f. zijlstra, md phd thoraxcenter university medical center groningen, the netherlands
DESCRIPTION
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. Presenter Disclosure Information. - PowerPoint PPT PresentationTRANSCRIPT
FZ 2008-1University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
Presenter Disclosure Information
Disclosure Information…The following relationships exist related to this presentation:
Tone Svilaas No disclosures
Pieter J. Vlaar No disclosures
Iwan C. van der Horst No disclosures
Gilles F.H. Diercks No disclosures
Bart J.G.L. de Smet No disclosures
Ad F.M. van den Heuvel No disclosures
Rutger L. Anthonio No disclosures
Gillian A. Jessurun No disclosures
Eng-Shiong Tan No disclosures
Albert J.H. Suurmeijer No disclosures
Felix Zijlstra No disclosures
FZ 2008-2University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
Svilaas T et al. TAPAS - study design. Am heart J 2006;151:597 - FZ 2008-3
University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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 2008-4
University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
FZ 2008-5University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
FZ 2008-6University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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)
FZ 2008-7University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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%
Svilaas T et al. NEJM 2008;358:557 - FZ 2008-8University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
FZ 2008-10University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
FZ 2008-11University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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 2008-12University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
Mortality at 1 year
Log-Rank p = 0.040
*Unpublished results
University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
Mortality or non-fatal ReMI at 1 year
Log-Rank p = 0.016
*Unpublished results
FZ 2008-15University Medical Center Groningen
Thr
ombu
s as
pira
tion
durin
g pr
imar
y P
CI
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