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B avarian R eperfusion A lternati V es E valuation Kastrati et al AHA 2003

B avarian R eperfusion A lternati V es E valuation Kastrati et al AHA 2003. Aim - To compare pre-treatment with reteplase and abciximab with abciximab alone on clinical outcome after PCI for STEMI Methods 253 patients randomized < 12hrs symptoms

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B avarian R eperfusion A lternati V es E valuation Kastrati et al AHA 2003

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  1. BavarianReperfusionAlternatiVes EvaluationKastrati et al AHA 2003 • Aim - To compare pre-treatment with reteplase and abciximab with abciximab alone on clinical outcome after PCI for STEMI • Methods • 253 patients randomized < 12hrs symptoms • 2 boluses of 5U reteplase + abciximab 12hr infusion or abciximab 12hr infusion alone • Almost 3/4 required transfer (mean 39km) for PCI and the rest had on-site PCI • Primary end-point - MI size assessed by SPECT 99m technecium sestamibi up to 10 days later

  2. Results

  3. Results • TIMI III flow was more frequent at the beginning of PCI with combined Rx (40% vs 18%; p<0.001) • Post PCI TIMI III flow was similar (mean ca 87%) • No difference in outcome with sub-group analysis ie. Early vs late randomization; PCI delay vs no delay; transfer vs no transfer

  4. Clinical Implications • Transfer for PCI in STEMI has been shown to be a safe strategy (PRAGUE 2, DANAMI2) • Transfer for PCI is superior to thrombolysis (PRAGUE 2, DANAMI 2, AIR-PAMI) • No convincing evidence that facilitated PCI is superior to primary PCI (ON-TIME, DANAMI2) • Modest sized trial and primary end point that would detect only large treatment benefits • Results of larger study FINESSE by 2005

  5. StrokePreventionUsing anORal ThrombinInhibitorin AtrialFibrillation VHalperin et al AHA 2003 • Hypothesis - Ximelagatran (oral direct thrombin inhibitor; 36mg bid) is as effective as warfarin in preventing thromboembolic complications in high risk patients (>75yrs, prior CVA, HF, HT) with non-valvular AF • Methods • 3922 patients randomized in a double-blind trial (true or sham INR testing). Warfarin INR 2-3 • Clinical follow-up - mean 20 months • Primary end-points - all CVAs and systemic emboli

  6. Results • No significant difference in primary event rates • 51 vs 37 events (Ximeg vs Warf) • 1.6% vs 1.2% per annum (Ximeg vs Warf) • absolute difference +0.45% per annum (95% CI 0.13-1.03%) • No significant difference in the composite of all cause mortality + primary event rates • absolute difference +0.10% per annum (95% CI 0.97-1.18%)bb

  7. Complications Elevated serum transaminase (>3x ULN) 6% vs 0.8%

  8. Clinical Implications • Has definitive non-inferiority been demonstrated in this study? • Advantages of Ximelagatran include low bleeding complications and fixed dosing without the need for titration or monitoring • Cautions include the need for monthly LFTs for the first 6 months of treatment • Studies of efficacy in other clinical indications are awaited • Cost implications require clarification

  9. REVERSingAtherosclerosisand aggressiveLipid Lowering • Aim - To compare the relative efficacy of pravastatin 40mg and atorvastatin 80mg in influencing atheroma progression • Methods - • 654 patients randomized with symptomatic CAD and LDL-C 125mg/dl to 210mg/dl • IVUS performed at 0 and 18 months in a single target coronary artery (>20% stenosis; 502 patients had 2 studies) • Primary end point - Percentage change in atheroma volume

  10. Results of IVUS assessment No difference in adverse events, liver or muscle enzymes

  11. Results of Biochemistry Atheroma progression was less with atorvastatin at all levels of LDL

  12. Clinical Implications • The first major comparison of two statin drugs and of moderate vs high intensity treatment • More aggressive statin treatment prevents progression in coronary atheroma without an excess of side effects • High dose atorvastatin reduces inflammatory markers • Impact on clinical outcome remains unclear • 4 large clinical studies underway comparing statin regimes on clinical outcome including PROVE-IT

  13. VALsartan In AcuteMyocardialINfarcTionPfeffer at al NEJM 2003;349:1893-1906 • Hypothesis - Valsartan alone or in combination with captopril will improve survival after MI • Methods - • 14,703 patients within 10 days of MI and with HF or LV dysfunction • randomized to captopril (50mg tds), valasartan (160mg bd) or both (50mg tds; 80mg bd) • Median follow-up 24.7 months • Primary end point - All-cause mortality

  14. All Cause Mortality • Valsartan 19.9% • Combination 19.3% • Captopril 19.5% Combination therapy reduced cumulative re-admission for HF and MI

  15. Adverse Events * Statistically different from the captopril group

  16. Clinical Implications • Valsartan is as effective as captopril in improving clinical outcome following MI • Combined therapy with an AII receptor antagonist and ACE inhibitor confers no advantage after MI and may lead to adverse events • Valsartan may be considered for patients who are unable to tolerate ACE inhibitors

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