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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
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
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
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
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
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)
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%
Primary endpoint: Myocardial blush grade Svilaas T et al. NEJM 2008;358:557 - FZ 2008-8 P < 0.001  Patients (%) Thrombus aspiration Conventional PCI
ST-segment elevation resolution Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9 Patients (%) Thrombus aspiration Conventional PCI P < 0.001
Myocardial blush grade and death or death/reinfarction at 30-days FZ 2008-10 Myocardial blush grade P = 0.001
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 ?
TAPAS one year outcome: Myocardial blush grade and death or death/reinfarction at 1 year FZ 2008-12 Myocardial blush grade P = 0.001
Mortality at 1 year Log-Rank p = 0.040 *Unpublished results
Mortality or non-fatal ReMI at 1 year Log-Rank p = 0.016 *Unpublished results
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

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Zilstra Tapas Slides

  • 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