VBWG OASIS-5 The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes trial.

Slides:



Advertisements
Similar presentations
Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 Trial Efficacy and Safety.
Advertisements

TIMI 11BESSENCE Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis Antman EM et al, Circulation 1999 Oct 12;100(15):
Update on Anti-platelets Gabriel A. Vidal, MD Vascular Neurology Ochsner Medical Center October 14 th, 2009.
PCI - A prospective, randomized, double- blind substudy of patients undergoing PCI in the CURE trial.
Keith A A Fox Royal Infirmary & University of Edinburgh CURE and PCI-CURE.
Timing of Intervention in Patients with Acute Coronary Syndromes (TIMACS) AHA, 2008.
Update on the Medical Management of Acute Coronary Syndrome.
Khawar Kazmi. Thrombosis LipidsInflammation Thrombus Platelets and thrombin Quiescent Plaque Plaque rupture PATHOGENESIS ACUTE CORONARY SYNDROME.
TROPHY TRial Of Preventing HYpertension. High-normal BP increases CV risk Vasan RS et al. N Engl J Med. 2001;345: Incidence of CV events in women.
Long-term Outcomes of Patients with ACS and Chronic Renal Insufficiency Undergoing PCI and being treated with Bivalirudin vs UFH/Enoxaparin plus a GP IIb/IIIa.
Stanford ACS Guidelines 2003 David P. Lee, M.D. John S. Schroeder, M.D. *Donald Schreiber, M.D. Division of Cardiovascular Medicine and *Department of.
Study by: Granger et al. NEJM, September 2011,Vol No. 11 Presented by: Amelia Crawford PA-S2 Apixaban versus Warfarin in Patients with Atrial Fibrillation.
lopidogrel in nstable Angina to Prevent ecurrent vents
Women's Health Study: Low-Dose Aspirin in Primary Prevention Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Dr.
Download from Slide 1 AGGRASTAT ® † (tirofiban, MSD) to ZOCOR ™ † (simvastatin, MSD) (A to Z) Trial Results from the AGGRASTAT.
COURAGE: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Purpose To compare the efficacy of optimal medical therapy (OMT)
CHARM-Alternative: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Alternative Purpose To determine whether the angiotensin.
CHARM-Preserved: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Preserved Purpose To determine whether the angiotensin.
The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study To reviewers and moderators: These.
VBWG CHARISMA Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance trial.
Slide 1 AGGRASTAT ™ † (tirofiban, MSD) to ZOCOR ™ † (simvastatin, MSD) (A to Z) Trial Results from the AGGRASTAT Phase † Trademarks of Merck & Co., Inc.,
Pharmacological strategies to reduce periprocedural bleeding
An International Randomized Trial of Early Versus Delayed Invasive Strategies in Patients with Non-ST Segment Elevation Acute Coronary Syndromes TIMACS.
VBWG HPS. Lancet. 2003;361: Gæde P et al. N Engl J Med. 2003;348: Recent statin trials: Reduction in primary outcome in patients with diabetes.
OASIS 5 Access AHA 2006 Martial Hamon, Shamir Mehta, Gabriel Steg, David Faxon, Prafulla Kerkar, Hans-Jürgen Rupprecht, Jean-Francois Tanguay, Rizwan Afzal,
PPAR  activation Clinical evidence. Evolution of clinical evidence supporting PPAR  activation and beyond Surrogate outcomes studies Large.
Prasugrel vs. Clopidogrel for Acute Coronary Syndromes Patients Managed without Revascularization — the TRILOGY ACS trial On behalf of the TRILOGY ACS.
16th Interventional Cardiology Symposium Montreal, Quebec / June 14-16, 2007 Adapted from a presentation by: Shamir R. Mehta, MD, MSc, FRCPC, FACC “Transitioning.
Compared to Heparin/Enoxaparin with GP IIb/IIa inhibitors,Bivalirudin monotherapy significantly reduces major bleeding while providing similar ischemic.
Aim To determine the effects of a Coversyl- based blood pressure lowering regimen on the risk of recurrent stroke among patients with a history of stroke.
AIRE: Acute Infarction Ramipril Efficacy study Purpose To determine whether the ACE inhibitor ramipril reduces mortality in patients with evidence of heart.
Oral Rivaroxaban for Symptomatic Venous Thromboembolism.
BEST: Beta-blocker Evaluation Survival Trial Purpose To determine whether the β-blocker bucindolol reduces morbidity and mortality in patients with advanced.
SPARCL Stroke Prevention by Aggressive Reduction in Cholesterol Levels trial.
Vorapaxar for Secondary Prevention in Patients with Prior Myocardial Infarction Benjamin M. Scirica, MD, MPH On behalf of the TRA 2°P-TIMI 50 Steering.
Which Early ST-Elevation Myocardial Infarction Therapy (WEST) Trial Paul W. Armstrong, WEST Steering Committee Published in The European Heart Journal.
LIPID: Long-term Intervention with Pravastatin in Ischemic Disease Purpose To determine whether pravastatin will reduce coronary mortality and morbidity.
A Randomized Trial of Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism Schulman S et al. Proc ASH 2011;Abstract 205.
HOPE: Heart Outcomes Prevention Evaluation study Purpose To evaluate whether the long-acting ACE inhibitor ramipril and/or vitamin E reduce the incidence.
Safety and Efficacy of Intravenous Enoxaparin in Elective Percutaneous Coronary Intervention: An International Randomised Evaluation One year follow-up.
Naotsugu Oyama, MD, PhD, MBA A Trial of PLATelet inhibition and Patient Outcomes.
Baseline Characteristics Current or Former Smoker Diabetic Hypertension 25.7 Prior MI Prior Heart Failure.
VBWG HOPE-TOO: Results of the HOPE Study Extension.
Collaborative Atorvastatin Diabetes Study CARDS Dr Sachin Kadoo.
The INT egrelin and E noxaparin R andomized assessment of A cute C oronary syndrome Treatment T rial Sponsored by the Canadian Heart Research Centre, Key.
Safety and Efficacy of Switching from Either UFH or Enoxaparin Plus a GP IIb/IIIa Inhibitor to Bivalirudin Monotherapy in Patients with Non-ST Elevation.
The Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT-4 PCI) Trial ASSENT- 4 PCI Trial Presented.
OASIS-2 OASIS-2 OVERVIEW 10,141 patients evaluating Hirudin vs. Heparin and 3712 patients evaluating Warfarin vs. Standard Therapy International (16 Countries)
MICHELANGELO: OASIS 5 Women’s Substudy Dr. Eva Swahn Department of Cardiology, Heart Centre, University Hospital, Linköping Sweden Disclosure Funded by.
FRagmin® and Fast Revascularization during InStablity in Coronary artery disease FRISC II.
Hypothesis: baseline risk status of the patients and proximity to a recent cardiovascular event influence the response to dual anti-platelet therapy. Patients.
VBWG OASIS-6 The Sixth Organization to Assess Strategies in Acute Ischemic Syndromes trial.
Gregg W. Stone MD for the ACUITY Investigators Gregg W. Stone MD for the ACUITY Investigators A Prospective, Randomized Trial of Bivalirudin in Acute Coronary.
Organization for the Assessment of Strategies for Ischemic Syndromes 6 (OASIS-6) Trial Presented at The American College of Cardiology Scientific Session.
Gregg W. Stone MD for the ACUITY Investigators A Prospective, Randomized Trial of Bivalirudin in Acute Coronary Syndromes Final One-Year Results from the.
Comparison of Fondaparinux and Enoxaprin in Acute Coronary Syndrome OASIS-5 Presented by: Maram Mobara.
Over Time Additional Risk Factors Can Progress: Effect of Cholesterol and BP on CHD Risk in MRFIT Trial
Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT-4 PCI) Trial ASSENT- 4 PCI Trial Presented at.
HOPE: Heart Outcomes Prevention Evaluation study
SOCRATES Trial design: Patients with acute ischemic stroke were randomized in a 1:1 fashion to receive either ticagrelor 180 mg load + 90 mg BID or aspirin.
ASSENT-3 PLUS 1,639 patients with STEMI Treatment Group A
Seeking the Optimal Upstream Therapy for Patients with ACS: Fondaparinux- Low Bleeding Rate and Low Cost Sanjit S. Jolly MD, Interventional Cardiologist,
EUCLID Trial design: Patients with peripheral arterial disease (PAD) were randomized to ticagrelor 90 mg twice daily (n = 6,930) vs. clopidogrel 75 mg.
The Hypertension in the Very Elderly Trial (HYVET)
% Heparin + GPI IIb/IIIa Bivalirudin +
What oral antiplatelet therapy would you choose?
ARISE Trial Aggressive Reduction of Inflammation Stops Events
Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 Trial Ron J.G. Peters,
OASIS-5: Study Design Randomize N=20,078 Enoxaparin (N=10,021)
Bleeding and Outcomes OASIS Registry, OASIS - 2, CURE (n=34,146) Death
Presentation transcript:

VBWG OASIS-5 The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes trial

VBWG US hospital discharges in ACS AHA. Heart Disease and Stroke Statistics–2005 Update million hospital discharges/year STEMI 1.17 million 500,000 Acute coronary syndromes UA/NSTEMI

VBWG OASIS-5: Background The combined use of anticoagulants, antiplatelet agents, and invasive coronary procedures in a routine early invasive strategy reduces ischemic coronary events but also increases bleeding in selected patients with ACS OASIS-5 was conducted to assess whether fondaparinux, a selective inhibitor of factor Xa, would preserve the anti-ischemic benefits of enoxaparin and further reduce bleeding MICHELANGELO OASIS 5 Steering Committee. Am Heart J. 2005;150: OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Hypotheses In the acute treatment of patients with UA/NSTEMI fondaparinux is: Noninferior to enoxaparin in preventing death, MI, or refractory ischemia through day 9 Superior to enoxaparin as determined by lower major bleeding events through day 9 Superior to enoxaparin in benefit/risk balance as determined by lower rate of death, MI, refractory ischemia, and major bleeding MICHELANGELO OASIS 5 Steering Committee. Am Heart J. 2005;150: OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Study design Patients with NSTE ACS, chest discomfort 60 y,  ST segment,  cardiac biomarkers Outcomes Primary:Efficacy Death, MI, refractory ischemia at 9 d SafetyMajor bleeding at 9 d Benefit/riskDeath, MI, refractory ischemia, major bleeding at 9 d Secondary: Primary outcomes plus each component at 30 d and 6 mo MICHELANGELO OASIS 5 Steering Committee. Am Heart J. 2005;150: ASA, clopidogrel, GP IIb/IIIa, planned cath/PCI per local practice Randomize N = 20,078 Fondaparinux 2.5 mg sc qd Enoxaparin 1 mg/kg sc bid

VBWG OASIS-5: Baseline characteristics Enoxaparin (n = 10,021) Fondaparinux (n = 10,057) Age (years)66.6 Male (%) Time from pain onset (hours)12.7 Heart rate (bpm)73.0 Systolic BP (mm Hg) Diagnosis at study entry (%) UA Suspected MI OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Medical history Enoxaparin (n = 10,021) Fondaparinux (n = 10,057) MI 25.7 PCI/CABG Stroke Heart failure Hypertension Diabetes Current/former smoker Any ECG abnormality ST  ≥1 mm % OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Concomitant in-hospital medications following randomization Enoxaparin (n = 10,021) Fondaparinux (n = 10,057) ASA97.5 Clopidogrel/ticlopidine UFH ACEI/ARB β-blocker Lipid-lowering agent % OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Treatment effect on primary efficacy outcome at 9 days Death, MI, refractory ischemia Enoxaparin Cumulative event rate Time (days) Fondaparinux HR 1.01 ( ) OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Treatment effect on primary safety outcome at 9 days HR 0.52 ( ) P < Enoxaparin Fondaparinux Time (days) 0.06 Major bleeding Cumulative event rate OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Net clinical benefit at 9 days Death, MI, refractory ischemia, major bleeding Enoxaparin Time (days) Fondaparinux HR 0.81 ( ) P < Cumulative event rate OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Primary and secondary efficacy outcomes at 9 days Prespecified noninferiority margin = P = RI = refractory ischemia Hazard ratio (95% CI) Fondaparinux better Enoxaparin better Death/MI/RI Death/MI Death MI RI Fondaparinux (n = 10,057) Enoxaparin (n = 10,021) % OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Primary and secondary efficacy outcomes at 30 days *P = 0.13 † P = 0.02 Death/MI/RI* Death/MI Death † MI RI Hazard ratio Fondaparinux (n = 10,057) Enoxaparin (n = 10,021) % Fondaparinux better Enoxaparin better OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Death, MI, refractory ischemia at 6 months Enoxaparin Fondaparinux HR 0.93 ( ) P = 0.06 Time (days) Cumulative event rate OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Net clinical benefit at 6 months Enoxaparin Time (days) Fondaparinux Death, MI, refractory ischemia, major bleeding HR 0.86 ( ) P < Cumulative event rate 0.20 OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Primary and secondary efficacy outcomes at 6 months Death/MI/RI* Death/MI † Death † MI RI Hazard ratio (95% CI) Enoxaparin (n = 10,021) % Fondaparinux better Enoxaparin better Fondaparinux (n = 10,057) *P = 0.06 † P = 0.05 OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Summary Primary outcome (death, MI, refractory ischemia) Fondaparinux was similar to enoxaparin in reducing the risk of ischemic events Primary safety outcome Rate of major bleeding was significantly lower for fondaparinux vs enoxaparin Benefit/risk assessment Rate of combined death, MI, refractory ischemia, and major bleeding was significantly lower for fondaparinux vs enoxaparin At 9 days OASIS-5 Investigators. N Engl J Med. 2006;354:

VBWG OASIS-5: Summary, cont’d Overall, durable long-term results were observed with fondaparinux vs enoxaparin; results occurred early and remained consistent through study end –Strong trend toward lower rate of death, MI, or refractory ischemia at 30 days (P = 0.13) through 6 months (P = 0.06) Net clinical benefit in favor of fondaparinux at 6 months was demonstrated by significantly lower rate of combined death, MI, refractory ischemia, major bleeding (P < 0.001) OASIS-5 Investigators. N Engl J Med. 2006;354: