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Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study - CRUISE
Description:
Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study
Hypothesis:
The role of intravascular ultrasound (IVUS) in contemporary high-pressure coronary stenting remains controversial. The objective of this study was to determine if IVUS-assisted stenting results in better outcomes when compared with angiography-assisted stenting.
Study Design
Study Design:
Patients Enrolled: 522
Drug/Procedures Used:
Sixteen of 45 centers participating to the Stent Anti-Thrombotic Regimen Study (STARS) were selected for an ultrasound substudy. The use of IVUS was assigned on a center-by-center basis, that is, each center performed either IVUS or angiographic optimization of stent deployment. The primary end point was angiographic minimal luminal diameter, ultrasound minimal luminal diameter and ultrasound minimal stent area. The secondary end point was a combined end point including death, MI and target vessel revascularization (TVR) at 9 months follow-up.
Principal Findings:
Complete data at 9 months were available for 499 of 522 patients enrolled. The IVUS-guided group had a larger minimal luminal diameter (2.9mm +/- 0.4 vs. 2.7mm +/- 0.5, p < 0.001), a lower residual diameter stenosis (7.6 +/- 10.4% vs. 9.8 +/- 11.2%, p < 0.001), a larger stent area (7.78mm2 +/- 1.72 vs. 7.06mm2 +/- 2.13, p < 0.001) and higher final balloon size and inflation pressure (3.88mm +/- 0.51 vs. 3.69mm +/- 0.59 for size, and 18.0 atm +/- 2.58 vs. 16.6 atm +/- 3.01 for pressure; both p <0.001). TVR was significantly lower in the IVUS group (8.5% vs. 15.3%, p <0.05), while there were no differences in the incidence of death or MI. Additional therapy based on IVUS information was used in 36% of patients (higher pressures in 59% of patients, larger balloons in 33.7% and an additional stent in 7%).
IVUS-guided stent deployment results in improved stent expansion and a lower TVR compared with angiographic guidance alone.
Interpretation:
There were no differences in death or MI rates, and the observed benefit was limited to a reduction of an already low TVR rate. Due to the unusual study design that was dictated by the larger STARS trial, the study has several limitations and the possibility of bias in revascularization strategies cannot be excluded.
References:
1. Fitzgerald PJ, Oshima A, and Hayase M. Circulation 2000;102:523–30.
Keywords: Coronary Artery Disease, Follow-Up Studies, Constriction, Pathologic, Stents
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