SAN DIEGO — In a pooled analysis of four trials, a drug-coated balloon was safer and more effective than percutaneous transluminal angioplasty, according to data presented at TCT 2018.
The researchers pooled results from four studies of the DCB (IN.PACT Admiral, Medtronic): IN.PACT SFA, IN.PACT Japan, IN.PACT China and IN.PACT Global, resulting in an overall population of 1,837 patients treated for peripheral artery disease with the DCB and 143 patients treated with PTA.
They performed analyses on an imaging cohort of 926 patients who had the DCB and 143 who had PTA (mean age, 69 years; 69% men), and a propensity-matched cohort of 466 patients who had the DCB and 136 who had PTA (mean age, 69 years; 70% men).
“The rationale for pooling the data from all of the studies was to inform clinicians about outcomes of the IN.PACT DCB in a large, diverse population and enhance patient treatment decisions,” Cardiology Today’s Intervention Editorial Board Member Mehdi Shishehbor, DO, PhD, MPH, said during a presentation. “This large pool of data also covers a more broad spectrum of patient characteristics and lesion types that extend beyond the reach of a typical [investigational device exemption trial] single-cohort DCB analysis. A third party was used to analyze the data.”
The primary efficacy endpoints were 12-month primary patency, defined as freedom from restenosis based on duplex ultrasound-derived peak systolic velocity ratio of 2.4 or less, and freedom from clinically driven target lesion revascularization, defined as reintervention of the target lesion due to symptoms or a decline of 0.15 or 20% in ankle-brachial index. The primary safety endpoint was freedom from device- and procedure-related death at 30 days and freedom from major target limb amputation, clinically driven target vessel revascularization and thrombosis at 12 months.
In the imaging cohort, the primary efficacy endpoint was achieved in 88.8% of the DCB group vs. 53.9% of the PTA group (log-rank P < .001), whereas 12-month freedom from clinically driven TLR occurred in 94.3% of the DCB group vs. 80.2% of the PTA group (log-rank P < .001), said Shishehbor, who is professor of medicine at Case Western Reserve University School of Medicine, director of the Interventional Cardiovascular Center at University Hospitals and co-director of the Vascular Center at Harrington Heart and Vascular Institute, University Hospitals.
The primary safety endpoint was met in 94.1% of patients in the DCB group vs. 78% of those in the PTA group (P < .001), he said.
In the propensity-matched analysis, the primary efficacy outcome was met in 90.5% of the DCB group vs. 53.8% of the PTA group (log-rank P < .001), whereas 12-month freedom from clinically driven TLR occurred in 96.9% of the DCB group vs. 80.7% of the PTA group (log-rank P < .001), according to the researchers.
The primary safety endpoint occurred in 96.3% of the DCB group vs. 78.4% of the PTA group (P < .001).
In both analyses, the DCB was favored across all subgroups based on age, diabetes status, Rutherford classification, lesion length, total vs. partial occlusion, sex and stenting, Shishehbor said.
“This is the largest multiethnic, pooled, independently adjudicated drug-coated balloon series to date,” he said. “The IN.PACT Admiral DCB demonstrated superior patency and freedom from clinically driven TLR over PTA for 12 months in both the imaging and the propensity-matched analyses. Furthermore, the IN.PACT Admiral DCB continues to demonstrate a superior safety profile compared to PTA. Importantly, in multiple subgroup analyses ... the IN.PACT Admiral DCB consistently remained superior to PTA for primary patency and freedom from clinically driven TLR. We look forward to further analyses from [this] initiative.” – by Erik Swain
Shishehbor M, et al. Keynote Interventional Studies 1: Endovascular Interventions. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: The studies were funded by Medtronic. Shishehbor reports he is a consultant and adviser to Abbott Vascular, Boston Scientific, Medtronic, Philips/Spectranetics and Terumo.