Characteristics of dyspnoea and associated clinical outcomes in the CHAMPION PHOENIX study

2017 ◽  
Vol 117 (06) ◽  
pp. 1093-1100 ◽  
Author(s):  
William A. Parker ◽  
Deepak L. Bhatt ◽  
Jayne Prats ◽  
Jonathan R. S. Day ◽  
Philippe Gabriel Steg ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Initial Treatment ◽  
Primary Outcome ◽  
Initial Therapy ◽  
P2y12 Inhibitors ◽  
Intention To Treat ◽  
Supplementary Material ◽  
Composite Primary Endpoint ◽  
Treat Population

SummaryDyspnoea may be induced by some reversibly-binding P2Y12 inhibitors, including cangrelor and ticagrelor. Dyspnoea was not associated with any compromise to the efficacy of ticagrelor in the PLATO study. The CHAMPION PHOENIX study (NCT01156571) compared initial treatment with cangrelor versus initial treatment with clopidogrel in patients undergoing PCI. We investigated the incidence, characteristics, and associated clinical outcomes in patients with dyspnoea in CHAMPION PHOENIX. Adverse events (AEs) of dyspnoea to 48 hours were recorded in patients randomised to cangrelor or clopidogrel in CHAMPION PHOENIX. The composite primary endpoint of death, myocardial infarction, ischaemia-driven revascularisation, or stent thrombosis as well its individual components were assessed in patients who did or did not report dyspnoea. A total of 68 (1.2 %) cangrelor-treated patients and 18 (0.3 %) clopidogrel-treated patients reported dyspnoea (p<0.001). Most dyspnoea events in cangrelor-treated patients were considered mild (71 %) or moderate (28 %) and only one event was considered severe and led to discontinuation of cangrelor. The dyspnoea events in the clopidogrel-treated patients were mild (78 %) or moderate (22 %). Characteristics of dyspnoea were consistent with those seen in the CHAMPION programme as a whole. In the modified intention-to-treat population, rates of the composite primary outcome and its individual components were not affected by the presence of dyspnoea in cangrelor-treated patients. Cangrelor-related dyspnoea is transient, usually mild or moderate, and unlikely to lead to discontinuation of therapy. The occurrence of dyspnoea does not seem to be associated with any reduction in the efficacy of cangrelor compared with clopidogrel as initial therapy in PCI patients.Supplementary Material to this article is available online at www.thrombosis-online.com.

scholarly journals Mesenchymal stem cell transplantation after acute myocardial infarction: a meta-analysis of clinical trials

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Armin Attar ◽  
Fateme Bahmanzadegan Jahromi ◽  
Shahin Kavousi ◽  
Ahmad Monabati ◽  
Asma Kazemi
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Clinical Outcomes ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Cell Number ◽  
Time Interval ◽  
Mesenchymal Stem Cell Transplantation ◽  
And Control

Abstract Background Trials investigating the role of mesenchymal stem cells (MSCs) in increasing ejection fraction (LVEF) after acute myocardial infarction (AMI) have raised some controversies. This study was conducted to find whether transplantation of MSCs after AMI can help improve myocardial performance indices or clinical outcomes. Methods Randomized trials which evaluated transplantation of MSCs after AMI were enrolled. The primary outcome was LVEF change. We also assessed the role of cell origin, cell number, transplantation time interval after AMI, and route of cell delivery on the primary outcome. Results Thirteen trials including 956 patients (468 and 488 in the intervention and control arms) were enrolled. After excluding the biased data, LVEF was significantly increased compared to the baseline among those who received MSC (WMD = 3.78%, 95% CI: 2.14 to 5.42, p < 0.001, I2 = 90.2%) with more pronounced effect if the transplantation occurred within the first week after AMI (MD = 5.74%, 95%CI: 4.297 to 7.183; I2 = 79.2% p < 0.001). The efficacy of trans-endocardial injection was similar to that of intracoronary infusion (4% [95%CI: 2.741 to 5.259, p < 0.001] vs. 3.565% [95%CI: 1.912 to 5.218, p < 0.001], respectively). MSC doses of lower and higher than 107 cells did not improve LVEF differently (5.24% [95%CI: 2.06 to 8.82, p = 0.001] vs. 3.19% [95%CI: 0.17 to 6.12, p = 0.04], respectively). Conclusion Transplantation of MSCs after AMI significantly increases LVEF, showing a higher efficacy if done in the first week. Further clinical studies should be conducted to investigate long-term clinical outcomes such as heart failure and cardiovascular mortality.

scholarly journals Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n1162
Author(s):  
Karim Asehnoune ◽  
Charlene Le Moal ◽  
Gilles Lebuffe ◽  
Marguerite Le Penndu ◽  
Nolwen Chatel Josse ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Placebo Group ◽  
Odds Ratio ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Double Blind ◽  
Intention To Treat ◽  
Dexamethasone Group ◽  
All Cause Mortality ◽  
Treat Population

Abstract Objective To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery. Design Phase III, randomised, double blind, placebo controlled trial. Setting 34 centres in France, December 2017 to March 2019. Participants 1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months. Interventions Participants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure. Main outcomes measures The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered). Results Of the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46). Conclusions Dexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness. Trial registration ClinicalTrials.gov NCT03218553 .

P3607Temporal trends in the characteristics, management, and clinical outcomes of patients with prior myocardial infarction who are admitted with an acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Eisen ◽  
A Schechter ◽  
O Itzhaki Ben Zadok ◽  
E Harari ◽  
N Shlomo ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Clinical Outcomes ◽  
High Risk Group ◽  
Late Time ◽  
P2y12 Inhibitors ◽  
Prior Myocardial Infarction ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Time Utilization

Abstract Background Patients with prior myocardial infarction (MI) are at increased risk for recurrent cardiovascular events. Advances in treatment in the last decade has improved prognosis of patients with acute coronary syndrome (ACS), yet it is not known whether similar trends exist in patients with prior MI who are admitted with an ACS, a particularly high-risk group. Methods Patients admitted with ACS who were enrolled in the ACS Israeli Surveys (ACSIS). Patients were stratified by early (2000–2008) and late (2010–2016) time-periods and by prior MI status. Clinical outcomes included 30-d MACE (death, MI, stroke, unstable angina, stent thrombosis, urgent revascularization) and 1-year mortality. Results A total of 15,211 ACS patients were included, of whom 4627 (30%) had a prior MI. These patients were older (67y vs. 63y), more commonly male, had more prior comorbidities, and a higher proportion had a GRACE score>140 (38.4% vs 12.2%). Patients with prior MI received more prior medications such as aspirin, statins, antihypertensives and hypoglycemics. During time, utilization of guideline-recommended therapies such as P2Y12 inhibitors, statins, and PCI had significantly improved in patients with prior MI. However, compared with patients without prior MI, they were still treated less commonly by PCI (61% vs. 74%). Overall, patients with prior MI had a higher 30-d MACE (13.7% vs 17.2%, p<0.001) and 1-year mortality (8.2% vs. 13.1%, p<0.001). In patients with prior MI, during time, 30d MACE nearly halved (22.7% to 11.8%) and 1-year mortality also decreased (15.5% to 10.7%). Upon adjustment, prior MI was independently associated with 1-year mortality (HR 1.13, 95% CI 1.01–1.26, p=0.04) and the late time-period was associated with reduced 1-year mortality (HR 0.75, 95% CI 0.65–0.84, p<0.001). Conclusion Patients with prior MI have a worse prognosis after ACS despite being treated with prior medications and improvement in guideline-based therapies. Although still undertreated, their clinical outcome has significantly improved throughout the years.

scholarly journals Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial

2021 ◽  
Vol 14 (2) ◽  
Author(s):  
Kenji Kanenawa ◽  
Kyohei Yamaji ◽  
Hiroaki Tashiro ◽  
Takenori Domei ◽  
Kenji Ando ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Patient Selection ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Bleeding Risk ◽  
Primary Outcome Measure ◽  
Minor Bleeding ◽  
High Bleeding Risk ◽  
The Impact

Background: We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial. Methods: Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding. Results: Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P <0.001) and were frailer according to the Canadian Study of Health and Aging Clinical Frailty Scale (intermediate, 21.4% versus 14.1%; high, 6.4% versus 2.1%; P <0.001). The cumulative 1-year incidences of the primary outcome measure, all-cause death, and major bleeding were significantly higher in the nonenrolled group than in the enrolled group (7.2% versus 4.5%, P =0.03; 4.1% versus 0.9%, P <0.001; and 4.3% versus 2.1%, P =0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P <0.001; 9.9% versus 3.0%, P <0.001; and 13.5% versus 3.5%, P <0.001, respectively). Conclusions: Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.

scholarly journals Long-term β-blocker therapy and clinical outcomes after acute myocardial infarction in patients without heart failure: nationwide cohort study

2020 ◽  
Vol 41 (37) ◽  
pp. 3521-3529 ◽  
Author(s):  
Jihoon Kim ◽  
Danbee Kang ◽  
Hyejeong Park ◽  
Minwoong Kang ◽  
Taek Kyu Park ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Acute Myocardial Infarction ◽  
Clinical Outcomes ◽  
Primary Outcome ◽  
Coronary Revascularization ◽  
Blocker Therapy ◽  
Β Blocker ◽  
Insurance Data

Abstract Aims To investigate the association between long-term β-blocker therapy and clinical outcomes in patients without heart failure (HF) after acute myocardial infarction (AMI). Method and results Between 2010 and 2015, a total of 28 970 patients who underwent coronary revascularization for AMI with β-blocker prescription at hospital discharge and were event-free from death, recurrent myocardial infarction (MI), or HF for 1 year were enrolled from Korean nationwide medical insurance data. The primary outcome was all-cause death. The secondary outcomes were recurrent MI, hospitalization for new HF, and a composite of all-cause death, recurrent MI, or hospitalization for new HF. Outcomes were compared between β-blocker therapy for ≥1 year (N = 22 707) and β-blocker therapy for &lt;1 year (N = 6263) using landmark analysis at 1 year after index MI. Compared with patients receiving β-blocker therapy for &lt;1 year, those receiving β-blocker therapy for ≥1 year had significantly lower risks of all-cause death [adjusted hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.72–0.91] and composite of all-cause death, recurrent MI, or hospitalization for new HF (adjusted HR 0.82; 95% CI 0.75–0.89), but not the risks of recurrent MI or hospitalization for new HF. The lower risk of all-cause death associated with persistent β-blocker therapy was observed beyond 2 years (adjusted HR 0.86; 95% CI 0.75–0.99) but not beyond 3 years (adjusted HR 0.87; 95% CI 0.73–1.03) after MI. Conclusion In this nationwide cohort, β-blocker therapy for ≥1 year after MI was associated with reduced all-cause death among patients with AMI without HF.

Myocardial Infarction with and without ST-segment Elevation: a Contemporary Reappraisal of Similarities and Differences

2020 ◽  
Vol 16 ◽  
Author(s):  
Andreas Mitsis ◽  
Felice Gragnano
Keyword(s):  
Myocardial Infarction ◽  
Clinical Presentation ◽  
Standard Of Care ◽  
Epidemiologic Studies ◽  
Total Occlusion ◽  
St Segment Elevation ◽  
P2y12 Inhibitors ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Similarities And Differences

Abstract:: Understanding the similarities and differences between myocardial infarction with or without ST-segment elevation is an essential step for a proper patients’ management in current practice. Both syndromes are caused by a critical stenosis or a total occlusion of coronary arteries (mostly due to thrombosis on atherosclerotic plaque), and manifest with a similar clinical presentation. Recent epidemiologic studies show that the relative incidence of ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) moves in an opposite fashion (decreasing and increasing respectively), with a prognosis that is worse at short-term follow-up for STEMI but comparable at long-term. Current management differs, as for STEMIs an immediate reperfusion is recommended, while for NSTEMIs risk stratification is mandatory in order to stratify patients’ risk, and then decide the timing for coronary angiography. Periprocedural and technical aspects of the interventional management as well antithrombotic medications are for the most similarly implemented in the two types of MI, with routine radial access, DES implant, and novel P2Y12 inhibitors representing the standard of care in both cases. The following review article aims to compare the two types of MI, with and without persistent ST-segment elevation. The main purpose is to explore their similarities and differences and address areas of uncertainty with regards to clinical presentation, therapeutic management, and prognosis. The identification of high-risk NSTEMI patients is important as they may require an individualised approach that can substantially overlap with current STEMI recommendations and their mortality remains high if their management is delayed.

scholarly journals Effects of stent generation on clinical outcomes after acute myocardial infarction compared between prediabetes and diabetes patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yong Hoon Kim ◽  
Ae-Young Her ◽  
Myung Ho Jeong ◽  
Byeong-Keuk Kim ◽  
Sung-Jin Hong ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Clinical Outcomes ◽  
Secondary Outcome ◽  
Drug Eluting Stent ◽  
Diabetes Group ◽  
Repeat Revascularization ◽  
Group A ◽  
Group B ◽  
Diabetes Patients

AbstractWe investigated the effects of stent generation on 2-year clinical outcomes between prediabetes and diabetes patients after acute myocardial infarction (AMI). A total of 13,895 AMI patients were classified into normoglycemia (group A: 3673), prediabetes (group B: 5205), and diabetes (group C: 5017). Thereafter, all three groups were further divided into first-generation (1G)-drug-eluting stent (DES) and second-generation (2G)-DES groups. Patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization were the primary outcome. Stent thrombosis (ST) was the secondary outcome. In both prediabetes and diabetes groups, the cumulative incidences of POCOs, any repeat revascularization, and ST were higher in the 1G-DES than that in the 2G-DES. In the diabetes group, all-cause death and cardiac death rates were higher in the 1G-DES than that in the 2G-DES. In both stent generations, the cumulative incidence of POCOs was similar between the prediabetes and diabetes groups. However, in the 2G-DES group, the cumulative incidences of Re-MI and all-cause death or MI were significantly higher in the diabetes group than that in the prediabetes group. To conclude, 2G-DES was more effective than 1G-DES in reducing the primary and secondary outcomes for both prediabetes and diabetes groups.

scholarly journals Treatment with a DPP-4 inhibitor at time of hospital admission for COVID-19 is not associated with improved clinical outcomes: data from the COVID-PREDICT cohort study in The Netherlands

2021 ◽  
Author(s):  
Rick I. Meijer ◽  
Trynke Hoekstra ◽  
Niels C. Gritters van den Oever ◽  
Suat Simsek ◽  
Joop P. van den Bergh ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cohort Study ◽  
Hospital Admission ◽  
Clinical Outcomes ◽  
Primary Outcome ◽  
Infectious Complications ◽  
Glucose Lowering ◽  
Diabetes Severity ◽  
Outcome Mortality

Abstract Purpose Inhibition of dipeptidyl peptidase (DPP-)4 could reduce coronavirus disease 2019 (COVID-19) severity by reducing inflammation and enhancing tissue repair beyond glucose lowering. We aimed to assess this in a prospective cohort study. Methods We studied in 565 patients with type 2 diabetes in the CovidPredict Clinical Course Cohort whether use of a DPP-4 inhibitor prior to hospital admission due to COVID-19 was associated with improved clinical outcomes. Using crude analyses and propensity score matching (on age, sex and BMI), 28 patients using a DPP-4 inhibitor were identified and compared to non-users. Results No differences were found in the primary outcome mortality (matched-analysis = odds-ratio: 0,94 [95% confidence interval: 0,69 – 1,28], p-value: 0,689) or any of the secondary outcomes (ICU admission, invasive ventilation, thrombotic events or infectious complications). Additional analyses comparing users of DPP-4 inhibitors with subgroups of non-users (subgroup 1: users of metformin and sulphonylurea; subgroup 2: users of any insulin combination), allowing to correct for diabetes severity, did not yield different results. Conclusions We conclude that outpatient use of a DPP-4 inhibitor does not affect the clinical outcomes of patients with type 2 diabetes who are hospitalized because of COVID-19 infection.

scholarly journals 270. Clinical Outcomes of Ceftriaxone versus Penicillin G for Complicated Viridans Group Streptococci Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S137-S137
Author(s):  
Stephanie Wo ◽  
Yanina Dubrovskaya ◽  
Justin Siegfried ◽  
John Papadopoulos ◽  
Shin-Pung Jen
Keyword(s):  
Clinical Outcomes ◽  
Hospital Readmission ◽  
Protective Factor ◽  
Primary Outcome ◽  
Bloodstream Infections ◽  
Penicillin G ◽  
Eligibility Criteria ◽  
Extended Spectrum Beta Lactamase ◽  
Increased Risk ◽  
Viridans Group Streptococci

Abstract Background Viridans group streptococci (VGS) is an infrequent yet significant cause of bloodstream infections, and complicated cases may require prolonged antibiotic therapy. Ceftriaxone (CTX) and penicillin G (PCN G) are both considered first line options for VGS infections, but comparisons between these agents are limited. We evaluated the clinical outcomes amongst patients treated with CTX and PCN G for complicated VGS bacteremia. Methods This was a single-center, retrospective study of adult patients with ≥1 positive VGS blood culture who were treated with either CTX or PCN G/ampicillin (both included in PCN G arm) between January 2013 and June 2019. The primary outcome was a composite of safety endpoints, including hospital readmission due to VGS or an adverse event (AE) from therapy, Clostridioides difficile infections, treatment modification or discontinuation due to an antibiotic-related AE, and development of extended-spectrum beta lactamase resistance. Secondary outcomes included the individual safety endpoints, VGS bacteremia recurrence, hospital readmission, and all-cause mortality. Results Of 328 patients screened for inclusion, 94 patients met eligibility criteria (CTX n= 64, PCN G n=34). Median age was 68 years (IQR 56–81) and 68% were male. Study patients did not present with critical illness, as reflected by a median Pitt bacteremia score of 0 in the CTX and 1 in the PCN G arms, P=0.764. Streptococcus mitis was the most common VGS isolate and infective endocarditis (IE) was the predominant source of infection. CTX was not significantly associated with increased risk of the primary outcome (14% vs. 27%; P= 0.139). The driver of the composite outcome was hospital readmission due to VGS bacteremia or therapy complications. Results were similar in the subgroup of patients with IE (12.5% vs. 23.5%). No secondary endpoints differed significantly between groups. On multivariate analysis, source removal was a protective factor of the primary outcome (OR 0.1; 95% CI 0.020–0.6771; P= 0.017). Conclusion Despite potential safety concerns with the prolonged use of CTX in complicated VGS bacteremia, this study did not demonstrate a higher rate of treatment failure, adverse events, or resistance. These findings warrant further exploration. Disclosures All Authors: No reported disclosures

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