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					Thrombus aspiration during primary PCI




                                              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
                                         University Medical Center Groningen                         FZ 2008-1
Thrombus aspiration during primary PCI

                                                                         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                 FZ 2008-2
Thrombus aspiration during primary PCI

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

                                                                         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

                                         University Medical Center Groningen     Svilaas T et al. TAPAS - study design. Am Heart J 2006;151:597 -
                                                                                                                                       FZ 2008-4
Thrombus aspiration during primary PCI
                                                                               1071 STEMI patients randomized




                                                    535 were assigned to                             536 were assigned to
                                                     thrombus aspiration                               conventional PCI


                                         33 did not undergo PCI                                33 did not undergo PCI
                                         502 underwent primary PCI                             503 underwent primary PCI
                                             295 underwent TA followed by                          485 underwent balloon dilation
                                                  direct stenting                                       followed by stenting
                                             153 underwent TA with additional                        12 underwent conventional PCI
                                                  balloon dilation                                      with additional TA
                                               54 had crossover to conventional                       6 had crossover to TA
                                                  PCI




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


                                         University Medical Center Groningen                                             FZ 2008-5
Thrombus aspiration during primary PCI

                                                       Baseline clinical characteristics
                                                 Characteristic                Thrombus aspiration   Conventional
                                                                                    N = 535            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)




                                         University Medical Center Groningen                                   FZ 2008-6
Thrombus aspiration during primary PCI

                                            Baseline angiographic characteristics
                                                 Characteristic                Thrombus aspiration   Conventional
                                                                                    N = 535            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%



                                         University Medical Center Groningen                                 FZ 2008-7
Thrombus aspiration during primary PCI

                                         Primary endpoint: Myocardial blush grade

                                                          60
                                                                                    P < 0.001
                                                          50                          46
                                                                                                                   41
                                           Patients (%)




                                                                  0/1
                                                          40                   37
                                                                  2
                                                                                                                                 32
                                                                  3
                                                          30                                          26

                                                          20            17

                                                          10

                                                          0
                                                                      Thrombus aspiration            Conventional PCI



                                         University Medical Center Groningen                    Svilaas T et al. NEJM 2008;358:557 - FZ 2008-8
Thrombus aspiration during primary PCI

                                                          ST-segment elevation resolution
                                                                                            P < 0.001

                                                         60                         57
                                                                  < 30%
                                                         50
                                          Patients (%)




                                                                  30-70%                                                       44
                                                                  > 70%                                          38
                                                         40
                                                                               31
                                                         30

                                                         20                                         18
                                                                      13
                                                         10

                                                         0
                                                                      Thrombus aspiration            Conventional PCI



                                         University Medical Center Groningen                  Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9
Thrombus aspiration during primary PCI

                                             Myocardial blush grade and death or
                                                death/reinfarction at 30-days
                                                                                       P = 0.001


                                            10
                                                                                                                 8,1
                                              8             Death
                                                            Death/reinfarction                            5,7
                                              6

                                                                                                 3,9
                                              4
                                                                                       2,9

                                              2                           1,6
                                                              1,1

                                              0
                                                                      3                      2              0 or 1
                                                                                 Myocardial blush grade

                                         University Medical Center Groningen                                         FZ 2008-10
Thrombus aspiration during primary PCI

                                           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
                                                                               ?      FZ 2008-11
Thrombus aspiration during primary PCI
                                          TAPAS one year outcome: Myocardial blush grade and
                                                 death or death/reinfarction at 1 year
                                                                                        P = 0.001


                                             16                                                                14,8
                                             14            Death
                                             12                                                           11
                                                           Death/reinfarction
                                             10
                                                                                                 7,6
                                               8
                                                                           6,1
                                               6                                       4,7
                                                               3,7
                                               4
                                               2

                                               0
                                                                       3                     2             0 or 1
                                                                                 Myocardial blush grade

                                         University Medical Center Groningen                                    FZ 2008-12
Thrombus aspiration during primary PCI

                                                                               Mortality at 1 year
                                                              12               Conventional PCI
                                                                               Thrombus-Aspiration
                                                              10

                                                              8
                                              Mortality (%)




                                                                                                               Log-Rank p = 0.040
                                                              6

                                                              4

                                                              2

                                                              0
                                                                   0            100         200      300                    400
                                                                                       Time (days)
                                         University Medical Center Groningen                         *Unpublished results
Thrombus aspiration during primary PCI

                                                                           Mortality or non-fatal ReMI at 1 year
                                                                           12        Conventional PCI
                                                                                     Thrombus-Aspiration
                                               Death or Reinfarction (%)

                                                                           10                                           Log-Rank p = 0.016

                                                                            8

                                                                            6

                                                                            4

                                                                            2

                                                                            0
                                                                                0    100           200       300                  400
                                                                                             Time (days)   *Unpublished results
                                         University Medical Center Groningen
Thrombus aspiration during primary PCI

                                          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




                                         University Medical Center Groningen      FZ 2008-15

				
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