Lessons from the TA TASTE STE trial Prospective Registry based - - PowerPoint PPT Presentation

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Lessons from the TA TASTE STE trial Prospective Registry based - - PowerPoint PPT Presentation

Aug 06, 2023 625 likes •780 views

Lessons from the TA TASTE STE trial Prospective Registry based Randomized Clinical Trials (RRCT) a new concept for clinical research Stefan James, Uppsala University Ole Frbert, rebro University, Gran Olivecrona, Lund University,

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SWEDE HEART

Prospective Registry based Randomized Clinical Trials (RRCT) – a new concept for clinical research

Lessons from the TA

TASTE STE trial

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

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Weaknesses 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

Randomized Clinical Trials- RCT

SWEDE HEART

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Thrombus aspiration in Sweden

ESC guidelines SWEDE HEART

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Vlaar, P.J. et al. The Lancet 2008; 371:1915-20

TAPAS

Fröbert, O. et al. Int J Cardiol. 2010; 145:572-3 HR (95% CI): 1.21 (1.08-1.35)

/ Swedish registry data

PCI alone (N=16 417) TA+PCI (N=3 666)

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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.

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SWEDE HEART

Data entry on line by the

  • perator

Registry based Randomized Trial

Automatic linkage with population registry Automated data checks

Clinical background and prior CV disease Personal data Angiographic background data

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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 exclusion crieteria met?

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Information for consent

Did the patient consent? Are inclusion and exclusion crieteria met?

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Randomized All primary PCI:s 7244 patients

TA TAST STE inclusion rate

Date Patients

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All patients with STEMI in Sweden and Iceland undergoing primary or rescue PCI. N=11 709 *) Enrolled in TASTE TE N=7259 N=3621 assigned to thrombus aspiration N=3399 underwent thrombus aspiration N=222 underwent conventional PCI

TASTE TE trial enrollment flow chart

Not enrolled N=4697 N=3623 assigned to conventional PCI N=3535 underwent conventional PCI N=1162 underwent thrombus aspiration N=3445 underwent conventional PCI N=178 underwent thrombus aspiration N=3621 were followed up N=3623 were followed up N=1162 were followed up N=3535 were followed up Enrolled in Denmark N=247 Erroneous enrollments N=15 Randomized in TASTE TE N=7244

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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

SWEDEPAD

SWEdish 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

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  • New concept for clinical research
  • Combines the advantages of a clinical registry and

randomized study

  • Complement to classical RCT –No substitute

R-RCT vs. classical RCT

RRCT Evaluation of therapeutic

  • ptions available/used in

routine clinical care RCT Approval of new pharmaceutical agents and medical devices

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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
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  • 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

Conclusions