Oct 17th 2020

OPTIMIZE—coverage of TCT Connect 2020

Trial Prospective, Randomized Evaluation of Sirolimus-Eluting Coronary Stents with Fixed-Wire and Rapid-Exchange Delivery Systems and a Novel Bioresorbable Drug Carrier

OPTIMIZE evaluated a novel, low profile 0.031 inch drug-eluting stent (Svelte) on an integrated delivery system that can utilize smaller catheters, facilitate transradial access and direct stenting. 1,639 subjects (72% male, 30% diabetic, 57% acute coronary syndrome, mean age 65.4 years) with 1,988 lesions (74% Type B2/C, 36% moderate-severely calcified, 20% vessel angulation > 45°) were 1:1 randomized at 74 sites in the US, Europe and Japan. The first results of the 1-year outcomes did not establish non-inferiority of the Svelte DES stent compared to existing drug-eluting stents (Xience/Promus). The primary endpoint of target lesion failure (TLF) at one year was 10.3% in the Svelte group and 9.5% in the Xience/Promus group, which was surprisingly high. The investigators point to the high-sensitivity troponin biomarkers as having an impact of these results.  This does raise some questions regarding whether the direct stenting strategy may contribute to higher TLF.  It is also unclear based on the presentation how frequently intravascular imaging was used to optimize the PCI results, but an IVUS sub-study will evaluated, which included 60 patients total (30 patients in each arm).