News | Stents Drug Eluting | May 29, 2018

OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES

Onyx 1-Month OCT study provides potential insights on DAPT duration in complex patients following stent implantation

OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES

May 29, 2018 – Investigators recently unveiled clinical data from the independently run Onyx 1-Month OCT Study showing strong early vessel healing in its target patient population at one month following implantation of the Resolute Onyx drug-eluting stent (DES). The target population contained a high percentage of patients with complex coronary artery disease.

Presented at the EuroPCR Annual Meeting, May 22-25 in Paris, France, data from 15 patients – including 13 with acute coronary syndrome (ACS) – were evaluated using optical coherence tomography (OCT). OCT is a light-based intracoronary imaging modality that provides extremely high-quality images of the coronary wall, especially of the structures closest to the vessel lumen.

In the Onyx 1-Month OCT Study, patients implanted with the Resolute Onyx DES demonstrated an excellent early healing profile. Results showed an average of 88 percent of struts covered by neointimal formation (new cell growth over stent struts) and 92.3 percent of the total stented area showing complete strut coverage at one month, which includes the covered areas in between the struts.

“The signal of early healing is crucial for patients who may need to interrupt or discontinue dual antiplatelet therapy (DAPT) within a short period of time after receiving a stent,” said Elvin Kedhi, M.D., Ph.D., interventional cardiologist at Isala Hartcentrum in Zwolle, the Netherlands, one of the lead principal investigators of the Onyx 1-Month OCT Study. “These data help expand the growing body of clinical evidence that may support physicians in tailoring DAPT regimens for complex patients.”

The Onyx 1-Month OCT Study is the latest of several Medtronic-funded studies helping to generate additional clinical evidence to reinforce the understanding of healing and shorter DAPT regimens in complex patients. Last year, Medtronic announced the Onyx ONE Global Study, a randomized clinical trial that will compare one-month DAPT between two DES for the first time, which is currently enrolling. A similar study will launch in the U.S. and Japan later this calendar year and will help inform DAPT guidelines for newer-generation DES that currently favor bare-metal stents (BMS) for patients at an increased risk of bleeding who might require a shorter DAPT regimen.

In a separate analysis presented at the EuroPCR meeting, new data from the DAPT-STEMI trial in patients treated with the Resolute Integrity DES, showed excellent results in a prospective prespecified registry that evaluated all patients after six months of DAPT duration, prior to randomization. At six months, the patient-oriented composite primary endpoint (all-cause mortality, any myocardial infarction [MI], any revascularization, stroke and TIMI major bleeding [net NACCE]) occurred in 4.2 percent of patients, with low rates of target lesion revascularization (1.1 percent) and stent thrombosis (0.7 percent).

The Resolute Onyx DES with thinner struts features Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables greater deliverability and conformability to the vessel wall. With Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. Core Wire Technology also enables thinner struts while maintaining structural strength.

The Resolute Onyx DES received CE (Conformité Européene) Mark in September 2014 and U.S. Food and Drug Administration (FDA) approval in April 2017.

For more information: www.medtronic.com

Related Content

Experimental Vaccine May Reduce Post-Stroke Blood Clot Risk
News | Antiplatelet and Anticoagulation Therapies | November 01, 2018
A vaccine may one day be able to replace oral blood thinners to reduce the risk of secondary strokes caused by blood...
Thrombolytic Science Initiates Phase 2 Trial of Novel Ischemic Stroke Treatment Regimen
News | Antiplatelet and Anticoagulation Therapies | September 07, 2018
A new Phase 2 clinical trial looks to confirm the efficacy and safety of Thrombolytic Science LLC’s (TSI) sequential...
Bleeds and Benefit With Aspirin Balanced in Diabetes Patients
News | Antiplatelet and Anticoagulation Therapies | September 05, 2018
Aspirin prevented serious vascular events in patients with diabetes who did not already have cardiovascular disease,...
Extended Post-Hospital Oral Anticoagulant Use Reduces Non-Fatal Blood Clots
News | Antiplatelet and Anticoagulation Therapies | August 31, 2018
Use of an oral anticoagulant in medically ill patients for 45 days following hospital discharge reduces the rate of non...
AFib Patients Want More Information About Anticoagulation Reversal
News | Antiplatelet and Anticoagulation Therapies | June 27, 2018
Results from a 902-person, five-country survey of people living with atrial fibrillation (AF) reinforce the importance...
Lower Oral DOAC Anticoagulant Use Associated With More Thromboembolic Events Than Warfarin. #HRS 2018
News | Antiplatelet and Anticoagulation Therapies | May 18, 2018
May 18, 2018 — Nearly half of patients prescribed warfarin and just under one third of those using newer direct oral
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

 

Feature | Antiplatelet and Anticoagulation Therapies | May 07, 2018
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated...
The largest trial to date for short-term DAPT concluded the practice cannot be deemed safe due to a higher adverse event rate. Image courtesy of the American Heart Association. #ACC18

The largest trial to date for short-term DAPT concluded the practice cannot be deemed safe due to a higher adverse event rate. Image courtesy of the American Heart Association.

News | Antiplatelet and Anticoagulation Therapies | March 19, 2018
The combined rate of death from any cause, heart attack or stroke within 18 months was not significantly different in...
The Xarelto booth at ACC.18

The Xarelto booth at the 2018 American College of Cardiology meeting. 

News | Antiplatelet and Anticoagulation Therapies | March 14, 2018
March 14, 2018 — A late-breaking analysis of the landmark COMPASS study presented at the American College of Cardiolo
Overlay Init