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|Patient-Level Survival Analysis Demonstrates No Link Between Paclitaxel Dose and Mortality in Patients Treated with IN.PACT Admiral DCB|
Data Presented Today at LINC Reiterate Commitment to Patient Safety and Data Transparency
DUBLIN and LEIPZIG, Germany - January 22, 2019 - Medtronic plc (NYSE:MDT) today announced new data shared on the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) in the superficial femoral (SFA) and popliteal arteries. Outcomes from the IN.PACT DCB Paclitaxel Safety Analysis, an independent, patient-level survival analysis inclusive of all IN.PACT DCB clinical programs, were presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany. A manuscript detailing outcomes from the IN.PACT DCB Paclitaxel Safety analysis was also accepted and is in press with the Journal of the American College of Cardiology (JACC).
Key data highlights:
Patient-Level Safety Analysis
"This independently adjudicated analysis includes 1,837 patients treated with IN.PACT Admiral and followed long-term," said Dr. Schneider. "In contrast to a recently published summary-level meta-analysis-which included 28 trials with different devices, designs, levels of monitoring, and follow-up periods-the findings from this study showed neither paclitaxel use, nor dose had any effect on mortality at five years."
The analysis evaluated all-cause mortality across IN.PACT studies. This included device- or procedure-related death through five years and paclitaxel-related events through 12 months. Upon review of other endovascular therapies in published literature, it was found that the mortality rates across IN.PACT DCB studies are comparable to or lower than what would be expected in similar patient populations. 1-5 Authors also found no significant difference between nominal dose in those with overall survival through five years. Furthermore, patients who died were older and shared a statistically higher level of co-morbidities at baseline, including coronary artery disease, diabetes, and chronic kidney disease, versus those with higher overall survival rates. Across all studies, results were reviewed and adjudicated by an independent clinical events committee.
"Individual patient data meta-analysis (IPD-MA) offers several advantages over the aggregate data meta-analysis (AD-MA) that renders it as a more powerful statistical approach, allowing for more thorough and more appropriate analyses," said Dr. Gheorghe Doros. "The advantages are realized by being able to utilize more accurate outcome data, such as time of event and time of drop-out, individual patient covariates, such as paclitaxel dose, patient comorbidities, as well as lesion and procedural characteristics, and more sophisticated statistical models, such as frailty Cox regression and inverse probability of treatment weighting (IPTW)."
"In light of recent discussions around the safety of paclitaxel-coated and -eluting technologies, it's now more important than ever for Medtronic and our industry peers to be forthcoming with all our clinical data," said Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic, Peripheral, and Venous division at Medtronic. "The evidence presented today at LINC underscores our ongoing commitment to patient safety, improved long-term outcomes, and data transparency."
IN.PACT SFA Japan Three-Year Results
IN.PACT SFA Japan demonstrated a 68.9 percent primary patency in the DCB group compared to 46.9 percent in the PTA group at three years based on Kaplan-Meier estimates (p=0.001). The three-year freedom from CD-TLR rates based on Kaplan-Meier estimates were 84.4 percent in the DCB group compared to 81.3 percent in the PTA group (p=0.451). In IN.PACT SFA Japan, major adverse events were also lower in the DCB group at three years with a rate of 20.9 percent compared to 31.0 percent in the PTA group (p=0.306), with no major target limb amputations in either study arm. The mortality rate was also lower in the DCB arm at 6.0 percent, versus 6.9 percent in the PTA group.
"We stand behind IN.PACT Admiral DCB, which is well supported by evidence from our robust clinical program," said Simona Zannetti, M.D., vice president, Clinical Research, Medical Affairs, and Education, Medtronic Aortic, Peripheral, and Venous. "In line with our commitment to timely data dissemination-and the physicians and patients we serve-it is critical that we continue to review, report, and publish our findings."
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1. Caro J, Migliaccio-Walle K, Ishak KJ, Proskorovsky I. The morbidity and mortality following a diagnosis of peripheral arterial disease: long-term follow-up of a large database. BMC Cardiovasc Disord 2005;5:14.