SAVER Registry and Turbo Power Laser Report Results

iset spotlight

Submitted on Tue, 01/29/2019 - 23:44

HOLLYWOOD, FL—Data presented for the first time in the US were featured during the 31st annual International Symposium on Endovascular Therapy (ISET). On Tuesday morning, Marianne Brodmann, MD, shared data from the Stellarex Vascular E-Registry (SAVER), and George Adams, MD, updated the audience on the Turbo Power Laser in peripheral arterial disease (PAD).

Dr. Brodmann spoke first and explained that SAVER is a prospective, single-arm study that took place at multiple sites in Europe. Patients included in the study had intermittent claudication or ischemic rest pain due to superficial femoral artery and/or popliteal PAD and underwent treatment with the Stellarex drug-coated balloon. Patients in the registry are Patients are treated with PTA using the Stellarex DCB per the IFU.

Currently, the analysis includes cohort 1 only, which represents patients with Rutherford Clinical Category 2 to 3. More than 1,500 patients’ data are currently tracked in the registry, and the data reported at this time are on the first 500 patients through 1-year follow-up. “[The

first 500 patients] were all above the knee patients,” said Dr. Brodmann. Some patients were lost to follow-up, but at least 80% of patients were available for follow-up at 12 months, she noted.

The study had primary safety and primary efficacy endpoints. The safety endpoint was freedom from device/procedure-related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure. The primary effectiveness endpoint was freedom from clinically-driven target lesion revascularization (CD-TLR) at 1 year post-procedure, as adjudicated by the Clinical Events Committee (CEC). 

Dr. Brodmann shared that there was an excellent 12-month Stellarex safety profile, with CV-related death and major amputation rates around 1% and no procedure/device-related death.

Procedural complications were low with distal embolization and thrombosis rates at less than 1%, respectively. At 12 months, the all-cause mortality rate was 2.5% and the CD-TLR rate was 11%. Additionally, 88% of patients had improved Rutherford category, and this correlated improvements in quality of life scales at 12 months. “Therefore, I think this is a reinforcement of the safety profile and effectiveness for the Stellarex balloon in a real-world patient population,” said Dr. Brodmann.

Later in the morning, George Adams, MD, spoke on the effectiveness of Turbo Power Laser in PAD, which included different settings and different lesion characteristics, assessed with IVUS and followed out to 12-months. Dr. Adams explained that the big picture of his report involves personalization of care, including whether you treat certain populations differently (diabetics vs not, hypertensive vs non, etc) and whether you treat differently based on plaque morphology.

Most patients included in the study were male and had an array of comorbidities. The mean age of patients was approximately 70, according to Dr. Adams, and patients were Rutherford 3 and 4.

Acute angiographic outcomes indicated that procedural success (>50% reduction in DS) occurred across all lesion morphologies, and acute IVUS outcomes indicated an increase in MLA that was seen across laser settings and morphologies.

During the presentation, Dr. Adams showed IVUS slides and advocated for the use of the technology. “It’s very powerful to use this 3-dimensional view rather than a 2-dimensional angiographic view,” he said.

He concluded by stating that this final acute analysis gives a first idea of how the laser performs in different lesion morphologies. “Further analysis will help to clarify how laser settings play into outcomes in different lesions,” he said. “This might be a first step to develop a personalized algorithm to optimize treatment for each patient.”

—Lauren LeBano