Davide Capodanno: The Key Point Behind TUXEDO-2
Davide Capodanno, Full Professor of Cardiology at the University of Catania, shared a post on LinkedIn about a recent article by Sripal Bangalore et al, published in Jama Network:
“TUXEDO-2, in plain terms. The trial was designed to test non-inferiority of ticagrelor vs prasugrel in patients with diabetes and multivessel disease, using a composite endpoint mixing ischemic and bleeding events. The NI margin was 5%, but the 95% CI of the difference ranged from minus 2.07% to plus 6.74%.
To me, this is an inconclusive result: it cannot confidently rule out benefit or harm. Still, I’m comfortable with the authors’ and the journal’s conclusion-ticagrelor did not meet non-inferiority, seemingly due to numerical increases in both ischemic and bleeding events.
This is now the second trial suggesting that the two drugs are not exactly on the same level. Ticagrelor was not superior to prasugrel in ISAR-REACT 5, and it was not non-inferior in TUXEDO-2. This may sound like nuance, but it’s actually the key point.
In both trials, ticagrelor was the one being tested against prasugrel, not the other way around. The burden of proof was on ticagrelor-and it didn’t quite carry it. With the comparison reversed, and given these statistical designs and endpoints, results might have been the same, or maybe not.
Add to this that one trial was in ACS and the other not strictly so, and the picture becomes even more blurred.
Bottom line: we really need a patient-level meta-analysis. A study-level one would probably just add another layer of confusion.”
Title: Ticagrelor vs Prasugrel in Patients With Diabetes and Multivessel Coronary Artery Disease
Authors: Sripal Bangalore, Santosh Kumar Sinha, Rakendra Singh, Ashok Kumar Parida, Rohit Mody, Rajpal Abhaichand, Darshan Banker, Aziz Khan, Arun Kalyansundaram, Nagaraja Moorthy, Kunal Mahajan, Bishav Mohan, Bhaveesh Meel, Rajpal Singh, Sanjay Porwal, Ajit Bhagwat, Charantharayail Gopalan Bahuleyan, Deepak Davidson, Sudheer Koganti, Sunil Kumar Garsa, Prafulla Kerkar, Gopala Krishna Koduru, Madhu Sreedharan, Prashant Jagtap, G Manohar, Santosh Kumar, Priyadarshini Arambam, Nagma Khan, Varsha Koul, Krishnankutty Sudhir, Upendra Kaul
Read the Full Article on Jama Network.
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