Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS

Table 3 Safety and efficacy outcomes at follow-up

Endpoints and clinical events	EE-BRS (n = 147)		EES (n = 249)		P-value log rank	P-value PY event rate
Endpoints and clinical events	% (n) KM	100 PY (95% CI)	% (n) KM	100 PY (95% CI)	P-value log rank	P-value PY event rate
TLF^a	11.7 [16]	7.2 (4.1–11.7)	9.7 [24]	5.2 (3.3–7.7)	0.40	0.39
Cardiac death	3.4 [5]	2.1 (0.7–5.0)	4.4 [11]	2.3 (1.1–4.1)	0.84	>0.99
TV-MI	3.6 [5]	2.2 (0.7–5.1)	2.8 [7]	1.5 (0.6–3.1)	0.69	0.69
TLR	5.5 [7]	3.1 (1.2–6.3)	3.3 [8]	1.7 (0.7–3.3)	0.23	0.36
MACE^b	15.2 [20]	9.1 (5.6–14.1)	15.3 [38]	8.3 (5.9–11.4)	0.75	0.83
All-cause death	3.4 [5]	2.1 (0.7–5.0)	6.8 [17]	3.5 (2.1–5.6)	0.35	0.45
Any MI	4.9 [7]	3.1 (1.3–6.4)	3.2 [8]	1.7 (0.7–3.3)	0.40	0.36
TVR	9.3 [11]	4.9 (2.5–8.8)	6.6 [16]	3.4 (2.0–5.5)	0.29	0.46
ST^c	1.4 [2]	0.9 (0.1–3.1)	1.2 [3]	0.6 (0.1–1.8)	0.90	>0.99
Early	[2]		[2]
Acute	(0)		[2]
Subacute	[2]		(0)
Late	(0)		[1]
Very late	(0)		(0)
Definite	[1]		[1]
Probable	[1]		[2]

Shown are the clinical outcomes represented as endpoints and clinical events. Three patients were lost to follow-up in the everolimus-eluting bioresorbable scaffolds group. The results are presented by 2-year Kaplan–Meier estimates and are also reported in event rates per 100 patient years with 95% confidence intervals to adjust for the variable time to follow-up between both groups. A p-value < 0.05 was considered as statistically significant; no significant differences were found between both treatment groups at follow-up
^aTarget lesion failure was defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization
^bMajor adverse cardiac events were defined as a composite of all-cause death, any myocardial infarction and clinically driven target vessel revascularization
^cDevice thrombosis was defined as early if observed between 0 and 30 days after index procedure, including a further distinction between acute ≤ 24 h and subacute > 1–30 days. Device thrombosis was defined as late if ≤ 1 year and as very late if > 1 year
EE-BRS everolimus-eluting bioresorbable scaffolds, EES everolimus-eluting stents, PY patient years, KM Kaplan–Meier, CI confidence interval, TLF target lesion failure, TV-MI target vessel myocardial infarction, TLR target lesion revascularization, MACE major adverse cardiac events, MI myocardial infarction, TVR target vessel revascularization, ST device thrombosis

ISSN: 1475-2840