Landmark Indian trial Tuxedo-2 favours Prasugrel over Ticagrelor in high-rise diabetic patients after stunting

New Orleans, Nov 10: New data from the TUXEDO-2 trial, the largest head-to-head comparison of two major anti-platelet drugs in diabetic patients undergoing percutaneous coronary intervention (PCI) in India, reveals that Prasugrel demonstrated superior outcomes compared to Ticagrelor in reducing serious adverse cardiovascular events.

The results, presented today as a Late-Breaking Clinical Trial at the American Heart Association (AHA) Scientific Sessions in New Orleans, suggest a potential shift in the clinical management of high-risk diabetic patients following the placement of drug-eluting stents.

Addressing a Clinical Consensus Gap

Dual anti-platelet therapy (DAPT), combining aspirin with a potent P2Y12 inhibitor such as Clopidogrel, Ticagrelor, or Prasugrel, is critical for preventing thrombosis after coronary stenting. While international guidelines generally recommend more potent agents (Ticagrelor or Prasugrel) over Clopidogrel in high-risk patients, the choice between Ticagrelor and Prasugrel has remained debatable, with previous trials offering conflicting evidence.

The European guidelines have leaned towards preferring Prasugrel in this context, while the American guidelines have remained silent on Prasugrel, primarily recommending Ticagrelor. In India, Ticagrelor has often been the agent of choice in the absence of firm national consensus.

TUXEDO-2 Trial Highlights Benefits for Diabetics

The TUXEDO-2 trial, led by Dr. Upendra Kaul, compared Ticagrelor and Prasugrel head-to-head in 1,800 diabetic patients across 66 Indian centres who underwent multi-vessel angioplasty. Diabetic patients are inherently at higher risk for adverse outcomes, including stent clotting.

The revealing results showed that Prasugrel showed a clear trend of lower composite endpoint of death, heart attacks, stroke, and bleeding compared to Ticagrelor.

Dr. Upendra Kaul, Principal Investigator, commented, "The TUXEDO-2 data is a crucial supplement to the existing evidence, particularly the ISAR-REACT 5 German trial, and strongly suggests that Prasugrel should be the preferred anti-platelet agent in this specific, vulnerable population of diabetic patients. We now have substantial evidence supporting the superior performance of Prasugrel in a cohort most susceptible to catastrophic thrombotic events." He also anticipates that this data will influence future clinical guidelines both nationally and internationally

The findings are particularly relevant as Prasugrel offers the added practical advantage of being a once-a-day medication, compared to Ticagrelor which must be taken twice a day, simplifying patient adherence and reducing compliance issues, which are often cited as a challenge in chronic cardiovascular care. In addition, ticagrelor has a side effect of shortness of breath in around one quarter of patients.

The TUXEDO-2 results were presented by Dr. Sripal Bangalore and Dr. Upendra Kaul at the Late-Breaking Trial session of the American Heart Association Scientific Sessions. This Research was coordinated by Batra Hospital and Medical Research centre New Delhi, with Dr Priyadarshi Arambam its Manager and Clicebo solutions Pvt Ltd as the CRO.