Publicado no site Vascular News matéria sobre a eficácia do uso do balão farmacológico Admiral InPact em pacientes com lesões da artéria femoral superficial. Segue matéria na integra:
In.Pact Admiral drug-coated balloon outperforms standard angioplasty in landmark study
Saturday, 05 Apr 2014 13:27
Patients with peripheral arterial disease in the upper leg experienced significantly better outcomes at 12 months after treatment with the In.Pact Admiral drug-coated balloon (Medtronic) than with standard balloon angioplasty, according to a landmark clinical study reported for the first time at the Charing Cross Symposium (5–8 April, London, UK)
According to the presentation, the In.Pact SFA trial enrolled 331 subjects at 57 sites across Europe and the USA. All study subjects were randomised to treatment with the drug-coated balloon or percutaneous transluminal angioplasty (PTA). Key endpoints were:
The clinically driven target lesion revascularisation rates at 12 months were 2.4% for the drug-coated balloon group and 20.6% for the angioplasty group (p<0.001), a highly statistically significant difference. Target lesion revascularisation accounted for repeat procedures due to recurrent symptoms related to the treated lesion
Per protocol, primary patency rates were assessed at 12 months of follow-up and showed a highly statistically significant difference: 82.2% for the drug-coated balloon group and 52.4% for the angioplasty group (p<0.001). Primary patency at 360 days was also calculated by Kaplan-Meier survival estimates; at this specific time point, it was 89.8% for the balloon group and 66.8% for the angioplasty group. Primary patency means a restoration of adequate blood flow through the treated segment of the diseased artery.
The In.Pact Admiral drug-coated balloon received the CE mark in 2009 but remains an investigational medical device in the USA, where it is under review by the US Food and Drug Administration (FDA). No drug-coated balloon has currently received FDA approval.
Presented at the Charing Cross Symposium, the results of the In.Pact SFA trial are expected to be submitted to the FDA as part of the company’s application for pre-market approval of the drug-coated balloon, according to Medtronic.
“The results of this rigorously conducted, randomised, controlled trial warrant a review of current treatment guidelines for peripheral arterial disease in the lower extremities,” says the principal investigator Gunnar Tepe, chief of radiology at RoMed Klinikum in Rosenheim, Germany.
“In fact, they should lead to a reconsideration of how we treat patients with claudication, as the highest level of clinical evidence now distinguishes the In.Pact Admiral drug-coated balloon as a primary therapy for atherosclerosis in the superficial femoral artery.”
To ensure data accuracy and reliability, patency endpoints underwent evaluation by an independent imaging core lab, while all clinical events were adjudicated by an independent clinical events committee. To prevent bias, both the imaging core lab and the clinical events committee were blinded to the patients’ randomisation assignment, it says in a Medtronic release.
The vast majority (approximately 95%) of the patients had moderate or severe claudication. The remaining 5% suffered from rest pain because of more advanced arterial disease.
In addition to disease severity, other baseline characteristics—including diabetes (40.5% vs. 48.6%) and hypertension (91.4% vs. 88.3%), as well as mean lesion length (8.94 cm vs. 8.81 cm) and percent of total occlusions (25.8% vs. 19.5%)—were also similar between the two groups, with no statistically significant differences. Clinical outcomes, however, significantly favoured the drug-coated balloon group it was said in the presentation.
“Based on the addition of these compelling new data to the positive results of previous studies, we see a path to establishing a new standard of care for SFA disease with an optimized and trusted medical technology," said Tony Semedo, a senior vice president at Medtronic and president of the company’s Endovascular Therapies business. “The In.Pact Admiral has the lowest reported revascularisation rate of any medical technology for the treatment of superficial femoral arterial disease; and in this particular vessel bed, our device also has the highest reported primary patency rate, with minimal need for durable implants.”
According to Medtronic, to date, 24 clinical studies of the In.Pact Admiral involving more than 4,200 patients have been undertaken. In a press release it says: “Results presented at medical meetings and published in peer-reviewed medical journals consistently show positive patient outcomes with the novel medical device, which is coated with paclitaxel and leaves no scaffolding behind.”