OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020
Ngày 22/10/2020 10:38 | Lượt xem: 102

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.

Source CardiovascularNews

Duc Tin Clinic

Print Chia sẽ qua facebook bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua google bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua twitter bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua MySpace bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua LinkedIn bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua stumbleupon bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua icio bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua digg bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua yahoo bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua yahoo bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua yahoo bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020 Chia sẽ qua yahoo bài: OPTIMIZE IDE study of Svelte drug-eluting stent shared at TCT Connect 2020

Tin tức liên quan

CUSTOMER REVIEWS

  • I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

    I sincerely thank you !. Tel: 0938303275

  • Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

    Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

  • As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

  • The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

  • I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search
Customer support

    Phone: (028) 3981 2678
    Mobile: 0903 839 878 - 0909 384 389

TOP