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Long-term effectiveness and safety of statin therapy

A retrospective real-world study of symptomatic patients with peripheral arterial occlusive disease after revascularisation

Main Takeaway

  • Initiating statin therapy in symptomatic patients with peripheral arterial occlusive disease (PAOD) after index revascularisation was efficacious and safe
    • The treatment benefits in this patient population included prolonged survival benefits, lower risk of major amputation, and lower risk of cardiovascular events

Why This Matters

  • Statin therapy has been underutilised in this therapeutic landscape and there is a need to increase awareness for the secondary prevention of PAOD
    • This real-world study utilising health insurance claims data supports the use of statin therapy in patients with PAOD

Study Design

  • Retrospective study: utilising health insurance claims data from BARMER (Germany’s second-largest insurance fund) is part of a larger project on outcomes of patients with PAOD after revascularisation (2008–2018)
    • 22,208 symptomatic patients with PAOD (mean age = 71.1 years; women = 50.3%) were included in the study
    • A comparison was made between patients with and without statin therapy in addition to antithrombotics during the first quarter after discharge (new users versus nonusers)
  • All analyses were stratified into patients with chronic limb‐threatening ischemia (CLTI) and intermittent claudication (IC)
    • Propensity score matching: n = 10,922 (CLTI: n = 4,224; IC: n = 6,698)
    • Key inclusion criteria: statin-naive patients without statin utilisation for ≥3 years before index stay; patients with ≥1 prescription for an antithrombotic agent during the first quarter after discharge
    • Key exclusion criteria: patients aged <40 years; patients with prior major amputation or recorded myopathy; patients discharged without revascularisation and death; patients with major amputation; and patients with cardiovascular events during the first quarter after discharge
    • Primary outcome: all-cause mortality during follow-up
    • Secondary outcomes: incident major amputation and cardiovascular events (myocardial infarction, stroke, or transient ischemic attack)
    • Safety outcomes: incident diabetes mellitus and incident myopathy

Key Results

  • Long-term effectiveness outcomes in the matched sample:
    • New users had a significant 5% lower probability for all-cause mortality versus the nonusers
      • CLTI: HR: 0.75; 95% CI, 0.68–0.84
      • IC: HR: 0.80; 95% CI, 0.70–0.92
    • Statin initiation was associated with:
      • 7% lower risk of major amputation in CLTI group (HR, 0.73; 95% CI, 0.58–0.93)
      • A lower risk for cardiovascular events in IC group (HR, 0.80; 95% CI, 0.70–0.92)
      • 8.8% lower probability of dying in the CLTI group (37.3% versus 46.1%)
      • 3.4% lower probability of dying in the IC group (15.5% versus 18.9%)

Long-term safety outcomes in the reduced matched study sample: No significant differences were detected in the probability for incident diabetes mellitus (in the reduced sample) or myopathy between the study groups

Limitations

  • This is a hypothesis generating study (not a hypothesis testing study)
  • Propensity-score matching could not fully exclude all potential sources of bias
  • The study included only patients insured at a single health insurance fund
  • The study did not address all contraindications, statin intolerance, or other adverse reactions
  • The inexistent association of statin use and diabetes mellitus or myopathy risk in the study sample maybe due to insufficient differentiation by statin type

Reference

  1. Peters F, Kuchenbecker J, Kreutzburg T, Marschall U, Debus ES, Behrendt CA. Long-term effectiveness and safety of initiating statin therapy after index revascularization in patients with peripheral arterial occlusive disease. J Am Heart Assoc. 2020;9(22):e018338. doi: 10.1161/JAHA.120.018338.
MAT-QA-2100066/V1/OCT2021