Patient enrollment DIAS-4 vs. Endovascular Therapy

What does the cath lab offer?

MERCI® Retrieval System

Mechanical Thrombectomy: The MERCI Trial

• 151 pts with intracranial occlusions treated <8 hr from symptom onset (no control group)

• Recanalization in 48%; SICH in 8%

• Improved patient outcomes with recanalization

– 46% vs 10% without disability at 90 days

Smith WS et al. Stroke. 2005;36:1432

FDA Approval of MERCI Retriever:August 2004

Indications for Use:

“The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment."

Food and Drug Administration website. Available at http://www.fda.gov/cdrh/pdf3/k033736.pdf. Accessed Jan 24, 2008

L5

Multi MERCI

Slide courtesy of WS Smith.

Improved Recanalization

48.2

57.3 60.3

69.5

0102030405060708090

100

%

DeviceRecanalization

FinalRecanalization

MERCI

Multi MERCI L5

Mechanical Thrombectomy: PENUMBRA®

Penumbra System: Registration Trial

• 125 patients• NIHSS 17.6• Recanalization (TIMI 2-3) 82%• SICH 11.2%• Nondisabled (mRS 0-2) outcome 90

d 25%• Death 90 d 33%

SOLITAIRE With the Intention For Thrombectomy (SWIFT) Study :

Mechanical Recanalization: Misperceptions about Terminology: regulatory

Two mechanical thrombectomy devices have been approved for use in stroke

patients by the FDA

Misperceptions in brain ischemia: technology, terminology, tissue and time

True or False?

“The term "FDA approval" is never appropriate to describe a device that is legally marketed under a 510(k). The correct term is "cleared for marketing" or "cleared by FDA". Neurothrombectomy devices currently on the market in the US have been cleared via the 510(k) pathway.”

Natalie Getzoff, MD, Medical OfficerNeurodiagnostic and Neurotherapeutic Devices BranchDivision of Ophthalmic, Neurological, and ENT DevicesFood and Drug Administration

Mechanical Recanalization: Misperceptions

Our job to figure out which patients benefit from these devices

How well are we doing?

Misperceptions in brain ischemia: technology, terminology, tissue and time

Case series:“My recanalization rate

is bigger than yours”

Mechanical Recanalization: Misperceptions about Terminology: recanalization

Misperceptions in brain ischemia: technology, terminology, tissue and time

Thomas TomsickDepartment of Radiology University Hospital Cincinnati, Ohio

confusing and misleading

•

Mechanical Recanalization: Misperceptions about Technology: recanalization

Complete success

Partial success

No success

Misperceptions in brain ischemia: technology, terminology, tissue and time

no recanalization

recanalization

Endovascular Therapy: Clinical Trials

MR Rescue

IMS 3

DEFUSE 2

MRIbaseline

Intra-arterial therapy

MRIpost-procedure

(reperfusion)

MRIday 5

(infarct volume)

Favorable clinical response:

• NIHSS score of 0-1 at day 30 or improvement of NIHSS score by ≥ 8 points between baseline and day 30

DEFUSE 2 Protocol

66 yo, MCA M1 occlusion

Recanalization of ant temporal branch of MCA

Recanalization; 20% reperfusion = TIMI 2, TICI 2A

74 yo, R MCA occlusion at 9 hrs (witnessed), NIHSS 12

Early f/u DWI/PWI at 11 hrs; NIHSS 6cath lab merci (10 hrs) and 3 mg IA tPA (10.5 hrs)

Baseline DWI; NIH 12 5-day FLAIR; NIH 37 ccm 10 ccm

79 yo female, left hemiplegia

Angiogram pre and post Penumbra device (7 hrs)

DWI at Day 3

DWI / PWI 10 hrs after cath labDWI / PWI 10 hrs after cath lab

CTP at 6 hrs (prior to cath lab)

Patient enrollment DIAS-4 vs. Endovascular Therapy

Must avoid biased enrollment in DIAS (M1s cath lab, M2s DIAS; high NIH vs. low; investigator impression of prognosis)

Various non-biased strategies possible

Communication/consensus with IA team on a site-specific plan