A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch

Final Results of the AGILITY Trial

Authors


  • Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT00686647

  • Conflict of interest: Dr. Weisz is a consultant to Tryton Medical. Dr. Gershony is a founder and owns equity in AngioScore. Dr. O'Shaughnessy is on the speaker bureau for AngioScore. Dr. Turco is an employee of Covidien. Dr. Leon serves on AngioScore's Medical Advisory Board.

Correspondence to: Giora Weisz, MD, Associate Professor of Clinical Medicine, Center for Interventional Vascular Therapy, NewYork Presbyterian Hospital, Columbia University Medical Center, Columbia University, 161 Fort Washington Avenue, 6th Floor, New York, NY 10032. E-mail: gw2128@columbia.edu

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.

Methods and 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).

Conclusion

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. © 2013 Wiley Periodicals, Inc.

Ancillary