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A secondary indication may be to ensure that systemic immunosuppression is safe in the face of a positive T-spot result.
Here, patients with a secondary indication showed less favourable outcome.
In order to assess whether the indication for ICD implantation had effect on the outcomes, we compared the scores on different scales of patients with a primary indication versus a secondary indication for ICD implantation.
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"It could very well be that you need to think differently about how you would create a framework around the secondary indication and the primary indication," Gottlieb said, adding that he doesn't have an answer but the agency has been asking the question.
The proportion of patients with a secondary prevention indication was 39%.
These data are, however, consistent with data from a previous retrospective study of patients undergoing ICD implantation (mainly for a secondary prevention indication) at a single centre.
Patients with a secondary prevention indication were more likely to receive appropriate ICD therapy compared with primary prevention (56 vs. 24%, P < 0.001).
Studies were excluded if: patients had experienced recent myocardial infarction or coronary revascularisation (≤45 days before enrolment); they compared device variants (eg, different pacing strategies); patients had familial cardiac conditions with a high risk of sudden cardiac death or patients had a secondary prevention indication for ICD.
"Rarely do you find a drug that fails in its primary indication and then ultimately succeeds for its secondary indication," says Sahm Adrangi, Kerrisdale's co-founder.
The secondary indication for amifostine's use (and approval) is for the cytoprotection of irradiated oral epithelium and the prevention of oral mucositis.
When combining the ToF + ICD group with the ICD group, a less favourable outcome on the UCL scale in palliative reactions was observed for patients with secondary indication for ICD.
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