Systematic Evaluation of Patients Treated With

Neurothrombectomy Devices for Acute Ischemic Stroke

Primary Results of the STRATIS Registry
Nils H. Mueller-Kronast, MD; Osama O. Zaidat, MD; Michael T. Froehler, MD, PhD;
Reza Jahan, MD; Mohammad Ali Aziz-Sultan, MD; Richard P. Klucznik, MD;
Jeffrey L. Saver, MD; Frank R. Hellinger, Jr, MD, PhD; Dileep R. Yavagal, MD;
Tom L. Yao, MD; David S. Liebeskind, MD; Ashutosh P. Jadhav, MD, PhD;
Rishi Gupta, MD; Ameer E. Hassan, DO; Coleman O. Martin, MD;
Hormozd Bozorgchami, MD; Ritesh Kaushal, MD; Raul G. Nogueira, MD;
Ravi H. Gandhi, MD; Eric C. Peterson, MD; Shervin R. Dashti, MD, PhD;
Curtis A. Given, II, MD; Brijesh P. Mehta, MD; Vivek Deshmukh, MD; Sidney Starkman, MD;
Italo Linfante, MD; Scott H. McPherson, MD; Peter Kvamme, MD;
Thomas J. Grobelny, MD; Muhammad S. Hussain, MD; Ike Thacker, MD; Nirav Vora, MD;
Peng Roc Chen, MD; Stephen J. Monteith, MD; Robert D. Ecker, MD;
Clemens M. Schirmer, MD, PhD; Eric Sauvageau, MD; Alex Abou-Chebl, MD;
Colin P. Derdeyn, MD; Lucian Maidan, MD; Aamir Badruddin, MD;
Adnan H. Siddiqui, MD, PhD; Travis M. Dumont, MD; Abdulnasser Alhajeri, MD;
M. Asif Taqi, MD; Khaled Asi, MD; Jeffrey Carpenter, MD; Alan Boulos, MD;
Gaurav Jindal, MD; Ajit S. Puri, MD; Rohan Chitale, MD; Eric M. Deshaies, MD;
David H. Robinson, MD; David F. Kallmes, MD; Blaise W. Baxter, MD;
Mouhammad A. Jumaa, MD; Peter Sunenshine, MD; Aniel Majjhoo, MD;
Joey D. English, MD; Shuichi Suzuki, MD; Richard D. Fessler, MD;
Downloaded from http://ahajournals.org by on June 5, 2022

Josser E. Delgado Almandoz, MD; Jerry C. Martin, MD; Diogo C. Haussen, MD;
on behalf of the STRATIS Investigators

Received January 11, 2017; final revision received June 26, 2017; accepted July 20, 2017.
From the Advanced Neuroscience Network/Tenet South Florida (N.H.M.-K., R.K.); St Vincent Mercy Hospital, Toledo, OH (O.O.Z.); Vanderbilt
University Medical Center, Nashville, TN (M.T.F., R.C.); University of California Los Angeles (R.J., J.L.S., D.S.L., S. Starkman); Brigham and Women’s
Hospital, Boston, MA (M.A.A.-S.); Methodist Hospital, Houston, TX (R.P.K.); Florida Hospital Neuroscience Institute, Winter Park (F.R.H., R.H.G.);
University of Miami Miller School of Medicine/Jackson Memorial Hospital, FL (D.R.Y., E.C.P.); Norton Neuroscience Institute, Norton Healthcare,
Louisville, KY (T.L.Y., S.R.D.); University of Pittsburgh Medical Center, PA (A.P.J.); WellStar Neurosciences Network, WellStar Kennestone Regional
Medical Center, Marietta, GA (R.G.); Valley Baptist Medical Center, Harlingen, TX (A.E.H.); St Luke’s Hospital of Kansas City, MO (C.O.M.); Oregon
Health and Science University Hospital, Portland, OR (H.B.); Emory University School of Medicine, Grady Memorial Hospital, Atlanta, GA (R.G.N.,
D.C.H.); Baptist Health Lexington/Central Baptist, KY (C.A.G.); South Broward Hospital, Hollywood, FL (B.P.M.); Providence St Vincent Medical
Center, Portland, OR (V.D.); Baptist Hospital of Miami, FL (I.L.); St Dominic’s–Jackson Memorial Hospital, MS (S.H.M.); University of Tennessee
Medical Center, Knoxville (P.K.); Advocate Christ Medical Center, Oak Lawn, IL (T.J.G.); Cleveland Clinic, OH (M.S.H.); Baylor University Medical
Center, Dallas, TX (I.T.); OhioHealth Riverside Methodist Hospital, Columbus (N.V.); Memorial Hermann Texas Medical Center, Houston (P.R.C.);
Swedish Medical Center First Hill Campus, Seattle, WA (S.J.M.); Maine Medical Center, Portland (R.D.E.); Geisinger Clinic, Danville, PA (C.M.S.);
Baptist Medical Center–Jacksonville, FL (E.S.); Baptist Hospital Louisville, KY (A.A.-C.); Barnes Jewish Hospital, St Louis, MO (C.P.D.); Mercy San
Juan Medical Center and Mercy General, Carmichael, CA (L.M.); Presence St Joseph Medical Center, Joliet, IL (A. Badruddin); Buffalo General Medical
Center, NY (A.H.S.); University of Arizona Medical Center, Tucson (T.M.D.); University of Kentucky Hospital, Lexington (A.A.); Los Robles Medical
Center, Thousand Oaks, CA (M.A.T.); Aurora Hospital, Milwaukee, WI (K.A.); West Virginia University/Ruby Memorial Hospital, Morgantown, WV
(J.C.); Albany Medical Center, NY (A. Boulos); University of Maryland Medical Center, Baltimore (G.J.); University of Massachusetts Memorial Medical
Center, Worcester (A.S.P.); Crouse Hospital, Syracuse, NY (E.M.D.); Virginia Mason Medical Center, Seattle, WA (D.H.R.); Mayo Clinic–Rochester, MN
(D.F.K.); Erlanger Medical Center, Chattanooga, TN (B.W.B.); ProMedica Toledo Hospital, OH (M.A.J.); Banner University Medical Center, Phoenix,
AZ (P.S.); McLaren Flint, MI (A.M.); California Pacific Medical Center, San Francisco (J.D.E.); University of California, Irvine, Orange (S. Suzuki); St
John Providence Hospital, Detroit, MI (R.D.F.); Abbott Northwestern Hospital, Minneapolis, MN (J.E.D.A.); and Carolinas Medical Center, Charlotte,
NC (J.C.M.).
Guest Editor for this article was Emmanuel Touzé, PhD.
Presented in part at the International Stroke Conference, Houston, TX, February 22–24, 2017.
The online-only Data Supplement is available with this article at http://stroke.ahajournals.org/lookup/suppl/doi:10.1161/STROKEAHA.
117.016456/-/DC1.
Correspondence to Nils H. Mueller-Kronast, MD, Advanced Neuroscience Network/Tenet South Florida, 5352 Linton Blvd, Delray Beach, FL 33484.
E-mail muellerkronast@gmail.com
© 2017 American Heart Association, Inc.
Stroke is available at http://stroke.ahajournals.org DOI: 10.1161/STROKEAHA.117.016456

2760
 Mueller-Kronast et al   Primary Results of the STRATIS Registry    2761

Background and Purpose—Mechanical thrombectomy with stent retrievers has become standard of care for treatment
of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of
Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process
timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials.
Methods—STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire
Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom
onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level
meta-analysis.
Results—A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score
was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to
arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively.
The Core lab–adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At
90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered
a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture
was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of
achieving modified Rankin Scale score 0 to 2.
Conclusions—This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in
the community. The decrease of clinical benefit over time warrants optimization of the system of care.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.   
(Stroke. 2017;48:2760-2768. DOI: 10.1161/STROKEAHA.117.016456.)
Key Words: ischemic stroke ◼ Mindframe Capture ◼ registry ◼ Solitaire ◼ stent
◼ system of care ◼ thrombectomy

S ince the publication of 5 seminal randomized clinical tri-

als comparing mechanical thrombectomy (MT) with best
medical therapy in 2015,1–5 treatment for intracranial large ves-
sel occlusion with stent retrievers has become standard of care
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Revascularization Device (Solitaire) and Mindframe Capture Low
Profile Revascularization Device (Mindframe) in patients experi-
encing an acute ischemic stroke because of large intracranial vessel
occlusion. The registry was designed to enroll 1000 patients at ≤60
academic and nonacademic US sites with the following eligibility

and has been endorsed by various guidelines around the world
≤6 hours from symptom onset.6,7 These trials varied in their
inclusion criteria, time windows, and imaging protocols, and
4 of the trials were stopped before the enrollment targets were
reached because of efficacy. A patient-level prespecified pooled
meta-analysis of 4 randomized clinical trials which used the
Solitaire stent retriever as the first device (Safety and Efficacy
in Solitaire Stent Thrombectomy or SEER8) in 401 patients in
the intervention arm has been published, providing Level 1 evi-
dence regarding the use of this device in a clinical trial setting.
The goal of the STRATIS registry (Systematic Evaluation of
Patients Treated with Neurothrombectomy Devices for Acute
Ischemic Stroke) was to prospectively analyze the results of
MT within the Food and Drug Administration 510(k) approval
window of 8 hours for intracranial large vessel occlusion in a
real world setting without additional restrictions on imaging
protocols or technique. The protocol was designed to capture
detailed information on system of care factors, process times,
and technique and correlate them with imaging and clinical
outcomes at 90-day follow-up. In addition, a comparison to a
similar cohort, the SEER intervention arm (SWIFT PRIME,
ESCAPE, EXTEND-IA, REVASCAT), was undertaken to
reference the results of STRATIS against those of the random-
ized clinical trials.
Methods
Study Design and Inclusion Criteria
The STRATIS registry was a prospective, multicenter, nonran-
domized, observational registry evaluating the use of Solitaire
criteria: (1) any confirmed large intracranial vessel occlusion with
associated symptoms, (2) intention to be treated with a Medtronic
market–released neurothrombectomy device as the initial device to
remove thrombus, (3) treatment within 8 hours of stroke onset, (4)
modified Rankin Scale (mRS) score ≤1 prior to stroke onset, (5) pre-
treatment National Institutes of Health Stroke Scale (NIHSS) score ≥8
and ≤30, and (6) not participating in a multicenter randomized clini-
cal trial. Patients were consented for participation ≤7 days postproce-
dure or hospital discharge (whichever came first). Site enrollment was
capped at 75 patients to ensure inclusion of patients from a diverse
group of centers and prehospital systems. No additional requirements
on center volume, workflow, or imaging selection were specified.
Cranial DICOM imaging (Digital Imaging and Communications in
Medicine) was centrally collected and interpreted by an independent
imaging core laboratory for site of occlusion, modified Thrombolysis
in Cerebral Infarction (mTICI), and Alberta Stroke Program Early
CT Score.9,10 The SWIFT PRIME (Solitaire With the Intention for
Thrombectomy as Primary Endovascular Treatment) definitions for
puncture, symptomatic intracranial hemorrhage (sICH), and vessel
segments were applied.1 A technique core laboratory reviewed proce-
dural reports and classified procedural technique. All subjects with a
known neurological deterioration between enrollment and discharge
were adjudicated by a Clinical Events Committee for primary cause
of neurological deterioration. The definitions of the time metrics
reported are included in Table I in the online-only Data Supplement.
The protocol was approved by the local institutional review boards.
Outcome Measures
The primary outcome was defined as the severity of disability as
assessed by mRS score at 90 days postprocedure. Secondary outcome
measures included prehospital and hospital workflow times, such as
time from door to puncture (DTP) and time from puncture to reper-
fusion (PTR). Reperfusion was defined as mTICI ≥2b, assessed by
both site and independent imaging core laboratory using the mTICI
grading scale.10 Safety evaluations included incidence of neurological
 2762  Stroke  October 2017

Table 1.  Baseline and Workflow Characteristics in STRATIS and SEER Intervention
Characteristic SEER Intervention STRATIS P Value
Age, y 67.3±12.7 (401) [69.0] (59.0, 78.0) 67.8±14.7 (984) [69.0] (59.0, 79.0) 0.269
Sex: male 48.6% (195/401) 54.2% (533/984) 0.066
Medical history
 Atrial fibrillation 35.7% (143/401) 37.5% (369/984) 0.540
 Hypertension 63.3% (254/401) 72.4% (712/984) 0.001
 Diabetes mellitus 12.6% (48/380) 25.6% (252/984) <0.001
 Current or previous tobacco use 36.8% (129/351) 47.3% (465/984) 0.001
Preprocedure
 Prestroke mRS
  
0 N/A 76.0% (748/984) N/A
  
1 N/A 21.2% (209/984) N/A
  
2 N/A 2.7% (27/984)* N/A
 Initial qualifying NIHSS score 16.6±4.9 (398) [17] (13, 20) 17.3±5.5 (984) [17] (13, 22) 0.042
 IV-tPA delivered 80.5% (323/401) 64.0% (628/982) <0.001
 ASPECTS: per imaging core laboratory† 8.3±1.7 (388) [9.0] (7.0, 10.0) 8.2±1.6 (763) [8.0] (8.0, 9.0) 0.091
  
0–5 5.7% (22/388) 7.5% (57/763)
  
6–7 21.6% (84/388) 15.5% (118/763)
  
8–10 72.7% (282/388) 77.1% (588/763)
Time metrics
 Stroke onset to enrolling hospital arrival 143.5±122.2 (400) [104.5] (55.0, 199.0) 149.3±101.0 (907) [138.0] (57.0, 222.0) 0.030
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 Stroke onset to alteplase initiation 122.9±49.2 (322) [114.0] (86.0, 150.0) 113.3±50.5 (622) [100.0] (78.0, 139.0) 0.001
 Hospital arrival to alteplase initiation 28.7±66.0 (265) [36.0] (24.0, 54.0) 42.1±26.5 (336) [37.5] (26.0, 51.5) 0.503
 Stroke onset to puncture 263.1±194.7 (394) [225.0] (157.0, 302.0) 226.4±100.0 (976) [208.0] (149.5, 293.5) 0.011
 Hospital arrival to puncture 122.0±173.7 (392) [93.0] (68.5, 126.5) 80.1±49.4 (901) [72.0] (46.0, 102.0) <0.001
 Imaging to puncture 68.9±34.7 (394) [63.0] (46.0, 85.0) 71.2±46.4 (824) [62.0] (38.5, 92.0) 0.642
 Alteplase to puncture 107.2±206.5 (259) [68.0] (43.0, 103.0) 102.0±73.5 (613) [86.0] (46.0, 142.0) 0.001
 Puncture to TICI 2b/3 or completion 45.9±31.0 (348) [38.0] (24.0, 60.0) 45.6±29.0 (939) [37.0] (25.0, 58.0) 0.740
 Stroke onset to TICI 2b/3 or completion 293.6±126.5 (349) [274.0] (196.0, 365.0) 271.1±105.7 (945) [255.0] (188.0, 342.0) 0.020
Target intracranial occlusion location‡ <0.001
 Not reported 2.5% (10/401) 0.8% (8/984)
 Internal carotid artery terminus 18.2% (73/401) 22.6% (222/984)
 Middle cerebral artery: first segment (M1) 71.1% (285/401) 54.7% (538/984)
 Middle cerebral artery: second segment (M2) 8.2% (33/401) 17.3% (170/984)
 Middle cerebral artery: third segment (M3) 0.0% (0/401) 0.2% (2/984)
 Posterior cerebral artery 0.0% (0/401) 0.2% (2/984)
 Basilar artery 0.0% (0/401) 4.2% (41/984)
 Vertebral artery 0.0% (0/401) 0.1% (1/984)
Data are % (n/N) or mean±SD (N) [median] (IQR). ASPECTS, Alberta Stroke Program Early CT Score; CT, computed tomography; mRS, modified Rankin Scale;
mTICI, modified Thrombolysis in Cerebral Infarction; NIHSS, National Institutes of Health Stroke Scale; STRATIS, Systematic Evaluation of Patients Treated With
Neurothrombectomy Devices for Acute Ischemic Stroke; and IV-tPA, intravenous tissue-type plasminogen activator.
*The protocol was amended to restrict enrollment to mRS 0–1 to ensure consistency with SWIFT PRIME enrollment criteria.
†Baseline imaging received for 835 patients. Of which, 72 were not evaluated for ASPECTS (38 posterior stroke, 30 no noncontract CT, 4 not evaluable), resulting in
763 patients evaluable for ASPECTS.
‡For STRATIS, assessed by the Techniques Core Laboratory based on operative reports.
 Mueller-Kronast et al   Primary Results of the STRATIS Registry    2763
deterioration events, sICH, all-cause mortality, and incidence of
device- and procedure-related serious adverse events up to 90 days
postindex stroke procedure. A patient-level comparison with the
SEER database was performed.
Subgroup analyses were performed based on age, 6 to 8 hours
treatment window, distal occlusion location, use of perfusion imag-
ing, and tandem occlusion.
Statistical Analysis
Descriptive statistics were used to present the data using the mean,
standard deviation, and median with interquartile range or frequency
distribution as appropriate. For 2-group comparisons, t tests or the
Wilcoxon rank-sum test was used for continuous variables and the
χ2 test or Fisher exact test for categorical variables as appropriate.
Comparisons were made between the STRATIS and SEER popula-
tions using nominal overall data and then adjusted for baseline char-
acteristics, including age, baseline NIHSS, sex, location of occlusion,
time from stroke onset to arrival at the enrolling hospital, Alberta
Stroke Program Early CT Score, and delivery (yes/no) of intravenous
tissue-type plasminogen activator (IV-tPA). For adjusted models with
binary or ordinal outcomes, logistic regression was used for compari-
sons among groups; in particular, the effect of time to treatment on
outcomes was evaluated via binary logistic regression with the inci-
dence of mRS 0 to 2 as outcome and time from emergency medical
services (EMS) arrival to arterial puncture as the predictor of inter-
est, with age, NIHSS at baseline, and vessel of occlusion location
as covariates. The odds ratio and confidence interval were derived
along with the corresponding P value. For mortality, a sensitivity
analysis using the method of Rubin11 was conducted to evaluate the
effect of missingness on reported outcomes, including age, NIHSS,
Alberta Stroke Program Early CT Score, and occlusion location as
baseline characteristics, along with time from onset to puncture and
discharge mRS as predictors of the missing data. All statistical tests
were 2-sided, with P values <0.05 considered statistically significant.
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Statistical analyses were conducted in SAS version 9.2 or above
(SAS Institute, Cary, NC) and R version 3.2 or above (R Foundation
for Statistical Computing, Vienna, Austria).
Results
From August 2014 to June 2016, 1000 patients were enrolled
at 55 US centers. Sixteen patients were identified to be screen
failures and excluded from the analysis, resulting in a total
of 984 patients included in the intent-to-treat analysis popula-
tion. Patient disposition is presented in Figure I in the online-
only Data Supplement.
Baseline demographic and clinical characteristics are pre-
sented in Table 1. The mean age was 67.8 years, and 54.2%
were male. The median initial qualifying NIHSS score was
17. Most patients had no significant prestroke functional dis-
ability. A total of 64.0% of patients received treatment with
IV-tPA.
45.2% of patients were transferred from another facility
to an enrolling hospital. The mean distance from EMS scene
to enrolling hospital was 29 miles (median 14 miles), with
65.2% of patients incurring their stroke within <25 miles from
an enrolling hospital. The median times from onset to arrival
at the enrolling hospital (door), DTP, and PTR were 138, 72,
and 36 minutes, respectively. High enrolling centers (≥30
patients) achieved significantly shorter median DTP times, 67
versus 86 minutes (P<0.001).
The location of target occlusions (ie, vessel treated on first
device pass) are presented in Table 1. Tandem occlusions,
defined as cases in which an extracranial lesion accompanied
the principal lesion treated, were reported in 14.9% (147/984)
of patients. Solitaire was the first MT device used in 96.9%
and Mindframe in 3.1% of patients.
The median time from puncture to imaging core lab–
assessed substantial reperfusion (mTICI ≥2b; PTR) was 37
minutes. Core laboratory–assessed substantial reperfusion
was achieved in 87.9% (724/824) of cases with evaluable
postprocedure angiograms. Emboli to new vascular territory
were observed in 0.8% (7/824) of patients. At 24-hour follow-
up, the incidence of sICH was 1.4% (12/841).
At 90-day follow-up, good functional outcome (mRS score
0–2) was achieved in 56.5% (512/906) of patients and excel-
lent functional outcome (mRS score 0–1) in 43.2% (391/906).
Ninety-day outcomes could not be obtained in 78 patients.
Increased time from EMS arrival at stroke scene to puncture
was associated with a reduced likelihood of good functional
outcome at 90 days (P=0.004; Figure 1), with an associated
odds ratio of 0.79 (95% confidence interval, 0.68–0.93) per
hour of delay in a model adjusting for age, NIHSS at baseline,
and occlusion location. A summary of baseline characteris-
tics and outcomes by time from EMS arrival at stroke scene
to puncture is presented in Table II in the online-only Data
Figure 1. Frequency of good functional out-
come by time from emergency medical services
(EMS) arrival at stroke scene to puncture.
Increased time from EMS arrival at stroke scene
to puncture was associated with a reduced like-
lihood of good functional outcome at 90 days
(P=0.004), with an associated odds ratio (OR) of
0.79 (95% confidence interval [CI], 0.68–0.93)
per hour of delay.
 2764  Stroke  October 2017
Supplement. For sensitivity purposes, models using other sets
of baseline covariates along with time were assessed, with
similar results as presented in Table III in the online-only Data
Supplement.
The incidence of neurological deterioration events was
9.2%. The incidence of site-reported study device–related
and index procedure–related serious adverse events was 0.2%
(2/984) and 1.7% (17/984), respectively. A summary of the
serious adverse events is included in Table IV in the online-
only Data Supplement.
Overall, the all-cause mortality rate ≤90-day follow up was
14.4% (142/984). As a sensitivity analysis, multiple imputa-
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tion was performed for subjects missing 90-day mRS scores
(n=78/984 or 7.9%). The resulting overall 90-day mortality
rate of 15.3% from the imputation model11 was similar to the
raw rate of 14.4% based on available data.
Among patients who achieved substantial reperfusion per
the adjudication of the imaging core laboratory, favorable out-
comes were observed. Good functional outcome was achieved
in 60.0% of substantial reperfusers versus 40.4% of nonre-
perfusers (P<0.001), and mortality was 12.7% in substantial
reperfusers versus 23.0% in nonreperfusers (P=0.008).
Comparison With Recent Stent-Retriever
Randomized Controlled Trials
Comparing the STRATIS population with the SEER interven-
tion group (n=401),8 significant differences were observed in
several baseline characteristics and time metrics. STRATIS
enrolled patients of similar age but with significantly greater
proportion of vascular risk factors, significantly higher mean
baseline neurological deficit, and fewer patients treated with
IV-tPA compared with the SEER intervention group (Tables 1
and 2). The median time from onset to arrival at enrolling
hospital was significantly longer in STRATIS, whereas the
median times from onset to IV-tPA initiation, onset to punc-
ture, enrolling hospital arrival to puncture, and onset to revas-
cularization were significantly shorter in STRATIS.
In unadjusted analysis, the rate of substantial reperfusion
was significantly higher in STRATIS (87.9% versus 76.6%;
P<0.001). The rate of good functional outcome (mRS score
0–2) was similar between study populations (56.5% versus
54.0%; P=0.43), while the rate of excellent functional outcome
Figure 2. Distribution of modified Rankin Scale
(mRS) scores at 90-day follow-up in STRATIS
and SEER Intervention group.
(mRS score 0–1) was significantly higher in STRATIS (43.2%
versus 35.8%; P=0.01). When adjusted for baseline character-
istics, these patterns of outcome persisted while the overall dis-
tribution of mRS at 90 days (via the shift test) was significantly
more favorable in STRATIS than in SEER (common odds ratio,
1.38; 95% confidence interval, 1.11–1.71; P=0.004). Figure 2
shows the distribution of mRS scores at 90 days. Mortality rate
and incidence of sICH were similar between study populations
in both unadjusted and adjusted analysis.
Subgroups
Age
Analysis by age showed less favorable rates of clinical out-
come with increasing age. Rates of good functional out-
come decreased for each 5-year increment of age from <65
to >90 years from 64.3% to 26.5% (P<0.001), while mortal-
ity increased from 7.9% to 35.1% (P<0.001; Table V in the
online-only Data Supplement).
Seven- to Eight-Hour Window
In an analysis of a subset of patients outside of American
Heart Association/American Stroke Association guidelines,
patients treated between 6 and 8 hours (n=119) from onset
to puncture achieved similar rates of substantial reperfu-
sion, good functional outcome, and mortality compared with
those treated within 6 hours (Table VI in the online-only Data
Supplement).
Distal Occlusions
When compared with M1 occlusions, substantial reperfusion
was achieved less often in M2 occlusions; however, similar
rates of good functional outcome and mortality were observed
(Table VII in the online-only Data Supplement).
Perfusion Imaging
Perfusion imaging was performed in 378 patients. When com-
pared with patients who did not undergo perfusion imaging
(PI−), the patients who underwent perfusion imaging (PI+)
had a significantly lower NIHSS and were more directly
admitted, but the onset to door and onset to puncture times
were similar. The rate of good functional outcome was 62.2%
in PI+ patients versus 53.0% in PI− patients (P<0.001; Table
VIII in the online-only Data Supplement).
 Mueller-Kronast et al   Primary Results of the STRATIS Registry    2765
Tandem Occlusion
Eighty out of 147 patients who had a tandem occlusion under-
went carotid stenting. The median PTR was significantly lon-
ger in patients with tandem occlusion (52.5 versus 34 minutes;
P<0.001). Significantly more patients with tandem occlusion
received IV-tPA. Similar rates of good functional outcome and
sICH were observed. Mortality was numerically lower in the
tandem occlusion group (11.7% versus 16.4%; P=0.20; Table
IX in the online-only Data Supplement).
Discussion
We report the largest prospectively collected registry of
patients undergoing thrombectomy with Solitaire. STRATIS
demonstrates that MT can be safely performed in the com-
munity with similar process metrics and clinical outcomes
to those observed in the randomized trials. 56.5% of patients
achieved an mRS score of 0 to 2 at 90 days, while the rate of
successful reperfusion (mTICI 2b-3) was 87.9% and 90-day
all-cause mortality was 14.4%. sICH occurred in 1.4% of
patients.
There was a significantly longer median time from symp-
tom onset to arrival at the enrolling hospital in STRATIS
compared with SEER (138.0 versus 104.5 minutes; P=0.03);
however, the median time from stroke onset to puncture was
17 minutes shorter in STRATIS, primarily driven by a sig-
nificantly shorter median DTP time (93 versus 72 minutes;
P<0.001). This decrease may suggest an increasing awareness
on the importance of rapid hospital workflow since publica-
tion of the SEER trials.
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The time from EMS scene arrival to puncture, or the system
of care interval, is highly dependent on geography, EMS orga-
nization, and hospital process. In STRATIS, the median sys-
tem of care interval was 152 minutes. Each hour of delay was
associated with a 5.5% absolute decline in the likelihood of
achieving good outcome (mRS score 0–2; Figure 1) or num-
ber needed to harm of 18. 45.2% of patients were transferred
from another facility to the enrolling hospital, even though
65% of patients incurred their stroke within 25 miles from the
enrolling hospital (Figure 3).
The median EMS scene arrival to enrolling hospital arrival
time interval was as long as the median DTP time, outlining
importance to optimize processes both inside and outside the
hospital. High enrollment volume (≥30 patients) was asso-
ciated with a statistically shorter DTP interval with a trend
toward better functional outcome, which replicates the experi-
ence of trauma and cardiac centers.12,13
There is extensive discussion on how to best avoid trans-
fers to an intervention-capable hospital. Multiple EMS sys-
tems have already adopted policies to transport directly to an
intervention-capable hospital, either based on a field severity
score or for all patients to avoid the delays associated with
secondary hospital to hospital transfers.14,15
Perfusion imaging resulted in an increase in average DTP
time of 15.7 minutes. However, despite this delay, perfusion
imaging was associated with significantly higher rates of good
clinical outcomes. Further analysis is needed to understand
the causes of this association, which may include better selec-
tion of patients with mismatch, use of perfusion in higher vol-
ume centers, or other factors. Our finding will reinvigorate the
ongoing discussion about the benefits of perfusion imaging
against the impact of associated time delay in the selection of
patients with salvageable tissue.
Technical outcomes were statistically significantly superior
in STRATIS with more patients achieving mTICI 2b-3 reper-
fusion, confirming that the results of these trials can be repro-
duced—and even improved—in the community. Significantly
more patients in STRATIS achieved near normal functional
outcome. It should be noted that the site-reported TICI scores
Figure 3. Distance in miles from stroke scene
to enrolling hospital. Fourteen patients had a
stroke ≥150 miles from the enrolling hospital.
 2766  Stroke  October 2017

Table 2.  Technical, Safety, and Clinical Outcomes in STRATIS and SEER Intervention
Unadjusted Analysis Adjusted Analysis*
Adjusted Odds Ratio
SEER P
STRATIS P Value (95% CI): STRATIS
Intervention Value
Outcome vs SEER Intervention
Postprocedure angiographic outcomes—per imaging core laboratory†
Successful reperfusion (mTICI 2b-3) 87.9%
76.6% (285/372) <0.001 2.50 (1.78–3.51) <0.001
(724/824)
Final emboli to new vascular territory N/A 0.8% (7/824) N/A N/A N/A
Efficacy outcomes
mRS score at 90 days 2.6±1.9 (400) 2.4±2.1 (906)
0.121 1.38 (1.11–1.71) 0.004
[2.0] (1.0, 4.0) [2.0] (1.0, 4.0)
Functional independence (mRS score 0–2) 56.5%
54.0% (216/400) 0.432 1.27 (0.98–1.64) 0.074
(512/906)
Excellent outcome (mRS score 0–1) 43.2%
35.8% (143/400) 0.012 1.53 (1.17–1.99) 0.002
(391/906)
Early neurological improvement: NIHSS reduction ≥8 54.4%
59.9% (240/401) 0.067 0.79 (0.61–1.02) 0.071
points or reaching 0–1 at 24 h (478/879)
Safety outcomes
All-cause mortality ≤90 days 14.4%
12.0% (48/401) 0.263 0.96 (0.66–1.41) 0.840
(142/984)
Incidence of neurological deterioration events ≤90 days
N/A 9.2% (91/984) N/A N/A N/A
postprocedure—per CEC‡
Incidence of study device-related SAEs ≤90 days post 0.2% (2/984)
N/A N/A N/A N/A
procedure—per site report [2]
Incidence of procedure-related SAEs ≤90 days post 1.7% (17/984)
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N/A N/A N/A N/A

procedure—per site report [23]
Symptomatic intracranial hemorrhage at 24 h§ 2.5% (10/401) 1.4% (12/841) 0.248 0.55 (0.22–1.34) 0.189
Parenchymal hematoma at 24 h 8.0% (32/401) 2.9% (25/850) <0.001 0.30 (0.17–0.54) <0.001
Data are % (n/N) or mean±SD (N) [median] (IQR). For SAEs, data are % (n/N) [#events]. CEC indicates Clinical Events Committee; CI, confidence
interval; IV-tPA, intravenous tissue-type plasminogen activator; mRS, modified Rankin Scale; mTICI, modified Thrombolysis in Cerebral Infarction;
N/A, not available; NIHSS, National Institutes of Health Stroke Scale; SAE, serious adverse event; STRATIS, Systematic Evaluation of Patients
Treated With Neurothrombectomy Devices for Acute Ischemic Stroke.
*Adjusted for baseline covariates, including age, NIHSS, sex, ASPECTS, site of occlusion, IV-tPA yes/no, and time from onset to door.
†Imaging core laboratory received and read angiograms for 846 patients, of whom 22 were not evaluable for reperfusion status, resulting in
824 evaluable angiograms.
‡Any event causing neurological deterioration (≥4 points worsening from baseline on the NIHSS scale).
§Defined as any parenchymal hematoma type 1, parenchymal hematoma type 2, remote intraparenchymal hemorrhage, or intraventricular
hemorrhage per imaging core laboratory and associated with a ≥4 points worsening on the NIHSS scale within 24 hours.

overestimated the reperfusion success (Table X in the online-
only Data Supplement). This needs to be taken into account
when comparing to other, non-core laboratory adjudicated,
registries. Patients with distal occlusions (M2 and distal) did
not differ in functional outcome or mortality. This experience
corroborates findings of a recent large retrospective analysis
of distal occlusions.16
Within the STRATIS cohort, patients treated beyond the
current guideline recommendation between 6 and 8 hours
from symptom onset achieved the same rate of good clinical
outcomes as patients treated within 6 hours from onset, sug-
gesting that treatment beyond 6 hours may be considered.
STRATIS enrolled patients with tandem extra- and intracra-
nial occlusions. In patients with tandem lesions, the median
PTR interval was 18.5 minutes longer than in those without,
but rates of good reperfusion and good functional outcomes
were similar in patients with and without tandem occlusion.
There was no evidence of sICH or higher mortality even with
a high portion of systemically thrombolyzed patients. The fre-
quency of good functional outcomes in patients with tandem
lesions was similar. Treatment of tandem occlusions may,
therefore, be reasonable.
At this point, the benefit of MT in an older population is
not well understood. Two out of the 4 SEER trials excluded
patients >80 years. In STRATIS, there was no specified age
cutoff. The mean age in STRATIS is numerically higher than
that in the SEER cohort and slightly lower than that reported
in Get With The Guidelines-Stroke registry of lower 70s.17,18
Even though the PTR times were similar, there was a statisti-
cally significant decline of good outcome by age in STRATIS,
 Mueller-Kronast et al   Primary Results of the STRATIS Registry    2767
with only 26% of patients ≥90 years achieving functional
independence, but no inference can be made concerning the
treatment effect. Further randomized studies are needed to
assess the benefit and the cost-effectiveness of MT in the older
population.
Limitations
Our study has limitations. First, STRATIS is a single-arm,
prospective, postmarket registry and does not include a
control arm. However, the study represents the largest
cohort published to date reporting outcomes of on label
stent-retriever MT. In addition, to minimize bias on Alberta
Stroke Program Early CT Score and TICI scoring and
improve adjudication of complications, STRATIS used 2
core laboratories and a Clinical Events Committee. Second,
the interpretation of reported outcomes in the subgroups
analyzed should be viewed with caution because the study
did not include any active comparator groups. Finally, the
documentation of prehospital time intervals proved to be
challenging and is associated with a higher level of data
loss, limiting the interpretation of the data. Seventy-eight
patients could not be contacted for assessment of 90-day
outcome. Baseline characteristics, reperfusion success, and
mRS at discharge were similar or better in the cohort with
missing 90-day outcome, suggesting that those patients
would have had similar or better outcomes (Table XI in the
online-only Data Supplement).
Conclusions
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STRATIS reports the largest to date cohort of patients who
underwent thrombectomy with a stent retriever in commu-
nity and academic hospitals. Despite enrolling a population
with higher mean neurological deficit and more risk factors
than SEER, results demonstrate that MT with Solitaire is
both safe and effective and that the technical and clinical out-
comes of the landmark trials using the same device cannot
only be reproduced but exceeded. The mean DTP intervals
could be reduced by 34%. Every hour of delay in the system
of care interval from EMS scene arrival to puncture was asso-
ciated with a 5.5% absolute decline in achieving good func-
tional outcome. The clinical outcomes seem to be similar for
patients with tandem occlusions. This corroborates findings
from randomized studies that a treatment benefit exists for
these patients. Our findings of similar clinical outcomes in the
subpopulations treated between 6 and 8 hours from symptom
onset compared with those treated within 6 hours and with
distal occlusions compared with proximal occlusions support
the conduct of randomized trials for these indications.
Sources of Funding
This study was sponsored by Medtronic. An academic steering com-
mittee supervised trial design and operations. A publications com-
mittee comprised of the academic steering committee and academic
principal investigators who enrolled most patients interpreted the
results and wrote the report. The sponsor of the study was respon-
sible for site management, data management and monitoring, safety
reporting, and statistical analysis. The corresponding author had
full access to all the study data and had final responsibility for the
decision to submit for publication. STRATIS is registered with
ClinicalTrials.gov, NCT02239640.
Disclosures
Dr Mueller-Kronast serves as a scientific consultant regarding trial
design and conduct to Medtronic. Dr Zaidat serves as a consultant
to Medtronic, Stryker, and Penumbra. Dr Froehler serves as a sci-
entific consultant to Medtronic, Stryker, and Blockade and has
received a National Institutes of Health (NIH) grant. Dr Aziz-Sultan
is an expert witness for BMC and serves as a scientific consultant
to Medtronic. The University of California, Regents receives fund-
ing for Dr Jahan’s services as a scientific consultant regarding trial
design and conduct to Medtronic/Covidien and is an employee of the
University of California, which holds a patent on retriever devices
for stroke. Dr Klucznik is on the Speakers’ Bureau for Medtronic.
The University of California, Regents receives funding for Dr Saver’s
services as a scientific consultant regarding trial design and con-
duct to Covidien and Stryker and is an employee of the University
of California, which holds a patent on retriever devices for stroke.
Dr Hellinger is on the Speakers’ Bureau for Medtronic and serves as
a consultant to Penumbra, Cordis Neurovascular (J&J). Dr Yavagal
has received honoraria from Medtronic and serves as a scientific con-
sultant to Medtronic, Neuralanalytics, Inc. Drs Sunenshine, Thacker,
and Yao serve as a consultant/proctor to Medtronic. Dr Liebeskind
has received an NIH grant and serves as a scientific consultant to
Stryker and Medtronic. Drs Abou-Chebl and Hassan have received
honoraria from Medtronic. Dr Baxter is on the Spearkers’ Bureau, has
received honoraria, has ownership interest, and serves as a consul-
tant to Penumbra. Dr Bozorgchami serves as a consultant to Neuravi.
Dr Delgado has received honoraria from Penumbra. Dr English has
received honoraria from Medtronic, Stryker Neurovascular, and
Penumbra. Dr Given is on the Speakers’ Bureau and serves as a con-
sultant to Medtronic. Dr Gupta serves as a consultant to Medtronic
and Stryker Neurovascular. Dr Linfante is on the Speakers’ Bureau for
Medtronic and Stryker and has ownership interest in Three Rivers. Dr
Nogueira serves as a consultant to Medtronic, Stryker Neurovascular,
Penumbra, Neuravi, Allm Inc. Dr Schirmer has received honoraria
from AANS and Toshiba and has ownership interest in NTI. Dr
Siddiqui serves as a consultant to Medtronic, Codman, Penumbra,
Stryker, Microvention, Guidepoint Global Consulting, WL Gore &
Associates, Three Rivers, Corindus, Amnis Therapeutics, CereVasc,
Pulsar Vascular, The Stroke Project, Cerebrotech Medical Systems,
Rapid Medical, Neuravi, Silk Road Medical, Rebound Therapeutics,
Claret Medical, Intersocietal Accreditation Commission, and MUSC
and has ownership interest in StimMed, Valor Medical, Cardinal
Health, and Medina Medical Systems. Dr Taqi serves as a consultant
to Stryker Neurovascular. The other authors report no conflicts.
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