title: Early and late effects of coumarin therapy started before percutaneous coronary intervention: Clinical, angiographic and cost-effective outcome of the Balloon Angioplasty and Anticoagulation Study (BAAS).
abstract: BACKGROUND
  Coronary angioplasty frequently creates a thrombogenic surface with subsequent mural thrombosis that may lead to acute complications and possibly stimulates the development of restenosis. Whether coumarins can prevent these complications is unclear.
  
  
  METHODS
  In the Balloon Angioplasty and Anticoagulation Study (BAAS), the effect of coumarins started before the procedure on early and late outcome was studied. Patients were randomised to aspirin only or to aspirin plus coumarins. Half of the patients were randomised to undergo six-month angiographic follow-up. Study medication was started one week before coronary angioplasty and the target international normalised ratio (INR) was 2.1-4.8 during angioplasty and six-month follow-up. 'Optimal' anticoagulation was defined as an INR in the target range for at least 70% of the follow-up time. In addition, cost-effectiveness of coumarin treatment was measured.
  
  
  RESULTS
  At one year death, myocardial infarction, target-lesion revascularisation and stroke were observed in 14.3% of the 530 patients randomised to aspirin plus coumarin versus in 20.3% of the 528 patients randomised to aspirin alone (relative risk 0.71; 95% CI 0.54-0.93). The incidence of major bleedings and false aneurysms during hospitalisation was 3.2% and 1.0%, respectively, (relative risk 3.39; 95% CI 1.26-9.11). Optimal anticoagulation was an independent predictor of late thrombotic events (relative risk, 0.33; 95% CI, 0.19-0.57). Quantitative coronary analysis was performed of 301 lesions in the ASA group and of 297 lesions in the coumarin group. At six months, the minimal luminal diameter was similar in the ASA and coumarin group. However, optimal anticoagulation was an independent predictor of angiographic outcome at six months. Optimal anticoagulation led to a 0.21 mm (95% CI: 0.05-0.37) larger MLD as compared with suboptimal anticoagulation whereas aspirin use led to a 0.12 mm (95% CI -0.28-0.04) smaller MLD. When including all costs, the savings associated with coumarin treatment were estimated at € 235 per patient after one year.
  
  
  CONCLUSIONS
  Coumarin pretreatment reduces early and late events in patients undergoing percutaneous coronary intervention at the expense of a small increase in nonfatal bleeding complications. Furthermore, an optimal level of anticoagulation is associated with a significantly better outcome as compared with a suboptimal level of anticoagulation. In addition, coumarin treatment reduces costs.
authors.forename: J M
authors.initials: JM
authors.lastname: Ten Berg
authors.forename: J C
authors.initials: JC
authors.lastname: Kelder
authors.forename: M J
authors.initials: MJ
authors.lastname: Suttorp
authors.forename: E G
authors.initials: EG
authors.lastname: Mast
authors.forename: E T
authors.initials: ET
authors.lastname: Bal
authors.forename: J M P G
authors.initials: JM
authors.lastname: Ernst
authors.forename: H W M
authors.initials: HW
authors.lastname: Plokker
keywords: coumarin therapy; percutaneous coronary intervention