Medtronic Publishes Correction Letter and Revised Analysis of IN.PACT Global Postmarket Study in JACC
March 7, 2019—Medtronic announced the publication of a correction letter by Peter A. Schneider, MD, et al online ahead of print in Journal of the American College of Cardiology (JACC). The letter addresses key revisions to the data in the IN.PACT Global postmarket study, which is part of the company's In.Pact Admiral clinical program for the treatment of femoropopliteal artery disease.
The letter was issued in advance of the revised analysis of the data, which has been accepted for publication by JACC. Dr. Schneider presented the updated analysis at the VIVA Physicians Vascular Leaders Forum held March 1–2, 2019 in Washington, DC.
In a February 15 statement, Medtronic noted that there was a programming error in the clinical data reporting, isolated to the 2- and 3-year follow-up periods in the postmarket study. The error affected the In.Pact paclitaxel safety analysis, which was recently presented at LINC 2019, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany and published online in JACC.
According to Medtronic, the initial conclusions from the patient level meta-analysis remain intact:
- The data found no correlation between paclitaxel dose and long-term survival.
- The data demonstrated no difference in mean nominal dose of paclitaxel between overall survival in patients treated with a drug-coated balloon (DCB) and those who died.
- At 5 years, there was no statistically significant difference in all-cause mortality between the DCB and plain percutaneous transluminal angioplasty (PTA) arms.
In addition to the full cohort, a standard cohort has been included by the investigators in the JACC analysis to correct a baseline imbalance between DCB and PTA. This was done by identifying a subgroup of DCB patients who met the inclusion criteria for the pivotal studies from the IN.PACT clinical program, including IN.PACT SFA, IN.PACT Japan, and IN.PACT China. There was a smaller difference in mortality when only the patients who mirrored the baseline variables in the control PTA group were included. When adjusted for these baseline imbalances, all-cause mortality between DCB and PTA was 13.2% versus 11% (P = .188), respectively, advised Medtronic.
The company also advised that it will share all patient-level data with the FDA in support of the agency's paclitaxel safety analysis and will do the same to support the independent VIVA Physicians analysis. Additionally, after publication of the revised JACC manuscript, the company will correct all impacted materials in the public domain.
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