Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep ApNea: A Serial 3-Vessel Optical Coherence Tomography Study (VISION)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Relative proliferation volume within stent segment (% of stent volume)
研究概览
简要总结
Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults. Compared to the general population, OSA occurs more often in patients with coronary artery disease (CAD), with a reported prevalence of 38% to 65%. Emerging evidence indicates OSA initiates and exacerbates coronary atherosclerosis. Moreover, several observational studies indicate the presence of OSA was associated with higher rate of restenosis and repeat revascularization (mainly attributed non-culprit lesion revascularization) after percutaneous coronary intervention (PCI). OSA might initiate endothelial injury by repetitive bursts of sympathetic activity that occur with apneas and hypopneas. Moreover, untreated OSA reduces endothelial repair capacity. Whether OSA could exacerbate neointimal proliferation and plaque progression in the non-culprit lesion after drug-eluting stent (DES) implantation remains less studied. The investigators aimed to evaluate neointimal proliferation and strut coverage within stent segment as well as changes of plaque volume and morphology in the non-culprit lesion by optical coherence tomography (OCT) in patients with versus without OSA at 12-month follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years old
- •Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery
- •3-vessel OCT was available visually (at least one pullback/vessel)
- •Written informed consent
排除标准
- •Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index ≥10/h)
- •Previous or current use of continuous positive airway pressure (CPAP)
- •Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3)
- •STEMI within 1 week
- •Prior PCI or CABG
- •Chronic kidney disease [eGFR<60ml/(min*1.73m2)]
- •Aortic-coronary ostial lesion
- •Left main lesion
- •Chronic total occlusion
- •In-stent restenotic lesion
- •A tortuous vessel and/or severely calcified lesion or severe stenosis and the OCT catheter could not pass across the lesion
- •Massive residual thrombus on angiography despite thrombus aspiration or thrombectomy
- •Planned elective PCI within 12 months
- •Severe comorbidities: eg. malignancy (life expectancy <2 years)
- •Known or planned pregnancy
结局指标
主要结局
Relative proliferation volume within stent segment (% of stent volume)
时间窗: 12 months
次要结局
- Minimal lumen area within stent segment(12 months)
- Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization)(12 months)
- Maximum area stenosis within stent segment(12 months)
- Total proliferation volume within stent segment(12 months)
- Prevalence of TCFA(Baseline)
- Change of total lipid volume index in the non-culprit lesion(12 months)
- Prevalence of neoatherosclerosis(12 months)
- Total lipid volume index(Baseline)
- Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts(12 months)
- Prevalence of plaque rupture(Baseline)
- Maximum proliferation area within stent segment(12 months)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital