The first-ever presentation of 12-month data from the randomised multicentre IN.PACT SFA trial revealed that treatment with the IN.PACT Admiral drug-eluting balloon (Medtronic) was significantly superior to percutaneous transluminal angioplasty in terms of reinterventions and patency. The results were presented at the Charing Cross Symposium 2014 (5–8 April 2014, London, UK).
The randomised controlled IN.PACT SFA trial results showed that clinically-driven target lesion revascularisation rates were significantly lower with the drug-eluting balloon as compared to those achieved with angioplasty (2.4% vs. 20.6%, p<0.001). Similarly, the primary patency rate achieved with IN.PACT Admiral was 82.2%, while the primary patency achieved with angioplasty was 52.45% (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 drug-eluting balloon group and 66.8% for the angioplasty group.
According to Gunnar Tepe, Rosenheim, Germany, who presented the 12-month results of the trial, there is robust level 1 evidence to show that the IN.PACT Admiral drug-eluting balloon has achieved the lowest target lesion revascularisation and highest patency rates ever reported with an endovascular therapy in the superficial femoral artery.
An analysis of weighted average clinically-driven target lesion revascularisation rates at 12 months showed a lower reintervention rate with the Admiral drug-eluting balloon (2.4%) than with any other technology: 26.4% for percutaneous transluminal angioplasty, 14.3% for bare metal stents and 10.2% with drug-eluting stents.
“The results of this rigorously conducted randomised controlled trial warrant a review of current treatment guidelines for peripheral artery disease in the lower extremities,” said Tepe, who is the trial’s principal investigator. “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.”
The IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the USA and patients were randomised to either receive treatment with a drug-eluting balloon or percutaneous transluminal angioplasty. 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.
The two cohorts were well-matched with regard to baseline patient demographics. Nearly all of the patients had moderate or severe claudication and approximately 5% suffered from rest pain because of more advanced disease. Other baseline characteristics including diabetes (40.5% vs. 48.6%) and hypertension (91.4% vs. 88.3%), as well as mean lesion length (8.94cm vs. 8.81cm) and percentage of total occlusions (25.8% vs. 19.5%) were also similar between the two groups.
The IN.PACT Admiral drug-coated balloon received the CE mark in 2009 but remains an investigational medical device in the United States, where it is under review by the FDA.
Audience recognises the impact of drug-eluting balloons
Following the presentation of the IN.PACT SFA data, the voting results at the Charing Cross Symposium 2014 captured a powerful shift in audience perception regarding the value of drug-eluting balloons in peripheral arterial disease. While just two years ago, a poll identified that 27% viewed drug-eluting balloons as an alternative to stents, in 2014, 72% now do so.
Voting questions from previous years were presented again this year, in order to assess the clinical views of audience members with regard to drug-eluting balloons. The results then captured the data on the year-on-year shift in perception towards these devices, and indeed the phenomenon of drug elution itself. The audience response polls revealed that nearly 90% voted that drug-elution was worthwhile in the superficial femoral artery. Last year, just 57% cast their vote stating that drug-elution was worthwhile in this anatomical region.
Roger Greenhalgh, London, UK and chairman of the symposium, noted that the voting trends likely reflected the multidisciplinary nature of the meeting itself as the audience members and faculty are composed of the leading vascular surgeons, interventional radiologists and interventional cardiologists.
Two years ago, when delegates at Charing Cross 2012 were asked what the role for drug-eluting balloons was, 27% voted that they were an alternative to stents; 33% voted that they should be used for in-stent restenosis; 19% voted that they should be used as a last resort and 21% voted that they had no role. Now in 2014, 72% voted that drug-eluting balloons are an alternative to stents; 21% voted that they should be used for in-stent restenosis; 3% believed that they should be used as a last resort and 4% voted that they had no role at all.
There was a similar swing in opinion regarding the cost-effectiveness of drug-eluting balloons. In 2011, 75% of voters stated that they did not find drug elution cost-effective in the superficial femoral artery and only 25% voted that they did. Yet in 2014, 67% said, yes, drug elution is cost-effective in the superficial femoral artery and 33% said it was not.
The voting also revealed a sharp shift seen in favour of drug-eluting balloons from last year. In 2013, 57% of the delegates voted that drug elution was worthwhile in the superficial femoral artery, while 43% believed that it was not. In contrast, in 2014, an overwhelming 87% agreed with the proposition “drug elution is worthwhile in the superficial femoral artery” while 13% did not.