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PD SURG

Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial

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Year of Publication: 2010

Authors: Adrian Williams, Steven Gill, Thelekat Varma, et al.

Journal: Lancet Neurology

Citation: Lancet Neurol 2010;9:581-91

Link: https://doi.org/10.1016/S1474-4422(10)70093-4

PDF: http://www.thelancet.com/article/S1474442210700934/pdf

Clinical Question

Does DBS plus medical therapy improve QoL more than medical therapy alone in advanced PD?

Study Overview

Objective

To assess whether DBS plus best medical therapy improved quality of life more than best medical therapy alone in advanced PD

Study Summary

  • PDQ-39 improved 5.0 points (surgery) vs 0.3 points (medical); difference -4.7 (P=0.001)
  • 19% of surgery patients had serious surgery-related adverse events including 1 death

Intervention

Bilateral STN-DBS (97%) plus best medical therapy vs best medical therapy alone

Patients per Arm

183 vs 183

Bottom Line

In patients with advanced PD, adding DBS to best medical therapy improved patient-reported quality of life on the PDQ-39 summary index with a between-group difference of -4.7 points at 1 year (surgery -5.0 vs medical -0.3; 95% CI -7.6 to -1.8; P=0.001). 366 patients randomised 1:1 across 13 UK neurosurgical centres. STN was the predominant target (with a small number of GPi cases). Pragmatic UK trial; published Lancet Neurology 2010 (Williams et al.).

Major Points

  • Primary: PDQ-39 summary index change from baseline at 1 year — surgery -5.0 vs medical -0.3; between-group difference -4.7 (95% CI -7.6 to -1.8), P=0.001.
  • UPDRS Part III motor (off medication) change from baseline: surgery -17.2 vs medical -0.4; between-group difference in mean change -16.8 (95% CI -20.1 to -13.4), P<0.0001.
  • Levodopa equivalent dose at 1 year: surgery 894 mg/day vs medical 1347 mg/day (difference 453 mg/day, ~34% lower with surgery; P<0.0001).
  • 366 patients randomised 1:1 at 13 UK neurosurgical centres. Pragmatic design — of 178 who had surgery, 174 STN and 4 GPi; 176 bilateral.
  • Surgery-related SAEs: 36 of 178 patients who had surgery had 43 events; most common was infection (n=16); 1 procedure-related death (haemorrhage).
  • PDQ-39 domain benefits significant in mobility, activities of daily living, and bodily discomfort only; stigma change -5.2 (95% CI -10.4 to 0.03; p=0.05) — not significant; also not significant in social support, cognition, or communication.
  • Dyskinesia at 1 year: 48% (75/155) surgery vs 14% (21/151) medical reported none (P<0.0001); off time also improved with surgery.
  • Patients recruited had advanced PD with motor complications despite optimised medical therapy.
  • Funded by UK Medical Research Council, Parkinson's UK, and UK Department of Health.
  • STN was the predominant target (~98% of surgeries who received DBS); GPi used in 4/178.

Design

Study Type: Randomized, open-label

Blinding: Open-label

Sample Size: 366

Centers: 13

Follow-up Duration: 1 year

Inclusion Criteria

  • Parkinson's disease per UK Brain Bank criteria
  • Inadequate symptom control with medication
  • Age-adjusted score >5 on Dementia Rating Scale-II (DRS-II)
  • Fitness for surgery

Exclusion Criteria

  • Not explicitly detailed

Arms

FieldDBS + best medical therapyControl
InterventionBilateral subthalamic nucleus (STN) DBS in ~98% of surgeries (GPi in 4/178); plus best medical therapyBest medical therapy without DBS
Duration12 months12 months

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
PDQ-39 summary index change from baseline at 1 yearPrimary-0.3 points-5.0 points0.001
UPDRS Part III motor (off medication) change from baselineSecondarySurgery -17.2 vs medical -0.4; between-group difference in mean change -16.8 (95% CI -20.1 to -13.4), P<0.0001
No dyskinesia at 1 yearSecondary48% (75/155) surgery vs 14% (21/151) medical, P<0.0001
Levodopa equivalent dose at 1 yearSecondarySurgery 894 mg/day vs medical 1347 mg/day; ~34% lower with surgery, P<0.0001

Criticisms

  • Open-label design
  • No sham surgery control
  • 19% serious surgery-related adverse events (including 1 procedure-related death from haemorrhage)
  • Smaller PDQ-39 effect than reported in 6-month DBS trials (4.7 vs 8.7 points)

Funding

UK Medical Research Council, Parkinson's UK, and UK Department of Health

Based on: PD SURG (Lancet Neurology, 2010)

Authors: Adrian Williams, Steven Gill, Thelekat Varma, et al.

Citation: Lancet Neurol 2010;9:581-91

Reviewed by: Ahmed Koriesh, MD

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