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Archive for the ‘General Cardiology’ Category

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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COMPASS

Eikelboom et al report on the COMPASS trial: DOI: 10.1056/NEJMoa1709118. There is an accompanying editorial by Eugene Braunwald (DOI: 10.1056/NEJMe1710241).

ABSTRACT

BACKGROUND

We evaluated whether rivaroxaban alone or in combination with aspirin would be
more effective than aspirin alone for secondary cardiovascular prevention.

METHODS

In this double-blind trial, we randomly assigned 27,395 participants with stable
atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plusaspirin group after a mean follow-up of 23 months.

RESULTS

The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin
group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z = −4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P = 0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.

CONCLUSIONS

Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.

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Medically treated NSTEMI

Feldman et al (European Heart Journal: Acute Cardiovascular Care
2017, Vol. 6(3) 262–271) report on the characteristics and outcomes of patients presenting with a non ST elevation acute coronary syndrome.

Abstract

Background:

Medically managed individuals represent a high-risk group among patients with non–ST-elevation acute myocardial infarction (NSTE-AMI). We hypothesized that prognosis in this group is heterogeneous, depending on whether medical management was decided with or without coronary angiography (CAG).

Methods:

Using data from the French Registry of Acute ST-Elevation or Non–ST-Elevation Myocardial Infarction (FASTMI), we analysed data from 798 patients with NSTE-AMI who were medically managed (i.e. without revascularization during the index hospitalization). Patients were categorized according to the performance of CAG and, if performed, to the extent of coronary artery disease (CAD).

Results:

There were marked differences in baseline demographics, according to whether CAG was performed and to the extent of CAD. While the overall mortality rate at five years was high (56.2%), it differed greatly between groups,
with patients who did not undergo CAG having a higher mortality rate (77.4%) than patients who underwent CAG (36.7%, p<0.001), and a higher mortality rate even than patients with multivessel CAD (54.2%, p<0.001). By multivariable
analysis, non-performance of CAG was an independent predictor of all-cause mortality among medically managed NSTEAMI patients (adjusted hazard ratios (95% confidence intervals) 3.19 (1.79–5.67) at 30 days, 2.28 (1.60–3.26) at one year,
and 1.63 (1.28–2.07) at five years; all p<0.001).

Conclusion:

Medically managed patients with NSTE-AMI are a heterogeneous group in terms of baseline characteristics and outcomes. The highest risk patients are those who do not undergo CAG. Non-performance of CAG is a strong predictor of death.

 

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AF Screening

Freedman et al present a white paper from the AF-SCREEN International Collaborative. This important paper collates evidence for AF screening and provides insights into the risk of asymptomatic atrial fibrillation and the temporal relationship between AF and ischemic stroke.

 

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DAPT Duration in Acute Coronary Syndrome

Wilson et al summarize the evidence for duration of dual antiplatelet therapy in patients with acute coronary syndrome.  The DAPT score use is also highlighted.

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Area: Height Ratio in Patients With Proximal Ascending Aortic Dilation and Trileaflet Aortic Valve

Masri et al report an observational longitudinal study of patients with proximal dilation of the ascending aorta and trileaflet aortic valves. The authors report the relationship between ascending aortic area to height ration (as assessed by CT or MRI) and clinical outcome.

Abstract

BACKGROUND:

In patients with a dilated proximal ascending aorta
and trileaflet aortic valve, we aimed to assess (1) factors independently
associated with increased long-term mortality and (2) the incremental
prognostic utility of indexing aortic root to patient height.

METHODS:

We studied consecutive patients with a dilated aortic root (≥4
cm) that underwent echocardiography and gated contrast-enhanced thoracic
aortic computed tomography or magnetic resonance angiography between
2003 and 2007. A ratio of aortic root area over height was calculated
(cm2/m) on tomography, and a cutoff of 10 cm2/m was chosen as abnormal,
on the basis of previous reports. All-cause death was recorded.

RESULTS:

The cohort comprised 771 patients (63 years [interquartile range,
53–71], 87% men, 85% hypertension, 51% hyperlipidemia, 56% smokers).
Inherited aortopathies, moderate to severe aortic regurgitation, and severe
aortic stenosis were seen in 7%, 18%, and 2%, whereas 91% and 54% were
on β-blockers and angiotensin-converting enzyme inhibitors, respectively.
Aortic root area/height ratio was ≥10 cm2/m in 24%. The Society of
Thoracic Surgeons score and right ventricular systolic pressure were 3.3±3
and 31±7 mm Hg, respectively. At 7.8 years (interquartile range, 6.6–8.9),
280 (36%) patients underwent aortic surgery (76% within 1 year) and 130
(17%) died (1% in-hospital postoperative mortality). A lower proportion of
patients in the surgical (versus nonsurgical) group died (13% versus 19%,
P<0.01). On multivariable Cox proportional hazard analysis, aortic root area/
height ratio (hazard ratio, 4.04; 95% confidence interval [CI], 2.69–6.231)
was associated with death, whereas aortic surgery (hazard ratio, 0.47;
95% CI, 0.27–0.81) was associated with improved survival (both P<0.01).
For longer-term mortality, the addition of aortic root area/height ratio ≥10
cm2/m to a clinical model (Society of Thoracic Surgeons score, inherited
aortopathies, hypertension, hyperlipidemia, medications, aortic regurgitation,
and right ventricular systolic pressure), increased the c-statistic from 0.57
(95% CI, 0.35–0.77) to 0.65 (95% CI, 0.52–0.73) and net reclassification
index from 0.17 (95% CI, 0.02–0.31) to 0.23 (95% CI, 0.04–0.34), both
P<0.01. Of the 327 patients with aortic root diameter between 4.5 and 5.5
cm, 44% had an abnormal aortic root area/height ratio, of which 78% died.

CONCLUSIONs:

In patients with dilated aortic root and trileaflet aortic
valve, a ratio of aortic root area to height provides independent and
improved stratification for prediction of death.

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AHA 2016: Initial Look