TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial
Ngày 20/10/2020 09:05 | Lượt xem: 89

CeloNova BioSciences has announced interim results from the randomised Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE), the first randomised 14-day dual antiplatelet therapy (DAPT) study of high bleeding risk patients (HBR), during a late-breaking clinical science session at TCT Connect 2020 (14–18 October, virtual).

“Today marks a very significant milestone in providing valuable clinical insights into the DAPT duration and stent choice for high bleeding risk patients formally excluded from clinical trials,” stated Professor Robert Byrne (Royal College of Surgeons in Ireland [RSCI] University of Health Sciences, Dublin, Ireland), a principal investigator in the COBRA REDUCE trial.

“I would like to thank my colleagues for their outstanding support in successfully completing this portion of the study despite challenges brought on by the COVID-19 world pandemic. We look forward to concluding patient follow-up and secondary analysis at 12 months,” said Byrne.

In the COBRA REDUCE trial, 100% of enrolled patients were on oral anticoagulation therapy (OAC) with over 90% of patients presenting with atrial fibrillation (AF). OAC is a major bleeding criterion, per the Academic Research Consortium for high bleeding risk (ARC-HBR). Furthermore, close to half of all patients in the study share a second or third major or minor ARC-HBR bleeding criteria, such as recent ischaemic stroke, cancer, anaemia, or severe or end-stage chronic kidney disease. It was noted that significantly less patients in the COBRA PzF NCS arm received a reduction in OAC intensity compared to the DES arm (COBRA: 46% vs. DES: 56%; p=0.006). Both study arms presented with highly complex lesions and the COBRA PzF NCS arm presented with statistically higher bifurcation rates (COBRA: 20% vs DES: 15%; p=0.034).

The COBRA REDUCE study randomised 996 HBR patients across 59 enrolling global sites to receive either COBRA PzF NCS (n=495) with 14-day DAPT or an FDA-approved DES (n=501) with three or six months DAPT. COBRA PzF NCS demonstrated the following interim results:

  • Numerically less bleeding in the co-primary endpoint of BARC class ≥2 bleeding after 14 days (COBRA: 7.5% vs DES: 8.9%; p=0.477) and statistically less bleeding over DES in BARC class 1-5 after randomization (COBRA: 13% vs. DES: 18.3%; p=0.026).
  • Numerically similar rates in the composite co-primary endpoint of ischemic safety compared to the DES arm (COBRA: 7.7% vs DES: 5.2%; p=0.061). Additional analysis showed statistical non-inferiority when the composite endpoint includes only cardiac-related mortality.
  • Equal low probable and definite stent thrombosis (0.6%) in both groups (not powered).
  • Low initial ischemic-driven TLR at 6 months (3.7%).

“We are pleased with COBRA PzF NCS’ preliminary performance with just 14-days DAPT in aspects of bleeding and ischemic events,” said Carl St Bernard, president and chief executive officer of CeloNova. “Finding the right DAPT balance is critical to reducing the complexity and complications of long-DAPT regimens following stent placement. The COBRA REDUCE study has advanced our understanding of how to best strike this balance.”

“It is encouraging to see that the COBRA stent demonstrated a very low stent thrombosis rate with just 14-days DAPT in this high-risk patient population,” said Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA) and a member of the COBRA REDUCE steering committee. “We hope to gain further insight into its efficacy with 14-days DAPT in the secondary analysis at 12 months.”

COBRA REDUCE’s final co-primary endpoint analysis and secondary endpoints, including composite of all-cause death, cardiac death, MI, ischemia-driven TLR, definite and probable stent thrombosis and ischemic stroke at 12-months, are expected to be revealed in Q2 of 2021.

Source CardiovascularNews

Duc Tin Clinic

Print Chia sẽ qua facebook bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua google bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua twitter bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua MySpace bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua LinkedIn bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua stumbleupon bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua icio bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua digg bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua yahoo bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua yahoo bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua yahoo bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial Chia sẽ qua yahoo bài: TCT Connect 2020: CeloNova announces interim data from 14-day DAPT trial

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