Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea (VISION)

Capital Medical University

Status: Unknown

Conditions: Coronary Artery Disease; Obstructive Sleep Apnea of Adult

Treatments: Other: Non-OSA; Other: OSA

Study type: Observational

Funder types: Other

Identifiers

NCT04022824

2017034

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 to 80 years old
2. Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery
3. 3-vessel OCT was available visually (at least one pullback/vessel)
4. Written informed consent

Exclusion criteria

1. Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index ≥10/h)
2. Previous or current use of continuous positive airway pressure (CPAP)
3. Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3)
4. STEMI within 1 week
5. Prior PCI or CABG
6. Chronic kidney disease [eGFR<60ml/(min*1.73m2)]
7. Aortic-coronary ostial lesion
8. Left main lesion
9. Chronic total occlusion
10. In-stent restenotic lesion
11. A tortuous vessel and/or severely calcified lesion or severe stenosis and the OCT catheter could not pass across the lesion
12. Massive residual thrombus on angiography despite thrombus aspiration or thrombectomy
13. Planned elective PCI within 12 months
14. Severe comorbidities: eg. malignancy (life expectancy <2 years)
15. Known or planned pregnancy

Trial design

84 participants in 2 patient groups

OSA

Treatment:

Other: OSA

Non-OSA

Treatment:

Other: Non-OSA