OPTIMIZE: Novel Fixed-Wire Drug-Eluting Stent Does Not Achieve Non-Inferiority Compared to Existing Systems

New findings presented at Transcatheter Cardiovascular Therapeutics (TCT) 2020 showed that the Slender Integrated Delivery System (IDS), a novel, low-profile drug-eluting stent (DES) did not achieve non-inferiority compared to existing DES.

Slender IDS, the ultra-low profile fixed-wire DES from Svelte Medical Systems, and the corresponding rapid exchange system Direct RX, are designed to facilitate transradial (TR) access and direct stenting (DS), reducing the time and cost of percutaneous coronary intervention (PCI). Both systems were evaluated for non-inferiority to other systems in the OPTIMIZE trial.

OPTIMIZE was a prospective, randomized trial evaluating the safety and efficacy of Svelte IDS and RX DES compared to existing DES systems (Xience or Promus). A total of 1,639 subjects with ischemic heart disease and three or less de novo stenotic lesions (34mm or less in length) in two or less native coronary arteries amenable to PCI were enrolled. A total of 1,988 lesions were randomized to either Svelte IDS or one of the control DES. The primary endpoint was rate of target lesion failure (TLF), powered for non-inferiority, at a 12-month follow-up. Secondary endpoints include components of TLF, Major Adverse Cardiovascular Events (MACE), and stent thrombosis at 12 months.

The rate of TLF at 12 months was 10.3% in the Svelte group and 9.5% in the Xience/Promus group (P = 0.034). The prespecified margin for non-inferiority was 0.025, which was not achieved. No significant differences were observed between the two groups for the secondary endpoint.

An independent analysis was conducted to assess if rates of TLF differ across treatment groups, and if relative risk (RR) was less than a pre-specified protocol 1.55 non-inferiority margin. In this assessment, RR for Svelte IDS was 1.09 (95% CI, 0.81 – 1.46), meaning non-inferiority was achieved.

“Based on the prespecified study statistical analysis plan, Svelte DES did not quite meet the threshold for non-inferiority using the prespecified absolute non-inferiority margin,” said lead investigator Dean J. Kereiakes, MD, during the presentation. “However, independent analyses of OPTIMIZE results using either a comparable relative non-inferiority margin with the protocol definition of [myocardial infarction (MI)] or the SCAI definition of MI clearly demonstrate non-inferiority of Svelte DES to Xience/Promus.”

 

Kereiakes D. Prospective, Randomized Evaluation of
Sirolimus-Eluting Coronary Stents with FixedWire and Rapid-Exchange Delivery Systems and a Novel  Bioresorbable Drug Carrier: the OPTIMIZE IDE Trial. Presented at TCT 2020.