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European Society of Cardiology 2014 Meeting Update / September 1st 2013

 

Welcome

Hello

Welcome to a supplementary Critical Care Reviews Newsletter, bringing you the major research presented at the European Society of Cardiology Congress 2013, currently in progress in Amsterdam. The following studies have been concurrently published in the New England Journal of Medicine this morning.

Presentations from this meeting will be available via the vodcasts webpage, once they are published online.

 

Research

Randomized Controlled Trials

New England Journal of Medicine:     Direct Oral Anticoagulants

Eikelboom and colleagues performed a randomized, phase 2 dose-validation study in 252 patients, comprising two cohorts (aortic- or mitral-valve replacement either within the past 7 days or at least 3 months earlier), comparing dose adjusted dabigtran with dose adjusted warfarin for the prevention of venothromboembolism. They reported:

  1. early trial termination due to excessive harm in the dabigatran arm (dabigatran versus warfarin)
    • strokes (n=9 (5%) versus n=0 (0%))
    • myocardial infarction (n=3 (2%) versus n=0 (0%))
    • death (n=1 versus n=2)
    • composite of stroke, transient ischemic attack, systemic embolism, myocardial infarction, or death (n=15 (9%) versus n=4 (5%); hazard ratio 1.94; 95% CI 0.64 to 5.86; P=0.24)
    • major bleeding (n=7 (4%) versus n=2 (2%))  
    • any bleeding (n=45 (27%) versus n=10 (12%); hazard ratio 2.45; 95% CI 1.23 to 4.86; P=0.01)
    • Increased bleeding with dabigatran was noted in both cohorts

Full Text:  Eikelboom. Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN study). New Eng J Med 2013;epublished September 1st   

 

The Hokusai-VTE Investigators completed an international, multi-centre, randomized, double-blind, noninferiority study in 8,292 patients with acute venous thromboembolism, who had initially received heparin, comparing edoxaban (n=4,118) (either 60 mg once daily or dose adjusted to 30 mg once daily), with warfarin (n=4,122), for 3 to 12 months, and found:

  1. for the primary efficacy outcome (recurrent symptomatic venous thromboembolism), edoxaban was noninferior to warfarin (edoxban 3.2% versus warfarin 3.5%; hazard ratio 0.89; 95% CI 0.70 to 1.13; P<0.001 for noninferiority).
  2. less major or clinically relevant nonmajor bleeding with edoxaban (8.5% versus 10.3%; hazard ratio 0.81; 95% CI 0.71 to 0.94; P=0.004 for superiority)
  3. in patients with pulmonary embolism associated right ventricular dysfunction (n=938), there was a reduced rate of recurrent venous thromboembolism with edoxaban (3.3% versus 6.2%; hazard ratio 0.52; 95% CI 0.28 to 0.98)
  4. no difference in adverse events between the two groups.

Full Text:  Hokusai-VTE Investigators. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism (Hokusai-VTE study). New Eng J Med 2013;epublished September 1st

 

New England Journal of Medicine:     Coronary Thrombus Aspiration

Using the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), Fröbert et al undertook a multicenter, prospective, randomized, controlled, open-label clinical trial in 7,244 patients with STEMI undergoing PCI, and compared manual thrombus aspiration followed by PCI with PCI alone, and found:

  1. no 30-day mortality effect (aspiration group 2.8% versus PCI-only group 3.0%; hazard ratio 0.94; 95% CI 0.72 to 1.22; P=0.63)
  2. a trend for reduced rates of hospitalization for recurrent myocardial infarction at 30 days with aspiration (0.5% versus 0.9%; hazard ratio 0.61; 95% CI 0.34 to 1.07; P=0.09)
  3. a trend for reduced rates of stent thrombosis with aspiration (0.2% versus 0.5%; hazard ratio 0.47; 95% CI 0.20 to 1.02; P=0.06)
  4. no differences between groups for stroke or neurologic complications at discharge (P=0.87)

Full Text: Fröbert. Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction. New Eng J Med 2013;epublished September 1st   

 

New England Journal of Medicine:     Prasugrel before Percutaneous Coronary Intervention

Montalescot and colleagues performed an international, multi-centre, phase 3, randomized, double-blind, event-driven study in 4,033 patients with non-ST elevation acute coronary syndrome and a positive troponin level scheduled to undergo coronary angiography within 48 hours after randomization, comparing administering prasugrel 30mg (pretreatment group) at the time of diagnosis versus administering it after coronary angiography if PCI was indicated (pretreatment group additional 30mg, late treatment group 60mg). They found:

  1. no difference in the rate of the primary efficacy end point  (composite of death from cardiovascular causes, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor rescue therapy at day 7) (hazard ratio with pretreatment 1.02; 95% CI 0.84 to 1.25; P=0.81)
  2. increased rate of Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes at day 7 with pretreatment (hazard ratio 1.90; 95% CI 1.19 to 3.02; P=0.006)
  3. rates of TIMI major bleeding and life-threatening bleeding not related to CABG were increased by a factor of 3 and 6, respectively

Full Text:  Montalescot. Pretreatment with Prasugrel in Non–ST-Segment Elevation Acute Coronary Syndromes (ACCOAST study). New Eng J Med 2013;epublished September 1st    

 

New England Journal of Medicine:     Preventive Angioplasty

Wald et al performed a multi-centre, randomized controlled trial in 465 patients with acute STEMI undergoing infarct-artery PCI, and compared preventive (non-infarct artery) PCI (n=234) with no preventive PCI (n=231). They reported:

  1. after a mean follow up of 23 months, the trial was terminated early by the data and safety monitoring committee
  2. reduced rates of the primary outcome (a composite of death from cardiac causes, nonfatal myocardial infarction) with preventive PCI (n=21 versus n=53, hazard ratio 0.35; 95% CI 0.21 to 0.58; P<0.001)
  3. reduced hazard ratio with preventive PCI for
    • death from cardiac causes 0.34 (95% CI 0.11 to 1.08)
    • nonfatal myocardial infarction 0.32 (95% CI 0.13 to 0.75)
    • refractory angina 0.35 (95% CI 0.18 to 0.69) 

Full Text:  Wald. Randomized Trial of Preventive Angioplasty in Myocardial Infarction (PRAMI study). New Eng J Med 2013;epublished September 1st   

   

New England Journal of Medicine:     Acute Pericarditis

Imazio et al completed a multicenter, randomized, placebo controlled, blinded trial in 240 patients  with acute pericarditis, evaluating colchicine (n=120, 0.5 mg twice daily for 3 months or dose adjusted 0.5 mg once daily), in addition to conventional antiinflammatory therapy with aspirin or ibuprofen, and found:

  1. colchicine therapy was associated with reduced rates of
    • primary outcome occurance (incessant or recurrent pericarditis) (16.7% versus 37.5%; relative risk reduction 0.56; 95% CI 0.30 to 0.72; NNT 4; P<0.001)
    • symptom persistence at 72 hours (19.2% versus 40.0%, P=0.001),
    • recurrences per patient (0.21 versus 0.52, P=0.001)
    • hospitalization (5.0% versus 14.2%, P=0.02).
    • remission at 1 week (85.0% versus 58.3%, P<0.001)
  2. no difference in adverse effects or rates of study-drug discontinuation betweeen the two study groups

Full Text:  Imazio. A Randomized Trial of Colchicine for Acute Pericarditis (ICAP Study). New Eng J Med 2013;epublished September 1st 

 

Journal of the American Medical Association:     Otamixaban in NSTE Coronary Syndromes

Steg and colleagues undertook an international, multi-centre, randomized, double-blind, active-controlled superiority trial in 13,229 patients with non-ST elevation acute coronary syndrome and a planned early invasive strategy, comparing otamixaban, a novel intravenous direct factor Xa inhibitor, with unfractionated heparin plus downstream eptifibatide, and found:

  1. no difference in the incidence of the primary efficacy outcome (a composite of all-cause death or new myocardial infarction at day 7); otamixaban 5.5% (279 of 5105 patients) versus unfractionated heparin plus eptifibatide 5.7% (310 of 5466 patients); adjusted relative risk 0.99; 95% CI 0.85-1.16; P =0 .93
  2. no differences in secondary outcomes, including procedural thrombotic complications
  3. an increase with otamixaban therapy in the primary safety outcome of Thrombosis in Myocardial Infarction (TIMI) major or minor bleeding at day 7 (3.1% vs 1.5%; RR 2.13; 95% CI 1.63-2.78; P < 0.001)

 

 

I hope you find these brief summaries and links useful. This week's full newsletter should be out later today.

Rob

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