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Randomized Controlled Trial

Randomized Controlled Trial

YUKON Choice PC has undergone robust randomized Controlled trials to prove its efficacy and safety. ISAR Test 4 is the first prospective, randomized trial which compare 3 DES for their efficacy and safety. YUKON choice PC, Cypher and Xience are compared head to head in an all-comer population. In ISAR TEST -4, YUKON has shown non-inferiority to Xience and Cypher in a prospective randomized trial in over 2600 patients done in Europe.

Randomised controlled trials are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. They have several important features:

  • Random allocation to intervention groups
  • Patients and trialists should remain unaware of which treatment was given until the study is completed-although such double blind studies are not always feasible or appropriate
  • All intervention groups are treated identically except for the experimental treatment
  • Patients are normally analysed within the group to which they were allocated, irrespective of whether they experienced the intended intervention (intention to treat analysis)
  • The analysis is focused on estimating the size of the difference in predefined outcomes between intervention groups.

Other study designs, including non-randomised controlled trials, can detect associations between an intervention and an outcome. But they cannot rule out the possibility that the association was caused by a third factor linked to both intervention and outcome. Random allocation ensures no systematic differences between intervention groups in factors, known and unknown, that may affect outcome. Double blinding ensures that the preconceived views of subjects and clinicians cannot systematically bias the assessment of outcomes. Intention to treat analysis maintains the advantages of random allocation, which may be lost if subjects are excluded from analysis through, for example, withdrawal or failure to comply. Meta-analysis of controlled trials shows that failure to conceal random allocation and the absence of double blinding yield exaggerated estimates of treatment effects.

 


 

Randomised Trials


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