Yet another great trial by the Kings College group. This along with the initial Orbita should set the new bar for proper sham placebo control for all device trials.
This trial confirms the long-held belief that PCI “works” for symptoms. However, I disagree with some who have interpreted this trial to suggest PCI should become the first option for angina control. Combined with Orbita 1, it could perhaps be argued that PCI offers benefit to Med naive patients but may offer less benefit to Med refractory patients. While I think this is a defensible position, I would not move to a default strategy of PCI for symptom control on the basis of such a short follow up study.
Statistical calculations for this were not provided by the authors. The trial was not powered to detect differences in the rates of acute coronary syndrome or stroke and we recommend caution when interpreting these results.
Please refer to other trials that were powered for hard endpoints like ISCHEMIA, ISCHEMIA-CKD etc.
This trial was designed and powered to assess symptoms.
Numerous trials assessed hard outcomes; see COURAGE, FAME 2, ISCHEMIA and ISCHEMIA-CKD. In brief, percutaneous coronary intervention in stable coronary artery disease did not reduce mortality or myocardial infarction
Got it - thank you. I guess I thought it counter-intuitive that symptom relief would yield no benefit in hard outcomes (as measured by the other trials). But of course that is possible and meaningful nonetheless. Thanks again for your work
Yet another great trial by the Kings College group. This along with the initial Orbita should set the new bar for proper sham placebo control for all device trials.
This trial confirms the long-held belief that PCI “works” for symptoms. However, I disagree with some who have interpreted this trial to suggest PCI should become the first option for angina control. Combined with Orbita 1, it could perhaps be argued that PCI offers benefit to Med naive patients but may offer less benefit to Med refractory patients. While I think this is a defensible position, I would not move to a default strategy of PCI for symptom control on the basis of such a short follow up study.
It would be interesting to see if there’s any relevance to the 2 strokes in the PCI arm vs 0 in the placebo arm…
Statistical calculations for this were not provided by the authors. The trial was not powered to detect differences in the rates of acute coronary syndrome or stroke and we recommend caution when interpreting these results.
Please refer to other trials that were powered for hard endpoints like ISCHEMIA, ISCHEMIA-CKD etc.
symptom relief but not improved outcomes? I guess that can be... thank you
This trial was designed and powered to assess symptoms.
Numerous trials assessed hard outcomes; see COURAGE, FAME 2, ISCHEMIA and ISCHEMIA-CKD. In brief, percutaneous coronary intervention in stable coronary artery disease did not reduce mortality or myocardial infarction
Got it - thank you. I guess I thought it counter-intuitive that symptom relief would yield no benefit in hard outcomes (as measured by the other trials). But of course that is possible and meaningful nonetheless. Thanks again for your work