title: Continued benefit of  coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.
abstract: OBJECTIVE
  This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years.
  
  
  BACKGROUND
  The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation.
  
  
  METHODS
  Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle.
  
  
  RESULTS
  No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance.
  
  
  CONCLUSIONS
  The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.
authors.affiliation: Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Kiemeneij
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: C
authors.initials: C
authors.lastname: Macaya
authors.forename: W
authors.initials: W
authors.lastname: Rutsch
authors.forename: G
authors.initials: G
authors.lastname: Heyndrickx
authors.forename: P
authors.initials: P
authors.lastname: Albertsson
authors.forename: J
authors.initials: J
authors.lastname: Fajadet
authors.forename: V
authors.initials: V
authors.lastname: Legrand
authors.forename: P
authors.initials: P
authors.lastname: Materne
authors.forename: J
authors.initials: J
authors.lastname: Belardi
authors.forename: U
authors.initials: U
authors.lastname: Sigwart
authors.forename: A
authors.initials: A
authors.lastname: Colombo
authors.forename: J J
authors.initials: JJ
authors.lastname: Goy
authors.forename: C M
authors.initials: CM
authors.lastname: Disco
authors.forename: M A
authors.initials: MA
authors.lastname: Morel
mesh_terms: D000787:Angina Pectoris / Q000145:classification / Q000150:complications / Q000401:mortality / Q000601:surgery*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D002423:Cause of Death; D001026:Coronary Artery Bypass; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D009203:Myocardial Infarction / Q000209:etiology; D016016:Proportional Hazards Models; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D012008:Recurrence; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents / Q000009:adverse effects / Q000592:standards*; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome