Szymański Filip M, Gałązka Zbigniew, Płatek Anna E, Górko Dariusz, Ostrowski Tomasz, Adamkiewicz Karolina, Łęgosz Paweł, Ryś Anna, Semczuk-Kaczmarek Karolina, Celejewski Krzysztof, Filipiak Krzysztof J
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny..
Kardiol Pol. 2017;75(12):1332-1338. doi: 10.5603/KP.a2017.0150. Epub 2017 Jul 17.
Peripheral arterial disease (PAD) is in fact a group of disease entities with different symptoms and course but a common underlying cause, i.e. atherosclerosis. Atherosclerosis is known to be aggravated by several cardiovascular risk factors, including obstructive sleep apnoea (OSA).
Following paper is a protocol for the Peripheral ARtery Atherosclerotic DIsease and SlEep disordered breathing (PARADISE) trial, which aims to describe the prevalence of OSA in PAD patients scheduled for revascularisation, and to determine the effect of OSA on the procedure outcomes.
The PARADISE study is an observational cohort trial. It plans to include 200 consecutive patients hospitalised for revascularisation due to PAD. In every patient an overnight sleep study will be performed to diagnose sleep disorders. Accord¬ing to the results of the test, patients will be divided into two groups: group A - patients with OSA, and group B - patients without OSA (control group). All patients will also be screened for classical and non-classical cardiovascular risk factors. In some of the patients, during surgery, a fragment of atherosclerotic plaque will be collected for further testing. Patients will be followed for one year for adverse events and end-points. Primary end-point of the study will be the failure of revascularisa¬tion defined as recurrence or new onset of the symptoms of ischaemia from the treated region, a need for re-operation or procedure revision, or recurrence of ischaemia signs on the imaging tests.
The data obtained will help determine the incidence of OSA in the population of patients with PAD. The au¬thors expect to show that, as with other cardiovascular diseases associated with atherosclerosis, also in patients with PAD the incidence of undiagnosed OSA is high and its presence is associated with elevated cholesterol, inflammatory markers, and higher prevalence of arterial hypertension and poor control of other cardiovascular risk factors. In addition, due to increased oxidative stress and vascular endothelial injury associated with OSA, patients afflicted with this condition will not only have more advanced atherosclerotic lesions, but also in their histopathological examination their atherosclerotic plaque will exhibit evidence of greater instability and adverse morphology. We also expect to show that in patients with OSA, achieving cor¬rect control of cardiovascular risk factors will be more difficult. The study may improve PAD control through assuring better multispecialty care in PAD patients.
外周动脉疾病（PAD）实际上是一组症状和病程各异但病因相同的疾病实体，即动脉粥样硬化。已知包括阻塞性睡眠呼吸暂停（OSA）在内的多种心血管危险因素会加重动脉粥样硬化。
以下论文是外周动脉粥样硬化疾病与睡眠呼吸紊乱（PARADISE）试验的方案，该试验旨在描述计划进行血运重建的PAD患者中OSA的患病率，并确定OSA对手术结果的影响。
PARADISE研究是一项观察性队列试验。计划纳入200例因PAD住院进行血运重建的连续患者。对每位患者进行夜间睡眠研究以诊断睡眠障碍。根据测试结果，患者将分为两组：A组——OSA患者，B组——无OSA患者（对照组）。所有患者还将接受经典和非经典心血管危险因素筛查。部分患者在手术期间将采集动脉粥样硬化斑块碎片进行进一步检测。对患者随访一年，观察不良事件和终点情况。该研究的主要终点是血运重建失败，定义为治疗区域缺血症状复发或新发、需要再次手术或进行手术修正，或影像学检查显示缺血体征复发。
获得的数据将有助于确定PAD患者群体中OSA的发病率。作者期望表明，与其他与动脉粥样硬化相关的心血管疾病一样，PAD患者中未诊断出的OSA发病率也很高，其存在与胆固醇升高、炎症标志物、动脉高血压患病率升高以及其他心血管危险因素控制不佳有关。此外，由于与OSA相关的氧化应激增加和血管内皮损伤，患有这种疾病的患者不仅动脉粥样硬化病变更严重，而且在组织病理学检查中其动脉粥样硬化斑块将表现出更大的不稳定性和不良形态学证据。我们还期望表明，对于OSA患者，实现心血管危险因素的正确控制将更加困难。该研究可能通过确保为PAD患者提供更好的多专科护理来改善PAD的控制。
