Predictors of restenosis and cardiovascular events in patients undergoing percutaneous angioplasty for subclavian/innominate artery stenosis

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1 Predictors of restenosis and cardiovascular events in patients undergoing percutaneous angioplasty for subclavian/innominate artery stenosis Tadeusz Przewlocki, Anna Kablak Ziembicka, Piotr Pieniazek, Piotr Musialek, Artur Kozanecki, Agnieszka Roslawiecka, Daniel Rzeznik, Wiesława Tracz, Piotr Podolec Institute of Cardiology Collegium Medicum Jagiellonian University The John Paul II Hospital, Kraków, Poland

2 Potential conflicts of interest Speaker s name: TADEUSZ PRZEWLOCKI I have the following potential conflicts of interest to report: Research contracts Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) X I do not have any potential conflict of interest

3 The study aimed to evaluate outcome of percutaneous angioplasty (PTA) for subclavian/innominate artery (SA/IA) stenosis in terms of: symptom resolution AIM restenosis rate & predictors of restenosis factors influencing long-term cardiovascular (CV) outcome MATERIAL and METHODS 185 consecutive patients (102 men), mean age 61.1 ± 8.4 y.o. with SA/IA stenosis or occlusion were referred to PTA Clinical and ultrasonographic assessment was performed before hospital discharge, 6, 12 months after PTA, and then at yearly intervals. All patients were followed for the mean 49.7±28.3 (range 6-117) months. The incidence of restenosis, CV death, myocardial infarction (MI), ischemic stroke (IS), or a new revascularization for lesion progression were recorded.

4 Characteristic of patients and lesions referred to PTA (185 patients, 191 lesions) Left subclavian artery 148 (77.5%) Right subclavian artery 31 (16.2%) Innominate artery 12 (6.3 %) Stenosis SA/IA 159 (83.3%) Occlusion SA/IA 32 (16.7%) Mean stenosis grade 75.9 ± 15.9% Distal to VA origin lesions 5/191 (2.6%) Hypertension 144 (77.8%) Diabetes mellitus 42 (22.7%) Smoking 152 (82.1%) Hiperlipidaemia 171 (92.4%) Significant CAD (angio) 103 (55.7%) Stenosis >70% ICA /CCA 68 (36.7%) PAOD (lower limb claudication) 42 (22.7%) Renal artery stenosis >60% 15 ( 8.1%) Previous MI 52 (28%) Stroke or TIA 46 (24.9%) Any previous vascular procedure 30 (16.2%) 146 (79%)

5 Number of patients Symptoms in 185 patients referred to PTA 61.1% 100 % % % 30 posterior fossa ischemia 11.9% 22 upper limb claudication p. fossa ischemia + upper limb claudication 3.8% 3.8% 7 symptomatic coronary - subclav. steal 7 6 blood pressure control 7% 3.2% asymptomatic Pts

6 SA/IA PTA procedure & early results Procedural success 175 / 185 pts (94.6%) & 181 / 191 lesions (94.8%) Success in SA/IA stenosis 159 / 159 (100%) Success in occlusion 22 / 32 (68.8%) Referral to subclavian bypass 6 (3.2%) Femoral approach 191 (100%) Simultaneous radial/brachial approach 16 (8.4%) Predilation vs. Direct stenting 96 (53%) vs. 85 (47%) Major complications 3 (1.5%) Neuro / protection system 14 (7.6%) Ischemic stroke 1 Intracranial Mean stenosis cerebral gradehemorrhage before PTA (DS-QA) PTA 75.91± 15.9% Acute Meanlimb stenosis ischemia grade(long afterdissection PTA (DS-QA) distally PTA to stent) 14.91± 11.3% Minor complications 11 (5.9%) Balloon angioplasty 11 (6.1%) Transient occlusion of IA 1 1 stent implanted 156 (86.2%) Transient 2 stents implanted A-V block II 14 1 (7.7%) Bradycardia Balloon-expandable with drop stent in blood pressure (79%) Puncture Self-expandable site hematoma stent / pseudoaneurysm 39 8 (21%)

7 PTA of left subclavian & vertebral artery with cerebral protection (Gore NPS)

8 PTA of left subclavian & vertebral artery with cerebral protection (Gore NPS)

9 Pseudo-hypotonic lady with recurrent syncope Bilateral subclavian stenosis RSA LSA RSA LSA One stage bilateral procedure enabling farmacological control of extremely high pressure and resulting in complete syncope resolution

10 LSA recanalisation double-femoral and brachial acsess

11 Staged or simultaneous procedures of other arteries (185 patients) The other procedures scheduled during 6 months period Number of patients 86 (46.5%) Vertebral artery angioplasty or stenting 22 (11.9%) Carotid artery stenting 25 (13.5%) Carotid endarterectomy 8 (4.3%) PCI 41 (22.2%) CABG 8 (4.3%) Renal artery stenting 7 (3.8%) Lower limb artery revasc. 8 (4.3%)

12 Late results restenosis (follow-up 6 117, mean 49.7±28.3 months) Symptom resolution 157/169 (92.9%) Mean arm SBP difference (successful PTA pts) Restenosis: 22 (12.6%) out of 175 patients with > 6-month FU. 1/11 (9.1%) after POBA; 16 (10.2 %) after 1 stent implantation, and 5 (35.7%) after 2 stents implantation for 1 lesion; p< symptomatic restenoses treated with repeated PTA or stent Recurrent restenosis in 8 (40%) out of 20 patients with repeated procedure 6 treated with subsequent PTA 3 cutting balloon, 1 DES, 1 additional BMS, 1 balloon angioplasty Predictors of restenosis Relative risk Confidence interval before PTA: 35.8 ± 19.2 mmhg after PTA: 11.0 ± 4.5 mmhg p-value It should be strongly recommended to use 1 stent to cover 1 lesion, as restenosis rate is particularly high in patients with 2 stents hs-crp level <0.001 implanted to cover one lesion, accounting for 36%. Moreover, stent length did not turn out as an independent predictor Older age of restenosis. 2 and more stents implanted for 1 lesion Large stent diameter

13 Kaplan-Meier restenosis free survival 99.4% 98.3% 92.7% 87.7% secondary patency 83.2% primary patency Late restenosis (over 12 months after PTA) is relatively frequent, and it can occur even in third year of FU.

14 Late results cardiovascular events (follow-up 6 117, mean 49.7 ± 28.3 months) Composite (death/mi/is/ symptomatic lesion progression): 18 (10.3%) Death: 3 (1.7%) cardiovascular deaths (2 cardiac, 1 cerebral); Non-fatal MI: 3 (1.7%); Non-fatal stroke: 4 (2.3%); Symptomatic lesion progression: 8 (4.6%) Predictors of cardiovascular event Relative risk Confidence interval p-value Significant CAD Renal artery stenosis >50% <0.001 Hypertension Female gender

15 Conclusions PTA is effective method of the SA/IA stenosis treatment, leading to symptoms resolution in majority of patients Almost half of patients with subclavian artery occlusive disease had symptomatic lesions in the other vascular territories requiring intervention Restenosis rate is acceptable (13%), and it is associated with younger age, low stent diameter, number of implanted stents and baseline hs-crp level In the mean 4-year follow-up, CV event rate was moderate (10.3%), and it was independently associated with hypertension, concomitant CAD and renal artery stenosis.

16 Thank You!