Never wanting to miss an opportunity for some publicity, and who can blame them, Biotronik’s press department was in overdrive at EuroPCR last week, announcing that twelve-month results from the BIOSOLVE-I study with the DRug Eluting Absorbable Metal Scaffold (DREAMS) demonstrate safety and confirm vessel vasomotion.
In contrast to existing permanent stents, the DREAMS device is based on a slow-absorbing, high-strength magnesium backbone. The vessel is not caged as it would be with a permanent implant, thus the artery is theoretically able to resume its natural physiology.
DREAMS is made of a proprietary magnesium alloy coated with a matrix of a bioabsorbable polymer and paclitaxel to inhibit neointimal cell proliferation within the first few months after scaffold implantation. Mechanical properties of the magnesium alloy allow deployment of the device to be comparable to conventional metallic stents.
The BIOSOLVE-I first-in-man study is a prospective, multicenter, nonrandomized, European, first-in-man clinical trial evaluating the safety and efficacy of DREAMS. Forty-six patients were enrolled in two cohorts that evaluated the primary endpoint of target lesion failure (TLF) at 6 months for cohort 1 and at 12 months for cohort 2.
The results from the BIOSOLVE-I study were presented at the EuroPCR course in Paris by Professor Michael Haude, Lukaskrankenhaus, Neuss, Germany.
At one year, DREAMS demonstrated a low 7.0% rate of target lesion failure with no death or scaffold thrombosis. The target lesion revascularisation rate was 4.7%. The analysis showed an in-scaffold late lumen loss of 0.52 mm, which was further reduced from the 6-month results. Vasoreactivity at 12 months did not significantly change from the 6-month results, suggesting that the natural physiology of the vessels was already restored after 6 months of healing and could be sustained.
“The reduction of the 12-month late lumen loss is likely due to plaque regression and late expansive remodeling. At 6 months, we have already seen that vasomotion is restored, so the new results verify that the vessels are naturally adapting to accommodate flow,” said Professor Haude. “Additionally, we could further validate that the return of natural vessel angulation that we saw at 6 months was maintained also at 12 months. These results suggest a real restoration of the vessel’s natural architecture.”
“The particularly positive feature of the magnesium scaffold is its nice conformability to the vessel wall. A few months after DREAMS implantation, the artery is able to regain its original shape and physiology. This is the main benefit of the magnesium scaffold over the more rigid polymer-based platforms,” Professor Haude added.
“These positive one-year results confirm that we are working in the right direction. BIOTRONIK continues to invest in our DREAMS program as we believe that bringing vascular restoration therapy to patients without changing the way physicians implant a scaffold is important to the adoption of this technology,” stated Alain Aimonetti, Vice President of Sales and Marketing at BIOTRONIK Vascular Intervention. “An improvement of late lumen loss between 6 and 12 months shows us that the values become more predictable over time. It makes sense, especially for the bioabsorbable scaffolds, to focus on long-term outcomes and not so much on short-term results,” Aimonetti concluded. “We see huge potential for DREAMS since it combines deployment and postdilatation properties and long-term outcomes comparable to DES with the additional benefits of vascular restoration therapy.
Source: Biotronik Inc