Early Postmarket Experience After US Food and Drug Administration Approval With the Trevo Device for Thrombectomy for Acute Ischemic Stroke

Abstract

Our postmarket experience shows that in highly selected patients Trevo is safe and effective, even beyond 8 hours, despite longer procedure times and the need for adjuvant devices.

Efficacy and Safety of REVIVE SE Thrombectomy Device for Acute Ischemic Stroke: River JAPAN (Reperfuse Ischemic Vessels with Endovascular Recanalization Device in Japan)

“…The incidence of symptomatic ICH (6.3%) in RIVER JAPAN was similar to that reported in the MERCI (7.8%) 11) and Multi-MERCI (9.8%) 12) studies: Solitaire (0–20%), 3 , 6 , 7 , 23 – 26) and Trevo Pro (5–12%). 15 , 16 , 27) Similarly, asymptomatic ICH was observed in 25% of patients (12/48, 95% CI 13.6–39.6); MERCI 27.7%, 11) Multi-MERCI 30.5%, 12) Solitaire 16.5–40%, 3 , 23 , 25) and Trevo Pro 41%. 14) The number of deaths (2 [4.1%]) reported at 90-day follow-up in RIVER JAPAN was considerably lower than that reported in MERCI (43.5%) 11) and Multi-MERCI (34%) 12) studies: Solitaire 6.9–30%, 3 , 6 , 7 , 13 , 17 , 23 – 26) Trevo Pro 20–33%, 14 – 16 , 27 , 28) Penumbra, 24–32%.…”

“… 15 , 16 , 27) Similarly, asymptomatic ICH was observed in 25% of patients (12/48, 95% CI 13.6–39.6); MERCI 27.7%, 11) Multi-MERCI 30.5%, 12) Solitaire 16.5–40%, 3 , 23 , 25) and Trevo Pro 41%. 14) The number of deaths (2 [4.1%]) reported at 90-day follow-up in RIVER JAPAN was considerably lower than that reported in MERCI (43.5%) 11) and Multi-MERCI (34%) 12) studies: Solitaire 6.9–30%, 3 , 6 , 7 , 13 , 17 , 23 – 26) Trevo Pro 20–33%, 14 – 16 , 27 , 28) Penumbra, 24–32%. 20 , 21 , 29) These results were equivalent from other studies of mechanical thrombectomy.…”

“…Neurological outcome (mRS 0–2) after treatment with REVIVE may be considered significantly better than after treatment with the Merci Retriever because the lower limit of the 95% CI (47.4) for REVIVE was higher than the upper limit of the 95% CI (44) for the Merci Retriever. The proportion of patients with mRS 0–2 was 62.5% (30/48, 95% CI 47.4–76.0) at the 90-day follow-up in RIVER JAPAN; 27.7% (36/130) in MERCI; 36% (59/164, 95% CI 29–44) in Multi-MERCI; 58–71% with Solitaire 5 , 6 , 13) ; 40–55% with Trevo Pro 14 – 16) ; and 25–40% with Penumbra. 20 , 21) …”

“…Recanalization rates immediately post-procedure improved with experience, increasing from 68.4% (during roll-in) to 76.7% (after roll-in). Reperfusion rates reported for the newer stent retrievers in non-Japanese patients (TICI 2 or 3: Trevo Pro 86% to 93% 14 – 16) and Solitaire 88.8% 17) ) have improved in comparison to the Merci Retriever (Thrombolysis in Myocardial Infarction [TIMI] 2 or 3: MERCI 48.2% 11) and Multi-MERCI 55% 12) ) and the Penumbra System (TIMI 2 or 3: 81.6%). 18) Overall, stent retrievers have demonstrated improved recanalization rates and clinical outcome compared to the Merci Retriever.…”

Mechanical thrombectomy: Stent retrievers vs. aspiration catheters

“…Postmarketing studies have confi rmed the safety and effi cacy of the Trevo stentriever in patients with acute ischemic stroke. In one retrospective analysis of prospectively collected data, 89% of patients who had acute thrombectomy using the Trevo device achieved successful recanalization [28]. Good outcome, defi ned as mRS score ≤2, was achieved in 45% of patients.…”