Athletes Heart

September 28, 2017 Leave a comment

Pelliccia et al provide an excellent comprehensive review of assessment and diagnostic issues of Athletes heart (European Heart Journal (2017) 0, 1–27 doi:10.1093/eurheartj/ehx532). The diagnostic approach to discrimination from hypertrophc cardiomyopathy, dilated cardiomyopathy, arrhythmogenic cardiomyopathy, LV non-compaction and other pathologies is useful.

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Physical Activity and Mortality and Cardiovascular Events: PURE Study

September 28, 2017 Leave a comment

S A Lear et al report on the PURE study: a prospective cohort study examining the effect of physical activity on mortality and cardiovascular outcomes(Lancet http://dx.doi.org/10.1016/S0140-6736(17)31634-3).

ABSTRACT

Background

Physical activity has a protective effect against cardiovascular disease (CVD) in high-income countries, where physical activity is mainly recreational, but it is not known if this is also observed in lower-income countries, where physical activity is mainly non-recreational. We examined whether different amounts and types of physical activity are associated with lower mortality and CVD in countries at different economic levels.

Methods

In this prospective cohort study, we recruited participants from 17 countries (Canada, Sweden, United Arab Emirates, Argentina, Brazil, Chile, Poland, Turkey, Malaysia, South Africa, China, Colombia, Iran, Bangladesh, India, Pakistan, and Zimbabwe). Within each country, urban and rural areas in and around selected cities and towns were identified to reflect the geographical diversity. Within these communities, we invited individuals aged between 35 and 70 years who intended to live at their current address for at least another 4 ears. Total physical activity was assessed using the International Physical Activity Questionnaire (IPQA). Participants with pre-existing CVD were excluded from the analyses. Mortality and CVD were recorded during a mean of 6·9 years of follow-up. Primary clinical outcomes during follow-up were mortality plus major CVD (CVD mortality, incident myocardial infarction, stroke, or heart failure), either as a composite or separately. The effects of physical activity on mortality and CVD were adjusted for sociodemographic factors and other risk factors taking into account household, community, and country clustering.

Findings

Between Jan 1, 2003, and Dec 31, 2010, 168 916 participants were enrolled, of whom 141 945 completed the IPAQ. Analyses were limited to the 130 843 participants without pre-existing CVD. Compared with low physical activity
(750 minutes per week) were associated with graded reduction in mortality (hazard ratio 0·80, 95% CI 0·74–0·87 and 0·65, 0·60–0·71; p<0·0001 for trend), and major CVD (0·86, 0·78–0·93; p<0·001 for trend). Higher physical activity was associated with lower risk of CVD and mortality in high-income, middle-income, and low-income countries. The adjusted population attributable fraction for not meeting the physical activity guidelines was 8·0% for mortality
and 4·6% for major CVD, and for not meeting high physical activity was 13·0% for mortality and 9·5% for major CVD. Both recreational and non-recreational physical activity were associated with benefits.

Interpretation

Higher recreational and non-recreational physical activity was associated with a lower risk of mortality and CVD events in individuals from low-income, middle-income, and high-income countries. Increasing physical activity is a simple, widely applicable, low cost global strategy that could reduce deaths and CVD in middle age.

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Patent Foramen Ovale and Cryptogenic Stroke

September 18, 2017 Leave a comment

Three papers appeared in the September 14 issue of the New England Journal of Medicine:

  • N Engl J Med 2017;377:1011-21. DOI: 10.1056/NEJMoa1705915
  • N Engl J Med 2017;377:1022-32. DOI: 10.1056/NEJMoa1610057
  • N Engl J Med 2017;377:1033-42. DOI: 10.1056/NEJMoa1707404

and an accompanying editorial: DOI: 10.1056/NEJMe1709637

There appears to be reduced risk of stroke as well as increased risk of atrial fibrillation.

Mas et al report an open label randomized clinical trial in patients with recent stroke and PFO (with either atrial septal aneurysm or large inter-atrial shunt: compared PFO closure versus antiplatelet therapy versus anticoagulation.

ABSTRACT

BACKGROUND

Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy.

METHODS

In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3.

RESULTS

A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P = 0.02). The number of serious adverse events did not differ significantly between the treatment groups (P = 0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone.

CONCLUSIONS

Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation.

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Saver et al report on the long term (10 year) outcomes of the RESPECT study.

ABSTRACT

BACKGROUND

Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown.

METHODS

In a multicenter, randomized, open-label trial, with blinded adjudication of endpoint events, we randomly assigned patients 18 to 60 years of age who had
a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group). The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory.

RESULTS

We enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval [CI], 0.31 to 0.999; P = 0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI,0.18 to 0.79; P = 0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group.

CONCLUSIONS

Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was
associated with a lower rate of recurrent ischemic strokes than medical therapy
alone during extended follow-up

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Søndergaard et at report the REDUCE trial comparing PFO closure with antiplatelet therapy in patients with cryptogenic stroke.

ABSTRACT

BACKGROUND

The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions.

METHODS

In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet- only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction
detected on imaging.

RESULTS

We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P = 0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P = 0.04), but the incidence of silent brain infarction did not differ significantly between the study groups P = 0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P = 0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.

CONCLUSIONS

Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation.

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ESC 2017 STEMI Guideline Summary Sheet

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SYNTAX 2

Escaned et al (European Heart Journal (2017) 0, 1–11,doi:10.1093/eurheartj/ehx512) report on the SYNTAX 2 trial. IFR guided intervention was associated with improved outcomes to 1 year compared with SYNTAX-PCI cohort. Note the differences in terms of lesion selection, stents per lesion etc.

ABSTRACT

Aims

To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease.

Methods and results

The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries.
The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the
original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall
708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39–0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11–0.70, P = 0.007) and revascularization (HR 0.57, 95% CI 0.37–0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27–1.73, P = 0.43) and stroke
(HR 0.69, 95% CI 0.10–4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07–0.97, P = 0.045).

Conclusion

At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted.

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Oxygen Therapy in Myocardial Infarction

Hoffmann et al report on the DETO2X-SWEDEHEART study: a randomized clinical  trial of oxygen therapy (versus ambient air) in suspected acute myocardial infarction (DOI: 10.1056/NEJMoa1706222). There was no benefit. There is an accompanying editorial: DOI: 10.1056/NEJMe1709250

ABSTRACT

BACKGROUND

The clinical effect of routine oxygen therapy in patients with suspected acute myocardial
infarction who do not have hypoxemia at baseline is uncertain.

METHODS

In this registry-based randomized clinical trial, we used nationwide Swedish registries
for patient enrollment and data collection. Patients with suspected myocardial
infarction and an oxygen saturation of 90% or higher were randomly assigned
to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered
through an open face mask) or ambient air.

RESULTS

A total of 6629 patients were enrolled. The median duration of oxygen therapy was
11.6 hours, and the median oxygen saturation at the end of the treatment period
was 99% among patients assigned to oxygen and 97% among patients assigned to
ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as
compared with 254 patients (7.7%) in the ambient-air group. The median of the
highest troponin level during hospitalization was 946.5 ng per liter in the oxygen
group and 983.0 ng per liter in the ambient-air group. The primary end point of
death from any cause within 1 year after randomization occurred in 5.0% of patients
(166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned
to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to
1.21; P = 0.80). Rehospitalization with myocardial infarction within 1 year occurred
in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to
ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P = 0.33). The results were
consistent across all predefined subgroups.

CONCLUSIONS

Routine use of supplemental oxygen in patients with suspected myocardial infarction
who did not have hypoxemia was not found to reduce 1-year all-cause mortality.

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CANTOS

Ridker et al report on the results of the CANTOS trial: DOI: 10.1056/NEJMoa1707914

There is an accompanying editorial: DOI: 10.1056/NEJMe1709904

ABSTRACT

BACKGROUND

Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved.

METHODS

We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.

RESULTS

At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31).

CONCLUSIONS

Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway
with canakinumab at a dose of 150 mg every 3 months led to a significantly lower
rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering.

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