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SWEDE HEART

Lessons from the TASTE trial. Prospective Registry based Randomized Clinical Trials (RRCT) – a new concept for clinical research. Stefan James, Uppsala University

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SWEDE HEART

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  1. Lessons from the TASTE trial Prospective Registry based Randomized Clinical Trials (RRCT) – a new concept for clinical research Stefan James, Uppsala University Ole Fröbert, Örebro University, Göran Olivecrona, Lund University, David Erlinge, Lund University, Tomas Jernberg, Karolinska Institute, Stockholm, Bertil Lindahl, Uppsala University, Lars Wallenting, Uppsala University, Bo Lagerqvist, Uppsala University Sweden SWEDE HEART

  2. Weaknesses Randomized Clinical Trials- RCT Strengths • Correctly designed studies with adequate power are gold standard • Extinguishes confounding • Expensive • Highly selected populations due to exclusion criteria • Often selected specialized study centers • Often surrogate endpoints • Long time to plan and complete • Often sponsored by industry- only studies with economic interest will be performed SWEDE HEART

  3. Thrombus aspirationin Sweden ESC guidelines SWEDE HEART

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

  5. Number of cases annually: 80 000 RIKS-HIA 73 CCU hospitals, 100% SCAAR 30 PCI hospitals, 100% Percutaneous valves 7 hospitals, 100% Heart surgery 7 hospitals, 100% Secondary prevention 65 hospitals, 85% >150 variables (Baseline data, procedural and outcome measures) At monitoring: 95-96% agreement between files and registry.

  6. SWEDE HEART RegistrybasedRandomized Trial Personal data Data entry on line by the operator Automatic linkage with population registry Clinical background and prior CV disease Automated data checks Angiographicbackground data

  7. Two questions need to be answered: Did the patient consent orally? Are inclusion and no exclusion criteria met? Did the patient consent? Are inclusion and exclusioncrieteriamet?

  8. Information for consent Did the patient consent? Are inclusion and exclusioncrieteriamet?

  9. TASTEinclusion rate Patients All primary PCI:s Randomized 7244 patients Date

  10. TASTEtrial 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 outcome! 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=1162 were followed up N=3621 were followed up N=3623 were followed up N=3535 were followed up

  11. Ongoing and planned R-RCTs DETOX-AMI DETermination of the role of OXygen in Acute Myocardial Infarction, N=7000 VALIDATE Bivalirudin versus Heparin in NST and ST- Elevation myocardial infarction in patients on modern antiplatelet therapy in SWEDEHEART, N=6000 SWEDEPADSWEdish Drug Elution trial in Peripheral Arterial Disease N=2500 Prospect II-Absorb To test if the progress of non-flow obstructing lesions with a plaque burden >70% is reduced by treatment with Absorb™ Bioresorbable Vascular Scaffold (BVS) as compared to optimal medical therapy (OMT) N=300

  12. R-RCT vs. classical RCT • RRCT • Evaluation of therapeutic options available/used in routine clinical care • New concept for clinical research • Combines the advantages of a clinical registry and randomized study • Complement to classical RCT –No substitute RCT Approval of new pharmaceutical agents and medical devices

  13. RRCT Registry based Randomized Clinical Trials • Challenges • Design – simple, one main hypothesis • Variable definitions • Randomization on-line • Data completeness • Data validity • Monitoring- limited • Primary outcome variable- defined and available • Adjudication – selected outcome variables • Work load for regular clinical staff

  14. Conclusions • Large need for randomized trials (RCT) particularly for the evaluation of strategies, devices, pharmacological therapies • Classical RCTs are often not performed in broad representative patient populations • National clinical registries have representative patient populations and networks for collaboration • Prospective Registry based Randomized Clinical Trials (RRCT) is a new opportunity for clinical research • RRCT is ideal for one clinically important hypothesis with reliable hard endpoints

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