Devices with paclitaxel (PTX) increased survival at 2 years compared with other balloon angioplasty or stent devices, according to a study published in JACC: Cardiovascular Interventions.
For the multicenter cohort clinical trial, The Vascular Quality Initiative Data Extraction and Longitudinal Trend Analysis (DELTA) (ClinicalTrials.gov Identifier: NCT04110288), researchers analyzed data from the Society for Vascular Surgery Vascular Quality Initiative registry, which had 676 participating sites and 4893 providers as of May 2020. Between 2017 and 2020, patients who received PTX drug-coated balloon angioplasty (n=1769), percutaneous transluminal balloon angioplasty (n=1769), PTX drug-eluting stents (n=687), or bare-metal stents (n=687) were assessed for 2-year outcomes using a propensity-matching approach.
The recipients of any PTX and non-PTX device had a mean age of 71±11 and 71±11 years; 55.0% and 55.0% were men; body mass index (BMI) was 28±6 and 28±8 ; 90.0% and 90.0% had hypertension; 60.0% and 59.0% diabetes; 33.0% and 33.0% coronary artery disease; and 23.0% and 23.0% congestive heart failure, respectively.
At 2 years, survival was increased among patients who received any PTX device (89.5% vs 86.7%; hazard ratio [HR], 0.79; 95% CI, 0.72-0.87; P =.004). Stratified by device, survival was significantly higher among PTX drug-coated balloon recipients (88.9% vs 85.7%; HR, 0.77; 95% CI, 0.72-0.87; P =.005) and numerically higher among PTX drug-eluting stent recipients (91.3% vs 89.6%; HR, 0.84; 95% CI, 0.70-1.01; P =.36).
Interventional success at 2 years was higher among any PTX device recipients compared with non-PTX devices (81.6% vs 77.6%; HR, 0.82; 95% CI, 0.74-0.91; P <.001). Similar to survival, success was significantly higher among PTX drug-coated balloon recipients (81.4% vs 76.6%; HR, 0.80; 95% CI, 0.71-0.89; P <.001) and numerically higher among PTX drug-eluting stent recipients (81.9% vs 80.1%; HR, 0.91; 95% CI, 0.74-1.11; P =.25).
PTX device recipients had higher rates of independent ambulation at 1 year compared with non-PTX devices (86.0% vs 83.4%; HR, 0.85; 95% CI, 0.79-0.91; P =.008). Contrary to survival and success, independent ambulation was numerically higher among PTX drug-coated balloon recipients (86.1% vs 85%; HR, 0.93; 95% CI, 0.86-1.00; P =.29) and significantly higher among PTX drug-eluting stent recipients (85.6% vs 79.1%; HR, 0.69; 95% CI, 0.60-0.79; P =.0012).
No group differences in freedom for resumption of smoking at 1 year were observed (P =.44).
This study may have included some “healthy user” bias, as there were more patients with claudicants among the unmatched cohort who received a PTX device.
“Prospective, active surveillance of the SVS VQI Peripheral Vascular Intervention registry using the DELTA study did not demonstrate any signal for increased mortality following the use of PTX devices for the treatment of femoral popliteal occlusive arterial disease,” the study authors noted. “Instead, treatment with PTX devices was associated with improved 2-year survival when compared with nondrug devices. Further registry surveillance will continue until 2024 to determine if a signal is present between 2 and 5 years.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Bertges DJ, Eldrup-Jorgensen J, Robbins S, et al. Vascular quality initiative surveillance of femoropopliteal artery paclitaxel devices. JACC Cardiovasc Interv. Published online December 6, 2021. doi:10.1016/j.jcin.2021.08.058