Author + information
- Evan Shlofmitz1,
- Brad Martinsen2,
- Michael Lee3,
- Philippe Genereux4,
- Gautam Kumar5,
- Richard Shlofmitz6 and
- Jeffrey Chambers7
- 1Northwell Health, Manhasset, NY
- 2Cardiovascular Systems, Inc., St. Paul, MN
- 3UCLA Medical Center, Los Angeles, CA
- 4Hôpital du Sacré-Coeur de Montréal, Montreal, QC, Canada
- 5Emory University Hospital, Atlanta, GA
- 6St. Francis Hospital, Roslyn, NY
- 7Metropolitan Heart and Vascular Institute, Minneapolis, MN
PCI of severely calcified lesions is associated with high rates of MACE and restenosis. IVUS provides additional diagnostic information to aid in optimization of treatment. We sought to assess the outcomes of patients in which IVUS was used prior to treatment with Diamondback 360° Coronary Orbital Atherectomy System (OAS; CSI, St. Paul, MN) versus OAS alone.
ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with de novo severely calcified coronary lesions. Patients who had IVUS prior to treatment with OAS (n= 35) were compared to those treated with OAS alone (n=405). In this post-hoc sub-analysis we evaluated the procedural outcomes, as well as the resulting 3-year MACE rate composed of cardiac death, MI, and TVR.
Patients who underwent IVUS prior to OAS treatment (IVUS+OAS) were younger (68.1 ± 8.4 vs. 71.7 ± 10.0; p=0.0171) with higher BMI (32.6 ± 7.9 vs. 29.1 ± 5.7; p=0.0110) and they had lesions with lower pre-procedure percent stenosis (81.3 ± 7.6 vs 84.6 ± 9.0; p=0.0392). Both IVUS+OAS and OAS alone resulted in low rates of severe angiographic complications: severe dissection (0.0% vs. 3.5%; p= 0.6154); perforation (0.0% vs. 2.0%; p=1.0); persistent slow flow (0.0% vs. 0.7%; p=1.0); persistent no reflow (0.0% vs. 0.0%; p=1.0); and abrupt closure (2.9% vs. 1.7%; p=0.4876). There was a significant reduction in the number of stents used with IVUS+OAS (1.0 ± 0.2 vs. 1.3 ± 0.6, p= 0.0058) and a significantly increased post-OAS mean minimal lumen diameter (MLD) (1.6 ± 0.6 mm vs. 1.2 ± 0.5 mm, p=0.0007). The 3-year MACE (14.3% vs. 24.2%; p=0.2593) and TVR (2.9% vs. 10.6%; p=0.2029) rates were not significantly different between IVUS+OAS and OAS alone.
IVUS, which enables complete lesion assessment, may help optimize results with OAS, ensuring treatment from normal-to-normal tissue. The significant reduction in number of stents placed and the numerical trend toward reduced MACE and TVR may be attributed to the more accurate lesion assessment and stent sizing via IVUS. Further studies are needed to determine the optimal integration of intravascular imaging with OAS.