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Antiplatelets

Antiplatelets. Combination use of clopidogrel & aspirin. Why isn’t combination therapy suitable for everyone? Bhatt DL, et al. New Engl J Med 2006;354:1706–17 (CHARISMA). RCT in high risk primary or secondary prevention patients (n=15,603)

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Antiplatelets

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  1. Antiplatelets Combination use of clopidogrel & aspirin

  2. Why isn’t combination therapy suitable for everyone?Bhatt DL, et al. New Engl J Med 2006;354:1706–17 (CHARISMA) • RCT in high risk primary or secondary prevention patients (n=15,603) • Clopidogrel 75mg daily or placebo in addition to aspirin • Median 28 months • No benefit with clopidogrel plus aspirin on MI, stroke or CV death (primary endpoint) • ‘A total of 94 ischemic (secondary) endpoints were prevented with clopidogrel, at a cost of 93 moderate or severe bleeding events.’

  3. Combination therapy for ACS NICE. MI: secondary prevention. CG48. May 2007NICE. Unstable angina and STEMI. CG94. March2010

  4. What benefits does clopidogrel plus aspirin offer over aspirin alone in non-ST-segment-elevation ACS?The CURE Investigators. New Engl J Med 2001;345:494–502 • RCT in non-ST-segment-elevation ACS (n=12,562) • Clopidogrel (300mg loading dose, then 75mg daily) or placebo in addition to aspirin (75–325mg daily) • For every 100 people treated with clopidogrel plus aspirin instead of aspirin alone for a mean of 9 months • 2 fewer people had CV death, MI or stroke • 1 extra person had a major bleed.

  5. Placebo + aspirin CER is the event rate in the control group On average, 11 out of 100 people will have an event

  6. clopidogrel + aspirin If 100 patients are given treatment, on average, 9 will have an event. Two will be prevented from having an event by using clopidogrel

  7. Clarification over length of treatmenthttp://guidance.nice.org.uk/index.jsp?action=article&o=32888www.nice.org.uk/TA80 • ‘The Committee confirmed that the evidence supported their view that clopidogrel in combination with aspirin was both effective and cost-effective for the time span of the evidence-base’ • ‘The Committee wish to be clear that there was no intention that clinicians and funders should have flexibility in otherwise determining the period of treatment with clopidogrel to be offered to patients, except for the usual reasons of patient preference or experience including side effects and the like’ • ‘Accordingly the view of the Appraisal Committee is that the NHS in implementing the Guidance should make resources available to fund clopidogrel therapy for 12 months after the index event.’

  8. Plavix® SPCwww.emc.medicines.org.uk. Accessed 16th December 2009 • New cardiovascular events … prevented with relative risk reductions of: 22% (CI 8.6 to 33.4) during the 0–1 month study interval 32% (CI 12.8 to 46.4) during the 1–3 month study interval 4% (CI –26.9 to 26.7) during the 3–6 month study interval 6% (CI –33.5 to 34.3) during the 6–9 month study interval 14% (CI –31.6 to 44.2) during the 9–12 month study interval • ‘Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel plus [aspirin] group was not further increased, whereas the risk of haemorrhage persisted.’

  9. What about ST-segment-elevation ACS?NICE. MI: secondary prevention. CG48. May 2007

  10. Why is treatment advised for at least four weeks in ST-segment-elevation MI? • COMMIT RCT in Chinese patients (n=45,852) • Clopidogrel or placebo in addition to aspirin, mean 15 days • The combination reduced the risk of: • Death from any cause: NNT 167 • Death, MI or stroke; NNT 111 • No significant difference in major bleeding COMMIT Collaborative Group. Lancet 2005;366:1607–21 • CLARITY RCT (n=3,491) • Clopidogrel or placebo in addition to aspirin, median 4 doses • At angiography, day 8 or discharge, the combination reduced the risk of the primary outcome: NNT 15 • A composite of angiographic findings in the infarct-related artery, MI or death prior to angiography • At 30 days the combination reduced the risk of MI: NNT 56 • No significant increase in bleeding complications at any time point Sabatine MS, et al. New Engl J Med 2005;352:1179–89 (CLARITY)

  11. Coronary artery stents NICE. Coronary artery stents. TA71. October 2003 NICE. Acute coronary syndrome – prasugrel. TA182. October 2009 BMS = bare-metal stent DES = drug-eluting stent

  12. Drug-eluting stentsNICE. Drug-eluting stents. TA152. July 2008 BCIS = British Cardiovascular Intervention Society

  13. Summary of combination treatment • Non-ST-segment-elevation ACS • A combination of low-dose aspirin and clopidogrel 75mg daily is recommended • Combination treatment is continued for 12 months after the most recent acute episode of non-ST-segment-elevation ACS • ST-segment-elevation ACS • In those treated within the first 24 hours, a combination of low-dose aspirin and clopidogrel 75mg daily is recommended for at least 1 month after the most recent acute episode of ST-segment-elevation ACS • Patients undergoing coronary or carotid interventions e.g. stenting • In general, low-dose aspirin is prescribed with clopidogrel (or prasugrel▼) for up to 12 months after the procedure.

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