Results of the OPTIMIZE IDE study, assessing the Svelte drug-eluting stent (DES) Integrated Delivery System (SLENDER IDS) and Rapid Exchange (DIRECT RX) platforms (Svelte Medical Systems) were presented at TCT Connect 2020 (14 – 18 October, virtual). The study showed that use of the devices resulted in a 1.5% clinically-driven target lesion revascularisation (TLR) at one-year.
OPTIMIZE randomized 1,639 subjects (1:1 SLENDER IDS or DIRECT RX DES versus Xience (Abbott) or Promus (Boston Scientific) at 74 investigative sites in the USA, Japan and Europe in support of US and Japan regulatory approvals.
Under the prespecified study statistical analysis plan, the threshold for non-inferiority of one-year target lesion failure (TLF) using an absolute non-inferiority margin was not quite met (p=0.034 with 0.025 the prespecified threshold for non-inferiority). Unprecedented target vessel myocardial infarction (TVMI) rates of 8.8% were observed across both treatment groups, driven by the frequent use of high-sensitivity troponin biomarkers during periprocedural assessments, leading to overall TLF of 9.9%, nearly double the expected rate and effectively underpowering the study. Non-inferiority of the Svelte DES compared to the Xience and Promus DES was clearly established in independent analyses of the OPTIMIZE results using either a comparable relative non-inferiority margin with the protocol definition of MI (p=0.009), or the SCAI definition of MI (p=0.003), which specifically accounts for high-sensitivity troponin use in the assessment of peri-procedural TVMI.
Dean Kereiakes, (The Christ Hospital, Lindner Research Center, Cincinnati, USA) and co-principal investigator of the OPTIMIZE study, said: “The Svelte DES went head-to-head against the gold standard for DES and demonstrated exceptionally low TLR and stent thrombosis rates at one year. I regard the high TVMI rates observed in this study as artefact. When nearly one in three subjects assessed using high-sensitivity troponin assays is counted as TVMI across both treatment groups (including previously studied and highly regarded DES as the control), it is clear the protocol definition of TVMI, and not clinically meaningful TVMI, plagued this study.”
“The high TLF reported in both OPTIMIZE treatment groups is driven by the 25% of study subjects assessed peri-procedurally with high-sensitivity-troponin. These subjects accounted for 80% of all study TVMIs, yet 96% of them had no ECG changes and 88% were discharged post-procedure without delay, data that are not indicative of true clinical TVMI,” added Sunil Rao (professor of medicine, Duke University, Durham, USA) and co-principal investigator of the OPTIMIZE study. “With definition-driven TVMI placed into appropriate context, it is exciting to see the exceptional clinical outcomes achieved in OPTIMIZE with 79% of subjects undergoing TRI. The low profile of the Svelte DES, and especially SLENDER IDS, facilitates TRI. The significantly lower access site hematoma rates and strong one year clinical results in TRI subjects should be of interest to radial specialists seeking to downsize catheters and improve patient care.”
Direct stenting was undertaken in 30% of OPTIMIZE subjects, with 96% device success rates observed. Ronald Caputo (Levine Heart & Wellness in Naples, USA) and top-five user of SLENDER IDS for direct stenting in the OPTIMIZE study, stated: “SLENDER IDS offers a unique low-profile option especially attractive to radial operators. It and DIRECT RX are extremely deliverable stents. I was very impressed with their performance during the study and exceptional 1 year clinical outcomes.”
Investigators with prior experience direct stenting with SLENDER IDS in Europe also realised significant reductions in procedure, device and fluoroscopy times, as well as radiation exposure, compared with direct stenting using control DES.
Both SLENDER IDS and DIRECT RX hold CE mark certification and are commercially available in Europe.
“We are deeply grateful to each and every one of the patients, investigative team members and support personnel contributing to the OPTIMIZE study. Our highly differentiated platforms bring a new and unique approach to coronary stenting which improves procedural efficiency while enhancing patient outcomes and comfort, delivering value to all constituents – patients, physicians, providers and payers,” said Jack Darby, president and CEO of Svelte Medical Systems.