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OPTIMIST

Q: What were the key findings of the OPTIMIST trial?

Low-intensity post-IVT monitoring is feasible and safe in carefully selected low-risk stroke patients (NIHSS <10, no critical care needs). None of the 35 patients required ICU transfer or critical care intervention within 24 hours, and outcomes were excellent with 82.9% discharged home.

Optimal Post Tpa-Iv Monitoring in Ischemic STroke

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Year of Publication: 2020

Authors: Roland Faigle, Jaime Butler, Juan R. Carhuapoma, ..., Victor C. Urrutia

Journal: The Neurohospitalist

Citation: Neurohospitalist 2020;10(1):11-15

Link: https://doi.org/10.1177/1941874419845229

PDF: https://pmc.ncbi.nlm.nih.gov/articles/PMC6900650/

Clinical Question

Can post-IVT stroke patients with low NIHSS (<10) and no critical care needs at the end of the IVT infusion be safely monitored using a low-intensity monitoring protocol?

Bottom Line

Low-intensity post-IVT monitoring is feasible and safe in carefully selected low-risk stroke patients (NIHSS <10, no critical care needs). None of the 35 patients required ICU transfer or critical care intervention within 24 hours, and outcomes were excellent with 82.9% discharged home.

        Major Points
        Pragmatic single-arm safety study of 35 post-IVT patients at a comprehensive stroke center
Low-intensity protocol: q15min monitoring for first 2 hours, then q1h for 1 hour, q2h for 8 hours, then q4h until 24 hours post-IVT
0% of patients required ICU transfer or critical care intervention in first 24 hours (primary outcome)
Patients transferred to stroke unit (telemetry with 1:3 nurse ratio) without ICU capabilities
Median NIHSS improved from 3 at baseline to 1 at 24 hours and 0 at 90 days
82.9% discharged home; no in-hospital deaths
4 patients (11.4%) were stroke mimics
Two patients required ICU later: one for post-CEA care, one on day 4 for hemorrhagic transformation on heparin

      

Design

Study Type: Pragmatic, prospective, single-center, open-label, single-arm safety study

Randomization:

Blinding: Open-label (no blinding)

Enrollment Period: March 1, 2014 to March 31, 2018

Follow-up Duration: 90 days

Centers: 1

Countries: USA

Sample Size: 35

Analysis: Descriptive statistics; frequencies for categorical variables; medians with IQR for continuous variables; Stata version 15

Inclusion Criteria

Age 18-80 years
NIHSS <10 at time of presentation
NIHSS <10 at end of IVT infusion
No critical care needs by end of IVT infusion
Received IVT for acute stroke

Exclusion Criteria

Underwent endovascular therapy
Critical care needs by end of IVT infusion
NIHSS ≥10

Baseline Characteristics

Characteristic	Control	Active
Note	Single-arm study - no control group
N		35
Age - Median (range)		54 years (32-79)
Male		60.0%
Black race		62.9%
Pre-IVT NIHSS - Median (IQR)		3 (1-6)
Pre-IVT mRS - Median (range)		0 (0-4)
IVT window <3 hours		65.7%
BP systolic - Median (IQR)		157 mm Hg (140-177)
BP diastolic - Median (IQR)		86 mm Hg (75-100)
Glucose - Median (IQR)		119 mg/dL (94-138)
Hypertension		80.0%
Hyperlipidemia		42.9%
Diabetes mellitus		20.0%
Atrial fibrillation		14.3%
Smoking		28.6%
Antiplatelet use		40.0%
Anticoagulation use		2.9%
Statin use		37.1%
Mean infarct volume		3.4 mL (range 0-44.8)

Arms

Field	Low-intensity monitoring protocol
Intervention	Vital signs and neurological assessments: q15min during IVT and first hour post-IVT (standard care), then on stroke unit admission, q1h for 1 hour, q2h for 8 hours, then q4h until 24 hours post-IVT. Stroke unit had 1:3 nurse ratio without critical/intermediate care capabilities.
Duration	24 hours post-IVT, then 90-day follow-up

Outcomes

Outcome	Type	Intervention
Need for critical care intervention in first 24 hours after IVT, or perceived need to transfer patient to ICU even if no actual critical care intervention was performed	Primary	0/35 (0%)
NIHSS at 24 hours - Median (IQR)	Secondary	1 (0-3)
NIHSS improvement at 24 hours from baseline - Median (IQR)	Secondary	2 (0-4)
NIHSS at discharge - Median (IQR)	Secondary	1 (0-2)
mRS at discharge - Median (range)	Secondary	1 (0-3)
NIHSS at 90 days - Median (IQR), n=28	Secondary	0 (0-1)
mRS at 90 days - Median (range), n=33	Secondary	0 (0-6)
Discharge to home	Secondary	29/35 (82.9%)
Length of stay - Median (IQR)	Secondary	2 days (2-3)
Symptomatic hemorrhagic transformation	Adverse	0 (0%)
Asymptomatic hemorrhagic transformation	Adverse	4 (11.4%)
In-hospital death	Adverse	0 (0%)
Delayed ICU admission (after 24 hours)	Adverse	2 (5.7%) - 1 for post-CEA care, 1 on day 4 for hemorrhagic transformation on heparin

Subgroup Analysis

Stroke mimics comprised 11.4% of the cohort (3 conversion disorder, 1 seizure). No intracranial large vessel occlusions; one patient had extracranial ICA occlusion from dissection, another had symptomatic high-grade ICA stenosis.

Criticisms

Small sample size (n=35) limits generalizability and statistical power
Single-arm design without randomized comparison to standard monitoring
Single-center study at a comprehensive stroke center may not generalize to other settings
Not powered to show functional outcomes are comparable to standard-of-care monitoring
Excluded patients who underwent mechanical thrombectomy
Median time from end of IVT to transfer out of ED was 109 minutes (longer than intended 1 hour)
Results not generalizable to post-thrombectomy patients or those with higher NIHSS
Selection criteria may enrich for stroke mimics and very mild strokes

Funding

Dr Faigle supported by institutional KL2 grant from Johns Hopkins Institute for Clinical and Translational Research (ICTR), funded by Grant Number KL2TR001077 from National Center for Advancing Translational Sciences (NCATS), NIH

Based on: OPTIMIST (The Neurohospitalist, 2020)

Authors: Roland Faigle, Jaime Butler, Juan R. Carhuapoma, ..., Victor C. Urrutia

Citation: Neurohospitalist 2020;10(1):11-15

Content summarized and formatted by NeuroTrials.ai.

OPTIMIST

(2020)

Objective

To prospectively evaluate whether post-IVT stroke patients with low NIHSS (<10) and no critical care needs by end of IVT infusion may safely be cared for using a low-intensity monitoring protocol

Study Summary

• Low-intensity post-IVT monitoring was feasible and safe in selected low-risk patients (NIHSS <10)
• 0% required ICU transfer or critical care intervention within 24 hours
• 82.9% discharged home with median 90-day mRS of 0

Intervention

Low-intensity monitoring protocol: q15min for first 2 hours, then q1h for 1 hour, then q2h for 8 hours, then q4h until 24 hours post-IVT

Inclusion Criteria

Age 18-80, NIHSS <10 at presentation and end of IVT infusion, no critical care needs by end of IVT infusion, no endovascular therapy

Study Design

Arms: Single-arm (low-intensity monitoring protocol)

Patients per Arm: 35

Outcome

• Primary: 0/35 (0%) required ICU or critical care intervention within 24 hours
• Median NIHSS improved from 3 to 1 at 24 hours
• Median 90-day mRS: 0 (range 0-6)

Bottom Line

Major Points

Pragmatic single-arm safety study of 35 post-IVT patients at a comprehensive stroke center
Low-intensity protocol: q15min monitoring for first 2 hours, then q1h for 1 hour, q2h for 8 hours, then q4h until 24 hours post-IVT
0% of patients required ICU transfer or critical care intervention in first 24 hours (primary outcome)
Patients transferred to stroke unit (telemetry with 1:3 nurse ratio) without ICU capabilities
Median NIHSS improved from 3 at baseline to 1 at 24 hours and 0 at 90 days
82.9% discharged home; no in-hospital deaths
4 patients (11.4%) were stroke mimics
Two patients required ICU later: one for post-CEA care, one on day 4 for hemorrhagic transformation on heparin

Study Design

Study Type: Pragmatic, prospective, single-center, open-label, single-arm safety study
Randomization: No
Blinding: Open-label (no blinding)
Sample Size: 35
Follow-up: 90 days
Centers: 1
Countries: USA

Primary Outcome

Definition: Need for critical care intervention in first 24 hours after IVT, or perceived need to transfer patient to ICU even if no actual critical care intervention was performed

Control	Intervention	HR/OR	P-value
	0/35 (0%)	-

Limitations & Criticisms

Small sample size (n=35) limits generalizability and statistical power
Single-arm design without randomized comparison to standard monitoring
Single-center study at a comprehensive stroke center may not generalize to other settings
Not powered to show functional outcomes are comparable to standard-of-care monitoring
Excluded patients who underwent mechanical thrombectomy
Median time from end of IVT to transfer out of ED was 109 minutes (longer than intended 1 hour)
Results not generalizable to post-thrombectomy patients or those with higher NIHSS
Selection criteria may enrich for stroke mimics and very mild strokes

Citation

Neurohospitalist 2020;10(1):11-15

View Original Publication →

OPTIMIST

Optimal Post Tpa-Iv Monitoring in Ischemic STroke

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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