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).
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
- Successful implant of COMBO stent
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.
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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