Trial Results Often Struggle to Keep Pace With Evolving Technology

In a session devoted to issues in the analysis of clinical trials on Monday, two experts shared their perspective on how results should be interpreted when technology progresses faster than does the evidence base.

For instance, the COURAGE, FREEDOM, and SYNTAX trials all backed the notion that PCI is a less preferred therapy compared to medical therapy or surgery. Yet interventional cardiologists must reconcile these studies, published between 2007 and 2012, with the realities of clinical practice in 2015.

Keeping up the Pace

In the context of those trials, Patrick T. O’Gara, MD, of Brigham and Women’s Hospital, in Boston, Mass. stated that in the most seriously ill patients, CABG was presumed to outperform PCI.

“This is the same message we have heard for decades,” he said. He reminded attendees that in the COURAGE trial, only 31 of 1,077 patients in the PCI cohort received PCI with drug-eluting stents. Furthermore, COURAGE had no impact on clinical practice patterns across the U.S., according to O’Gara.

In modern-day practice, “we’ve gotten better at what we assess and what we can implant in the cath lab, and therefore we should think differently about the indications for revascularization,” he said. Nonetheless, O’Gara said he welcomes future discussion on how clinical practice can match the pace of technological advances. This may be enabled by shortening the delay between when trial results are presented and guideline recommendations are updated, as well as by streamlining the process in which evidence is assessed in peer-review journals.

The Clinical Angle

Ajay J. Kirtane, MD, SM, of NewYork-Presbyterian/Columbia University Medical Center, in New York, N.Y., offered the clinician’s perspective, suggesting that real-life practice has not lagged too far behind the pace of technology. Kirtane highlighted the advances made since the COURAGE, FREEDOM, and SYNTAX trials first began enrolling patients, citing the stent thrombosis rate from the SYNTAX trial and saying it “would [now] be unacceptable.” 

Today clinicians have access to newer-generation stents and better pharmacotherapy, he said, Lately, they have also made use of FFR-guided revascularization to better judge which patients should and should not be treated. “The use of FFR has gone up, certainly in the U.S. but also globally,” he said. Referencing the FAME trial, he noted that “we can stent less, but if we stent appropriately,” patients do benefit with better outcomes.

Stenting appropriately might also mean optimizing patients for PCI by way of intravascular imaging. IVUS, which has been increasingly adopted, is tied to better patient outcomes, Kirtane reported. “There’s no downside to using imaging, and there’s a margin of benefit. So why not use that for our patients?”

Kirtane emphasized a patient-centered approach to case selection, in that clinicians should “treat patients differently based on the acuity and severity of their symptoms. We should try to treat folks who will have the best outcomes,” he said, adding that the real question is how to risk-stratify more effectively.

In the end, Kirtane reasoned, “trial expertise and good clinical judgment should ideally be complementary. … [Y]ou can have all these guidelines and all these studies, but ultimately you’re treating individual patients.”

Disclosures:

• Kirtane reports receiving institutional grant/research support from Abbott Vascular, Abiomed, Boston Scientific Corporation, Eli Lilly and Company, Medtronic, St. Jude Medical and Vascular Dynamics.
• O’Gara reports no relevant conflicts of interest.