Randomized evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: rationale and design of the REDUCE trial

Camaro, Cyril; Damen, Sander; Brouwer, Marc A.; Kedhi, Elvin; Lee, Stephan W.; Verdoia, Monica; Barbieri, Lucia; Rognoni, Andrea; Hof, Arnoud W J van ‘t; Ligtenberg, Erik; Boer, Menko‐Jan de; Suryapranata, Harry; Luca, Giuseppe De

doi:10.1016/j.ahj.2016.04.016

Cited by 20 publications

(20 citation statements)

References 47 publications

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“…The baseline characteristics of included studies are shown in Table . Among the 10 trials, 3 trials exclusively enrolled ACS patients . The other seven trials enrolled both stable angina and ACS patients with reported outcomes for the ACS subgroup .…”

Section: Resultsmentioning

confidence: 99%

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Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Misumida

Abo-Aly

Kim

et al. 2018

Clinical Cardiology

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Section: Resultsmentioning

confidence: 99%

“…tctmd.com). 17,18 We excluded studies that did not report outcomes of interest in the ACS subgroup. 2,[19][20][21] The baseline characteristics of included studies are shown in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Misumida

Abo-Aly

Kim

et al. 2018

Clinical Cardiology

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“…The REDUCE trial compared 3 months of DAPT after ACS in patients treated with COMBO with standard 12 months of DAPT. Primary outcome was a composite endpoint of bleeding and ischemic events (cardiac death, MI, stroke, ST or TVR or BARC II, III and V bleeding) . Results have been presented at Transcatheter Therapeutics Congress in November 2017, and among ACS patients treated with COMBO stent, 3‐months DAPT is not inferior to 12‐months DAPT.…”

Section: Discussion and Limitationsmentioning

confidence: 99%

Three‐year clinical outcomes after dual‐therapy COMBO stent placement: Insights from the REMEDEE registry

Kalkman

Kerkmeijer

Menown

et al. 2018

Cathet Cardio Intervent

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Background The bio‐engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual‐therapy pro‐healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent. Methods and results The prospective, multicenter, investigator‐initiated, all‐comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow‐up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3‐year follow‐up there were only 73 patients taking DAPT. Conclusions At 3‐year follow‐up, patients treated with COMBO stent in the present large prospective all‐comers cohort, continue to show good clinical outcomes. http://Clinicaltrials.gov identifier: NCT01874002. Condensed abstract The COMBO stent is a sirolimus‐eluting stent with a luminal anti‐CD34‐antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all‐comers patients treated with COMBO stent. Target lesion failure at 3 year follow‐up was 10.7% and the rate of definite ST was 0.7%.

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“…In the REDUCE trial [ 47 ], 3-month vs. 12-month DAPT was assessed for safety and efficacy after implantation of a bioabsorbable polymer-based metallic sirolimus eluting stent with a luminal CD34+ antibody coating in patients with ACS. The rationale behind testing such a stent was to use the combination of abluminal release of sirolimus (to prevent neointima formation), and capture of endothelial progenitor cells (to enhance stent re-endothelialization).…”

Section: Evidence On Dapt Durationmentioning

confidence: 99%

Antiplatelet Therapy in Coronary Artery Disease: A Daunting Dilemma

Diver

Vashist

2018

JCM

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Percutaneous coronary intervention (PCI) with stenting for the treatment of acute coronary syndrome (ACS) is the contemporary standard of care. Such treatment is followed by dual antiplatelet therapy (DAPT) comprising of aspirin and a P2Y12 inhibitor. The efficacy of this therapy has been well established but the optimal duration of DAPT remains elusive, and has thus far attracted a prodigious deal of scientific attention. The decision regarding DAPT duration can be clinically challenging in the modern era with the evolution of newer stents, more potent antiplatelet agents, and novel anticoagulant drugs in addition to an older patient population with multiple comorbidities. Major societal guidelines have emphasized comprehensive assessment of ischemic and bleeding risk, in turn recommending individualization of DAPT duration, thus encouraging “shared decision making”. The following review is aimed at critically evaluating the available evidence to help make these crucial clinical decisions regarding duration of DAPT and triple therapy.

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Randomized evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: rationale and design of the REDUCE trial

Cited by 20 publications

References 47 publications

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Three‐year clinical outcomes after dual‐therapy COMBO stent placement: Insights from the REMEDEE registry

Antiplatelet Therapy in Coronary Artery Disease: A Daunting Dilemma

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