November 4, 2019
Trial Data Presented for Boston Scientific's Ranger DCB and Eluvia DES
November 5, 2019—Boston Scientific Corporation announced positive data for two devices within its peripheral drug-eluting product portfolio during separate late-breaking clinical trial presentations at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The presentations included the 12-month interim analysis of the Ranger drug-coated balloon (DCB; Boston Scientific Corporation) in the superficial femoral artery (SFA) from the RANGER II SFA trial and 24-month results for the Eluvia drug-eluting stent (DES; Boston Scientific Corporation) for the treatment of femoropopliteal disease in the IMPERIAL United States pivotal trial.
According to the company, the RANGER II SFA study evaluated the safety and effectiveness of the Ranger DCB (which has a low drug-dose density of paclitaxel) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with peripheral artery disease (PAD) in the SFA and proximal popliteal artery (PPA).
In the trial, the Ranger DCB showed the following results at 12 months:
- Higher primary patency rate by Kaplan-Meier estimate (89.2% vs 72.9%; P = .0022)
- Significantly lower target lesion revascularization (TLR) rate (6% vs 17.9%; P = .0018)
- No difference in all-cause mortality rates (2.3% vs 2.5%; P > .99)
Additionally, data from the pharmacokinetics substudy showed that 11 of 12 patients with an average lesion length of 154.2 mm had unmeasurable paclitaxel levels in venous plasma at approximately 1 hour after DCB deployment and removal.
RANGER II SFA Principal Investigator Ravish Sachar, MD, commented in the company’s announcement, "These excellent clinical data coupled with the ease of deliverability of the Ranger DCB are reassuring for physicians as we evaluate the most appropriate therapies based on individual patient needs. The high primary patency rate as well as the significantly lower TLR rate, which reduces the need for repeat procedures, are very encouraging."
In the 24-month analysis of IMPERIAL trial data, the Eluvia stent was compared with the Zilver PTX paclitaxel-eluting peripheral stent (Cook Medical) for the treatment of patients with symptomatic PAD who had SFA and PPA lesions up to 140 mm in length. Boston Scientific noted that the Eluvia stent utilizes a drug-polymer combination and offers controlled delivery and sustained release of a low dose of paclitaxel.
In the IMPERIAL study, the Eluvia stent exhibited the following results at 24 months:
- Primary patency rate by Kaplan-Meier estimate of 83% vs 77.1% for Zilver PTX
- Statistically significant lower clinically driven TLR rate (12.7% vs 20.1%; P = .0495)
- Low all-cause mortality rate (7.1% vs 8.3%; P = .6649), which is within the range expected for symptomatic PAD
The Ranger DCB gained European CE Mark in 2014. The company submitted for FDA approval of the device earlier this year. In the United States, the Ranger DCB is an investigational device and is not available for sale, advised Boston Scientific.