OPTIMIZE Pivotal Study 1 Year Outcomes Announced at TCT Connect
The Svelte® Drug-Eluting Stent (DES) achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year, the lowest ever reported in an Investigational Device Exemption (IDE) clinical study. Primary and secondary endpoint outcomes of the OPTIMIZE IDE study, designed to assess the safety and efficacy of the Svelte DES Integrated Delivery System (SLENDER IDS®) and Rapid Exchange (DIRECT RX®) platforms, were presented today during the Late-Breaking Trials session at TCT Connect.
OPTIMIZE randomized 1,639 subjects (1:1 SLENDER IDS or DIRECT RX DES vs. Xience® or Promus® DES) at 74 investigative sites in the US, Japan and Europe in support of US and Japan regulatory approvals. Under the prespecified study statistical analysis plan, the threshold for non-inferiority of 1 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 peri-procedural 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, M.D., F.A.C.C., the Medical Director at The Christ Hospital, Lindner Research Center in Cincinnati, Ohio and co-principal investigator of the OPTIMIZE study stated, "The Svelte DES went head-to-head against the gold standard for DES and demonstrated exceptionally low TLR and stent thrombosis rates at 1 year. I regard the high TVMI rates observed in this study as artifact. When nearly 1 in 3 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, M.D., F.A.C.C., Professor of Medicine at Duke University in Durham, North Carolina and co-principal investigator of the OPTIMIZE study. "With definition-driven TVMI placed into appropriate context, it’s 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 1 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, M.D., F.A.C.C., an interventional cardiologist at Levine Heart & Wellness in Naples, Florida and top-5 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 realized significant reductions in procedure, device and fluoroscopy times, as well as radiation exposure, compared with direct stenting using control DES.
SLENDER IDS and DIRECT RX utilize the same low profile, highly conformable stent with a new class of bioresorbable sirolimus-eluting drug carrier designed to minimize inflammation and promote vessel healing. 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.
About Svelte Medical Systems
Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.
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President and CEO
Svelte Medical Systems, Inc.