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RITA 3 Mortality Data at 10 years

rita310y

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Journal Club 29 July 2015

Paper

Plaque Characterization by Coronary Computed Tomography Angiography and the Likelihood of Acute Coronary Events in Mid-Term Follow-Up

Presenter

CB

Summary

BACKGROUND

Coronary computed tomography angiography (CTA)-verified positive remodeling and low attenuation plaques are considered morphological characteristics of high-risk plaque (HRP) and predict short-term risk of acute coronary syndrome (ACS).

OBJECTIVES

This study evaluated whether plaque characteristics by CTA predict mid-term likelihood of ACS.

METHODS

The presence of HRP and significant stenosis (SS) of $70% were evaluated in 3,158 patients undergoing CTA. Serial CTA was performed in 449 patients, and plaque progression (PP) was evaluated. Outcomes (fatal and nonfatal ACS) were recorded during follow-up (mean 3.9 2.4 years).

RESULTS

ACS occurred in 88 (2.8%) patients: 48 (16.3%) of 294 HRP(þ) and 40 (1.4%) of 2,864 HRP() patients. ACS was also significantly more frequent in SS(þ) (36 of 659; 5.5%) than SS() patients (52 of 2,499; 2.1%). HRP(þ)/SS(þ) (19%) and HRP(þ)/SS() (15%) had higher rates of ACS compared with no-plaque patients (0.6%). Although ACS incidence was relatively low in HRP() patients, the cumulative number of patients with ACS developing from HRP() lesions (n¼43) was similar to ACS patients with HRP(þ) lesions (n ¼ 45). In patients with serial CTA, PP also was an independent predictor of ACS, with HRP (27%; p < 0.0001) and without HRP (10%) compared with HRP()/PP() patients (0.3%).

CONCLUSIONS

CTA-verified HRP was an independent predictor of ACS. However, the cumulative number of ACS patients with HRP() was similar to patients with HRP(þ). Additionally, plaque progression detected by serial CTA was an independent predictor of ACS.

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Journal Club 22 July 2015

Paper

2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement

Presenter

AB

Summary

BACKGROUND

The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis
at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a selfexpanding
transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis.

OBJECTIVES

Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained.
METHODS Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients.

RESULTS

A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly
lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p ¼ 0.01).

CONCLUSIONS

In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years.

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Journal Club 15 July 2015

Paper

Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation

Presenter

KK

Summary

BACKGROUND

It is uncertain whether bridging anticoagulation is necessary for patients with
atrial fibrillation who need an interruption in warfarin treatment for an elective
operation or other elective invasive procedure. We hypothesized that forgoing
bridging anticoagulation would be noninferior to bridging with low-molecularweight
heparin for the prevention of perioperative arterial thromboembolism and
would be superior to bridging with respect to major bleeding.

METHODS

We performed a randomized, double-blind, placebo-controlled trial in which, after
perioperative interruption of warfarin therapy, patients were randomly assigned
to receive bridging anticoagulation therapy with low-molecular-weight heparin
(100 IU of dalteparin per kilogram of body weight) or matching placebo administered
subcutaneously twice daily, from 3 days before the procedure until 24 hours
before the procedure and then for 5 to 10 days after the procedure. Warfarin treatment
was stopped 5 days before the procedure and was resumed within 24 hours
after the procedure. Follow-up of patients continued for 30 days after the procedure.
The primary outcomes were arterial thromboembolism (stroke, systemic embolism,
or transient ischemic attack) and major bleeding.

RESULTS

In total, 1884 patients were enrolled, with 950 assigned to receive no bridging
therapy and 934 assigned to receive bridging therapy. The incidence of arterial
thromboembolism was 0.4% in the no-bridging group and 0.3% in the bridging
group (risk difference, 0.1 percentage points; 95% confidence interval [CI], −0.6 to
0.8; P = 0.01 for noninferiority). The incidence of major bleeding was 1.3% in the
no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI,
0.20 to 0.78; P = 0.005 for superiority).

CONCLUSIONS

In patients with atrial fibrillation who had warfarin treatment interrupted for an
elective operation or other elective invasive procedure, forgoing bridging anticoagulation
was noninferior to perioperative bridging with low-molecular-weight
heparin for the prevention of arterial thromboembolism and decreased the risk of
major bleeding.

Categories: Journal Club

Proposed Diagnostic Criteria for Coronary Embolism

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Journal Club 8 July 2015

Paper

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

Presenter

VF

Summary

BACKGROUND

Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk
of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug
that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular
events further is not known.

METHODS

We conducted a double-blind, randomized trial involving 18,144 patients who had
been hospitalized for an acute coronary syndrome within the preceding 10 days and
had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter)
if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to
3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination
of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin–ezetimibe) was compared
with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary
end point was a composite of cardiovascular death, nonfatal myocardial
infarction, unstable angina requiring rehospitalization, coronary revascularization
(≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years.

RESULTS

The median time-weighted average LDL cholesterol level during the study was 53.7 mg
per deciliter (1.4 mmol per liter) in the simvastatin–ezetimibe group, as compared
with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy
group (P<0.001). The Kaplan–Meier event rate for the primary end point at 7 years
was 32.7% in the simvastatin–ezetimibe group, as compared with 34.7% in the
simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points;
hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). Rates of prespecified
muscle, gallbladder, and hepatic adverse effects and cancer were similar
in the two groups.

CONCLUSIONS

When added to statin therapy, ezetimibe resulted in incremental lowering of LDL
cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL
cholesterol to levels below previous targets provided additional benefit.

Supplementary Material

The editorial is available here.

Journal Club 1 July 2015

Paper

Idarucizumab for Dabigatran Reversal

Presenter

DC

Summary

BACKGROUND

Specific reversal agents for non–vitamin K antagonist oral anticoagulants are lacking.
Idarucizumab, an antibody fragment, was developed to reverse the anticoagulant
effects of dabigatran.

METHODS

We undertook this prospective cohort study to determine the safety of 5 g of intravenous
idarucizumab and its capacity to reverse the anticoagulant effects of
dabigatran in patients who had serious bleeding (group A) or required an urgent
procedure (group B). The primary end point was the maximum percentage reversal
of the anticoagulant effect of dabigatran within 4 hours after the administration
of idarucizumab, on the basis of the determination at a central laboratory of the
dilute thrombin time or ecarin clotting time. A key secondary end point was the
restoration of hemostasis.

RESULTS

This interim analysis included 90 patients who received idarucizumab (51 patients
in group A and 39 in group B). Among 68 patients with an elevated dilute thrombin
time and 81 with an elevated ecarin clotting time at baseline, the median
maximum percentage reversal was 100% (95% confidence interval, 100 to 100).
Idarucizumab normalized the test results in 88 to 98% of the patients, an effect
that was evident within minutes. Concentrations of unbound dabigatran remained
below 20 ng per milliliter at 24 hours in 79% of the patients. Among 35 patients
in group A who could be assessed, hemostasis, as determined by local investigators,
was restored at a median of 11.4 hours. Among 36 patients in group B who underwent
a procedure, normal intraoperative hemostasis was reported in 33, and mildly
or moderately abnormal hemostasis was reported in 2 patients and 1 patient, respectively.
One thrombotic event occurred within 72 hours after idarucizumab administration
in a patient in whom anticoagulants had not been reinitiated.

CONCLUSIONS

Idarucizumab completely reversed the anticoagulant effect of dabigatran within
minutes.

Summary

Antidote tested in volunteers
The paper editorial is available here.

Categories: Journal Club