TY  - BOOK
AU  - Shlofmitz, Evan
TI  - Orbital Atherectomy for the Treatment of Long (>=25-40mm) Severely Calcified Coronary Lesions: ORBIT II Sub-Analysis
SN  - 1878-0938
PY  - 2020///
KW  - *Atherectomy, Coronary
KW  - *Coronary Artery Disease/th [Therapy]
KW  - *Percutaneous Coronary Intervention
KW  - *Vascular Calcification/th [Therapy]
KW  - Aged
KW  - Aged, 80 and over
KW  - Atherectomy, Coronary/ae [Adverse Effects]
KW  - Atherectomy, Coronary/mo [Mortality]
KW  - Coronary Artery Disease/dg [Diagnostic Imaging]
KW  - Coronary Artery Disease/mo [Mortality]
KW  - Female
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Myocardial Infarction/mo [Mortality]
KW  - Percutaneous Coronary Intervention/ae [Adverse Effects]
KW  - Percutaneous Coronary Intervention/is [Instrumentation]
KW  - Percutaneous Coronary Intervention/mo [Mortality]
KW  - Prospective Studies
KW  - Risk Assessment
KW  - Risk Factors
KW  - Severity of Illness Index
KW  - Stents
KW  - Time Factors
KW  - Treatment Outcome
KW  - United States
KW  - Vascular Calcification/dg [Diagnostic Imaging]
KW  - Vascular Calcification/mo [Mortality]
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available in print through MWHC library: 2002 - present
N2  - BACKGROUND: Orbital atherectomy (OA) is an effective method of lesion preparation of severely calcified vessels prior to stent deployment. Long calcified lesions may lead to higher risk of post-procedural complications, yet the optimal treatment strategy has not been established. In this study we sought to determine the safety and efficacy of OA in patients with long (>=25-40mm) calcified target lesions; CONCLUSIONS: Patients with long (>=25-40mm) calcified target lesions had similar outcomes in terms of MACE at 3years despite higher rates of MI, which mostly occurred in-hospital. Using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25mm) and long (>=25-40mm) groups. Further studies are warranted to determine how OA compares to focal force balloon angioplasty, rotational atherectomy and other novel treatment options for long severely calcified lesions; METHODS: ORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites. De novo, severely calcified coronary lesions were treated with OA prior to stenting. Patients treated with the OA device were stratified into two groups according to target lesion length as visually estimated by the investigator: those with short (<25mm; N=314) vs. long (>=25-40mm; N=118) lesions. Lesions >40mm were excluded per protocol. The primary endpoint was the 3-year major adverse cardiac event (MACE) rate, defined as a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR); RESULTS: The 3-year MACE rates in patients with short (<25mm) vs. long (>=25-40mm) lesions were 21.1% vs. 29.9% respectively (p=0.055). The rate of cardiac death (6.5% vs. 7.8%, p=0.592) and TVR (8.5% vs. 13.7%, p=0.153) did not significantly differ. The rate of MI (CK-MB>3x ULN) at 3years was significantly higher in patients with long (>=25-40mm) lesions (9.0% vs. 17.0%, p=0.024), with the majority occurring in-hospital (7.0% vs. 13.6%, p=0.037); SUMMARY FOR ANNOTATED TABLE OF CONTENTS: Percutaneous coronary intervention of long calcified lesions is inherently more complex and higher risk and may require more intensive lesion preparation. This sub-analysis of ORBIT II revealed that orbital atherectomy treatment of longer (>=25-40mm) lesions was associated with a higher rate of MACE at 30days, but not at 3years. This difference, however, was driven primarily by a higher in-hospital non-Q-wave MI rate; using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25mm) and long (>=25-40mm) groups. Copyright Published by Elsevier Inc
UR  - https://dx.doi.org/10.1016/j.carrev.2019.12.027
ER  -