One-Year IN.PACT SFA Results Show Improved Outcomes for Medtronic's Drug-Coated Balloon Versus Standard PTA

April 5, 2014—Twelve-month results from the IN.PACT SFA trial studying the In.Pact Admiral drug-coated balloon (DCB) (Medtronic, Inc., Minneapolis, MN) were presented at the Charing Cross international symposium in London. Principal investigator Gunnar Tepe, MD, presented the data, which showed that patients with peripheral artery disease in the superficial femoral artery (SFA) who were treated with the In.Pact Admiral device experienced significantly better outcomes at 12 months after treatment compared to those treated with standard percutaneous transluminal angioplasty (PTA).

The IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the United States. All patients in the study were randomized to treatment with the DCB or PTA. Among the key data presented were the clinically driven target lesion revascularization (CD-TLR) rates at 12 months, which were 2.4% for the DCB group and 20.6% for the PTA group (P < .001), a highly statistically significant difference. 

Per protocol primary patency rates were assessed at 12 months of follow-up and also showed a highly statistically significant difference: 82.2% for the DCB group and 52.4% for the PTA group (P < .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 DCB group and 66.8% for the PTA group.  
 
“The results of this rigorously conducted randomized controlled trial warrant a review of current treatment guidelines for peripheral artery disease in the lower extremities,” commented Dr. Tepe in the company’s press release. “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 SFA.” Dr. Tepe is chief of radiology at RoMed Klinikum in Rosenheim, Germany. 

Medtronic stated that to ensure data accuracy and reliability, patency endpoints underwent evaluation by an independent imaging core lab and an independent clinical events committee adjudicated all clinical events. To prevent bias, both the imaging core lab and the clinical events committee were blinded to the patients’ randomization assignment.

Additionally, study patients were well matched at the time of enrollment. Approximately 95% of the patients had moderate or severe claudication and the remaining 5% experienced rest pain because of more advanced arterial disease. Other baseline characteristics––including diabetes (40.5% vs 48.6%), hypertension (91.4% vs 88.3%), 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 DCB and PTA groups, with no statistically significant differences. Clinical outcomes, however, significantly favored the DCB group, noted Medtronic.

Medtronic advised that the In.Pact Admiral DCB received European CE Mark approval in 2009. It is an investigational device in the United States, where it is under review by the US Food and Drug Administration (FDA). The company will soon submit results of the IN.PACT SFA trial to the FDA as part of the application for premarket approval of the In.Pact Admiral.

In an interview with Endovascular Today, Dr. Tepe discussed the ramifications of this study and its data, stating, “This is a new level of evidence. It also supports what we have seen in other trials. I think it was very important to have level 1 evidence, showing that this drug-eluting balloon technology is really good. These latest data will help with drug-eluting balloon usage and will reinforce that drug-eluting balloons should be used in the future as a primary treatment.”