Ultrasound-Guided Stratification for Provisional Stenting With Focal Balloon Combination Catheter. Results From the Randomized Strategy for Intracoronary Ultrasound-Guided PTCA and Stenting (SIPS) Trial - SIPS

Description:

Ultrasound-Guided Stratification for Provisional Stenting With Focal Balloon Combination Catheter. Results From the Randomized Strategy for Intracoronary Ultrasound-Guided PTCA and Stenting (SIPS) Trial

Hypothesis:

Provisional stenting has been proposed as an alternative to routine stenting. The objective of this study was to determine if routine intracoronary ultrasound guidance (ICUS) can improve outcomes of provisional stenting when compared with standard angiography.

Study Design

Study Design:

Patients Enrolled: 269

Drug/Procedures Used:

A total of 269 patients (291 procedures) were randomized to either ICUS or angiography-guided provisional stenting. Stenting was discouraged unless a significant dissection was present or angiographic results were unacceptable. In the ICUS group, balloon sizing was determined using the ICUS-derived CLOUT (Clinical Outcomes with Ultrasound Trial) criteria; balloon dilation was performed using a combination ICUS/variable diameter balloon system (Oracle Focus, Endosonic), and repeat inflations were performed until the minimal lumen area was > 65% of the mean reference area. Clinical end points included procedure success (< 50% residual stenosis in the absence of repeat revascularization, myocardial infarction or death prior to discharge), angiographic restenosis, target lesion revascularization (TLR) and a composite of death, MI and repeat revascularization (MACE).

Principal Findings:

When compared with the angiography group, the ICUS group had a higher procedure success rate (94.7% vs 87.4%, p = 0.033), a larger acute gain (1.85 +/- 0.72 vs. 1.67 +/- 0.76, p = 0.02), and a similar minimal lumen diameter (2.49 +/- 0.66 vs. 2.38 +/- 0.67, p = 0.12). Stenting rates were similar (50.3% and 50.5% respectively, p = 0.96), while there was a trend toward a lower acute TLR rate in the ICUS group (2.3% vs. 5.7%, p = 0.15). At 6 months follow-up, there were no significant differences in minimal lumen diameter (1.71 +/- 0.94 vs. 1.57 +/- 0.90, p = 0.19) and restenosis rates (29% vs. 35%, p = 0.42). At 2-year follow-up, clinically driven TLR was significantly lower in the ICUS group when compared with the angiographic group (17% vs. 29%, p = 0.02), while there were no significant differences in MACE rates (30% vs. 37%, p = 0.2).

ICUS-guided provisional stenting results in a lower 2-year clinically driven TLR post interventions, but no difference in major adverse cardiac events.

Interpretation:

ICUS-guided provisional stenting results in a lower 2-year clinically driven TLR post interventions, but no difference in major adverse cardiac events.

References:

1. Axel W Frey, Hodgson JM, Muller C, Bestehorn HP, Roskamm H. Circulation 2000;102:2497-502.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Constriction, Pathologic, Stents


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