W. Schuyler Jones
SAN DIEGO — In a real-world population derived from CMS data, peripheral vascular interventions with drug-coated balloons were as safe as and possibly more effective than interventions with uncoated balloons, according to data presented at TCT 2018.
The researchers analyzed 82,906 U.S. patients who underwent peripheral vascular intervention with a DCB or uncoated balloon with or without stenting and/or atherectomy between April 2015 and December 2016.
“This is a broad opportunity to look at clinical practice in terms of safety and some effectiveness measures, and to evaluate specific things, such as where PAD care occurs, who is doing it, what are the characteristics of those patients and how do people adopt therapies,” W. Schuyler Jones, MD, interventional cardiologist and associate professor of medicine at Duke University School of Medicine and member of the Duke Clinical Research Institute, said during a presentation.
Among the cohort, 29% of patients had a DCB used in their procedure (mean age, 73 years; 54% women) and 71% had an uncoated balloon (mean age, 73 years; 53% women).
Those in the DCB group were more likely to have their procedure performed by a cardiologist than the uncoated balloon group (50.9% vs. 34.8%; P < .001), Jones said.
To balance the treatment groups, the researchers used inverse probability of treatment weighting. For example, Jones said, the weighting enabled both groups to consist of approximately 39% of patients who had their procedure performed by a cardiologist.
In an unadjusted analysis, the DCB group had a higher cumulative incidence of repeat femoropopliteal revascularization (28.9% vs. 26.8%; P < .001), but after weighting, the difference was attenuated (weighted HR = 1.03; 95% CI, 0.99-1.07).
At 1 year, compared with the uncoated balloon group, the DCB group had lower rates of all-cause mortality (12.4% vs. 17.3%; weighted HR = 0.86; 95% CI, 0.81-0.91), all-cause hospitalization (46% vs. 52.9%; weighted HR = 0.88; 95% CI, 0.85-0.9) and major lower extremity amputation (9.8% vs. 14.5%; weighted HR = 0.91; 95% CI, 0.86-0.96), Jones said.
“This is a broad look at clinical practice,” he said. “Despite this analysis, there’s a big opportunity for looking at device use in a real-world setting and how to [account for] things that matter such as anatomy and patient characteristics.”
Jones WS, et al. Keynote Interventional Studies 1: Endovascular Interventions. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Jones reports he receives research grants from AstraZeneca and Medtronic and honoraria from Bayer, Bristol-Myers Squibb and Janssen Pharmaceuticals.