5 studies that could make a big impact on interventional cardiology

1. RENOVATE-COMPLEX PCI found intravascular imaging-guided percutaneous coronary intervention (PCI) offered better outcomes compared to angiography-guided PCI procedures. With more than 1,600 patients enrolled, the study found the number of coronary incidents that occurred after PCI procedures guided by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) was about 7.7% vs. 12.3% for angiography-guided procedures.

"It really showed a benefit for use of intracoronary imaging," Rao explained. "The use of intracoronary imaging in the U.S. is still lagging behind that of other countries. For coronary trials, it was one of the more important trials to come out of ACC."

He said SCAI has dedicated resources to help operators who want to learn more about intravascular imaging to help boost the U.S. usage rates. He said this trial should help convince more facilities to adopt it.

2. The TRILUMINATE Pivotal Trial for the Abbott TriClip examined transcatheter edge to edge repair (TEER) of the tricuspid valve to reduce or eliminate regurgitation. The device was found to be superior to the current standard of care of using medical therapy alone, and clear improvements were seen in patient quality of life. While the results did not show a major difference in mortality and heart failure hospitalizations were only slightly lower in the device group, the big takeaway was that TEER made the patients feel much bette after treatment with the TriClip.
 
"These patients have very, very poor outcomes, and we know they are at high risk for heart failure and mortality. The data is complicated and mixed, but anything that improves the quality of life in our patients is valuable," Rao said.

3. Safety and Efficacy of TEER in Degenerative Mitral Regurgitation: Analysis from the STS/ACC TVT Registry. This review of MitraClip registry data from 19,088 patients treated with TEER confirmed that the device was associated with very good outcomes.. The rate of successful repairs that reduced or eliminated MR was 89%. Successful repairs also resulted in major reductions in mortality, heart failure readmissions and in the need for reinterventions at one year.

"I think this speaks to the fact that people are selecting their patients carefully and the technology continues to mature," Rao said. 

4. Five-Year Results of COAPT showed that using TEER to treat heart failure patients with secondary mitral regurgitation continued to show better outcomes across the board, beating the previous standard of care of medications only. 

"It showed a percutaneous approach to functional MR is a really durable procedure. At the end of the day, it does appear we now have a good option," Rao said. 

5. The FLAME study compared the FlowTriever aspiration device for acute massive pulmonary embolism (PE) to anticoagualtion medication alone, showing that the device significantly reduced in-hospital adverse events and had more than a 90% reduction in high-risk PE mortality. Rao said these findings help inform treatment decisions, which are increasingly moving toward a more aggressive, interventional, catheter-based removal of clots. Cardiology is also becoming more involved at the increasing number of hospitals creating PE responses teams (PERT).

"We are sorely in need to randomized trials in this space," Rao explained. 

Dave Fornell is a digital editor with Cardiovascular Business and Radiology Business magazines. He has been covering healthcare for more than 16 years.

Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com

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