Effect of Evolocumab on Chronic Total Occlusions (EVOLO-CTO)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on neointimal hyperplasia and target lesion failure (TLF) in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Chronic total occlusions (CTOs) are found in 15-25% of patients with stable angina pectoris. The presence of a CTO indicates unfavorable prognosis, with higher rate of major adverse cardiovascular events. Statins are frequently used after PCI in order to lower LDL cholesterol levels and reduce the chances of coronary artery obstruction recurring. Despite this preventive measure, high risk for restenosis and re-occlusion was observed a significant proportion of patients with CTOs undergoing PCI.
Proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid, profound, and consistent reductions in LDL-C levels. The effect of PCSK9 inhibitor in patients with CTO, after a recent PCI is not known.
In this study the investigators want to evaluate the effect of the PCSK9 inhibitor on neointimal hyperplasia and target lesion failure (TLF) in patients with CTOs receiving regular statin treatment. A serial of intravascular ultrasound imaging study will be performed to determine the restenosis at 48 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment arm Participants will receive PCSK9 inhibitors added to guideline recommended statin therapy. |
Drug: PCSK9 inhibitor
Evolocumab per every two weeks, starting at day 1 and up to week 48, added to guideline recommended statin therapy..
Other Names:
|
| Active Comparator: Control arm Patients will continue to taking guideline recommended statin therapy. |
Drug: Statin
Guideline recommended statin therapy.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Neointimal volume with intravascular ultrasound (IVUS) (mm3 per 1mm) [12 months]
Comparison of neointima volume by IVUS between PCSK9 inhibitors group and control group.
Secondary Outcome Measures
- Rate of Target Lesion Failure (TLF) [12 months]
TLF is defined as a composite of: all cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven target lesion revascularization (TLR).
- Change in angina status assessed with the Seattle Angina Questionnaire [3,12 months]
5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.
- Ischemia [3,12 months]
Ischemic burden assessed with CMR from baseline to 3 and 12 months follow-up
- Change in left ventricular systolic function assessed with CMR [3,12 months]
The left ventricular ejection fraction assessed with CMR from baseline to 3 and 12 months follow up
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥ 18 years of age with written informed consent
-
Presence of a CTO in native coronary artery.
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Stable angina or myocardial ischemia in a territory supplied by CTO
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CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
-
Target artery ≥2.5mm
-
Scheduled to undergo percutaneous coronary intervention (PCI)
-
LDL-C ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on any stable statin regimen for ≥ 4 weeks prior to enrollment; or LDL-C ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been receiving stable statin regimen for ≥ 4 weeks prior to enrollment
Exclusion Criteria:
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Acute myocardial infarction within 1 month
-
Known severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level >2.5 mg/dL);
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History of allergy to iodine contrast agents
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Allergy to PCSK9 inhibitors or any other ingredients contained in study drug
-
Pregnancy or breastfeeding
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Persistent or permanent atrial fibrillation
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Patients with history of coronary artery bypass graft
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Inability or unwilling to provide informed consent
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Malignant neoplasms or Major illness with life expectancy <1 year
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Planned coronary revascularization or major non-cardiac surgery 12 months after intervention
-
Patients previously treated with PCSK9 inhibitors.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anzhen Hospital | Beijing | Beijing | China | 100029 |
Sponsors and Collaborators
- Lin Zhao
Investigators
- Principal Investigator: Lin Zhao, MD, Beijing Anzhen Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-22