: PROFI : A Prospective, Randomized Trial of Proximal Balloon Occlusion vs. Filter Embolic Protection in Patients Undergoing Carotid Stenting Klaudija Bijuklic Fadija Hazizi, Andreas Wandler, Joachim Schofer Medical Care Center Prof. Mathey, Prof. Schofer Hamburg University Cardiovascular Center Germany TCT 2011

Disclosure Statement of Financial Interest I, Klaudija Bijuklic, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Background Randomized trials revealed a higher periprocedural stroke rate after filter protected Carotid Artery Stenting (CAS) compared to carotid endarterectomy. Brott TG et al. N Engl J Med 2010;363:11-23 Mas JL et al. Stroke 2004;35:18-20

Background Potential disadvantages of filters Filter Have to cross the lesion before protection is installed Allow small particles to pass through or along the filter

Background Potential advantages of proximal balloon occlusion Is placed before crossing the lesion Induces reversed flow by occluding external and common carotid artery Debris is aspirated before balloon deflation Proximal balloon occlusion may be more effective than filters in preventing cerebral embolization

Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) A sensitive tool to identify new cerebral ischemic lesions after CAS Before After CAS

Study Design Design DESIGN: Prospective, randomized, dual- arm, single-center clinical evaluation of filter versus proximal balloon protected Carotid Artery Stenting (CAS) OBJECTIVE: To compare the incidence (Primary Endpoint), number, and volume (Secondary Endpoint) of new cerebral ischemic lesions assessed by DW-MRI after CAS PRINCIPAL INVESTIGATOR Joachim Schofer, MD PhD Medical Care Center Prof. Mathey Prof. Schofer, Hamburg University Cardiovascular Center, Germany 62 Patients randomized Proximal balloon n=31 Crossover to filter (n=1) 30 d Follow-up (Clinical and Duplex Ultrasound) DW-MRI Filter n=31 Crossover to proximal balloon (n=1) CAS DW-MRI h after CAS

Major Inclusion Criteria Symptomatic internal carotid artery (ICA) stenosis ≥ 60% Asymptomatic ICA stenosis ≥ 80% Lesion passage with the filter possible without predilatation Sufficient landing zone (> 4 cm) for the filter Contralateral ICA occlusion Ipsilateral ECA occlusion Major Exclusion Criteria

Baseline Characteristics Patients characteristics Filter Balloonp-value Mean age (years±SD) 71.7± ±6.6n.s. ≥ 80 years (%) 26 13n.s. Male (%) 77.4 n.s. Symptomatic (%) n.s. Diabetes (%) n.s. Smoking (%) n.s. Hypertension (%) n.s. Dyslipidemia (%) n.s. Coronary artery disease (%) n.s. Procedural variables Mean duration of procedure (min±SD) 22 ± 730 ± Mean time of protection (min±SD) 5.26± ±1.9n.s.

Incidence of new Cerebral Ischemic Lesions (Primary Endpoint) (27/31) (14/31) Filter Balloon

Filter Incidence of new Cerebral Ischemic Lesions Subgroups 12

(Secondary Endpoint) Filter Balloon Mean Number of new Cerebral Ischemic Lesions

FilterBalloon Mean Volume of new Cerebral Ischemic Lesions (Secondary Endpoint)

MACCE at 30 Days FilterBalloonp-value Death00 Major Stroke00 Minor Stroke1 (3.2%)0n.s. Myocardial infarction 00 (Secondary Endpoint)

Conclusions Whether this translates into a reduced periprocedural stroke rate has to be shown in a larger randomized trial with clinical endpoints. In this single center randomized trial in patients undergoing carotid artery stenting the incidence, number, and volume of new cerebral ischemic lesions were significantly lower under proximal balloon protection than under filter protection.

Study Design Design DESIGN: Prospective, randomized, dual-arm, single-center clinical evaluation of filter versus proximal balloon protected CAS OBJECTIVE: To compare the incidence (PE), number, and volume of new ischemic lesions assessed by DW-MRI after CAS PRINCIPAL INVESTIGATOR Joachim Schofer, MD PhD Medical Care Center Prof. Mathey Prof. Schofer, Hamburg University Cardiovascular Center, Germany 84 patients screened Between May 2010 and August patients did not meet inclusion criteria 62 patients randomized Proximal balloon n=31 Crossover to filter (n=1) Clinical and duplex ultrasound follow-up at 30 d Before and h after CAS DW-MRI evaluted by 2 blinded radiologists Filter n=31 Crossover to proximal balloon (n=1)

Ipsi- and Contralateral Lesion Incidence Ipsi- and contralateral Ipsilateral Contralateral

Reasons not to randomize Exclusion criteria for proximal balloon occlusion - Contralateral occlusion of ICA (n=7) - Ipsilateral occlusion of ECA (n=4) - Incomplete Circle of Willis (n=3) - Stenoses of both ICA and both VA (n=1) Exclusion criteria for filter protection - None of the patients (n=0) Other exclusion criteria - Pacemaker (n=2) - Claustrophobia (n=3) - In-stent restenosis (n=1) - Contralateral major stroke (n=1)

Number of Ipsi- vs Contralateral Lesions

Volume of Ipsi-vs Contralateral Lesions