In addition, rates of major adverse cardiac events (MACE) between the two groups were similar at six months:
- MACE – IN.PACT Falcon DEB 10.0%, Taxus DES 16.3%
- death – IN.PACT Falcon DEB 1.1%, Taxus DES 1.1%
- myocardial infarction (MI) – IN.PACT Falcon DEB 1.1%, Taxus DES 5.5%
- target lesion revascularization (TLR) – IN.PACT Falcon DEB 4.4%, Taxus DES 7.7%
- target vessel revascularization (TVR) – IN.PACT Falcon DEB 7.8%, Taxus DES 11.0%
Importantly for assessing the results, nearly two-thirds (64.9%) of the vessels treated in the BELLO study with Medtronic’s IN.PACT Falcon DEB were smaller than 2.25 mm in diameter, for which no DES is currently available.
The PACIFIER (Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis) study enrolled 91 patients across three hospitals in Germany. The one-year results demonstrated a statistically significant advantage in preventing the superficial femoral artery (SFA) from renarrowing when using the Medtronic IN.PACT Pacific
drug-eluting balloon versus conventional, uncoated balloons.
On the primary endpoint results of LLL at six months, there was a statistically significant difference (p = 0.0014) and exceedingly low rate (-0.01mm) of LLL associated with the use of Medtronic’s IN.PACT Pacific drug-eluting balloon compared to patients treated with an uncoated balloon (0.65mm). PACIFIER also significantly favored the IN.PACT Pacific drug-eluting balloon on a composite of death, amputation, and the need for target lesion revascularization (TLR) at one year (7.1% versus 34.9%, p=0.002).
“While preliminary drug-eluting balloon data from uncontrolled trials have been promising, the interventional community has eagerly awaited the results from a randomized trial to validate the clinical benefit of Medtronic’s IN.PACT drug-eluting balloons,” commented Michael Werk, M.D., assistant medical director for the Department of Radiology at the Martin Luther Hospital in Berlin and PI and presenter of the PACIFIER trial. “Earlier research has hypothesized that drug-eluting balloons can reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularization, and now the one-year results of PACIFIER show, in a randomized forum, to what extent these results are possible.”