O-023 Reperfusion with adapt technique using ACE68 and ACE64 is safe and effective in large vessel occlusions of the anterior circulation – the promise study results
Bibliographic record
Abstract
Purpose PROMISE study aimed to observe the safety and effectiveness of Penumbra System (PS) with ACE68 and ACE64 Reperfusion Catheters in patients with acute ischemic stroke (AIS) from large vessel occlusion (LVO), treated with ADAPT (A Direct Aspiration First Pass Technique) as front-line treatment. Materials and methods This was a prospective, single-arm, multicenter study across 20 European centers. Inclusion criteria were anterior circulation LVO within 6 hours of ictus; NIHSS≥2; CT-ASPECTS ≥6; or MR-ASPECTS ≥5. Primary endpoints included success in angiographic revascularization (mTICI 2b-3), and clinical independence (mRS 0–2) at 90 days. Secondary endpoints included safety events, functional improvement at 7–10 days, procedural metrics and quality of life. mTICI scores and safety endpoints were adjudicated by core laboratory and clinical events committee, respectively. Results A total of 204 patients were enrolled. Median age was 74 [IQR 65–80]. Primary occlusion vessels were 17.2% (35/204) patients with ICA occlusion, 3.9% (8/204) with Carotid T, 60.8% (124/204) with M1% and 18.1% (37/204) with M2. Median baseline CT ASPECT score was 9 [IQR 8–10]. Median baseline and 7–10 day NIHSS scores were 16 [IQR 11–20] and 3 [IQR 1–8], respectively. A reduction of ≤10 points or 7–10 days NIHSS of 0–1 was reported in 67.9% (127/187) patients. Prior to endovascular procedure, IV rtPA was administered in 61.8% (126/204) patients. After PS treatment, 70.3% (142/202) patients achieved mTICI 2b/3. Final revascularization (mTICI 2b/3) was achieved in 93.1% (188/202). Revascularization to mTICI 2 c/3 was achieved 63.9% (129/202). Median time from stroke to revascularization (mTICI 2b/3) was 245.5 min [IQR 192–305]. Median time from puncture to revascularization (mTICI 2b/3) was 31 min [IQR 20–53]. Day-90 mRS of 0–2 was achieved in 61.0% (122/200). In the subgroup analysis by occlusion location, final revascularization (mTICI 2b/3) in the ICA/Carotid T was 95.2% (40/42) and 90 day mRS of 0–2 was achieved in 64.3% (27/42), final revascularization (mTICI 2b/3) in the MCA M1 was 92.7% (114/123) and 90 day mRS of 0–2 was achieved in 57.0% (69/121) and the final revascularization (mTICI 2b/3) in the MCA M2 was 91.9% (34/37) and 90 day mRS of 0–2 was achieved in 70.3% (26/37). There was no significant difference in the safety rates by treatment location. Safety rates were favorable (sICH=2.9%; ENT=1.5%). 90 day morbidity, defined as mRS score (3–5), was observed in 31.5% (63/200). 90 day all cause-mortality was observed in 7.5% (15/200). Device and procedure-related SAEs were reported in 2.0% (4/204) and 4.9% (10/204), respectively. No deaths were device-related. Conclusion PROMISE study demonstrated safety and efficacy with latest generation of PS Reperfusion Catheters (ACE68/64) in patients with acute ischemic stroke from large vessel occlusion, using ADAPT as front-line treatment. Disclosures P. Navia: 2; C; Penumbra Inc. P. Schramm: 2; C; Penumbra Inc. R. Papa: None. J. Parra: None. A. Weitz: None. W. Weber: None. J. Fiehler: None. P. Michel: None. V. Pereira: None. T. Krings: None. L. Pierot: None. J. Gralla: None. P. Santalucia: None. T. Lo: None.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".