12-Month Outcomes With a Paclitaxel DES: Highlighting the Impact of Vessel Sizing

In a Tuesday ISET 2023 session, Venita Chandra, MD, from Stanford University in Stanford, California, presented study results on the use of paclitaxel with a drug-eluting stent (DES) and the importance of vessel sizing. Stent selection takes reference vessel diameter into consideration; undersizing is a known predictor for restenosis, and oversizing by a large amount increases wall stress and may result in neointimal hyperplasia. But what is the impact of moderate oversizing?

Dr. Chandra discussed the Global Clinical Program for Zilver PTX (Cook Medical), which includes more than 2400 patients, as well as the Zilver PTX China Study, which was a 1-year study of 178 Chinese patients. Regarding the China study, she shared procedural information, seen below, as well as outcomes.

She also reviewed outcomes in freedom from target lesion recurrence (TLR) from the Global Clinical Program, including patency with stent size and vessel diameter (see below) as well as a study by Kojiro Miki, et al that showed chronic stent enlargement resulted in greater lumen area after implantation of a self-expanding paclitaxel-eluting stent (PES) with a large diameter at the mid-term follow-up. Stent diameter might be important for stent patency in procedure with PES for superficial femoral artery lesions.

Dr. Chandra concluded that positive results indicate that Zilver PTX is safe and effective in Chinese patients, with clinical improvement demonstrated by Rutherford, ankle-brachial index, and walking impairment. High rates of freedom from TLR and primary patency were seen, and both are similar to previous studies. Lesion length was the only predictor for restenosis, with smaller stents and smaller vessel size being nearly significant. Results with the 5 mm and 6 mm stents highlight that adequate stent oversizing of at least 1 mm larger than the RVD is needed for optimal patency. Results with the 5 mm and 6 mm stent highlight that adequate stent oversizing of at least 1 mm larger than the RVD is needed for optimal patency.