Patients with symptomatic femoropopliteal artery disease and complex lesions who were treated with a drug-coated balloon experienced similar outcomes with patients with standard lesions, according to results presented at the Charing Cross Symposium.
Researchers analyzed data from 281 standard-use patients (mean age, 67; 63% men) and 1,125 wider-use patients (mean age, 69; 69% men) from the IN.PACT Global Study of a DCB (IN.PACT Admiral, Medtronic).
Standard use was defined as investigational device exemption-like lesions and patients. Wider-use patients were those with complex lesions who would normally be excluded from pivotal trials.
“The most important findings were that: No. 1, the results for what we call the ‘standard use’ … came out very similar to the actual trial results,” Gary Ansel, MD, an interventional cardiologist at OhioHealth in Columbus and Cardiology Today’s Intervention Editorial Board member, said in an interview. “That reconfirms the results, that they had a really significant decrease in the need for repeat procedures as well as an improved patency. And then it also showed that for the wider use of more complex procedures, that they still had less than a 10% need for a repeat procedure.”
The primary efficacy endpoint included freedom from clinically driven target lesion revascularization at 12 months. Composite safety endpoints were freedom from procedure- and device-related mortality at 30 days and freedom from clinically driven target vessel revascularization at 12 months.
Freedom from clinically driven TLR by Kaplan-Meier analysis was achieved in 96.6% of standard-use patients and 91.7% of wider-use patients (log-rank P = .005) at 1 year. Standard-use patients exhibited lower rates of clinically driven TLR (3.4%) vs. wider-use patients (8.5%; P = .004), Ansel said during a presentation.
Most standard-use and wider-use patients achieved the primary safety endpoint (96.2% vs. 91%, respectively; P = .003). Major adverse effects, defined as a composite of death, major target limb amputation, clinically driven TVR and thrombosis, affected 13% of wider-use patients vs. 7.9% of standard-use patients (P = .026). Rate of major target limb amputation was extremely low in standard use patients (0%) and wider-use patients (0.3%; P > .999).
“When we get clinical trials, sometimes it’s such a narrow population that you don’t know if the technology is going to be worthwhile in the more everyday general population, but what this does is reconfirm that the IN.PACT Admiral drug-coated balloon shows improved benefit throughout all patients that we’ve seen that are going to get [this] intervention,” Ansel told Cardiology Today’s Intervention. – by Darlene Dobkowski
Ansel G, et al. Drug-coated balloon consensus update. Presented at: Charing Cross Symposium; April 25-28, 2017; London.
Disclosure: The study was funded by Medtronic. Ansel reports consulting for Bard, Cook Medical and Medtronic.