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 - REDUCE

Contribution To Literature:

A 3-month duration of DAPT was noninferior to 12 months of DAPT for a composite endpoint among patients with ACS receiving a novel COMBO sirolimus-eluting BPS.


The goal of the trial was to assess the safety and efficacy of 3 vs. 12 months of dual antiplatelet therapy (DAPT) in patients treated with the COMBO stent (sirolimus-eluting bioresorbable polymeric stent [BPS] with CD34+ antibody coating on the luminal side).

Study Design

Patients with acute coronary syndrome (ACS) were randomized in a 1:1 fashion to either 3 months (n = 751) or 12 months of DAPT (n = 745).

  • Total number of enrollees: 1,496
  • Duration of follow-up: 1 year

Inclusion criteria:

  • ACS
  • Successful implant of COMBO stent

Principal Findings:

The primary outcome, composite of all-cause death, myocardial infarction (MI), stent thrombosis, stroke, target vessel revascularization (TVR), or bleeding for 3-month vs. 12-month DAPT, was 91.7% vs. 91.5%, p for noninferiority < 0.001, p for superiority = 0.88.

  • All-cause mortality: 1.9% vs. 0.8%, p = 0.07
  • MI: 2.3% vs. 1.9%, p = 0.57
  • Stent thrombosis: 1.2% vs. 0.4%, p = 0.08
  • TVR: 3.3% vs. 3.4%, p = 0.35

Secondary outcomes for 3-month vs. 12-month DAPT:

  • Cardiac mortality: 1.1% vs. 0.4%, p = 0.13
  • Bleeding: 2.5% vs. 3.0%, p = 0.54


The results of this trial indicate that 3-month duration of DAPT was noninferior to 12-month DAPT for a composite endpoint among patients with ACS receiving a novel COMBO sirolimus-eluting BPS. There were, however, concerning safety signals with a higher risk of all-cause mortality and stent thrombosis with shorter duration of DAPT, with no difference in bleeding. The study was underpowered to assess these safety signals further.

Although the COMBO stent is a sirolimus-eluting stent (SES), it appears to have a higher late lumen loss (~0.3 mm) compared with the Cypher SES (0.15-0.2 mm). The clinical utility of this stent also remains to be defined. 


Presented by Dr. Harry Suryapranata at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2017), Denver, CO, November 1, 2017.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS

Keywords: Absorbable Implants, Acute Coronary Syndrome, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Revascularization, Platelet Aggregation Inhibitors, Sirolimus, Stents, Thrombosis, TCT17, Transcatheter Cardiovascular Therapeutics

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