University Medical Center Groningen

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FZ 2008-1

Thrombus Aspiration during Percutaneous coronary intervention in

Acute myocardial infarction Study (TAPAS)

Mortality and reinfarction at 1 year

F. Zijlstra, MD PhDThoraxcenter

University Medical Center Groningen,The Netherlands

University Medical Center Groningen

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FZ 2008-2

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

University Medical Center Groningen

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Svilaas T et al. TAPAS - study design. Am heart J 2006;151:597 - FZ 2008-3

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

University Medical Center Groningen

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Svilaas T et al. TAPAS - study design. Am Heart J 2006;151:597 - FZ 2008-4

TAPAS: Methods (2)

• Randomization before angiography to thrombus aspiration or conventional PCI

• Exclusion criteriaRescue PCI after thrombolysisLife expectancy < 6 months

• Standard treatmentHeparin, aspirin, clopidogrel, abciximab

• Intention to treat analysis

University Medical Center Groningen

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FZ 2008-5

1071 STEMI patients randomized

535 were assigned tothrombus aspiration

33 did not undergo PCI502 underwent primary PCI

295 underwent TA followed bydirect stenting

153 underwent TA with additionalballoon dilation

54 had crossover to conventionalPCI

536 were assigned toconventional PCI

33 did not undergo PCI503 underwent primary PCI

485 underwent balloon dilationfollowed by stenting

12 underwent conventional PCIwith additional TA

6 had crossover to TA

530 complete follow-up at 1 year530 complete follow-up at 1 year

University Medical Center Groningen

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FZ 2008-6

Baseline clinical characteristics

Characteristic Thrombus aspirationN = 535

ConventionalN = 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)

University Medical Center Groningen

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FZ 2008-7

Baseline angiographic characteristics

Characteristic Thrombus aspirationN = 535

ConventionalN = 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%

University Medical Center Groningen

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Svilaas T et al. NEJM 2008;358:557 - FZ 2008-8

Primary endpoint: Myocardial blush grade

3741

46

32

26

17

0

10

20

30

40

50

60

0/123

P < 0.001

Pati

ents

(%

)

Thrombus aspiration Conventional PCI

University Medical Center Groningen

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Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9

ST-segment elevation resolution

1318

31

38

57

44

0

10

20

30

40

50

60< 30%

30-70%

> 70%

Pati

ents

(%

)

Thrombus aspiration Conventional PCI

P < 0.001

University Medical Center Groningen

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FZ 2008-10

Myocardial blush grade and death or death/reinfarction at 30-days

1,1

2,9

5,7

1,6

3,9

8,1

0

2

4

6

8

10

3 2 0 or 1

Death

Death/reinfarction

Myocardial blush grade

P = 0.001

University Medical Center Groningen

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FZ 2008-11

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?

?

University Medical Center Groningen

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FZ 2008-12

TAPAS one year outcome: Myocardial blush grade and death or death/reinfarction at 1 year

3,74,7

11

6,17,6

14,8

0

2

4

6

8

10

12

14

16

3 2 0 or 1

Death

Death/reinfarction

Myocardial blush grade

P = 0.001

University Medical Center Groningen

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Mortality at 1 year

Log-Rank p = 0.040

*Unpublished results

University Medical Center Groningen

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Mortality or non-fatal ReMI at 1 year

Log-Rank p = 0.016

*Unpublished results

University Medical Center Groningen

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FZ 2008-15

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