News | Stents Drug Eluting | November 01, 2017

Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

One-year results from the REDUCE trial reported at TCT 2017

Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

Image courtesy of OrbusNeich

November 1, 2017 — OrbusNeich reported results from the REDUCE trial in the Late-Breaking Clinical Trial session at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, Oct. 29-Nov. 2 in Denver. The results provide fresh insights into the optimal treatment of patients with acute coronary syndrome (ACS) using the COMBO Dual Therapy Stent.

REDUCE is a physician-initiated, prospective, multicenter, randomized study, designed to demonstrate non-inferiority of a strategy of short-term (three months) dual antiplatelet therapy (DAPT) as compared to standard 12-month DAPT in patients with ACS treated with a COMBO stent. The trial found no difference in the primary endpoint between three and 12 months DAPT (8.2 percent vs. 8.4 percent, Pnoninferiority<0.001; Psuperiority=0.88) in the intent to treat (ITT) population. COMBO is the only stent with prospective randomized controlled trial-based evidence, to support such a strategy in an ACS population.1

The optimal duration of DAPT in ACS patients treated with drug-eluting stents (DES) is still under debate. The potential benefits of long-term DAPT in avoiding thrombotic complications may be counterbalanced by a higher risk of major bleeding complications. Per U.S. and European guidelines, DAPT is typically continued for at least 12 months following percutaneous coronary intervention (PCI) with DES or bare metal stents, primarily based on the CURE trial that was conducted 20 years ago, and the use of first-generation DES. Therefore, REDUCE provided an opportunity to explore different DAPT regimens and a new generation stent.

“The REDUCE trial shows that among ACS patients treated with a COMBO stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups,” said Harry Suryapranata, M.D., Ph.D., professor of interventional cardiology at Radboud University Medical Center in Nijmegen, The Netherlands, and one of the principal investigators who presented the data at TCT. “Therefore, this strategy could be considered if needed, even in an ACS population. Future larger trials are needed to further investigate and confirm the safety of short-term DAPT regimen in ACS patients, particularly, in the era of new adenosine diphosphate (ADP) antagonists and new generation DES.” 

The overall incidence of the primary endpoint event (a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularization, moderate and major bleeding (BARC II, III or V)) was low at 8.3 percent in comparison to the original estimate of 12 percent based on contemporary trials. Furthermore, the results were consistent across all subgroups (age, gender, STEMI versus non-STEMI, geographic region and diabetes) without any significant statistical interaction. A pre-specified landmark analysis of the primary outcome from 3 months (i.e. the intended deviation of antiplatelet therapy between the groups) out to 360 days did not reveal significant differences either.

Among the secondary endpoints, major bleeding rates were similar among the treatment arms (2.5 percent vs. 3 percent, P=0.54), with non-significantly different rates of overall mortality (1.9 percent vs. 0.8 percent, P=0.07), cardiac mortality (1.1 percent vs. 0.4 percent, P=0.13), and definite/probable ST (1.2 percent vs. 0.4 percent, P=0.08), although the study was not powered to assess these individual endpoints.

For more information: www.tctconference.com

Reference

1. Suryapranata H, De Luca G. REDUCE: A Randomized Trial of 3-Month vs 12-Month DAPT After Implantation of a Bioabsorbable Polymer-Based Metallic DES with a Luminal CD34+Antibody Coating in Patients with ACS. Late-breaking oral presentation at the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium, November 1, 2017.

Related Content

TCT Announces 2017 Late-breaking Clinical Trial Presentations

Related Content

The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in patients with pre-existing cardiovascular disease who were taking 81 milligrams (mg) baby aspirin, versus 325 mg of daily aspirin. Getty Images #ACC #ACC21 #ACC2021

The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in patients with pre-existing cardiovascular disease who were taking 81 milligrams (mg) baby aspirin, versus 325 mg of daily aspirin. Getty Images

News | Antiplatelet and Anticoagulation Therapies | May 15, 2021
May 15, 2021 — The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in pat
A Chinese registry study found there are higher event rates in patients with shorter dual-antiplatelet therapy (DAPT) after PCI procedures. There has been a lot of movement toward using shorter duration DAPT with newer generation drug-eluting stent technologies, but this study reinforces the need longer DAPT in many patients. The findings were presented as a late-breaking trial at SCAI 2021 today. 

A Chinese registry study found there are higher event rates in patients with shorter dual-antiplatelet therapy (DAPT) after PCI procedures. There has been a lot of movement toward using shorter duration DAPT with newer generation drug-eluting stent technologies, but this study reinforces the need longer DAPT in many patients. The findings were presented as a late-breaking trial at SCAI 2021 today. 

News | Antiplatelet and Anticoagulation Therapies | April 28, 2021
April 28, 2021 — An analysis of the prospective Chinese Fuwai PCI Registry, confirms long-term,...
Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) can potentiate all 3 sides of Virchow’s Triad of coagulopathy, including endothelial dysfunction, blood flow stasis, and hypercoagulability. Angiotensin-converting enzyme-2 (ACE-2)–dependent viral entry and the virus-induced inflammatory response can lead to endothelial dysfunction. Clotting Prevention in COVID-19 Patients, Thrombosis Prevention in COVID-19 Patients, Preventing blood clots in COVID-19 patients

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) can potentiate all 3 sides of Virchow’s Triad of coagulopathy, including endothelial dysfunction, blood flow stasis and hypercoagulability. Angiotensin-converting enzyme-2 (ACE-2)–dependent viral entry and the virus-induced inflammatory response can lead to endothelial dysfunction. Additional figure included in the JACC article.

Feature | Antiplatelet and Anticoagulation Therapies | March 22, 2021 | By Dave Fornell, Editor
A comprehensive review or more than 80 randomized controlled trials (RCTs) investigating how to best manage optimal a
Tailor PCI trial showed genetic testing may play a role in personalizing antiplatelet therapy after PCI.
News | Antiplatelet and Anticoagulation Therapies | September 02, 2020
September 2, 2020 — An international, first-of-its-kind cardiology trial used personalized genetic testing to reduce
Naveen Pereira, M.D., co-principal investigator of the TAILOR-PCI study, explaining the conclusions of the late-breaking trial data during the virtual ACC20 meeting. #ACC20 #ACC2020

Naveen Pereira, M.D., co-principal investigator of the TAILOR-PCI study, explaining the conclusions of the late-breaking trial data during the virtual ACC20 meeting. 

News | Antiplatelet and Anticoagulation Therapies | March 28, 2020
March 28, 2020 — The TAILOR-PCI trial that used genetic testing to guide which antiplatelet medication was given to p