Results from the multicentre, randomised, controlled BELLO and PACIFIER trials were presented on 16 May at EuroPCR 2012. Data shows statistically significant advantages of using an IN.PACT drug-eluting balloon (Medtronic) over a corresponding conventional treatment for coronary and peripheral artery disease, respectively.
Results from the BELLO trial
The physician-initiated BELLO (Balloon elution and late loss optimization) study enrolled 182 patients across 15 hospitals in Italy to evaluate the Medtronic IN.PACT Falcon drug-eluting balloon versus the Taxus drug-eluting stent (DES) from Boston Scientific for safety and effectiveness in reducing late lumen loss in small-vessel coronary artery disease.
With both devices eluting paclitaxel, the late lumen loss (LLL) rate associated with the IN.PACT Falcon drug-eluting balloon (0.09 mm ± 0.38 mm) was superior to the Taxus DES (0.30 mm ± 0.44 mm) on the primary endpoint of in-stent/in-balloon LLL at six months (p=0.001).
“The results of the BELLO study show that Medtronic’s IN.PACT Falcon drug-eluting balloon may be a viable alternative to drug-eluting stents in treating small coronary vessels that have narrowed due to atherosclerosis, in addition to vessels with in-stent restenosis,” said Antonio Colombo, Ospedale San Raffaele in Milan, co-principal investigator and presenter of the BELLO study. “Encouragingly, the angiographic findings of the independent core lab are concordant with the clinical results.”
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 revascularisation (TLR) – IN.PACT Falcon DEB 4.4%, Taxus DES 7.7%
•target vessel revascularisation (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 IN.PACT Falcon DEB were smaller than 2.25mm in diameter, for which no DES is currently available.
Results from the PACIFIER trial
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 IN.PACT Pacific drug-eluting balloon (Medtronic) 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 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 revascularisation 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 randomised trial to validate the clinical benefit of Medtronic’s IN.PACT drug-eluting balloons,” commented Michael Werk, assistant medical director, Department of Radiology, Martin Luther Hospital, Berlin, Germany and principal investigator and presenter of the PACIFIER trial. “Earlier research has hypothesised that drug-eluting balloons can reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularisation, and now the one-year results of PACIFIER show, in a randomised forum, to what extent these results are possible.”
The company announced that the global IN.PACT clinical programme will include 24 studies involving approximately 4,000 patients and 200 sites across more than 80 countries worldwide. Through these company-sponsored and physician-initiated studies, the IN.PACT drug-eluting balloons will be investigated thoroughly for the treatment of arterial disease in coronary and peripheral vessel beds.
Last month, for example, Medtronic announced the start of the IN.PACT Global SFA clinical study, an international research programme to evaluate the treatment of peripheral artery disease using the company’s IN.PACT Admiral drug-eluting balloon in up to 1,500 “real world” patients. The first patient in the study is expected to be enrolled by the end of May.
Medtronic IN.PACT drug-eluting balloons received CE mark approval in 2008 and 2009 and are available in many countries around the world. They are not commercially available in the United States.