Data presented at the Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany) show the reduction in target lesion revascularisation and major adverse events observed with In.Pact Pacific drug-coated balloon (Medtronic) in the PACIFIER study is sustained at two years.
Study presenter Michael Werk (Department of Radiology of the Martin-Luteher-Hospital, Hubertus-Hospital, Berlin, Germany) reported that the PACIFIER study was a proof-of-concept trial that was designed to demonstrate the efficacy of In.Pact Pacific drug-coated balloon in reducing restenosis of femoropopliteal stenosis and occlusions compared with standard percutaneous transluminal angioplasty (PTA; uncoated balloons). He added that it was an investigator initiated, multicentre study in which patients were randomised in a one-to-one fashion to receive the In.Pact Pacific balloon (41 patients; 44 lesions) or standard PTA (44 patients; 47 lesions), commenting: “The primary endpoint was six-month late lumen loss.”
At six months, the late lumen loss was -0.01mm in the drug-coated balloon arm and 0.65mm in the standard PTA arm (p=0.0014). Werk commented: “The significant reduction of late lumen loss was maintained in the three subgroups: restenotic vs. de novo lesions; total occlusions vs. stenoses; and long vs. short lesions.” Furthermore, there were three cases of target lesion revascularisation reported with the In.Pact Pacific balloon at six months but 10 reported for standard PTA; also while there were no further cases of target lesion revascularisation reported for the device at the 12-month follow-up point, five additional cases were reported for standard PTA.
However at two years, the rate of freedom from target lesion revascularisation was not significantly different between the two groups—84.7% for the In.Pact Pacific balloon vs. 68.7% for standard PTA (p=0.0689). Werk said: “The study was designed as a proof-of-concept, which meant that patients in the standard PTA arm who required re-intervention were able to receive the In.Pact Pacific balloon. This made proving increased efficacy with the device at two years difficult; therefore, this may be why the two-year result just missed significance.”
He concluded: “A sustained reduction in major adverse events and target lesion revascularisation was observed with the In.Pact Pacific balloon vs. standard PTA at two years. The rates of 16.7% target lesion revascularisation with the In.Pact Pacific balloon are consistent with previously reported literature for drug-coated balloon outcomes at two years. Perhaps most important of all, there were no coated-related adverse events noted.”