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

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 2017;Nov 1:[Epub ahead of print].

Editorial Comment: Gerber RT, Gershlick AH. A SENIOR moment? Bare-metal stents in elderly patients. Lancet 2017;Nov 1:[Epub ahead of print].

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

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Chronic Angina

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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