title: Restenosis and clinical outcome in patients treated with amlodipine after angioplasty: results from the Coronary AngioPlasty Amlodipine REStenosis Study (CAPARES).
abstract: OBJECTIVE
  Our intent was to investigate the effect of the dihydropyridine calcium channel blocker amlodipine on restenosis and clinical outcome in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).
  
  
  BACKGROUND
  Amlodipine has sustained vasodilatory effects and relieves coronary spasm, which may reduce luminal loss and clinical complications after PTCA.
  
  
  METHODS
  In a prospective, double-blind design, 635 patients were randomized to 10 mg of amlodipine or placebo. Pretreatment with the study drug started two weeks before PTCA and continued until four months after PTCA. The primary angiographic end point was loss in minimal lumen diameter (MLD) from post-PTCA to follow-up, as assessed by quantitative coronary angiography (QCA). Clinical end points were death, myocardial infarction, coronary artery bypass graft surgery and repeat PTCA (major adverse clinical events).
  
  
  RESULTS
  Angioplasty was performed in 585 patients (92.1%); 91 patients (15.6%) had coronary stents implanted. Follow-up angiography suitable for QCA analysis was done in 236 patients in the amlodipine group and 215 patients in the placebo group (per-protocol group). The mean loss in MLD was 0.30 +/- 0.45 mm in the amlodipine group versus 0.29 +/- 0.49 mm in the placebo group (p = 0.84). The need for repeat PTCA was significantly lower in the amlodipine versus the placebo group (10 [3.1%] vs. 23 patients [7.3%], p = 0.02, relative risk ratio [RR]: 0.45, 95% confidence interval [CI]: 0.22 to 0.91), and the composite incidence of clinical events (30 [9.4%] vs. 46 patients (14.5%), p = 0.049, RR: 0.65, CI: 0.43 to 0.99) within the four months follow-up period (intention-to-treat analysis).
  
  
  CONCLUSIONS
  Amlodipine therapy starting two weeks before PTCA did not reduce luminal loss, but the incidence of repeat PTCA and the composite major adverse clinical events were significantly reduced during the four-month follow-up period after PTCA with amlodipine as compared with placebo.
authors.affiliation: Department of Cardiology, Rikshospitalet, University of Oslo, Norway.
authors.forename: B
authors.initials: B
authors.lastname: Jørgensen
authors.forename: S
authors.initials: S
authors.lastname: Simonsen
authors.forename: K
authors.initials: K
authors.lastname: Endresen
authors.forename: K
authors.initials: K
authors.lastname: Forfang
authors.forename: K
authors.initials: K
authors.lastname: Vatne
authors.forename: J
authors.initials: J
authors.lastname: Hansen
authors.forename: J
authors.initials: J
authors.lastname: Webb
authors.forename: C
authors.initials: C
authors.lastname: Buller
authors.forename: G
authors.initials: G
authors.lastname: Goulet
authors.forename: J
authors.initials: J
authors.lastname: Erikssen
authors.forename: E
authors.initials: E
authors.lastname: Thaulow
mesh_terms: D017311:Amlodipine / Q000627:therapeutic use*; D015906:Angioplasty, Balloon, Coronary; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D002121:Calcium Channel Blockers; D017311:Amlodipine