Determinants of long-term outcome in patients after percutaneous stent-assisted management of symptomatic subclavian or innominate artery stenosis or occlusion.

Aims: 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.
Methods and Results: 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).
Conclusions: 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.