Uppsala Clinical Research Center UCR Uppsala Clinical Research Center Thrombus Aspiration in ST- Elevation myocardial infarction in Scandinavia (TASTE trial) Main results at 30 days Ole Fröbert, MD, PhD - on behalf of the TASTE investigators Departement of Cardiology Örebro University Hospital Sweden

Background Intracoronary thrombus aspiration may reduce distal embolization and improve reperfusion No previous randomized trial on thrombus aspiration has been powered for hard endpoints Current ESC recommendation: class IIa with a level of evidence B

/ Swedish registry data TAPAS / Swedish registry data TA+PCI (N=3 666) PCI alone (N=16 417) HR (95% CI): 1.21 (1.08-1.35) Data 2005-2009 Vlaar, P.J. et al. The Lancet 2008; 371:1915-20 Fröbert, O. et al. Int J Cardiol. 2010; 145:572-3

Methods (1) All 29 Swedish, 1 Icelandic and 1 Danish PCI center Inclusion criteria STEMI and ability to provide oral consent <24 h symptoms correspondence between ECG and angio findings Exclusion criteria need for emergency CABG age <18 years previous randomization in TASTE 1:1 randomization to manual thrombus aspiration and PCI vs. PCI alone

Methods (2) Endorsed aspiration catheters Eliminate (Terumo), Export (Medtronic) and Pronto (Vascular Solutions) Anticoagulation and platelet inhibition according to current guideline recommendations Primary endpoint time to all-cause death at 30 days Secondary endpoints time to rehospitalization with reinfarction at 30 days time to stent thrombosis at 30 days

Methods (3) TASTE introduces the Registry-based Randomized Clinical Trial (RRCT) concept Online health quality registries (SCAAR and SWEDEHEART) serve as on-line platforms for: randomization case record forms follow-up

TASTE trial enrollment flow chart Enrolled in Denmark N=247 All patients with STEMI in Sweden and Iceland undergoing primary or rescue PCI. N=11 709 *) Enrolled in TASTE N=7259 Not enrolled N=4697 Erroneous enrollments N=15 Randomized in TASTE N=7244 No patients (0) were lost to follow-up of the primary endpoint! N=3621 assigned to thrombus aspiration N=3623 assigned to conventional PCI N=3399 underwent thrombus aspiration N=222 underwent conventional PCI N=3445 underwent conventional PCI N=178 underwent thrombus aspiration N=1162 underwent thrombus aspiration N=3535 underwent conventional PCI N=3621 were followed up N=3623 were followed up N=1162 were followed up N=3535 were followed up

TASTE and previous studies

Baseline clinical characteristics

Baseline procedural characteristics

Post randomization characteristics (1)

Post randomization characteristics (2)

All-cause mortality at 30 days HR 0.94 (0.72 - 1.22), P=0.63 Per protocol analysis based on actual treatment: HR 0.88 (0.66 - 1.17), P=0.38

Reinfarction at 30 days HR 0.61 (0.34 - 1.07), P=0.09 Per protocol analysis based on actual treatment: HR 0.67 (0.36 - 1.20), P=0.19

Additional results

p

TASTE vs. TAPAS

TASTE vs. TAPAS

Conclusions This large, prospective, registry-based randomized clinical trial showed: no reduction of mortality at 30 days no significant reduction of hospitalization for MI or of stent thrombosis at 30 days no reduction of other important clinical endpoints during hospitalization Our findings leave little role for manual thrombus aspiration as a routine adjunct to PCI in STEMI

Participating centers Steering committee Stefan K. James, MD, PhD (chair) Bo Lagerqvist, MD, PhD Göran K. Olivecrona, MD, PhD Michael Mæng, MD, PhD (DENMARK) Thórarinn Gudnason, MD, PhD (ICELAND) Ole Fröbert, MD, PhD (PI) Participating centers 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. 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.