title: A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial.
abstract: BACKGROUND
  The provisional approach for bifurcation stenting with side-branch balloon angioplasty is associated with dissections and suboptimal results requiring kissing balloon techniques or bailout stenting. We hypothesized that using a scoring balloon for the side branch and a drug-eluting stent for the main vessel might improve outcomes of true bifurcation lesions.
  
  
  RESULTS
  A total of 93 patients with complex bifurcations were enrolled in a multicenter, single-arm, prospective clinical trial. A drug-eluting stent was deployed in the main vessel following dilatation of the side-branch stenosis with a scoring balloon. The overall angiographic success rate was 93.5%, and procedural success rate was 91.4%. The final diameter stenosis was 13.9% ± 7.2% for the main vessel and 33.3% ± 22.9% for the side branch. Crossover to stent deployment in the side branch was required in 10.8%. The postscoring balloon dissection rate was 8.2% and 6% (all ≤ class C) for the main vessel and side branch respectively, which was reduced to 1.1 and 2.1% poststenting. At 9-month follow-up, the composite MACE rate [cardiac death, myocardial infarction, or target lesion revascularization (TLR)] was 5.4%, including a TLR rate of 3.3% (1.1% from hospital discharge to 9 months).
  
  
  CONCLUSIONS
  The 9-month results of the AGILITY trial support a simple provisional strategy for treating complex true bifurcation lesions with deployment of a drug-eluting stent in the main vessel after dilatation of the side-branch vessel with a scoring balloon. This strategy was associated with excellent and safe procedural results, a low rate of crossover to side-branch stenting, and favorable outcomes.
authors.affiliation: NewYork Presbyterian Hospital, Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.forename: D Christopher
authors.initials: DC
authors.lastname: Metzger
authors.forename: Henry A
authors.initials: HA
authors.lastname: Liberman
authors.forename: Charles D
authors.initials: CD
authors.lastname: O'Shaughnessy
authors.forename: John S
authors.initials: JS
authors.lastname: Douglas
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turco
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Gary
authors.initials: G
authors.lastname: Gershony
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States