scholarly journals Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management: A prespecified subgroup analysis from VALIDATE-SWEDEHEART

2019 ◽  
Vol 8 (6) ◽  
pp. 510-519 ◽  
Author(s):  
Sebastian Völz ◽  
Oskar Angerås ◽  
Sasha Koul ◽  
Inger Haraldsson ◽  
Giovanna Sarno ◽  
...  

Aims: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin. Methods and results: A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43–0.67, p<0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52–0.84, p<0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28–0.60, p<0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44–0.75, p<0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint ( p=0.976) or major bleeding ( p=0.801). Conclusions: Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K K Lee ◽  
A V Ferry ◽  
A Anand ◽  
F E Strachan ◽  
A R Chapman ◽  
...  

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


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Z M Xiao ◽  
N Rosenthal ◽  
A Kartashov ◽  
A Levorsen ◽  
B Shah

Abstract Background/Introduction Enoxaparin and unfractionated heparin (UFH) are guideline-recommended anticoagulants for patients with acute coronary syndrome (ACS) including unstable angina (UA) and myocardial infarction with (STEMI) or without ST-elevation (NSTEMI). Prior efficacy and safety evidence are mainly from clinical trials. Economic data is lacking. Purpose To examine differences in utilization, effectiveness, safety, and costs in treating ACS between enoxaparin and UFH using real-world data. Methods Using Premier Healthcare Database from 859 U.S. hospitals, inpatients 18 years or older with a diagnosis of initial episode of ACS between 2010–2016 were analyzed. Outcomes included 30-day risk of non-fatal myocardial infarction (MI), recurrent angina, in-hospital mortality, composite ischemic complication (having MI/recurrent angina/death), major bleeding, and costs. Multivariable regression was used to compare outcomes between enoxaparin and UFH monotherapy. Results Among 1,048,053 eligible patients (UA: 219,259; NSTEMI: 582,134; STEMI: 246,660), prevalence of enoxaparin monotherapy was 12.0%, 13.9%, and 5.1% and of UFH monotherapy was 45.1%, 43.1% and 59.8% for UA, NSTEMI, and STEMI patients, respectively. Compared to UFH, enoxaparin was associated with lower odds of MI (Adjusted Odds Ratio [OR]=0.95; 95% Confidence Interval (CI): 0.92, 0.99), recurrent angina (OR=0.88; 95% CI: 0.78, 0.98), in-hospital mortality (OR=0.88; 95% CI: 0.81, 0.95) and composite ischemic complications (OR=0.95; 95% CI: 0.92, 0.98) among NSTEMI patients but not in UA or STEMI patients. Enoxaparin was associated with lower odds of major bleeding in all three patients cohorts (UA: OR=0.77, 95% CI: 0.66, 0.91; NSTEMI: OR=0.68; 95% CI: 0.64, 0.72; STEMI: OR=0.72, 95% CI: 0.63, 0.83). Cost savings per patient during index admission and 30-day follow-up for enoxaparin over UFH was $2,813 for UA, $2,332 for NSTEMI and $2,928 for STEMI patients. Conclusions Enoxaparin was associated with lower odds of ischemic complications including death, lower costs and better safety than UFH among NSTEMI patients. Its relative effectiveness varied between patients with different ACS presentations. Improving upstream selection of appropriate anticoagulants in different type of ACS patients has the potential to optimize clinical outcomes and costs. Acknowledgement/Funding This study was funded by Sanofi Inc


2021 ◽  
Vol 10 (9) ◽  
pp. 1863
Author(s):  
Jorge Rodríguez-Capitán ◽  
Andrés Sánchez-Pérez ◽  
Sara Ballesteros-Pradas ◽  
Mercedes Millán-Gómez ◽  
Rosa Cardenal-Piris ◽  
...  

The clinical significance of non-obstructive coronary artery disease is the subject of debate. Our objective was to evaluate the long-term cardiovascular prognosis associated with non-obstructive coronary artery disease in patients undergoing coronary angiography, and to conduct a stratification by sex, diabetes, and clinical indication. We designed a multi-centre retrospective longitudinal observational study of 3265 patients that were classified into three groups: normal coronary arteries (lesion <20%, 1426 patients), non-obstructive coronary artery disease (20–50%, 643 patients), and obstructive coronary artery disease (>70%, 1196 patients). During a mean follow-up of 43 months, we evaluated a combined cardiovascular event: acute myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death. Multivariable-adjusted Cox proportional hazard models showed a worse prognosis in patients with non-obstructive coronary artery disease, in comparison with patients of normal coronary arteries group, in the total population (hazard ratio 1.72, 95% confidence interval 1.23–2.39; p for trend <0.001), in non-diabetics (hazard ratio 2.12, 95% confidence interval: 1.40–3.22), in women (hazard ratio 1.75, 95% confidence interval 1.10–2.77), and after acute coronary syndrome (hazard ratio 2.07, 95% confidence interval 1.25–3.44). In conclusion, non-obstructive coronary artery disease is associated with an impaired long-term cardiovascular prognosis. This association held for non-diabetics, women, and after acute coronary syndrome.


Author(s):  
Ю.Н. Панина ◽  
В.И. Вишневский

По мере того как пандемия COVID-19 продолжает разворачиваться, растет и уровень понимания этиопатогенеза, диагностики и лечения данного заболевания. На сегодняшний день становится ясным, что инфекция, вызванная SARS-CoV-2, предрасполагает к состоянию гиперкоагуляции с некоторыми тромботическими событиями, включая острый коронарный синдром. Однако несмотря на то, что пандемия началась более года назад, неопределенность в отношении антикоагулянтной терапии у пациентов с COVID-19 продолжает преобладать. Учитывая, что в настоящее время нет стандартизированного подхода к антикоагулянтной терапии у пациентов с острым коронарным синдромом и COVID-19, нами был проведен обзор научной литературы по данной проблеме. В результате исследования было выявлено, что тактика ведения пациентов с острым коронарным синдромом и COVID-19 в целом не отличается от стандартно принятой. Однако следует уделять особое внимание лекарственным взаимодействиям между антитромбоцитарными препаратами, антикоагулянтами и терапией COVID-19. Также мы отметили, что помимо антикоагулянтных и противовоспалительных свойств гепарины обладают прямым противовирусным эффектом. Все пациенты с инфарктом миокарда с подъемом сегмента ST должны получать стандартную медикаментозную терапию, которая включает нефракционированный гепарин. У пациентов с инфарктом миокарда без подъема сегмента ST с ранней инвазивной стратегией рекомендуется использовать нефракционированный гепарин вместо низкомолекулярного гепарина в качестве антикоагулянта выбора. При этом использование у пациентов с инфарктом миокарда без подъема сегмента ST и COVID-19 низкомолекулярного гепарина предпочтительнее, чем нефракционированного гепарина. As the COVID-19 pandemic continues to unfold, the level of understanding of the etiopathogenesis, diagnosis and treatment of this disease is also growing. To date, it is becoming clear that infection caused by SARS-CoV-2 is a predisposition to a state of hypercoagulation with some thrombotic events, including acute coronary syndrome. However, despite the fact that the pandemic began 1 year ago, uncertainty about anticoagulant therapy in patients with COVID-19 continues to prevail. Given that there is currently no standardized approach to anticoagulation in patients with ACS and COVID-19, we conducted a review of the scientific literature on this problem. As a result of the study, it was found that the management tactics of patients with ACS and COVID-19 generally do not differ from the standard accepted ones. However, special attention should be paid to drug interactions between antiplatelet drugs, anticoagulants, and COVID-19 therapy. We also noted that in addition to anticoagulant and anti-inflammatory properties, heparins have a direct antiviral effect. All patients with ST-segment elevation myocardial infarction should receive standard medical therapy, which includes unfractionated heparin. In patients with non-ST-elevation myocardial infarction with an early invasive strategy, it is recommended to use heparin instead of low-molecular-weight heparin as the anticoagulant of choice. At the same time, the use of low-molecular-weight heparin in patients with myocardial infarction without ST-segment elevation and COVID-19 is preferable to unfractionated heparin.


2018 ◽  
Vol 9 (6) ◽  
pp. 589-598 ◽  
Author(s):  
Baris Gencer ◽  
Fabio Rigamonti ◽  
David Nanchen ◽  
Roland Klingenberg ◽  
Lorenz Räber ◽  
...  

Background: Controversy remains regarding the prevalence of hyperglycaemia in non-diabetic patients hospitalised with acute coronary syndrome and its prognostic value for long-term outcomes. Methods and results: We evaluated the prevalence of hyperglycaemia (defined as fasting glycaemia ⩾10 mmol/l) among patients with no known diabetes at the time of enrolment in the prospective Special Program University Medicine-Acute Coronary Syndromes cohort, as well as its impact on all-cause death, myocardial infarction, stroke and incidence of diabetes at one year. Among 3858 acute coronary syndrome patients enrolled between December 2009–December 2014, 709 (18.4%) had known diabetes, while 112 (3.6%) of non-diabetic patients had hyperglycaemia at admission. Compared with non-hyperglycaemic patients, hyperglycaemic individuals were more likely to present with ST-elevation myocardial infarction and acute heart failure. At discharge, hyperglycaemic patients were more frequently treated with glucose-lowering agents (8.9% vs 0.66%, p<0.001). At one-year, adjudicated all-cause death was significantly higher in non-diabetic patients presenting with hyperglycaemia compared with patients with no hyperglycaemia (5.4% vs 2.2%, p=0.041) and hyperglycaemia was a significant predictor of one-year mortality (adjusted hazard ratio 2.39, 95% confidence interval 1.03–5.56). Among patients with hyperglycaemia, 9.8% had developed diabetes at one-year, while the corresponding proportion among patients without hyperglycaemia was 1.8% ( p<0.001). In multivariate analysis, hyperglycaemia at presentation predicted the onset of treated diabetes at one-year (odds ratio 4.15, 95% confidence interval 1.59–10.86; p=0.004). Conclusion: Among non-diabetic patients hospitalised with acute coronary syndrome, a fasting hyperglycaemia of ⩾10 mmol/l predicted one-year mortality and was associated with a four-fold increased risk of developing diabetes at one year.


Author(s):  
Kamyar Kalantar-Zadeh ◽  
Gregory G. Schwartz ◽  
Stephen J. Nicholls ◽  
Kevin A. Buhr ◽  
Henry N. Ginsberg ◽  
...  

Background and objectivesCKD and type 2 diabetes mellitus interact to increase the risk of major adverse cardiovascular events (i.e., cardiovascular death, nonfatal myocardial infarction, or stroke) and congestive heart failure. A maladaptive epigenetic response may be a cardiovascular risk driver and amenable to modification with apabetalone, a selective modulator of the bromodomain and extraterminal domain transcription system. We examined this question in a prespecified analysis of BETonMACE, a phase 3 trial.Design, setting, participants, & measurementsBETonMACE was an event-driven, randomized, double-blind, placebo-controlled trial comparing effects of apabetalone versus placebo on major adverse cardiovascular events and heart failure hospitalizations in 2425 participants with type 2 diabetes and a recent acute coronary syndrome, including 288 participants with CKD with eGFR <60 ml/min per 1.73 m2 at baseline. The primary end point in BETonMACE was the time to the first major adverse cardiovascular event, with a secondary end point of time to hospitalization for heart failure.ResultsMedian follow-up was 27 months (interquartile range, 20–32 months). In participants with CKD, apabetalone compared with placebo was associated with fewer major adverse cardiovascular events (13 events in 124 patients [11%] versus 35 events in 164 patients [21%]; hazard ratio, 0.50; 95% confidence interval, 0.26 to 0.96) and fewer heart failure–related hospitalizations (three hospitalizations in 124 patients [3%] versus 14 hospitalizations in 164 patients [9%]; hazard ratio, 0.48; 95% confidence interval, 0.26 to 0.86). In the non-CKD group, the corresponding hazard ratio values were 0.96 (95% confidence interval, 0.74 to 1.24) for major adverse cardiovascular events, and 0.76 (95% confidence interval, 0.46 to 1.27) for heart failure–related hospitalization. Interaction of CKD on treatment effect was P=0.03 for major adverse cardiovascular events, and P=0.12 for heart failure–related hospitalization. Participants with CKD showed similar numbers of adverse events, regardless of randomization to apabetalone or placebo (119 [73%] versus 88 [71%] patients), and there were fewer serious adverse events (29% versus 43%; P=0.02) in the apabetalone group.ConclusionsApabetalone may reduce the incidence of major adverse cardiovascular events in patients with CKD and type 2 diabetes who have a high burden of cardiovascular disease.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Raffaele Bugiardini ◽  
Florencia Rolandi ◽  
Oscar Bazzino ◽  
Olivia Manfrini ◽  
Andres Pascua ◽  
...  

HYPOTHESIS. Women presenting with acute coronary syndrome are less likely to have significant coronary artery disease (CAD) than men, which could narrow wide differences in sex outcomes when evaluating the study population as a whole. METHODS. The Prognosis in Acute Coronary Syndromes Registry enrolled 823 patients (591 men and 232 women) who had been hospitalized for an acute coronary syndrome without ST-segment elevation and had undergone cardiac catheterization. We explored sex-based differences in presentation and outcomes, sorted by angiographic groups: obstructive (≥50% stenosis, accordingly to quantitative computerized analysis) versus non-obstructive CAD. Patients were followed up for 6 months. RESULTS. In obstructive CAD, women were older than men (71.4 ± 9.7 versus 64.4 ± 11.1 years, p<0.001), and had significantly higher rates of hypertension (51.9% versus 39.7%, p<0.001). Women were less likely to have smoked (19.3% versus 29.8%, p<0.01). A smaller percentage of women than men had non-ST elevation myocardial infarction as an index event (7.7% versus 22.8%, p<0.001) and positive troponin value (51.3% versus 67.4%, p<0.01). At follow-up women showed no differences in myocardial infarction, rehospitalization for unstable angina or revascularization, but they did suffer an increased rate of cardiovascular death (8.4% versus 3.4%, p<0.01), with a hazard ratio 2.34 (95%CI: 1.13– 4.84, p=0.023). Relation between sex and death remained significant even after adjustment for any confounders (hazard ratio 2.48; 95%CI: 1.19–5.15, p=0.015). In non-obstructive CAD group, the clinical characteristics and prognostic end-points (death: 0% men versus 1% women) did not significantly differ between men and women. CONCLUSIONS. In conclusion, women with obstructive CAD suffer an increased rate of cardiovascular death after acute coronary syndrome. Inclusion of large numbers of women with non-obstructive coronary disease in calculations based on the entire cohort may mistakenly shift results toward apparent outcome similarity with men.


BMJ ◽  
2006 ◽  
Vol 333 (7578) ◽  
pp. 1091 ◽  
Author(s):  
Keith A A Fox ◽  
Omar H Dabbous ◽  
Robert J Goldberg ◽  
Karen S Pieper ◽  
Kim A Eagle ◽  
...  

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