Improved procedural results of coronary angioplasty with intravascular ultrasound-guided balloon sizing: the CLOUT Pilot Trial. Clinical Outcomes With Ultrasound Trial (CLOUT) Investigators

Circulation. 1997 Apr 15;95(8):2044-52. doi: 10.1161/01.cir.95.8.2044.

Abstract

Background: Indiscriminate use of balloons larger than the angiographic reference segment lumen results in high rates of ischemic complications after percutaneous transluminal coronary angioplasty (PTCA). We hypothesized that angiographically unsuspected atheromatous remodeling with vessel expansion (the Glagov phenomenon) at and adjacent to PTCA target lesions would safely accommodate oversized balloons in selected patients undergoing PTCA with intravascular ultrasound (IVUS) guidance.

Methods and results: After angiographically guided PTCA of 104 lesions in 102 patients, IVUS was performed, and if atheromatous remodeling was present, PTCA was repeated with larger balloons sized halfway between the lumen and external elastic membrane. Plaque occupied a mean of 51+/-15% of the angiographically "normal" reference segments. Further balloon upsizing by 0.25 to 1.25 mm was therefore performed in 76 lesions (73%), increasing the nominal balloon-to-artery ratio from 1.12+/-0.15 after standard PTCA to 1.30+/-0.17 after IVUS-guided PTCA (P<.0001). As a result, the angiographic minimal luminal diameter further increased from 1.95+/-0.49 to 2.21+/-0.47 mm, the % diameter stenosis fell from 28+/-15% to 18+/-14%, and the IVUS lumen area rose from 3.16+/-1.04 to 4.52+/-1.14 mm2 (all P<.0001). The incidence of angiographic dissection was not increased after IVUS-guided balloon upsizing (37% versus 40%, P=.67), and major complications occurred in only 2 patients (1.9%).

Conclusions: The demonstration by IVUS of atheromatous remodeling permits the safe use of balloons traditionally considered oversized, resulting in significantly improved luminal dimensions without increased rates of dissection or ischemic complications.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Aortic Dissection / epidemiology
  • Aortic Dissection / etiology
  • Arteriosclerosis / diagnostic imaging
  • Arteriosclerosis / pathology
  • Arteriosclerosis / therapy*
  • Coronary Angiography
  • Coronary Disease / diagnostic imaging
  • Coronary Disease / pathology
  • Coronary Disease / therapy*
  • Coronary Vessels / diagnostic imaging*
  • Coronary Vessels / injuries
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Reference Standards
  • Ultrasonography