What Interventional Trials Impact Your Practice?

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon
 - Man holding glasses

In an effort to assess which clinical trials have had the greatest impact on cath lab practices today, Cardiovascular Business polled six leading interventional cardiologists about which trials they would designate as the biggest gamechangers.


The participants are:

  • Harold L. Dauerman, MD, Director of Cardiovascular Cath Labs at the University of Vermont (UVM) in Burlington,Vt.
    Top Picks: FAME, HORIZONS-AMI, SPIRIT IV, SYNTAX
  • Stephen G. Ellis, MD, Section Head, Invasive and Interventional Cardiology at Cleveland Clinic.
    Top Picks: FAME, HORIZONS-AMI, PLATO, PARTNER, SYNTAX
  • David R. Holmes, Jr., MD, President of the American College of Cardiology; Interventional Cardiologist at Mayo Clinic in Rochester, Minn.
    Top Picks: PARTNER, PLATO, PROTECT-AF, TRITON-TIMI
  • Gregg W. Stone, MD, Director of Cardiovascular Research at New York-Presbyterian Hospital/Columbia Medical Center in New York City.
    Top Picks: FAME, HORIZONS-AMI, PLATO, PARTNER, SYNTAX
  • Christopher J. White, MD, President of the Society of Coronary Angiography Interventions; Chairman of the Department of Cardiovascular Diseases, Ochsner Health System in New Orleans.
    Top Picks: FAME, HORIZONS-AMI, PLATO, PARTNER, SYNTAX
  • Alan C. Yeung, MD, Director of Interventional Cardiology, Stanford University Medical Center in Stanford, Calif.
    Top Picks: FAME, PARTNER, RESOLUTE/ENDEAVOR, SYNTAX

Surprisingly, the selected trials focused less on stents themselves, but rather, on how physicians decide which patients and lesions are most appropriate for stenting, and which are not. The adjunctive pharmacologic approach to PCI also garnered attention, with the expanding antiplatelet choices and the confirmed bleeding reduction with bivalirudin. Of course, the potential for transcatheter aortic valve replacement (TAVR), while not currently available in U.S. cath labs, is already on the forefront of their minds as well.

FAME gets more famous

The most commonly chosen trial was FAME, which assessed 1,005 patients with multivessel coronary artery disease (CAD), who were randomized to multivessel PCI guided by fractional flow reserve (FFR), compared with PCI guided by angiography alone (N Engl J Med 2009;360:213-224). Tonino et al reported a 30 to 40 percent decrease in cardiac events, including death, MI and the need for repeat stenting or bypass surgery in the FFR arm. Also, researchers reported that patients who received the additional blood flow test received one-third fewer stents than the group examined only with an angiogram.  

White calls FAME "the biggest gamechanger," while Ellis credits the trial with "bringing physiology into the cath lab," as opposed to basing the science of interventional cardiology solely on anatomic assessment of the patient.    

Performing FFR provides "confidence in the cath lab that can appropriately inform us whether a particular lesion is significant or not," Yeung says. "Conversely, a positive stress test often doesn't tell us which lesion is most responsible."

"The use of physiology-guided stenting," says Ellis, "has become our standard for measuring indeterminate lesions or figuring out whether it's physiologically important. Sometimes that leads to intervention, sometimes not. If a physician measures FFR and wants to be aggressive, 0.8 can be the cutoff."

Interventional cardiology is in the hot seat, due to several highly publicized cases of stenting overutilization. "Our physicians are under scrutiny to ensure their procedures are appropriate in patients with stable coronary disease, and we need evidence of ischemia in either noninvasive or an invasive test to know that intervention is the appropriate pathway," Stone says.

Despite the clamoring for complete appropriate use criteria (AUC) adherence, White says that "AUC is a tool, but not a means to an end. When you attempt to codify those behaviors, it sometimes disregards good clinical judgment. AUC should be used as a measurement of variation, and physicians should not be afraid of it, but instead, use the tool to improve care.   

"As we have become more quality conscious as a specialty, we also have become more cost conscious," White says. "FAME is a cost-effective pathway to achieve the highest quality outcomes."

From an economic perspective, a FAME substudy found that the overall mean costs at one year were significantly less in the FFR-guided arm ($14,315 vs. $16,700) (Circulation 2010;122[24]:2491-2633). A bootstrap simulation indicated that the FFR-guided