COMPASS study finds ADAPT non-inferior to stent retriever for first-line mechanical thrombectomy

2422

The COMPASS study has found that the use of ADAPT as first-line mechanical thrombectomy therapy for acute ischaemic stroke results in non-inferior functional outcomes as compared to the stent retriever first approach.

The results were presented at the International Stroke Conference (ISC; 24–26 January, Los Angeles, USA) by principal investigator J Mocco (New York, USA).

Other recent trials which demonstrated improved patient outcomes with endovascular therapy, as compared to medical therapy, included a majority of patients treated with stent retrievers. This study comes after the ASTER trial, which was powered to show superiority of the ADAPT approach but only showed first line aspiration to be non-inferior to first line stent retriever therapy.

The COMPASS study aimed to evaluate whether acute ischaemic stroke patients, treated with the ADAPT approach within six hours of symptom onset do not have inferior clinical outcomes to those treated with a stent retriever first approach.

The study was a prospective, randomised international, multicentre, blinded assessment concurrent controlled trial. The patients treated had anterior circulation emergent large vessel occlusion and had to be treated within six hours of onset. Patients were randomised 1:1 to receive either ADAPT or stent retriever as the first line therapy and assessment was done by a blinded core lab adjudication of imaging and blinded mRS and NIHSS certified clinical assessment.

Only FDA approved stent retrievers or aspiration catheters were permitted, and physicians were allowed to use their preferred adjunctive techniques (including balloon guide catheter, or the solumbra technique).

The primary efficacy endpoint was functional outcome at 90 days as defined by mRS 0–2. Secondary efficacy endpoints included 90 day outcome assessed via mRS shift, TICI 2c or greater within 45 minutes of groin puncture, TICI 3 or greater within 45 minutes of groin puncture, time from groin puncture to TICI 2b or greater.

The safety endpoints were all cause mortality at 90 days, all intracranial haemorrhage with 24 hours, symptomatic ICH with 24 hours, and all symptomatic ICH. There was also a cost endpoint which was mean total device costs.

Fifteen centres enrolled patients in the COMPASS trial and of those centres, case history showed that six centres had a preference for ADAPT first line therapy (≥67% of cases), six centres had a preference for stent retriever as first line therapy (≥67% of cases) and three centres showed mixed technique with no apparent preference.

The trial enrolled 270 patients—134 patients in the aspiration arm and 136 patients in the stent retriever arm.

Mocco reported that the primary efficacy endpoint was met, as the COMPASS data show that ADAPT was non-inferior to stent retriever as first line therapy with a p value of 0.0014 (90 day mRS 0–2 was 49% in the stent retriever arm versus 52% in the ADAPT arm). The secondary outcomes were also promising for ADAPT, with 50% of patients in the ADAPT arm reaching TICI 2c or greater within 45 minutes versus 44% in the stent retriever arm; and 34% in the ADAPT arm with TICI 3 or greater within 45 minutes, compared to 23% in the stent retriever arm. Further Mocco indicated that the time to TICI 2b or greater was shorter in the ADAPT arm than in the stent retriever arm, with 22 minutes versus 33 minutes, respectively. He added however, that these are multiple comparisons and therefore are not statistically significant.

As for how the two arms performed in terms of cost, Mocco stated that these results are still being analysed and are expected to be presented at the European Stroke Organisation Conference (ESOC; 15–18 May, Gothenburg, Sweden).

Commenting on how the COMPASS data compare to the ASTER trial, Mocco said, “these data are a bit more robust for aspiration compared to the previously technically driven trial, ASTER. This may be due to use of newer and better catheters [ACE68 vs. ACE64] as well as possibly the use of balloon guide catheters.”

The study was funded by Penumbra which reviewed the initial grant proposal and provided the funding but played no role in the execution, data collection, analysis, interpretation or presentation.

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