Top-line results from a head-to-head trial comparing Boston Scientific‘s (NYSE:BSX) Ranger drug-coated balloon and Medtronic‘s (NYSE:MDT) In.Pact Admiral DCB found no statistically significant difference in patency rates between the two drug-device products.
The trial is the first of its kind, according to Boston Scientific’s president of peripheral interventions, Jeff Mirviss.
“As a leader in the peripheral space, we wanted to deliver the type of evidence that could help physicians and hospital systems utilize more evidence-based medicine in the field. We wanted to do the type of trial that could advance the field forward,” Mirviss told Drug Delivery Business News.
“In peripheral, unlike some other categories, there isn’t comparative data and many of the trials done to study a drug-coated balloon are done against a bare balloon. Because there isn’t comparative date, we thought this would help physicians make more informed comparative choices. That in and of itself is differentiated, because we will be the only company that will have comparative data for both our drug-coated balloon and also our drug-eluting stent.”
Boston Scientific’s Ranger device, which is available in a number of markets outside of the U.S., features a lower dose of paclitaxel than Medtronic’s In.Pact Admiral device, as well as a low profile, which helps physicians easily navigate lesions and speed up procedure times.
The company’s DCB also comes in an array of sizes.
“In Europe, today, and when we launch in the US, we will have a 200 millimeter length balloon. In some countries around the world that will be the longest drug-coated balloon that’s on the market and that’s obviously helpful in today’s cost-conscious world where we can deliver a cost-effective device and potentially save some time and money for the physician as well as the hospital,” Mirviss explained.
In the 150-patient Compare-1 pilot study, patients with peripheral artery disease were randomized to receive either Medtronic’s device or Boston Scientific’s product.
“I think many physicians would characterize this trial as a real world patient population in that they’re fairly complex patients. Roughly 40% of the patients had a total occlusion, which is 100% blockage in the SFA artery – the main artery in the leg. That’s a fairly high percentage, that’s a tough patient population to treat. Many physicians might say that’s among the toughest. Almost 60% or so had moderate to severe calcification, so again that’s another patient group that is considered very difficult to treat, and roughly about a third of the patients had diabetes,” Mirviss said.
He also noted that the study’s average lesion length was long – in the Ranger arm of the trial it was 111 mm.
After 12 months, the patency rate in the Ranger arm was 84%, compared to 89% in the Medtronic group.
The company plans to check in with the study’s patient population again after two years. Boston Scientific expects to bring the Ranger DCB to the U.S. and Japan markets by 2020, according to Mirviss.
Looking ahead, the company is hoping to launch its Eluvia drug-eluting stent in the U.S. in 2019, as well as a self-expanding drug-eluting stent for below-the-knee vessels in 2021.
“We’re quite bullish on the future of drug-eluting technologies, which is why we’re investing so much to bring them to market globally and invest in the type of clinical research that you saw today with the Compare trial,” Mirviss said.
