UCR Uppsala Clinical Research Center 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 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). New IIb n Current ESC recommendation: class IIa with a A level of evidence B
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 of 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
TASTE trial enrollment flow chart Enrolled in Denmark All patients with STEMI in Sweden and Iceland intended for N=247 primary or rescue PCI. N=11 724 * ) Enrolled in TASTE Not enrolled N=7259 N=4712 Erroneous enrollments N=15 No patients (0) were lost to follow-up of mortality, but for the other end-points, 6 were Randomized in TASTE N=7244 N=3621 assigned N=3623 assigned withdrawn on their own requests. to thrombus aspiration to conventional PCI N=3399 underwent N=3445 underwent N=1169 underwent N=3543 underwent thrombus aspiration conventional PCI thrombus aspiration conventional PCI N=222 underwent N=178 underwent conventional PCI thrombus aspiration N=3621 were N=3623 were N=1169 were N=3543 were followed up followed up followed up followed up
Outline of baseline characteristics
Outline of post randomization characteristics Randomized in TASTE Thrombus PCI Only P Value Aspiration 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
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
Reinfarction up to 1 year 2.7 2.7 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
Stent thrombosis up to 1 year 0.9 0.7 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
Death, hospitalization for MI or stent thrombosis up to 1 year 8.5% 8.5% PCI 8,0% 8,0% HR up to 1 year 0.94 (0.80 – 1.11), P=0.48 PCI+TA HR up to 30 days 0.86 (0.68 – 1.09), P=0.22
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
Steering committee • Michael Mæng, MD, PhD (DENMARK) Ole Fröbert, MD, PhD (PI) n • Thórarinn Gudnason, MD, PhD (ICELAND) Bo Lagerqvist, MD, PhD n • Stefan K. James, MD, PhD (chair) Göran K. Olivecrona, MD, PhD n Participating centers Karolinska Institutet, Södersjukhuset, Sweden. Borås Hospital, Sweden. Karolinska Solna and Huddinge Hospitals, Sweden. Capio, S:t Görans Hospital, Sweden. Karolinska University Hospital, Sweden. Danderyd University Hospital, Sweden. Kristianstad Hospital, Sweden. Eskilstuna Hospital, Sweden. Sahlgrenska University Hospital, Gothenburg, Sweden. Falun Hospital, Sweden. Skövde Hospital, Sweden. Gävle Hospital, Sweden. Sunderby Hospital, Sweden. Halmstad Hospital, Sweden. Sundsvall Hospital, Sweden. Helsingborg Hospital, Sweden. Trollhättan Hospital, Sweden. Jönköping Hospital, Sweden. Umeå University Hospital, Sweden. Linköping University Hospital, Sweden. Uppsala Clinical research center, Sweden. Lund University Hospital, Sweden. Västerås Hospital, Sweden. Malmö Hospital, Sweden. Örebro University Hospital, Sweden. Kalmar Hospital, Sweden. Karlskrona Hospital, Sweden. Landspitali University Hospital, Reykjavik, Iceland. Karlstad Hospital, Sweden. Aarhus University Hospital, Denmark.
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