Source / Disclosure
Secemsky EA, et al. Featured clinical studies: Part 2. Presentation location: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2022. Atlanta.
Disclosure: This study was funded by consortia such as BD, Boston Scientific, Cook Medical, Medtronic, and Philips. Secemsky receives institutional research grants from AstraZeneca, BD, Boston Scientific, Cook, Cardiovascular Systems Inc., Laminate Medical, Medtronic, and Philips and is a speaker or consultant for Abbott, BD, Bayer, Boston Scientific, Cook Medical, and Cardiovascular Systems Inc. I am reporting that. .. , Inari, Janssen, Medtronic, Philips. See Surveys for disclosure of relevant financial information for all other authors.
Atlanta — An analysis of 160,000 Medicare beneficiaries showed non-inferiority of paclitaxel-coated devices for mortality compared to uncoated devices for the treatment of peripheral arterial disease.
In the analysis, a scientific session presented at the Cardiovascular Angiography and Intervention Society Eric A. Sesemsky, MD, MSc, RPVI, FACC, FSCAI, FSVMDirector of Vascular Intervention at Beth Israel Dicones Medical Center, Richard A. and Susan F. Smith, Director of Vascular Research at Center for Cardiology Outcomes, Medical Assistant Professor at Harvard Medical School, Researchers Compare to Uncoated Devices Five years after revascularization of the femoral patellar artery using a paclitaxel-coated device.
The study was published at the same time Circulation: Cardiovascular intervention..
“We have a meta-analysis JAHA“Sekemsky said during the presentation. “But there were many limitations to these data. One of the major problems was the lack of 15% to 30% of the data. Therefore, many assumptions made here Perhaps there was a flaw. But the FDA responded quickly and we have been plagued by this problem. “
As Helio Previously reportedMeta-analysis by Konstantinos Katsanos, MD, PhD, MSc, EBIRInterventional radiology department and colleagues at Patras University Hospital in Lion, Greece, confirmed an increased risk of death in a five-year follow-up, motivated discussion, and went to two ongoing trials. Registration has been temporarily suspended.
As a result, the FDA A set of recommendations It discussed the potential benefits and risks associated with paclitaxel-coated devices and advised clinicians to ensure that patients were treated optimally and followed proper lifestyle practices. Authorities also said it was necessary to continue clinical research on drug-coated devices.
Therefore, Secmsky et al. Performed a pre-specified analysis designed based on FDA feedback and underwent femoral popliteal vascular regeneration using a drug-eluting stent or drug-coated balloon compared to bare metal. We evaluated the main consequences of death from all causes of 168,553 Medicare beneficiaries. Stent or percutaneous transluminal angioplasty from April 2015 to December 2018 (mean age 77 years, 45% female, 82% white, 46.7% severe lower limb ischemia). Patients were followed until 21 July 2021 (median follow-up, 3.5 years). Baseline characteristics were similar between patients who received the drug-coated device and those who did not.
“A randomized controlled trial with 4- to 5-year mortality rates would require 20,000-40,000 patients. This is the largest peripheral study to date and has already been treated. All patients receiving it should be excluded. The paclitaxel-coated device, which was the standard treatment until then, “said Sesemsky. “We were responsible for designing an actual study for the FDA and its peers to investigate the safety of paclitaxel devices using the Medicare database.”
Of the 32,000 patients with follow-up data for at least 5 years, researchers found uncoated devices (63.6%) and coated devices (62.5%; HR = 0.98; 95% CI, 0.96-0.99). ; P For non-inferiority <.0001).
After instrumental variable analysis, Secmsky et al. Observed that there was no difference in mortality risk between coated and uncoated devices after 1 year ().P Non-inferiority = .015) and 5 years follow-up (P In the case of non-inferiority <.01).
In a sensitivity analysis using negative control endpoints for acute MI, congestive heart failure, and pneumonia, researchers observed that the risk of paclitaxel devices was negligible compared to uncoated devices.
Drug-coated devices were similarly safe with respect to mortality in a subgroup of 4,212 low-risk patients with two or less comorbidities and no history of CLI (HR = 0.98; 95% CI, 0.87-1.1). The longest follow-up in this subgroup was 6.31 years.
The results were comparable among all other pre-specified subgroups.
“It’s time to update the latest regulatory communications for paclitaxel-coated peripherals,” says Secumsky. “Currently, there is a wealth of both prospective, randomized and observational data, but subsequent studies published since the December 2018 meta-analysis have yet to reproduce the harm associated with paclitaxel. Hmm.”