Endovascular thrombectomy for the treatment of acute ischemic stroke

To systematically review the literature on the efficacy and/or safety of endovascular thrombectomy in AIS compared to standard treatment and to identify ongoing randomized controlled trials (RCTs).

Method

Searches for RCTs were performed in Medline/Embase, and for ongoing trials: International Clinical Trial Registry Platform, Clinicaltrials.gov and ISRCTN registry (to June 15th, 2015).

Results

From the eight published RCTs, five showed the superiority of treatment that includes thrombectomy compared to standard care alone. From the 13 ongoing RCTs, 3 have been halted, one has not started, one has unknown status and eight will end between 2016 - 2020.

Conclusion

Evidence favours a combination of the standard therapy with endovascular thrombectomy. The selection criteria however limit the number of people who can benefit. Further studies are needed to prove its cost-effectiveness.

stroke; thrombectomy; systematic review; randomized controlled trial

Study	Country	Intervention groups	Device Type/Brand	Sample size	Recruitment Onset/end	Therapeutic Window	Culprit artery Inclusion criteria
NCT00359424 IMS III	USA, Canada, Australia, Europe	Endovascular Thrombectomy + IV rt-PA vs. IV rtPA	MERCIi retriever, Penumbra system or Solitaire FR or endovasc t-PA	656	Aug 2006 July 2012	rt-PA done within 3 hrs of symptoms onset. Randomisation done 40 minutes after rt-PA infusion onset.	ICA, M1 and basilar
NCT00389467 MR RESCUE	USA	Endovascular Thrombectomy vs. best medical care	MERCI retriever, Penumbra 'system (or endovasc t-PA )	118	May 2004 To 2011	Endovascular treatment ≤ 8 hrs from stroke onset.	ICA, M1 and M2.
NCT00640367 SYNTHESIS EXP	Italy	Endovascular therapies* vs. IV rt-PA	Not specified	362	Feb 2008 April 2012	Endovascular treatment ≤ 6 hrs from stroke onset.	Not specified
NCT01492725 EXTEND- IA	Australia and New Zealand	Endovascular Thrombectomy + IV rt-PA vs. IV rt-PA	Solitaire FR	70	Aug 2012 Oct 2014	Endovascular treatment ≤ 6 hrs from stroke onset.	ICA, M1 and M2
ISRCTN10888758 MR CLEAN	16 sites in the Netherlands	Endovascular therapies* vs. IV rt-PA	Not specified (devices approved by the FDA or CE and approved by their steering committee)	500	Dec 2010 March 2014	Endovascular treatment ≤ 6 hrs from stroke onset.	ICA, M1, M2, A1 and A2
NCT01778335 ESCAPE	Canada, USA, South Korea, Ireland, UK (22 centers)	Endovascular Thrombectomy + IV rt-PA vs. IV rtPA	Not specified (use of retrievable stents were recommended)	316	Feb 2013 Oct2014	Endovascular treatment ≤ 12 hrs from stroke onset.	ICA, M1, M1-MCA ( 2 or more M2-MCAs)
NCT01657461 SWIFT PRIME	USA/Europe	Endovascular Thrombectomy vs. IV rt-PA	Solitaire FR or Solitaire 2	196	Nov 2012 Jan 2015	Endovascular treatment ≤ 6 hrs from stroke onset.	ICA, M1
NCT01692379 REVASCAT	Spain	Endovascular Thrombectomy vs. best medical care**	Solitaire	206	Feb 2012 Dec 2014	Endovascular treatment ≤ 8 hrs from stroke onset	ICA, M1

Study	Country	90 days Rankin scale	Mortality	Symptomatic intracranial hemorrhage
NCT00359424 IMS III	USA, Canada, Australia, Europe	Proportion with a Rankin score ≤ 2 ≠ 1.5% (95%CI-6.1 to 9.1)	At 90 days 19.1% vs. 21.6% (p = 0.52)	At hrs after rt-PA initiation 6.2% vs. 5.9% (p = 0.83)
NCT00389467 MR RESCUE	USA	Mean score on the Ranking scale 3.9 vs. 3.9, p = 0.99	At 90 days 18.7% vs. 24.1%	5% vs. 3.7%
NCT00640367 SYNTHESIS EXP	Italy	Proportion with a Rankin score < 2 ≠ -4.4% (95%CI, -14.1 to 5.2) OR 0.82; 95%CI, 0.53-1.27 AdOR = 0.71 95%CI0.44-1.14	At day 7 8% vs. 6% p = 0.53	At day 7 6% vs. 6% p = 0.99
NCT01492725 EXTEND- IA	Australia and New Zealand	Rankin score 71% vs. 40% Generalized OR = 2.0; 95%CI 1.2-3.8	At 90 day 9% vs. 20% AdjOR = 0.45 (0.1-2.1)	0% vs. 6% (mean difference -6 (95%CI; -13 to 2)
ISRCTN10888758 MR CLEAN	16 sites in the Netherlands	Proportion with a Rankin score ≤ 2 ≠ 13.5% (95%CI, 5.9 to 21.2) Adjusted OR of 2.16 (95%CI, 1.39 to 3.38)	At 7days 11.6% vs. 12.4% At 30 days 18.9% vs. 18.4%	At 90 days 7.7% vs. 6.4%
NCT01778335 ESCAPE	Canada, USA, South Korea, Ireland, UK	Proportion with a Rankin score ≤ 2 53% and 29.3% RR 1.4 (95% 1.4-2.4) OR 2.6 (95%CI 1.7-3.8)	At 30 days 10.4% vs. 19% Dif 8.6%(0.8-16.6) RR = 0.5(0.3-1.0) AdRR = 0.5(0.3-0.8)	At 30 days 3.6% vs. 2.7% Dif = 1%(-2.9-4.8) RR = 1.4 (0.4-4.7) AdRR = 1.2(0.3-4.6)
NCT01657461 SWIFT PRIME	USA/Europe	Proportion with a Rankin score ≤ 2 60% and 35% RR = 1.70 (95%CI 1.23-2.33)	At 90 day 9% vs. 12% p = 0.50	At 27 hrs 0 vs. 3% p = 0.12
REVASCAT	Spain	Proportion with a Rankin score ≤ 2 43.7% and 28.2% OR = 2.1 (95%CI 1.2-4.0)	At 90 day 18% vs. 15.5% p = 0.60	At 90 days 1.9% vs. 1.9% p = 1.00

Study	Country	Intervention groups	Device Type Brand	Sample size	Therapeutic Window for endovascular treatment from stroke symptoms onset	Culprit artery Inclusion criteria	Recruitment Onset/end	Current status
NCT01062698 THRACE	FRANCE	Endovasc. Thrombectomy + IV rt-PA vs. IV rt-PA	MERCI, Catch Penumbra Solitaire	480	≤ 5 hrs	ICA, M1, basilar distal	Jan 2010 Dec 2012	Halted (Interim analysis showing results favouring the endovascular treatment)
NCT02135926	Austria Germany	Endovascular thrombectomy vs. best medical care	Solitaire Trevo	600	≤ 7 hrs;	ICAdistal,M1	March 2014 March 2018	Halted
NCT01429350 THERAPY	USA	Endovasc. Thrombectomy + IV rt-PA vs. IV rt-PA	Penumbra System	692	≤ 5 hrs	ICA, M1, M2	May 2012 Dec 2016	Halted
NCT02216565	FRANCE	Endovascular Thrombectomy + Best medical care* vs. best medical care*	Not specified	270	≤ 6 hrs	ICA distal,M1	Dec 2014 To March 2016	This study is currently recruiting participants.
NCT02419781	JAPAN	Endovasc. Thrombectomy + IV rt-PA vs. IV rt-PA	Any Device	200	≤ 8 hrs	ICA, M1	Oct 2014 To July 2017	This study is currently recruiting participants.
NCT01745692 PISTE	United Kingdom	Endovasc. Thrombectomy + IV rt-PA vs. IV rt-PA	Not specified mechanical thrombectomy	800	≤ 5.5hrs	ICA, M1, M2	Dec 2012 Aug 2017	This study is currently recruiting participants
NCT01717755 BASICS	Italy Netherlands Switzerland	Endovasc. Thrombectomy + IV rt-PA vs. IV rt-PA	MERCI Trevo Penumbra Solitaire	750	≤ 6 hrs	Basilar	Oct 2011 Oct 2017	This study is currently recruiting participants
NCT01852201 POSITIVE	USA	Endovascular Thrombectomy vs. best medical care^#	Penumbra, Solitaire and TREVO	750	≤ 12 hrs	ICA, M1	Sept 2013 May 2016	This study is currently recruiting participants
NCT01983644	China	Endovascular thrombectomy vs. IV rt-PA	RECO flow restoration device	130	≤ 4.5 hrs	ICA, M1/ M2	Sept 2013 To Nov 2015	This study is currently recruiting participants.
NCT02142283 DAWN	USA	Endovascular thrombectomy vs. best medical care	Trevo	500	6 to 24 hrs	ICA, M1	June 2014 To July 2017	This study is currently recruiting participants.
NCT02157532	Canada	Endovascular thrombectomy vs. best medical care*	Any approved stent-retriever device	480	≤ 5 hrs	ICA, M1, M2 and basilar	Jan 2013 Jan 2020	This study is currently recruiting participants.
NCT02216643 RESILIENT	BRAZIL	Endovasc. Thrombectomy vs. best medical care*	Solitaire FR	690	≤ 7.5 hrs	ICA, M1	March 2015 March 2018	Not yet recruiting
NCT01455935 WASSABI	USA	Endovascular thrombectomy vs. IV rt-PA vs. Standard medical care	Merci Penumbra	90	Unknown time of onset but less than 24 hours since last seen normal	MCA	Nov 2011 To Feb 2014	Status unknown (it has not been updated recently)

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[1] Correspondence: Cleusa Ferri; Hospital Alemão Oswaldo Cruz, Instituto de Educação e Ciências da Saúde; Rua João Julião, 245 / 1° andar; 01323-903 São Paulo SP, Brasil; E-mail: ferricleusa@gmail.com