The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

Lin, Chun‐Jen; Saver, Jeffrey L.

doi:10.3389/fneur.2020.524220

Cited by 11 publications

(10 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The observed postprocedure mTICI 2b to 3 rate (87.4% [95% CI, 84.6 %–90.3%]) fell within the range of our predetermined expected rate (85% [95% CI, 81.9%–88.1%]). The 95% CI of 84.6% to 90.3% is consistent with the 85% to 90% target effect mentioned by Lin and Saver 18 in their publication regarding minimal clinically important difference for substantial reperfusion. The observed 90-day mRS score 0 to 2 success rate (59.6% [95% CI, 55.3%–63.9%]) was better than expected (predetermined expected rate was 45% [95% CI, 40.3%–49.5%]).…”

Section: Discussionsupporting

confidence: 88%

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Zaidat

Fifi

Nanda

et al. 2022

Stroke

View full text Add to dashboard Cite

Background and Purpose: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting. Methods: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion–acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0–2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points. Results: Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%–90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%–59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%–18.3%). Conclusions: Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion–acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03464565.

show abstract

Section: Discussionsupporting

confidence: 88%

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Zaidat

Fifi

Nanda

et al. 2022

Stroke

View full text Add to dashboard Cite

show abstract

“…[13][14][15][16] The magnitude of this effect appears to be clinically relevant as successful reperfusion is one of the most important determinants of clinical outcome and an absolute increase of 5% in successful reperfusion is considered meaningful to patients. 26 One potential reason why such a difference was not reported by other trials may be that the current study included only a minority of patients treated with aspiration, which has been associated with lower rates of successful reperfusion when combined with intravenous alteplase. 27 Hence, a potential negative effect of the combined treatment with intravenous alteplase plus aspiration might have been averted and using stent-retrievers with concomitant proximal flow-arrest and/or distal aspiration seemed to translate into an overall favorable reperfusion rate in patients treated with intravenous alteplase plus thrombectomy.…”

Section: Discussionmentioning

confidence: 75%

Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial

et al. 2022

View full text Add to dashboard Cite

“…There was a solid rationale for the noninferiority margins for the primary and secondary outcomes in our study, which were also similar to the noninferiority margins used in other noninferiority MT randomized clinical trials . However, previous studies involving stroke and neuroendovascular expert surveys have identified that the minimal clinically important differences for functional independence and substantial reperfusion (eTICI grade of 2b to 3 within 3 passes) across 2 therapies should be set at much lower values, ranging between 1% and 5% and 3.1% and 5%, respectively . Unfortunately, the sample sizes required to show either superiority or noninferiority with such low margins have made their adoption impractical for device trials.…”

Section: Discussionmentioning

confidence: 83%

Thrombectomy With the pRESET vs Solitaire Stent Retrievers as First-Line Large Vessel Occlusion Stroke Treatment

Nogueira,

Lobsien,

Klisch

et al. 2024

JAMA Neurol

View full text Add to dashboard Cite

ImportanceStent retriever–based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking.ObjectiveTo determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever.Design, Setting, and ParticipantsThis study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset.InterventionsPatients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever.Main Outcomes and MeasuresThe primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a −12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers.ResultsOf 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, −2.57%; 95% CI, −11.42 to 6.28). As the lower bound of the 95% CI was greater than −12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, −4.83%; 95% CI, −10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, −0.63%; 95% CI, −9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis.Conclusions and RelevanceIn this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.

show abstract

The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

Cited by 11 publications

References 35 publications

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial

Thrombectomy With the pRESET vs Solitaire Stent Retrievers as First-Line Large Vessel Occlusion Stroke Treatment

Contact Info

Product

Resources

About