In a significant leap for cardiology, Dr. Elvin Kedhi, Professor, Â鶹AV Department of Medicine, has led a groundbreaking study, recently in The Lancet, that challenges longstanding treatment guidelines for severe aortic stenosis and complex coronary artery disease. The study, known as the TCW trial, explored a less-invasive alternative to traditional open-heart surgery and has already sparked a global conversation.
The study focuses on patients over 70 dealing with two major heart issues:
- Severe aortic stenosis: A narrowing of the heart’s aortic valve that restricts blood flow.
- Complex coronary artery disease: Blockages in multiple heart arteries that disrupt blood supply to the heart muscle.
Traditionally, these conditions are treated with surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) - a combination that can pose significant risks for older, frailer patients. Dr. Kedhi’s research explored a cutting-edge alternative: transcatheter aortic valve implantation (TAVI) combined with fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI).
“Previous studies showed TAVI was as good as or better than surgery for valve replacement, and FFR-guided PCI reduces unnecessary interventions by focusing only on arteries that truly need fixing,” explained Dr. Kedhi. “Putting these two minimally invasive approaches together made sense, especially given the risks of combining SAVR and CABG.”
A Closer Look at the Trial
The trial planned to enroll 340 patients but was forced to be stopped after 50% of enrollment due to significant differences between arms. A total of 172 patients from across Europe were randomly assigned to one of two groups:
- TAVI + FFR-guided PCI: The less-invasive approach.
- SAVR + CABG: The traditional surgical method.
The researchers monitored the patients for a year, tracking key outcomes like death, heart attacks, strokes and severe bleeding.
The Results
The findings were striking:
- Zero deaths occurred in the TAVI + PCI group, compared to a 10% mortality rate in the surgery group.
- Life-threatening bleeding was far less common in the less-invasive group (2% vs. 12%).
- Recovery times were shorter, with hospital stays averaging 7 days for TAVI + PCI patients versus 10 days for surgery patients.
“We expected good results, but we didn’t anticipate needing to stop the trial early due to the significant mortality differences,” said Dr. Kedhi. “It was clear we were onto something transformative.”
Why This Matters
Current guidelines still recommend the surgical approach, despite little evidence supporting it. “This has always been a topic of debate in heart teams,” Dr. Kedhi noted. “Our trial is the first to provide concrete, randomized evidence that less-invasive methods can achieve better outcomes.”
The study’s implications extend beyond patient care - it challenges the medical community to rethink long-standing practices. However, Dr. Kedhi stressed that surgery remains a valid option for younger patients or those with particularly complex coronary anatomy.
Overcoming Challenges
The road to these findings wasn’t easy. Recruiting patients for such a trial, especially during the COVID-19 pandemic, was a significant challenge. Many patients opted out of the trial upon hearing about the less-invasive option and chose TAVI + PCI outright. “Coordinating across multiple European centers and different specialities as well as restarting the trial after COVID required tremendous effort,” said Dr. Kedhi. “I am deeply grateful to my colleagues for their dedication.”
What’s Next?
While the results are promising, larger studies are needed to corroborate these findings and explore unanswered questions, such as the long-term benefits of this approach or the need for coronary revascularization in patients with aortic stenosis. Dr. Kedhi is optimistic about future research but acknowledges the challenges of securing funding for international trials.
“This trial is just the beginning,” he said. “We’ve already inspired further studies and I believe this approach will pave the way for safer, more effective heart care.”