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TAPAS study

TAPAS study

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    • 1. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) Mortality and reinfarction at 1 year F. Zijlstra, MD PhD Thoraxcenter University Medical Center Groningen, The Netherlands FZ 2008-1
    • 2. TAPAS: Background
      • Myocardial perfusion after primary PCI determines clinical outcome
      • Embolization of atherothrombotic material plays a crucial role in microvascular obstruction and impared myocardial perfusion
      • Previous trials have shown the feasibility of thrombus aspiration during primary PCI
      FZ 2008-2
    • 3. TAPAS: Methods (1)
      • Single center, prospective, randomized
      • Consecutive patients with STEMI
      • Primary endpoint
        • Myocardial blush grade (core lab)
      • Secondary endpoints
        • ST-segment elevation resolution
        • 30 day death and death / reinfarction
        • 1-year death and death / reinfarction
      Svilaas T et al. TAPAS - study design. Am heart J 2006;151:597 - FZ 2008-3
    • 4. TAPAS: Methods (2)
      • Randomization before angiography to thrombus aspiration or conventional PCI
      • Exclusion criteria
        • Rescue PCI after thrombolysis
        • Life expectancy < 6 months
      • Standard treatment
        • Heparin, aspirin, clopidogrel, abciximab
      • Intention to treat analysis
      Svilaas T et al. TAPAS - study design. Am Heart J 2006;151:597 - FZ 2008-4
    • 5. FZ 2008-5 1071 STEMI patients randomized 535 were assigned to thrombus aspiration
      • 33 did not undergo PCI
      • 502 underwent primary PCI
        • 295 underwent TA followed by
        • direct stenting
        • 153 underwent TA with additional
          • balloon dilation
        • 54 had crossover to conventional
        • PCI
      536 were assigned to conventional PCI
      • 33 did not undergo PCI
      • 503 underwent primary PCI
        • 485 underwent balloon dilation
        • followed by stenting
        • 12 underwent conventional PCI
          • with additional TA
        • 6 had crossover to TA
      530 complete follow-up at 1 year 530 complete follow-up at 1 year
    • 6. Baseline clinical characteristics FZ 2008-6 Characteristic Thrombus aspiration N = 535 Conventional N = 536 Age, years 63 ±13 63 ±13 Male gender 68% 73% Body mass index 27 ±4 27 ±4 Hypertension 33% 37% Family history 46% 45% Diabetes 11% 13% Hypercholesterolemia 24% 27% Current smoking 46% 48% Previous MI 10% 11% Total ischemic time (min) 190 (110-270) 185 (107-263)
    • 7. Baseline angiographic characteristics FZ 2008-7 Characteristic Thrombus aspiration N = 535 Conventional N = 536 Infarct related vessel LAD 43% 43% LCX 18% 15% RCA 37% 40% Multivessel disease 66% 69% TIMI flow grade 0 or 1 55% 60% 2 19% 16% 3 26% 25% Thrombus 49% 46%
    • 8. Primary endpoint: Myocardial blush grade Svilaas T et al. NEJM 2008;358:557 - FZ 2008-8 P < 0.001 Patients (%) Thrombus aspiration Conventional PCI
    • 9. ST-segment elevation resolution Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9 Patients (%) Thrombus aspiration Conventional PCI P < 0.001
    • 10. Myocardial blush grade and death or death/reinfarction at 30-days FZ 2008-10 Myocardial blush grade P = 0.001
    • 11. TAPAS: Summary of findings at 30 days
      • Thrombus aspiration results in improved myocardial reperfusion
      • Myocardial blush grade predicts 30-day rates of death and reinfarction
      • Does improved myocardial reperfusion translate into clinical benefit at 1 year?
      FZ 2008-11 ?
    • 12. TAPAS one year outcome: Myocardial blush grade and death or death/reinfarction at 1 year FZ 2008-12 Myocardial blush grade P = 0.001
    • 13. Mortality at 1 year Log-Rank p = 0.040 *Unpublished results
    • 14. Mortality or non-fatal ReMI at 1 year Log-Rank p = 0.016 *Unpublished results
    • 15. TAPAS: Mortality and reinfarction at 1 year
      • Myocardial blush grade predicts clinical outcome at 1 year
      • Thrombus aspiration results in a lower mortality and combined mortality and non-fatal reinfarction at 1 year
      FZ 2008-15