Information for Physicians: Medical Office Review of Dhruva et al.
On February 10, the Dhruva et al. paper analyzing CATH PCI and Chest Pain registry data published in JAMA. This paper has similar conclusions to Dr. Dhruva’s presentation on this same topic in November 2019 at the American Heart Association conference.
The Abiomed Medical Office has reviewed the Dhruva paper and supplement and identified a number of limitations. Dr. Seth Bilazarian, Abiomed’s Chief Medical Officer, outlines the limitations, including:
- This is a retrospective, observational study:
- The IABP AMI CGS unadjusted survival rate was 71% – a number not seen in any trial or FDA study.
- The analysis excluded IABP patients escalated to other therapies.
- The data mixes those who received Impella pre-PCI with those who received Impella as a bailout, rather than isolating the pre-PCI patients from those who had Impella support initiated after the PCI began.
- The 16,227 patients who received medical therapy making up 57.3% of the cohort in this shock population had a 20% mortality rate, substantially challenging the definition of shock in this data set. Not using inclusion criteria for cardiogenic shock established in multiple RCTs likely explains the low mortality in the medical treatment and IABP arms.
- The authors state, “there may be residual confounding whereby patients receiving intravascular microaxial LVADs had greater severity of illness than those receiving IABPs,” which is certainly a limitation which Impella users are familiar with and likely substantially confounds these conclusions.
- The authors’ conclusion conflicts with more than 10 years of outcomes data on Impella, which have been reported in more robust, previously published, FDA-audited, peer-reviewed, real-world studies and randomized controlled trials, such as the INOVA Study, the NCSI Study and the STEMI DTU pilot study. “Caution is recommended in making important patient management decisions for the patient you may be seeing today when data that conflicts with more than a decade of publications is presented from observational databases,” says Dr. Bilazarian.
Dr. Bilazarian also notes that Abiomed has made a broad commitment to evidence generation for Protected PCI and cardiogenic shock with randomized controlled trials (RCTs) and large real-world data collections. Abiomed is sponsoring the DANGER trial, a large shock RCT in Europe and has recently begun the STEMI-DTU RCT. On February 6, Abiomed announced RECOVER IV, in which patients will be randomized to receive either Impella pre-PCI or other treatment protocols, which can include any kind of non-Impella mechanical circulatory support.
Visit our clinical research page to read about previously announced and ongoing clinical trials of Impella, including two randomized controlled trials for cardiogenic shock.
Visit our FAQ page to learn more about previous attempts to randomize patients in the cardiogenic shock population.
Read the full letter from Dr. Bilazarian.
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/