Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University School of Medicine, The John Paul II Hospital, Krakow, Poland.
EuroIntervention. 2017 Dec 20;13(11):1355-1364. doi: 10.4244/EIJ-D-17-00133.
Incidence and determinants of restenosis and adverse events after endovascular management (PTA±stent) of the subclavian/innominate artery (SA/IA) stenosis/occlusion remain unclear due to the relatively short-term follow-up or limited size of prior studies. This large-scale, long-term prospective study investigated safety, efficacy, and prognosis after SA/IA PTA±stent.
The study involved 411 consecutive patients with symptomatic SA/IA stenosis/ occlusion; 393 were followed annually after successful PTA±stent for up to 16 (minimum one) years. Primary outcomes were freedom from restenosis and MACCE (cardiovascular death, myocardial infarction, stroke). Angiographic success rate was 99.7% in stenoses and 76.1% in occlusions. The incidence of any periprocedural complication was 4.4% (serious - 1.2%). Symptoms of limb ischaemia, vertebrobasilar insufficiency or angina resolved in 79.1%, decreased in 19.6%. Freedom from restenosis was 82.6% and 77.9% whereas freedom from MACCE was 86.6% and 78.3% at five and 10 years, respectively. MACCE determinants (HR; 95% CI) were previous myocardial infarction (5.36; 2.9-9.91), ischaemic stroke (2.03; 1.12-3.66), hs-CRP (1.04; 1.02-1.07), concurrent atherosclerosis (1.35; 1.00-1.82). Restenosis determinants were implantation of ≥2 stents (2.65; 1.23-5.72), stent diameter (0.45; 0.34-0.59), hs-CRP (1.06; 1.02-1.1), WBC (1.2; 1.07-1.35), age (0.97; 0.94-0.99), concurrent carotid or vertebral disease (1.85; 1.07-3.18), IA intervention (2.28; 1.08-4.84).
This study established long-term durability of stent-assisted PTA of symptomatic SA/IA disease and identified risk factors for restenosis and long-term MACCE. Patients at increased risk might benefit from targeted, intensified prevention measures.
由于先前研究的随访时间相对较短或样本量有限,经血管腔内治疗(PTA±支架)治疗锁骨下/无名动脉(SA/IA)狭窄/闭塞后的再狭窄和不良事件的发生率和决定因素仍不清楚。这项大规模、长期前瞻性研究调查了 SA/IA PTA±支架治疗后的安全性、疗效和预后。
该研究纳入了 411 例有症状的 SA/IA 狭窄/闭塞患者;393 例患者在成功接受 PTA±支架治疗后每年接受随访,随访时间长达 16 年(最少 1 年)。主要终点是无再狭窄和 MACCE(心血管死亡、心肌梗死、中风)。狭窄部位的血管造影成功率为 99.7%,闭塞部位为 76.1%。任何围手术期并发症的发生率为 4.4%(严重程度为 1.2%)。肢体缺血、椎基底动脉供血不足或心绞痛症状缓解了 79.1%,减轻了 19.6%。5 年和 10 年时无再狭窄率分别为 82.6%和 77.9%,无 MACCE 率分别为 86.6%和 78.3%。MACCE 的决定因素(HR;95%CI)为既往心肌梗死(5.36;2.9-9.91)、缺血性中风(2.03;1.12-3.66)、hs-CRP(1.04;1.02-1.07)、同时存在动脉粥样硬化(1.35;1.00-1.82)。再狭窄的决定因素为植入≥2 个支架(2.65;1.23-5.72)、支架直径(0.45;0.34-0.59)、hs-CRP(1.06;1.02-1.1)、白细胞计数(1.2;1.07-1.35)、年龄(0.97;0.94-0.99)、同时存在颈动脉或椎动脉疾病(1.85;1.07-3.18)、IA 介入(2.28;1.08-4.84)。
本研究证实了支架辅助治疗有症状的 SA/IA 疾病的长期耐久性,并确定了再狭窄和长期 MACCE 的危险因素。风险较高的患者可能受益于有针对性的强化预防措施。