A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs. a BMS With Short DAPT in Patients With Coronary Artery Disease Older Than 75 Years - SENIOR

Jan 16, 2018
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Boston Scientific
Date Presented:
11/01/2017
Date Published:
11/01/2017
Date Updated:
01/16/2018
Original Posted Date:
11/01/2017
References

Contribution To Literature:

Among elderly patients (age ≥75 years) undergoing PCI with a shorter duration of DAPT, use of a BP-DES resulted in lower adverse clinical event rates at 1 year compared with BMS.

Description:

The goal of the trial was to assess the safety and efficacy of shorter durations of dual antiplatelet therapy (DAPT) among elderly patients receiving a bioresorbable polymer (BP)-DES vs. bare-metal stent (BMS).

Study Design

Elderly patients undergoing primary percutaneous coronary intervention (PCI) were randomized in a 1:1 fashion to either BP-DES (n = 596) or BMS (n = 604). The DES used was Boston Scientific’s Synergy stent, which elutes everolimus. Patients received either 1 month (for stable angina) or 6 months (for acute coronary syndrome [ACS]) of DAPT.

  • Total number of enrollees: 1,200
  • Duration of follow-up: 1 year
  • Mean patient age: 81 years
  • Percentage female: 38%
  • Percentage with diabetes: 26%

Inclusion criteria:

  • Patients are ≥75 years
  • Presence of ≥1 stenosis (≥70%) in any coronary (or left main ≥50%) artery
  • Stable angina, silent ischemia, or ACS

Exclusion criteria:

  • Unable to comply with DAPT as indicated
  • Planned surgery within 1 month
  • Life expectancy <1 year
  • Prior hemorrhagic stroke
  • Indication for surgical revascularization
  • Known allergy to aspirin or P2Y12 inhibitor

Other salient features/characteristics:

  • Atrial fibrillation: 18%
  • Indication for PCI: stable angina: 20%, silent ischemia: 34%, ST-segment elevation myocardial infarction (STEMI): 11%
  • Radial approach: 80%
  • Multivessel disease: 32%
  • Stents per patient: 1.7

Only ~20% of patients were on DAPT beyond 6 months.

Principal Findings:

The primary outcome, all-cause mortality, MI, stroke, ischemia-driven target lesion revascularization (ID-TLR), for BP-DES vs. BMS, was 11.6% vs. 16.4%, p = 0.016.

  • All-cause mortality: 6.1% vs. 8%, p = 0.20
  • MI: 3.6% vs. 3.7%, p = 0.92
  • ID-TLR: 1.7% vs. 5.9%, p = 0.0002
  • Stroke: 2% vs. 0.8%, p = 0.08

Secondary outcomes for BP-DES vs. BMS:

  • BARC 2-5 bleeding: 4.5% vs. 5.0%, p = 0.68
  • Stent thrombosis: 0.5% vs. 1.4%, p = 0.13

Interpretation:

The results of this trial indicate that among elderly patients (age ≥75 years) undergoing PCI with a shorter duration of DAPT, use of a BP-DES resulted in lower adverse clinical event rates at 1 year compared with BMS (1 month for non-ACS, 6 months for ACS). This was driven predominantly due to a lower risk of repeat revascularization with DES. This trial suggests that PCI with a BP-DES may be a better alternative to BMS among elderly patients in whom reducing DAPT duration is desirable.

References:

Varenne O, Cook S, Sideris G, et al., on behalf of the SENIOR Investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet 2018;391:41-50.

Editorial Comment: Gerber RT, Gershlick AH. A SENIOR moment? Bare-metal stents in elderly patients. Lancet 2018;391:4-6.

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

Keywords: Absorbable Implants, Acute Coronary Syndrome, Angina, Stable, Coronary Artery Disease, Drug-Eluting Stents, Geriatrics, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Polymers, Stents, Stroke, Thrombosis, TCT17, Transcatheter Cardiovascular Therapeutics


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