The reliable outcomes of Getinge’s Advanta V12 have been reinforced by a new systematic literature review. A group of physicians from around the world joined to compare published studies of covered balloon-expandable (CBE) stents for aortoiliac occlusive disease (AIOD). “The Advanta V12 device stands out as the only solution with the most real-world, long-term data,” reads a Getinge press release.
The review, published in the Journal of Vascular Surgery (JVS) was headed by Bibombe Patrice Mwipatayi (Perth Institute of Vascular Research, University of Western Australia, Perth, Australia). It included 15 published articles reviewing 14 clinical studies of different CBE stents for AIOD. Eight of the studies covered prospective clinical trials and six were retrospective real-world studies.
“Each covered stent has a different design and technology, which means that it needs to be proven efficient and safe in its own trial,” said Mwipatayi.
The number of patients in reviewed Advanta V12/iCast studies totalled 611, compared to only 12 to 164 for the other reviewed devices. The duration of follow-up was longer for Advanta V12; between 8 and 60 months, compared with up to 12 months for the other stents.
Mwipatayi commented: “According to our analysis, long-term data is only available for a single device, the Advanta V12, with results favorable through five years.”
The technical success, patency, and freedom from target lesion revascularisation (TLR) at 12 months were similar among the reviewed devices. Beyond the first year, however, Advanta V12 is the only device with data out to five years, with primary patency of 74.7%.
As Advanta V12/iCast publications included real-world studies, these patients had more severe disease as compared with patients who received other stents. Disease severity was defined as the percentage of total occlusions and lesion length. The Advanta V12/iCast included a greater number of TASC (TransAtlantic Inter-Society Consensus) C/D lesions than LifeStream or BeGraft studies. The Getinge device was also the only device to currently have long-term data for primary patency and freedom from TLR.
“Real-world data is essential to demonstrate longevity of performance. In the past, there have been devices that looked positive in the first year, but after two or three years the patency dropped off dramatically.” said Jean-Paul de Vries (University Medical Center Groningen, Groningen, the Netherlands), a co-author of the review.
Advanta V12/iCast has a history of use in over 500,000 patients, with its ease of use and reliability, discussed in some of over 550 clinical publications.
“The results of this review show a favorable outcome for our well-proven Advanta V12 balloon expandable covered stent compared to newer devices,” says Jens Viebke, president Acute Care Therapies at Getinge. “Getinge’s Advanta V12 has been trusted by physicians for more than 15 years with solid clinical evidence.” Our stent continues to prove itself every day when it comes to helping patients with this severe condition.”