One year outcome of the Thrombus Aspiration in ST- Elevation - - PowerPoint PPT Presentation

One year outcome of the Thrombus Aspiration in ST- Elevation myocardial infarction in Scandinavia (TASTE trial)

Bo Lagerqvist, MD, PhD - on behalf of the TASTE investigators

Departement of Cardiology Uppsala University Hospital Uppsala, Sweden

UCR

Uppsala Clinical Research Center

Personal disclosures in relation to the presentation: None The TASTE trial was funded by the Swedish Association of Local Authorities and Regions; The Swedish Heart-Lung Foundation, The Swedish Research Council, Landspitali University Hospital Research Fund and by unrestricted grants from Terumo Medical Corporation, Medtronic and Vascular Solutions

Background

n No previous randomized trial on thrombus

aspiration has been powered for hard endpoints

n The single center TAPAS trial reported a trend to

lower mortality with thrombus aspiration after 1 month (p=0.07) that was significant at 1 year (p=0.04).

Background

n No previous randomized trial on thrombus

aspiration has been powered for hard endpoints

n The single center TAPAS trial reported a trend to

lower mortality with thrombus aspiration after 1 month (p=0.07) that was significant at 1 year (p=0.04).

n Current ESC recommendation: class IIa with a

level of evidence B

Background

n No previous randomized trial on thrombus

aspiration has been powered for hard endpoints

n The single center TAPAS trial reported a trend to

lower mortality with thrombus aspiration after 1 month (p=0.07) that was significant at 1 year (p=0.04).

n Current ESC recommendation: class IIa with a

level of evidence B

New IIb A

Background (2)

n TASTE introduced the Registry based Randomized

Clinical Trial concept (RRCT) using online databases for randomization, case record forms and follow-up

n The primary endpoint in TASTE , all-cause mortality at

30 days, did not differ significantly between the two treatment arms

n There were numerically non-significantly lower rates

• f stent thrombosis and hospitalization due to a new

myocardial infarction

Methods (1)

n All 30 Swedish and Icelandic PCI centers together with 1

Danish PCI center

n Inclusion criteria

q STEMI and ability to provide oral consent q <24 h symptom duration q correspondence between ECG and angio findings

n Exclusion criteria

q need for emergency CABG q age <18 years q previous randomization in TASTE

n 1:1 randomization to manual thrombus aspiration and PCI vs.

PCI alone

Methods (2)

n Endorsed aspiration catheters

q Eliminate (Terumo), Export (Medtronic) and Pronto

(Vascular Solutions)

n Anticoagulation and platelet inhibition according to

current guideline recommendations

n Primary endpoint

q time to all-cause death at 30 days

n Secondary endpoints

q time to all-cause death at 1 year q time to rehospitalization for reinfarction at 30 days, 1 year q time to stent thrombosis at 30 days, 1 year

All patients with STEMI in Sweden and Iceland intended for primary or rescue PCI. N=11 724 *) Enrolled in TASTE N=7259 N=3621 assigned to thrombus aspiration N=3399 underwent thrombus aspiration N=222 underwent conventional PCI

TASTE trial enrollment flow chart

Not enrolled N=4712 N=3623 assigned to conventional PCI N=3543 underwent conventional PCI N=1169 underwent thrombus aspiration N=3445 underwent conventional PCI N=178 underwent thrombus aspiration N=3621 were followed up N=3623 were followed up N=1169 were followed up N=3543 were followed up Enrolled in Denmark N=247 Erroneous enrollments N=15 Randomized in TASTE N=7244

No patients (0) were lost to follow-up of mortality, but for the other end-points, 6 were withdrawn on their own requests.

Outline of baseline characteristics

Randomized in TASTE PCI Only Thrombus Aspiration P Value Procedure-related medication - no. (%) Acetylsalicylic acid 3542 (97.8) 3546 (97.9) 0.80 Clopidogrel/ticlopidine 2395 (66.1) 2384 (65.8) 0.77 Ticagrelor 1015 (28.0) 1050 (29.0) 0.35 Prasugrel 538 (14.8) 562 (15.5) 0.44 Heparin 3074 (84.8) 3063 (84.6) 0.70 Bivalirudin 2835 (78.3) 2874 (79.4) 0.29 Glycoprotein IIb/IIIa inhibitor 630 (17.4) 558 (15.4) 0.02 Stent no. per procedure. Mean (± SD) 1.39 (0.81) 1.35 (0.77) 0.02 Direct stenting – no. (%) 843 (23.3) 1388 (38.3) <0.001 Drug-eluting stent implantation - no. (%) 1742 (48.1) 1703 (47.0) 0.39 Stent diameter (mm). Mean (± SD) 3.1 (0.5) 3.1 (0.5) 0.12 Total stent length (mm). Mean (± SD) 28.5 (16.4) 27.7 (15.9) 0.05 Procedural success (%) 3510 (96.9) 3522 (97.3) 0.24 Procedural x-ray time, sec (median (IQR)) 540 (349-878) 625 (438-923) <0.001

Outline of post randomization characteristics

TASTE 1 year results

All-cause mortality up to 1 year

HR up to 1 year 0.94 (0.78 – 1.15), P=0.57 HR up to 30 days 0.94 (0.72 - 1.22), P=0.63

2.7 2.7

Reinfarction up to 1 year

HR up to 1 year 0.97 (0.73 – 1.28), P=0.81 HR up to 30 days 0.61 (0.34 - 1.07), P=0.09

0.7 0.9

Stent thrombosis up to 1 year

HR up to 1 year 0.84 (0.50 – 1.40), P=0.51 HR up to 30 days 0.47 (0.20 - 1.02), P=0.06

8.5% 8,0%

Death, hospitalization for MI or stent thrombosis up to 1 year

PCI PCI+TA

HR up to 30 days 0.86 (0.68 – 1.09), P=0.22 HR up to 1 year 0.94 (0.80 – 1.11), P=0.48

8.5% 8,0%

All-cause mortality at 1 year

Conclusions

n Routine manual thrombus aspiration in this large,

prospective, registry-based randomized clinical trial powered for evaluation of mortality in patients with STEMI:

q Did not reduce mortality at 1 year q Did not reduce hospitalization for MI or of stent

thrombosis at 1 year

q The results were consistent across all major

subgroups including those associated with high thrombotic risk

n Routine thrombus aspiration should not be

recommended for PCI in STEMI

n

Ole Fröbert, MD, PhD (PI)

n

Bo Lagerqvist, MD, PhD

n

Göran K. Olivecrona, MD, PhD

Participating centers

Borås Hospital, Sweden. Capio, S:t Görans Hospital, Sweden. Danderyd University Hospital, Sweden. Eskilstuna Hospital, Sweden. Falun Hospital, Sweden. Gävle Hospital, Sweden. Halmstad Hospital, Sweden. Helsingborg Hospital, Sweden. Jönköping Hospital, Sweden. Linköping University Hospital, Sweden. Lund University Hospital, Sweden. Malmö Hospital, Sweden. Kalmar Hospital, Sweden. Karlskrona Hospital, Sweden. Karlstad Hospital, Sweden.

• Michael Mæng, MD, PhD (DENMARK)
• Thórarinn Gudnason, MD, PhD (ICELAND)
• Stefan K. James, MD, PhD (chair)

Karolinska Institutet, Södersjukhuset, Sweden. Karolinska Solna and Huddinge Hospitals, Sweden. Karolinska University Hospital, Sweden. Kristianstad Hospital, Sweden. Sahlgrenska University Hospital, Gothenburg, Sweden. Skövde Hospital, Sweden. Sunderby Hospital, Sweden. Sundsvall Hospital, Sweden. Trollhättan Hospital, Sweden. Umeå University Hospital, Sweden. Uppsala Clinical research center, Sweden. Västerås Hospital, Sweden. Örebro University Hospital, Sweden. Landspitali University Hospital, Reykjavik, Iceland. Aarhus University Hospital, Denmark.

Steering committee