Anticoagulation: a multicomponent intervention does not clearly reduce major bleeding in the elderly

Clinical bottom line (level 1b-)

  1. Elderly patients starting anticoagulation who received education and guideline-based dosing compared with usual care were not clearly less likely to have a major bleed, die or a recurrent venous thromboembolism.
Beyth et al: Annals of Internal Medicine 2000; 133 : 687-695
Expires October 2003

The study

Single-blinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, USA

325 patients (aged 65 to 94 mean 75, 57% female) requiring anticoagulation (indications included venous thromboembolism - 38%; atrial fibrillation - 17%, stroke - 15%, heart prostheses - 15%)

Excluded if
  • enrolled in another clinical trial
  • warfarin therapy planned for < 10 days, or already on warfarin
  • orthopaedic patient
  • early discharge
  • on high-dose heparin prophylactically
  • admitted from nursing home
  • too ill to give consent and no surrogate
  • did not live locally
  • aged < 65

Control Group: (n = 162, 162 analysed): usual care
Experimental Group: (n = 163, 163 analysed): multicomponent intervention: patient education about warfarin, training to increase patient participation, self-monitoring of prothrombin time and guideline-based management of warfarin dosing

100% followed for 3 months
Outcome notes:

  • major bleeding : overt bleeding leading to loss of at least 2 units of blood within 7 days or otherwise life-threatening

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
major bleeding 6 months 17
(10.5%)		 8
(4.91%)		 53%
(-5% to 79%)		 5.59%
(-0.18% to 11.4%)		 18
(NNT = 9 to infinity;
NNH = 550 to infinity)
death 6 months 26
(16.1%)		 21
(12.9%)		 20%
(-37% to 53%)		 3.17%
(-4.48% to 10.8%)		 32
(NNT = 9 to infinity;
NNH = 22 to infinity)
recurrent venous thromboembolism 6 months 21
(13.0%)		 14
(8.59%)		 34%
(-26% to 65%)		 4.37%
(-2.35% to 11.1%)		 23
(NNT = 9 to infinity;
NNH = 42 to infinity)

Comments

  1. Patients were stratified for baseline risk for major bleeding
  2. The study was too small to show any differences between the two groups.

Citation

  1. Beyth RJ, Quinn L, Landefeld CS: a multicomponent intervention to prevent major bleeding complications in older patient receiving warfarin: a randomized, controlled trial. Annals of Internal Medicine 2000; 133 : 687-695
Search Terms: from EBM journal
Contributor: Chris Ball, October 2001
Reviewer:

Clinical Question.
Patient elderly starting anticoagulation
Intervention or Exposure guideline-based dosing, education
Comparison usual care
Outcome major bleeding, death, recurrent venous thromboembolism