Patient-Level VHA Data Show No Association Between Paclitaxel-Coated Devices and Long-Term Mortality

February 23, 2021—In the first study examining the impact of paclitaxel-coated device (PCD) use on mortality in patients treated within the Veterans Health Administration (VHA), Gutierrez et al found no increased risk of long-term all-cause mortality associated with PCD use. The study was recently published in the Journal of the American Heart Association.

The authors used the Veterans Affairs Corporate Data Warehouse (VA CDW) and diagnosis and procedure codes to identify all patients with peripheral artery disease treated within the VHA who underwent femoropopliteal artery revascularization between October 1, 2015 and June 30, 2019. Endovascular interventions included any variation of drug-eluting stent (DES), drug-coated balloon (DCB), bare-metal stent (BMS), or percutaneous angioplasty balloon. Causes of death were obtained through the National Death Index. In the PCD cohort, the index procedure was defined as the first use of a PCD.

The study’s primary outcome was mortality, and overall survival was defined as the time from the date of procedure to the date of death from any cause. Survival for PCD as compared with non-PCD was estimated and stratified for claudication and critical limb ischemia using Kaplan-Meier estimates, with differences evaluated using the log-rank test. A Cox regression model was used to evaluate the association between PCDs and long-term survival, and stabilized inverse probability-weighted estimates were used to assess differences in outcomes.

Of 10,505 patients who underwent peripheral endovascular intervention, 2,265 (21.6%) received a PCD and 8,240 (78.4%) received a non-PCD (BMS or percutaneous angioplasty balloon). In the PCD cohort, 803 (35.5%) patients had a previous intervention with a non-PCD device. In those treated with a PCD, 897 (39.6%) were treated with a DCB alone, 1,201 (53%) were treated with a DES alone, and 167 (7.4%) were treated with a DCB and DES. In terms of demographics, the mean age of the overall population was 68.9 ± 8.2 years, 98.1% were men, and 73.5% were White.

Survival rates between the PCD and non-PCD groups at 2 and 3 years were similar (77.4% vs 79.7% and 70.7% vs 71.8%, respectively). The hazard ratio (HR) for all-cause mortality for patients treated with a PCD as compared with a non-PCD was 1.05 (95% CI, 0.94-1.16; P = .405), and the hazard remained similar after adjustment using inverse probability-weighted estimates (HR, 1.06; 95% CI, 0.95-1.18; P = .301).

Cause of death was available for 771 patients who died between October 1, 2015 and December 31, 2017, with 169 deaths (n = 1,328; 12.7%) in the PCD group and 602 deaths (n = 4,893; 12.3%) in the non-PCD group. Causes of death between the PCD and non-PCD groups were similar: cardiovascular (34.9% vs 39.7%; P = .284), complications from diabetes mellitus (13% vs 13.5%; P > .999), malignancy (11.8% vs 11%; P = .782), and infection (9.5% vs 8.5%; P = .646).

The authors noted that this current analysis reaffirms and adds to the results of industry-sponsored patient-level data studies and two prior large studies of Centers for Medicare & Medicaid Services beneficiaries by demonstrating no increased all-cause mortality risk through 3 to 4 years after the index procedure in a real-world United States population that includes patients aged < 65 years, who were not captured in the Medicare studies.