Undiscovered pathology of transient scaffolding t1remains a driver of failures in clinical trials

Table 2 Serial imaging analysis of the artery remodeling in ABSORB cohort A and B trials

Variable	Post-procedure (baseline)	6 mo	12 mo	24 mo	36 mo	60 mo	FriedmanP value
Intravascular ultrasound, 60-mo results of ABSORB cohort B (B1, n = 21, and B2, n = 30) trial
Mean vessel area in mm2, mean ± SD (n), BL-to-FUP P value	14.56 ± 3.82 (21)	14.92 ± 3.78 (21), 0.3925		15.88 ± 4.02 (21), 0.0014S		15.28 ± 4.53 (21), 2.1371	0.0193S
	13.61 ± 2.40 (30)		14.15 ± 2.61 (30), 0.2140		14.25 ± 2.57 (30), 0.0788	13.23 ± 2.70 (28), 0.2701	0.0337S
Mean lumen area in mm2, mean ± SD (n), BL-to-FUP P value	6.75 ± 1.19 (21)	6.59 ± 1.20 (21), 0.0610		7.24 ± 1.91 (21), 0.1995		7.46 ± 2.45 (21), 0.0851	0.0626
	6.31 ± 0.86 (30)		6.31 ± 1.01 (30), 0.5131		6.70 ± 1.48 (30), 0.0858	6.48 ± 1.50 (30), 0.5666	0.2221
Plaque burden in %, mean ± estimated SD (n)1, BL-to-FUP P value	53.64 ± 14.08 (21)	55.83 ± 14.15 (21), < 0.392		54.41 ± 14.35 (21), < 0.202		51.18 ± 16.81 (21), < 2.142	< 0.062
	53.64 ± 9.46 (30)		55.41 ± 10.22 (30), < 0.512		52.98 ± 11.70 (30), < 0.092	51.02 ± 11.81 (30), < 0.562	< 0.222
Mean plaque area in mm2, mean ± SD (n), BL-to-FUP P value	7.81 ± 2.98 (21)	8.33 ± 2.88 (21), 0.0660		8.64 ± 2.85 (21), 0.0004S		7.75 ± 2.62 (21), 4.4007	0.0025S
	7.30 ± 1.85 (30)		7.84 ± 1.92 (30), 0.0220S		7.55 ± 1.58 (30), 0.8121	6.79 ± 1.90 (28), 0.0108S	< 0.0001S
Intravascular ultrasound, 36-mo results of ABSORB cohort B (B1, n = 33, and B2, n = 45) trial
Mean vessel area in mm2, mean ± SD (n), BL-to-FUP P value	14.04 ± 3.80 (33)	14.44 ± 3.82 (33), 0.008S		15.35 ± 4.05 (33), < 0.001S		NA	NA
	13.79 ± 2.37 (45)		14.43 ± 2.64 (45), 0.03S		14.58 ± 2.67 (45), 0.002S	NA	0.18
Mean lumen area in mm2, mean ± SD (n), BL-to-FUP P value	6.53 ± 1.24 (33)	6.36 ± 1.18 (33), 0.02S		6.85 ± 1.78 (33),0.35		NA	NA
	6.29 ± 0.90 (45)		6.35 ± 1.17 (45), NS		6.81 ± 1.62 (45), 0.05S	NA	0.007S
Plaque burden in %, mean ± estimated SD (n)1, BL-to-FUP P value	53.49 ± 14.48 (33)	55.96 ± 14.80 (33), < 0.02S		55.37 ± 14.61 (33), < 0.35		NA	NA
	54.39 ± 9.35 (45)		55.99 ± 10.32 (45), NS		53.29 ± 12.68 (45), < 0.05S	NA	NA
Mean plaque area in mm2, mean ± SD (n), BL-to-FUP P value	7.52 ± 2.84 (33)	8.08 ± 2.87 (33), < 0.001S		8.49 ± 2.89 (33), < 0.001S		NA	NA
	7.50 ± 1.82 (45)		8.08 ± 1.94 (45), < 0.001S		7.77 ± 1.73 (45), NS	NA	0.004
Intravascular ultrasound, 24-mo (n = 25), and MSCT, 60 mo (n = 18), results of ABSORB cohort A trial
Mean vessel area in mm2, mean ± SD (n), BL-to-FUP P value	13.49 ± 3.74 (25)	13.79 ± 3.84 (25), 0.98	NA	12.75 ± 3.43 (19), 0.68	NA	NA	NA
	NA	NA	NA	13.17 (18) (18 mo baseline)	NA	11.93 (18), 0.26	NA
Mean lumen area in mm2, mean ± SD (n), BL-to-FUP P value	6.04 ± 1.12 (25)	5.19 ± 1.33 (25), < 0.0001S	NA	5.47 ± 2.11 (19), 0.12	NA	NA	NA
	NA	NA	NA	4.47 (18) (18 mo baseline)	NA	4.29 (18), 0.11	NA
Plaque burden in %, mean ± estimated SD (n)1, BL-to-FUP P value	55.23 ± 15.31 (25)	62.36 ± 17.37 (25), < 0.98	NA	57.10 ± 22.02 (19), < 0.68	NA	NA	NA
	NA	NA	NA	66.06 (18) (18 mo baseline)	NA	64.04 (18), < 0.26	NA
Mean plaque area in mm2, mean ± SD (n), BL-to-FUP P value	7.44 ± 2.83 (25)	8.60 ± 2.85 (25), < 0.0001S	NA	7.10 ± 2.02 (19), 0.80	NA	NA	NA
	NA	NA	NA	8.23 (18) (18 mo baseline)	NA	7.10 (18), 0.23	NA

Numbers are expressed in mean ± SD or n.

¹The SD cannot be directly calculated due to unavailability of the patient-by-patient matrix of the ABSORB trial, and presented as either a 5% deviation or adjusted by the maximum deviation for both numerator and denominator;

²The P value cannot be directly calculated due to unavailability of the patient-by-patient matrix of ABSORB trial, and performed as an estimated P value adjusted by the maximum P value in either numerator or denominator. The cells with “S” performed statistically significant changes (P < 0.05) of the variables. NS: Non-significant (P value > 0.05); NA: Non-available or not applicable.