200 to less than 1500 pg/mL, and 1500 pg/mL or greater were associated with adjusted hazard ratios of 2.27 (95% CI, 1.90 to 2.70), 3.63 (CI, 3.13 to 4.21), and 5.82 (CI, 4.81 to 7.05) and corresponding incidences of the primary outcome of 12.3% (226 of 1843), 20.8% (542 of 2608), and 37.5% (223 of 595), respectively. Adding NT-proBNP thresholds to clinical stratification (that is, the Revised Cardiac Risk Index [RCRI]) resulted in a net absolute reclassification improvement of 258 per 1000 patients. Preoperative NT-proBNP values were also statistically significantly associated with 30-day all-cause mortality (less than 100 pg/mL [incidence, 0.3%], 100 to less than 200 pg/mL [incidence, 0.7%], 200 to less than 1500 pg/mL [incidence, 1.4%], and 1500 pg/mL or greater [incidence, 4.0%]). Limitation: External validation of the identified NT-proBNP thresholds in other cohorts would reinforce our findings. Conclusion: Preoperative NT-proBNP is strongly associated with vascular death and MINS within 30 days after noncardiac surgery and improves cardiac risk prediction in addition to the RCRI. Primary Funding Source: Canadian Institutes of Health Research.

10.
Ann Thorac Surg ; 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31877292

RESUMO

BACKGROUND: Patients with mechanical heart valves (MHVs) require warfarin to prevent thromboembolism. Dabigatran was less effective than warfarin in patients with MHVs, which prompted a black box warning against the use of direct oral anticoagulants for this indication. However, rivaroxaban and apixaban, which inhibit factor Xa, have not been evaluated in patients with MHVs. To determine whether rivaroxaban and apixaban would be effective, we used MHV-induced thrombin generation assays to compare them with warfarin either alone or in combination with dabigatran. METHODS: Thrombin generation in the absence or presence of MHV leaflets or sewing ring segments (SRS) was quantified. Studies were done in control plasma, plasma from patients on warfarin, plasma containing varying concentrations of rivaroxaban, apixaban or dabigatran alone, or plasma containing rivaroxaban plus dabigatran. RESULTS: Mean endogenous thrombin potential (ETP) increased 1.2-, 1.5-, and 1.8-fold in the presence of leaflets, Teflon SRS, or Dacron SRS, respectively. Rivaroxaban and apixaban reduced ETP at concentrations above 50ng/mL, but were less effective than warfarin. When rivaroxaban and dabigatran were combined, they suppressed ETP in a more than additive manner. CONCLUSIONS: Whereas warfarin suppresses MHV-induced thrombin generation, MHVs induce the generation of factor Xa in concentrations that overwhelm clinically relevant concentrations of rivaroxaban or apixaban. When used in combination, rivaroxaban and dabigatran are more effective than either agent alone suggesting that concomitant inhibition of factor Xa and thrombin is better than inhibition of either clotting enzyme alone.

11.
Am Surg ; 85(11): 1262-1264, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31775968

RESUMO

Subcutaneous endoscopically assisted ligation (SEAL) technique is an effective and minimally invasive approach for indirect inguinal hernia repair in children. Not all patients are candidates for SEAL because of technical limitations. We hypothesized that preoperatively assessed patient-level factors may predict technical feasibility of SEAL repair. We performed a retrospective review of all patients who underwent indirect inguinal hernia repair between June 2012 and December 2014. All patients younger than two years and any patient older than two years who had a concomitant umbilical hernia were considered candidates for diagnostic laparoscopy with SEAL repair. We compared patients who had SEAL repair with those who had diagnostic laparoscopy with conversion to open repair. Univariate statistics was performed using the chi-squared and Student's t test. One hundred forty-one patients underwent diagnostic laparoscopy with intent to perform a SEAL repair. Seventeen patients were lost to follow-up. Of the remaining 124 patients, 66 had SEAL repairs, 35 had open repairs, and 23 had a SEAL repair with contralateral open repair. Patient age, BMI, gender, history of prematurity, and history of incarcerated hernia were similar between the SEAL and open groups. Sixty-two per cent of hernias were able to be repaired with SEAL technique. Hernia recurrence was seen in 3 of 123 total SEAL repairs and in 1 of 74 open repairs. The recurrence rate for SEAL repairs (2.4%) was not significantly different from the recurrence rate for open repairs (1.4%). No preoperative patient-level factors predicted technical inability to perform a successful SEAL repair. In this series, the recurrence risk of SEAL compared with open repair was low and not statistically significant. For practitioners with minimally invasive experience, SEAL should be considered a safe and successful option for inguinal hernia repair in pediatric patients undergoing routine diagnostic laparoscopy.

12.
Anesth Analg ; 129(6): 1468-1473, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31743165

RESUMO

BACKGROUND: Pain after cardiac surgery is largely treated with opioids, but their poor safety profile makes nonopioid medications attractive as part of multimodal pathways. Anti-inflammatory drugs reduce acute postoperative pain, but the role of steroids in reducing acute poststernotomy pain is unclear. We evaluated the association between the intraoperative administration of methylprednisolone and postoperative analgesia, defined as a composite of pain scores and opioid consumption, during the initial 24 hours after cardiac surgery. METHODS: We conducted a post hoc retrospective analysis of a large clinical trial in which adults having cardiac surgery were randomized 1:1 to receive 2 intraoperative doses of 250 mg IV methylprednisolone or placebo. Pain scores and opioid consumption were collected during the initial 24 hours after surgery. Methylprednisolone was considered to be associated with better pain control than placebo if proven noninferior (not worse) on both pain scores (defined a priori with delta of 1 point) and opioid consumption (delta of 20%) and superior to placebo in at least 1 of the 2 outcomes. This test was repeated in the opposite direction (testing whether placebo is better than methylprednisolone on postoperative pain management). RESULTS: Of 251 eligible patients, 127 received methylprednisolone and 124 received placebo. Methylprednisolone was noninferior to placebo on pain with difference in mean (CI) pain scores of -0.25 (-0.71 to 0.21); P < .001. However, methylprednisolone was not noninferior to placebo on opioid consumption (ratio of geometric means [CI]: 1.11 [0.64-1.91]; P = .37). Because methylprednisolone was not noninferior to placebo on both outcomes, we did not proceed to superiority testing based on the a priori stopping rules. Similar results were found when testing the opposite direction. CONCLUSIONS: In this post hoc analysis, we could not identify a beneficial analgesic effect after cardiac surgery associated with methylprednisolone administration. There are currently no data to suggest that methylprednisolone has significant analgesic benefit in adults having cardiac surgery.

13.
Can J Cardiol ; 35(11): 1596-1599, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31679628

RESUMO

Optimal postprocedural antithrombotic regimen is uncertain after transcatheter aortic valve replacement (TAVR). We developed an online questionnaire on post-TAVR antithrombotic management. After research ethics board approval, we distributed the survey to TAVR implanters across Canada. A total of 24 TAVR implanters from 17 centres responded to the survey for a response rate of 75%. Dual antiplatelet therapy for variable durations was the preferred initial treatment for patients in sinus rhythm after isolated TAVR, TAVR with a recent stent (≤ 1 month), and valve-in-valve procedures (71%, 96%, and 65%, respectively). Most respondents continued patients on acetylsalicylic acid indefinitely after these procedures (100%, 92%, 90%, respectively). In patients with atrial fibrillation, the CHA2DS2-VASC score was the preferred stroke risk score for 57% of respondents, the CHADS2 score was the preferred stroke risk score for 22% of respondents, and the CHADS65 score was the preferred stroke risk score for 17% of respondents. To determine the risk of bleeding, the HASBLED score was most often used (52%), but 48% of respondents indicated that they did not use a bleeding risk score. In the presence of atrial fibrillation, antithrombotic therapy choice varied widely. Our survey shows that dual antiplatelet therapy is the most common discharge regimen after TAVR in current practice. However, the choice and duration of antithrombotic regimen vary in patients requiring anticoagulation.

14.
Trials ; 20(1): 595, 2019 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-31619260

RESUMO

Following publication of the original article [1], we have been notified of a few mistakes in the "Sample size calculations" section, second paragraph.

15.
Can J Cardiol ; 35(10): 1416-1418, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31495682

RESUMO

In this article we review the perspectives in the literature around surgical treatment for infective endocarditis (IE) in people who use intravenous drugs (PUID). PUID are at increased risk for IE; however, controversy exists regarding how to best manage these patients. We explore the outcomes for surgical treatment in PUID with IE, contrasting these with patients with IE who do not use drugs. We describe some of the perspectives in the literature around second valve replacement for PUID with IE, arguing that moralistic arguments are not on the basis of evidence and perpetuate the stigma experienced by PUID who seek treatment for IE. Finally, we explore the role of substance use interventions in the treatment of PUID with IE, and advocate for further evidence. PUID with IE are a highly stigmatized patient subgroup for whom best practice management strategies are not always implemented, emphasizing the need for further research and advocacy.

16.
BMJ Open ; 9(9): e028585, 2019 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-31530593

RESUMO

INTRODUCTION: Bleeding during cardiac surgery is associated with increased morbidity and mortality. Tranexamic acid is an antifibrinolytic with proven efficacy in major surgeries. Current clinical practice guidelines recommend intraoperative use in cardiac procedures. However, several complications have been reported with tranexamic acid including seizures. This review intends to summarise the evidence examining the efficacy and safety of tranexamic acid in patients undergoing cardiac surgery. METHODS/DESIGN: We will search MEDLINE, Embase, PubMED, ACPJC, CINAHL and the Cochrane trial registry for eligible randomised controlled trials, the search dates for all databases will be from inception until 1 January 2019, investigating the perioperative use of topical and/or intravenous tranexamic acid as a stand-alone antifibrinolytic agent compared with placebo in patients undergoing open cardiac surgery. We categorised outcomes as patient critical or patient important. Selected patient-critical outcomes are: mortality (intensive care unit, hospital and 30-day endpoints), reoperation within 24 hours, postoperative bleeding requiring transfusion of packed red blood cells, myocardial infarction, stroke, pulmonary embolism, bowel infarction, upper or lower limb deep vein thrombosis and seizures. Those outcomes, we perceived as clinical experts to be most patient valued and patients were not involved in outcomes selection process. We will not apply publication date, language, journal or methodological quality restrictions. Two reviewers will independently screen and identify eligible studies using predefined eligibility criteria and then review full reports of all potentially relevant citations. A third reviewer will resolve disagreements if consensus cannot be achieved. We will present the results as relative risk with 95% CIs for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CIs. We will assess the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication TRIAL REGISTRATION NUMBER: CRD42018105904.

18.
Can J Cardiol ; 35(8): 1030-1038, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31376904

RESUMO

This review was undertaken to summarize and discuss the current evidence around antiplatelet therapy and coronary artery bypass grafting (CABG). Aspirin (ASA) monotherapy remains the standard of care among patients before and after CABG. The role of more intense antiplatelet therapy-specifically, P2Y12 inhibitors-in improving clinical outcomes and graft patency is becoming increasingly apparent. As such, we provide an overview of a variety of antiplatelet regimens. The review discusses the evidence around preoperative management of antiplatelet therapies, with a particular focus on timing of cessation. It also evaluates the current literature to elucidate the best antiplatelet therapy regimen after CABG, focusing on acute coronary syndrome (ACS). Whenever possible, data are presented from randomized controlled trials (RCTs) and meta-analyses. Although guidelines recommend use of dual antiplatelet therapy (DAPT) after CABG for patients with ACS, available evidence is limited to small RCTs, and meta-analyses are of substudies of larger RCTs. There is also considerable heterogeneity in patient population of these studies; a significant number of patients underwent off-pump CABG (OPCAB) in trials that demonstrate graft-patency benefit with DAPT. With this limited evidence, DAPT remains underused in the CABG population, even among patients presenting after ACS.

19.
Medicine (Baltimore) ; 98(34): e16880, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441862

RESUMO

INTRODUCTION: Saphenous vein graft (SVG) is the most common conduit used for coronary artery bypass grafting (CABG) surgery. Unfortunately, SVG are associated with poor long-term patency rates; a significant predictor of re-operation rates and survival. As such, medical therapy to prevent SVG narrowing or occlusion is of paramount importance. Aspirin (ASA) monotherapy is the standard of care after CABG, to improve long-term major adverse cardiovascular events (MACE) and graft patency. Benefits of dual antiplatelet therapy (DAPT) have not been well established in all CABG patients. We present a protocol for a network meta-analysis (NMA) comparing the effects of various antiplatelet therapy regimens on SVG patency, mortality, and bleeding among adult patients following CABG. METHODS: We will search CENTRAL, MEDLINE, EMBASE, CINAHL ACPJC, and grey literature sources (AHA, ACC, ESC, and CCC conference proceedings, ISRCTN Register, and WHO ICTRP) for randomized controlled trials (RCTs) which fit our criteria. RCTs that evaluate different antiplatelet regimens at least 3-months after CABG and have any of SVG patency, mortality, MACE, and major bleeding as outcomes will be selected. We will perform title and abstract screening, full-text screening, and data extraction independently and in duplicate. Two independent reviewers will also assess risk of bias (ROB) for each study, as well as evaluate quality of evidence using the GRADE framework. We will use R to perform the NMA and use low-dose ASA as reference within our network. We will report results as odds ratios with confidence intervals for direct comparisons, and credible intervals for indirect or mixed comparisons. We will use the surface under the cumulative ranking curve (SUCRA) to estimate the ranking of interventions. DISCUSSION: Given the limited direct comparison of various antiplatelet regimens, a network approach is ideal to clarify the optimum antiplatelet therapy after CABG. We hope that our NMA will be the largest quantitative synthesis evaluating antiplatelet regimens among patients requiring CABG. It should inform clinicians and guideline developers in selecting the most effective and safest antiplatelet regimen.Systematic Review registration: International Prospective Register for Systematic Reviews (PROSPERO)-CRD42019127695.


Assuntos
Ponte de Artéria Coronária/efeitos adversos , Inibidores da Agregação de Plaquetas/uso terapêutico , Ponte de Artéria Coronária/métodos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/cirurgia , Humanos , Meta-Análise em Rede , Veia Safena/transplante , Revisão Sistemática como Assunto , Resultado do Tratamento
20.
Europace ; 2019 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-31292622

RESUMO

AIMS: To evaluate the efficacy and safety of vernakalant for the cardioversion of atrial fibrillation (AF). METHODS AND RESULTS: We reviewed the literature for randomized trials that compared vernakalant to another drug or placebo in patients with AF of onset ≤7 days. We used a random-effects model to combine quantitative data and rated the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation). From 441 total citations in MEDLINE, EMBASE, and CENTRAL (December 2018), we identified nine trials evaluating 1358 participants. Six trials compared vernakalant to placebo, two trials compared vernakalant to ibutilide, and one trial compared vernakalant to amiodarone. We found significant methodological bias in four trials. For conversion within 90 min, vernakalant was superior to placebo [50% conversion, risk ratio (RR) 5.15; 95% confidence interval (CI); 2.24-11.84, I2 = 91%], whereas we found no significant difference in conversion when vernakalant was compared with an active drug (56% vs. 24% conversion, RR 2.40; 95% CI 0.76-7.58, I2 = 94). Sinus rhythm was maintained at 24 h in 85% (95% CI 80-88%) of patients who converted acutely with vernakalant. Overall, we judged the quality of evidence for efficacy to be low based on inconsistency and suspected publication bias. There was no significant difference in the risk of significant adverse events between vernakalant and comparator (RR 0.95; 95% CI 0.70-1.28, I2 = 0, moderate quality evidence). Vernakalant is safe and effective for rapid and durable restoration of sinus rhythm in patients with recent-onset AF. CONCLUSION: Vernakalant should be a first line option for the pharmacological cardioversion of patients with haemodynamically stable recent-onset AF without severe structural heart disease.

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