The IN.PACT Admiral drug-coated balloon (DCB) provides superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease in the superficial femoral arteries and/or popliteal arteries.
These results come from new two-year clinical data from the IN.PACT SFA trial. This data was presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) conference and also published simultaneously in the Journal of the American College of Cardiology (JACC).
This announcement follows the one-year results from the IN.PACT SFA Trial where the IN.PACT Admiral DCB resulted in highest rate of primary patency and the lowest rate of clinically-driven target lesion revascularisation at 12 months in a pivotal study of interventional treatments for peripheral arterial disease.
“The IN.PACT Admiral DCB has produced consistently strong clinical results over the longer-term. At two years, the IN.PACT Admiral DCB showed strong patency and very low target lesion revascularisation rates,” says John Laird, interventional cardiologist at UC Davis Medical Center, co-principal investigator for the IN.PACT SFA Trial and first author of the published results in JACC.
The IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the United States with a mean lesion length of 8.9cm±4.96cm. All study subjects were randomised to treatment with either the IN.PACT Admiral DCB or standard balloon angioplasty.
Two-year outcomes revealed the following:
· The DCB group showed the lowest reported clinically-driven target lesion revascularisation (CD-TLR) rate at two years, with 9.1% of patients requiring a repeat procedure, compared to 28.3% of patients in the PTA group (p<0.001).
· The data also showed a primary patency rate or restoration of blood flow through the treated artery of 78.9% in the DCB group, compared to 50.1% in the PTA group (p<0.001). Results are based on Kaplan-Meier survival estimates for primary patency at two years.
· The data continue to support an exceptional safety profile, with no major target limb amputations in either group (p>0.999) and low blood clot (thrombosis) rates of 1.5% in the DCB group, compared to 3.8% in the PTA group (p=0.243).
Michael R. Jaff, Paul and Phyllis Fireman chair in vascular medicine at the Massachusetts General Hospital, medical director of VasCore, the Vascular Ultrasound Core Laboratory, professor of medicine at Harvard Medical School and senior author of the published results in JACC says, “The consistency and durability of the DCB, combined with the benefit of not leaving a stent in the artery, make this a significant option for treating SFA disease.”
In a subgroup analysis from the In.pact SFA trial, two-year results also showed clinical superiority and consistency across various patient types that have been proven difficult to treat based on historical data, including people with diabetes and the female population.
For people with diabetes, the DCB group showed a higher restored blood flow rate of 73.3%, compared to 45.8% in the PTA group (p<0.001). In an evaluation of the female population, the DCB group showed a restored blood flow rate of 76.7%, versus 42.3% in the PTA group (p<0.001).
New two-year health economic data from the IN.PACT SFA trial U.S. cohort and one-year data from the In.pact Global Study in-stent restenosis (ISR) cohort are forthcoming and will be presented at the Vascular Interventional Advances (VIVA) 2015 conference on Monday, November 2.