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Comparison of mid-term clinical outcomes between on-label and off-label use of rotational atherectomy
Takayuki Mori1, Kenichi Sakakura2, Hiroshi Wada1
1Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
Insights
Mid-term outcomes after rotational atherectomy (RA) showed a trend towards worse results in off-label use compared to on-label use. Patients undergoing off-label RA require closer follow-up to monitor for major adverse cardiovascular events.
Area of Science:
- Cardiovascular Interventions
- Interventional Cardiology
- Vascular Surgery
Background:
- Rotational atherectomy (RA) is a key technique for complex coronary lesions.
- Off-label RA use is associated with higher in-hospital complications.
- Mid-term clinical outcomes of off-label versus on-label RA are not well-established.
Purpose of the Study:
- To compare mid-term clinical outcomes between off-label and on-label RA.
- To evaluate the incidence of major adverse cardiovascular events (MACE) in both groups.
Main Methods:
- Retrospective analysis of 156 patients in the off-label RA group and 94 in the on-label RA group.
- Primary endpoint: MACE (ischemia-driven target vessel revascularization, non-fatal MI, all-cause death).
- Secondary analysis: Quantitative coronary analysis in 154 patients with follow-up angiography within 1 year.
Main Results:
- No significant difference in late luminal loss between off-label and on-label RA groups (P=0.57).
- MACE incidence was 9.0% in the off-label group versus 3.2% in the on-label group (P=0.08).
- A trend towards worse mid-term outcomes was observed in the off-label RA group.
Conclusions:
- Mid-term clinical outcomes after rotational atherectomy tended to be worse in the off-label group.
- Patients undergoing off-label RA may require more intensive follow-up.
- Further research is needed to confirm these findings and optimize patient management.
Abstract:
While rotational atherectomy (RA) is used for complex lesions in percutaneous coronary intervention, there are several contraindications such as unprotected left main stenosis or left ventricular dysfunction. We previously reported that the incidence of in-hospital complications was significantly greater in off-label as compared to on-label use RA. However, the mid-term clinical outcomes between off-label and on-label RA have not been investigated. The purpose of this study was to compare the mid-term clinical outcomes between off-label (n = 156) and on-label RA (n = 94). The primary endpoint was the incidence of major adverse cardiovascular events (MACE) defined as the composite of ischemia-driven target vessel revascularization (TVR), non-fatal MI, and all-cause death. We also identified 154 patients who underwent RA and follow-up angiography within 1 year, and compared quantitative coronary analysis between the off-label group (n = 96) and on-label group (n = 58). There was no significant difference in late luminal loss between the groups (0.03 ± 0.53 mm in the off-label and -0.05 ± 0.44 mm in the on-label groups, P = 0.57). However, the incidence of MACE was less in the on-label group (3.2 %) as compared to the off-label group (9.0 %) without reaching statistical significance (P = 0.08). In conclusion, mid-term clinical outcomes tended to be worse in the off-label group than in the on-label group. We may have to follow-up the patient who underwent off-label RA more carefully than the patient who underwent on-label RA.
