In a retrospective analysis of CMS beneficiaries with peripheral artery disease followed for 2 years, paclitaxel-eluting stents were not associated with elevated risk for mortality compared with bare-metal stents.
As Cardiology Today’s Intervention previously reported, a summary-level meta-analysis published in December found that patients with PAD who had a revascularization procedure with a paclitaxel-coated device had elevated risk for mortality compared with controls at 2 and 5 years. As a result, the FDA launched an investigation and two ongoing trials were temporarily halted. Subsequent analyses using patient-level data have not found any evidence of a mortality risk related to paclitaxel-coated devices, nor did a retrospective study of CMS beneficiaries admitted for any kind of femoropopliteal revascularization.
Circulation recently published a correction to a 2016 article on the 5-year results of a trial comparing the first DES approved for use in peripheral arteries (Zilver PTX, Cook Medical) with percutaneous transluminal angioplasty, showing that 5-year mortality was higher in the DES group, not lower as previously reported.
For the current analysis, Eric A. Secemsky, MD, MSc, from the division of cardiology and the Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center and Harvard Medical School, and colleagues retrospectively analyzed 51,456 patients (mean age, 73 years; 54% men) from CMS databases who underwent peripheral stenting between December 2012 and September 2015. Median follow-up was 2 years, with the longest follow-up being 4.1 years.
During the study period, 51.7% of patients treated with a drug-eluting stent died compared with 50.1% of patients treated with a BMS (log-rank P = .16). After multivariable adjustment, the researchers found no relationship between stent type and mortality (HR for DES vs. BMS = 0.98; 95% CI, 0.93-1.03).
There was also no relationship between stent type and mortality in patients with critical limb ischemia (HR for DES vs. BMS = 0.97; 95% CI, 0.92-1.03) or acute limb ischemia (HR for DES vs. BMS = 0.99; 95% CI, 0.81-1.21), according to the researchers.
Use of DES increased over time, Secemsky and colleagues reported.
“We found no evidence of increased long-term mortality following peripheral artery revascularization with DES compared with BMS among CMS beneficiaries, suggesting the safety of these devices in routine practice,” the researchers wrote. – by Erik Swain
Disclosures: Secemsky reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.