Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference this week in Washington, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic (Minneapolis) augments what it already calls a robust body of evidence that continues to drive a reconsideration of the standard of care for peripheral artery disease (PAD) in leg arteries above the knee.
The IN.PACT Admiral DCB remains an investigational medical device in the U.S. No drug-coated balloon has yet received approval from the FDA.
The new data come from the real-world IN.PACT Global study, the largest and most rigorous post-market evaluation of its kind for any peripheral artery intervention, and from an ongoing economic outcomes analysis of the U.S. phase of the landmark IN.PACT SFA trial.
Together, the results show that the IN.PACT Admiral DCB is not only clinically superior, but also cost-effective for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) or proximal popliteal artery (PPA) at 12 months compared to standard percutaneous transluminal angioplasty (PTA).
IN.PACT SFA, a randomized controlled trial comparing the IN.PACT Admiral DCB to standard PTA head-to-head, found the lowest 12-month clinically-driven target lesion revascularization (CD-TLR) rate for any peripheral intervention ever studied (2.4% vs. 20.6%, respectively).
In recognition of the traditionally high costs associated with repeat revascularization following PTA, the IN.PACT SFA trial included a pre-specified economic analysis of the trial`s U.S. phase to evaluate the comparative cost-effectiveness of the IN.PACT Admiral DCB in terms of avoiding repeat revascularization.
An interim one-year report on this ongoing analysis, which has a primary two-year endpoint of total PAD-related costs for the target limb, found that treatment with the IN.PACT Admiral DCB is economically attractive, despite higher initial hospital costs.
The follow-up target-limb related medical care costs from discharge to one year were approximately $750 per patient lower in the DCB group than the PTA group, resulting in an incremental cost-effectiveness ratio (ICER) of about $2,900 per repeat revascularization avoided, which compares favorably to other cardiovascular therapies, including coronary drug-eluting stents.
In other news from the floor of TCT:
• St. Jude Medical (St. Paul, Minnesota) has secured CE mark and FDA clearance for the new OPTIS Integrated System. The system is a departure from traditional, mobile cart-based diagnostic tools and advances percutaneous coronary intervention (PCI) optimization via direct installation into a hospital's cardiac catheterization laboratory, fully integrating optical coherence tomography (OCT) and fractional flow reserve (FFR) into PCI workflow.
The approval of the OPTIS Integrated system marks the launch of the world's first PCI optimization system to offer OCT and angiography co-registration, which supports procedural decisions by providing high-resolution, 3-D OCT views of coronary anatomy while mapping the exact location of physician's current view via angiogram. The OPTIS Integrated system also integrates St. Jude Medical PressureWire fractional flow reserve (FFR) measurement technology to provide access to critical hemodynamic information during PCI.
St. Jude says OPTIS Integrated advances PCI optimization technology further by offering a side-by-side view of OCT and angiography via a co-registration to "map" culprit lesions and provide the visual data necessary to guide stent selection and deployment. In addition, FFR technology allows physicians to assess the severity of blood flow blockages. Direct tableside controls allow physicians to directly drive system operations while a new user interface prioritizes image display for increased visibility and operation. Stent planning tools enable enhanced precision in determining optimal stent sizing and placement.
• Micell Technologies (Durham, North Carolina) presented three-year clinical results from the DESSOLVE I and DESSOLVE II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent system (MiStent SES). MiStent SES is designed to optimize vessel healing in patients with coronary artery disease, and these data demonstrated desirable bare-metal stent type healing. Normal endothelial function was maintained and there was minimal progression of late lumen loss through 18 months' follow-up. In addition, the DESSOLVE studies had an overall target lesion revascularization (TLR) rate of 2.0% with no probable or definite stent thromboses related to MiStent SES at 3-years follow-up.
The MiStent SES is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES is intended to precisely and consistently control drug elution and limit polymer exposure duration, thereby reducing the safety risks associated with current commercially available drug-eluting stent technologies.
The MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES. //