Table 2.

Angiographic and clinical efficacy endpoints

	Trevo group	Merci group	Odds ratio (95% CI)	p value
Primary efficacy endpoint
Assigned device TICI ≥2 reperfusion as per core laboratory (intra-arterial lytic equals failure)	76/88 (86%)	54/90 (60%)	4·22 (1·92–9·69)	<0·0001*; <0·0001†
Angiographic efficacy endpoints
Assigned device TICI ≥2 as per site investigator	73/86 (85%)	58/88 (66%)	2·90 (1·32–6·61)	0·0047‡
Adjuvant therapy after assigned device	16/88 (18%)	28/90 (31%)	049 (0·23–1·05)	0·0851‡
Final TICI ≥2 reperfusion as per core laboratory	81/88 (92%)	69/90 (77%)	3·52 (1·33–10·35)	0·0068‡
Assigned device TICI§ reperfusion as per core laboratory				0·0001¶
0	8%	17%	0·44 (0·14–1·22)
1	2%	20%	0·09 (0·01–0·42)
2a	22%	20%	1·12 (0·51–2·47)
2b	54%	38%	1·93 (1·02–3·68)
3	14%	6%	2·68 (0·83–10·13)
Mean time to TICI ≥2 reperfusion or end of procedure	47·8 (44·2)	47·3 (38·8)	NA	0·53†
Clinical efficacy endpoint
90 day good outcome (modified Rankin score 0–2)	34/85 (40%)	19/87 (22%)	2·39 (1·16–4·95)	0·0130‡

TICI=thrombolysis in cerebral infarction grading scale score. NA=not applicable.

^*Non-inferiority hypothesis with Blackwelder’s method and a non-inferiority margin of 10%.

^†One-sided Wald test of superiority.

^‡Fisher’s exact test.

^§TICI grade 0 is no perfusion; grade 1 is perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion; grade 2a is perfusion of less than two-thirds of the vascular distribution of the occluded artery; grade 2b is perfusion of two-thirds or more of the vascular distribution of the occluded artery; grade 3 is full perfusion with filling of all distal branches.

^¶Wilcoxon rank sum.