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Archive for November, 2015

Journal Club 25 November 2015

Paper

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Presenter

VF

Summary

BACKGROUND

Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.

METHODS

In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who under-went PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.

RESULTS

We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated–stent group and in 154 patients (12.9%) in the bare-metal–stent group (risk difference, −3.6 percentage points; 95% confi-dence interval [CI], −6.1 to −1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P = 0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated–stent group and in 113 patients (9.8%) in the bare-metal–stent group (risk difference, −4.8 percentage points; 95% CI, −6.9 to −2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001).

CONCLUSIONS

Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy.

Supplementary Material

Supplementary material is available here.

Journal Club 18 November 2015

Paper

A Randomized Trial of Intensive versus Standard Blood-Pressure Control

Presenter

AL

Summary

BACKGROUND

The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain.

METHODS

We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.

RESULTS

At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The interven-tion was stopped early after a median follow-up of 3.26 years owing to a signifi-cantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P = 0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group.

CONCLUSIONS

Among patients at high risk for cardiovascular events but without diabetes, target-ing a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group.

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15 year Mortality Data from COURAGE Trial

The 15 year data from COURAGE trial have been published. The paper is available here.

Categories: Uncategorized

Journal Club 11 November 2015

Paper

Apixaban for Extended Treatment of Venous Thromboembolism

Presenter

SP

Summary

Background

Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose
regimen, may be an option for the extended treatment of venous thromboembolism.

Methods

In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg
and 5 mg, twice daily) with placebo in patients with venous thromboembolism who
had completed 6 to 12 months of anticoagulation therapy and for whom there was
clinical equipoise regarding the continuation or cessation of anticoagulation therapy.
The study drugs were administered for 12 months.

Results

A total of 2486 patients underwent randomization, of whom 2482 were included in
the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism
or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%)
who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who
were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence
interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving
5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1)
(P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo
group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban
group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo
group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group.
The rate of death from any cause was 1.7% in the placebo group, as compared with
0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group.

Conclusions

Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a
thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism
without increasing the rate of major bleeding.

Supplementary Material

ESC Venous Thromboembolism Guidelines

Selected Papers from AHA

Categories: Uncategorized

Empagliflozin (an inhibitor of sodium–glucose cotransporter 2) and Cardiovascular Outcomes

Empaglifozin associated with lower cardiovascular mortality despite little effect on non-fatal CV outcome in patients with type II diabetes mellitus. The paper is available here.

Categories: Uncategorized

Journal Club 5 November 2015

Paper

Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes

Presenter

PS

Summary

BACKGROUND

The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.

METHODS

We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.

RESULTS

At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).

CONCLUSIONS

In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year.