SPAF
VTE OS prevention
*Trial terminated early for safety
ACS: acute coronary syndromes; DVT: deep vein thrombosis; OS: orthopaedic surgery; PE: pulmonary embolism; SPAF: stroke prevention in atrial fibrillation; VTE: venous thromboembolism
0.2
0.5
1
2
Favours NOAC
Favours warfarin
Ruff CT, et al. Lancet. 2014;383:955–962.
14
NOACs and secondary prevention in ACS
CV death / MI / stroke
Estimate cumulative incidence (%)
– Largely driven by the introduction of the non-vitamin K oral anticoagulants (NOACs)
• Clinical practice needs to keep up with these changes to ensure that patients continue to receive optimal anticoagulation management
1. Kakkar AK et al. PLoS ONE 2013;8:e63479.
10
The new standard: scientific evidence
VTE secondary prevention ACS secondary prevention
DVT treatment
PE treatment
2
Slide to be adapted by presenter
Disclosures
• [Presenter credentials] • [Presenter disclosures]
3
Rationale for TMiP
• The treatment landscape for thromboembolic disease has evolved rapidly in recent years
Placebo
CV death
Placebo
All-cause death
Placebo
mITT p=0.020
ITT p=0.007
mITT p=0.002
ITT p=0.005
mITT p=0.002
ITT p=0.004
Rivaroxaban
Rivaroxaban
Rivaroxaban
Months
ITT: intention to treat Prins MH et al. Thromb J 2013;11:21.
Favours enoxaparin/VKA
16
…and safety
ROCKET AF
subgroup analysis
Major bleeding Overall (n/N; %)
7
Unmet need
• What’s wrong with the old standard?
8
Warfarin is a good drug
All-cause mortality, ischaemic stroke, and intracranial bleeds in relation to use of oral anticoagulation in patients with atrial fibrillation and different combinations of stroke and bleeding risks
5
Slide to be adapted by presenter
Accreditation
• [Insert local accreditation information here, if obtained]
6
One purpose
• Better care for patients with thromboembolic disease
Remedica, London, UK November 2014
Thrombosis Management in Practice is supported by an educational grant from Bayer HealthCare
1ቤተ መጻሕፍቲ ባይዱ
Welcome
Welcome to TMiP – Thrombosis Management in Practice Thrombosis Management in Practice (TMiP) is an innovative global educational programme, designed to help healthcare professionals worldwide provide optimal management for their patients with arterial and venous thromboembolic disease
11
NOACs and acute treatment of VTE
Drug
Study
VTE recurrence active/control (%)
HR/RR (95% CI)
Major bleeding active/control (%)
HR/RR (95% CI)
CI: confidence interval; HR: hazard ratio; RR: relative risk Fontana P et al. Eur Heart J 2014 35:1836–1843.
CHA2DS2-VASc 0–2 CHA2DS2-VASc ≥3
Risk for intracranial bleeding
HAS-BLED ≥3 Proportion surviving
p<0.00001 (n=1787)
p<0.00001 (n=59,817)
HRs range from 0.26 to 0.72 OAC no OAC
13
NOACs and stroke prevention in AF
Benefits are mainly driven by a large reduction in haemorrhagic stroke.
Four novel agents vs VKA in 72,000 patients
Efficacy Ischaemic stroke Haemorrhagic stroke Myocardial infarction All-cause mortality Safety Intracranial haemorrhage Gastrointestinal bleeding
Heterogeneity p=NS for all outcomes
15
NOACs have consistent efficacy…
pooled analysis Overall Age, years
Body weight, kg
Sex Male Female Creatinine clearance, ml/min
Primary efficacy outcome; ITT population Favours rivaroxaban
• Consequence: many patients are not sufficiently anticoagulated
– Registry data show that high-risk patients are undertreated, while low-risk patients are overtreated1
Favours LMWH/VKA
LMWH: low-molecular weight heparin; UFH: unfractionated heparin; VKA: vitamin K antagonist Castellucci LA et al. JAMA 2014;312:1122–1135.
Months
Months
CV: cardiovascular; HR: hazard ratio; ITT: intention to treat; MI: myocardial infarction; mITT: modified intention to treat; NNT: number needed to treat Mega J et al. N Engl J Med 2012;366:9‒19.
Educational objectives for today
• [To be tailored subject to the specific audience] • To discuss and review management of… • Practical guidance on responsible use of the NOACs
HAS-BLED 0–2 Proportion surviving
p<0.00001 (n=43,395)
p<0.00001 (n=53,797)
Years
HR: hazard ratio; OAC: oral anticoagulation Friberg L et al. Circulation 2012;125:2298–2307.