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. 2019 Oct 11;9(10):e026578. doi: 10.1136/bmjopen-2018-026578

Table 3.

Hierarchical and non-hierarchical subject counts of adverse events through 12 months (intent-to-treat population)

n (%) 30 days 6 months 12 months
Hierarchical events
TLF 2 (0.4) 8 (1.7) 11 (2.4)
 Cardiac death 1 (0.2) 3 (0.6) 4 (0.9)
 Target-vessel MI 1 (0.2) 3 (0.6) 3 (0.6)
 Target-lesion revascularisation 0 (0) 5 (1.1) 7 (1.5)
 Target vessel failure 2 (0.4) 11 (2.4) 14 (3.0)
 Major adverse cardiovascular events 4 (0.9) 14 (3.0) 18 (3.9)
Non-hierarchical events
Death 1 (0.2) 1 (0.2) 6 (1.3)
 Cardiac death 1 (0.2) 3 (0.6) 4 (0.9)
 Non-cardiac death 0 (0.0) 1 (0.2) 2 (0.4)
Myocardial infarction
Target vessel 1 (0.2) 3 (0.6) 3 (0.6)
Non-target vessel 2 (0.4) 3 (0.6) 4 (0.9)
Revascularisation
 Target lesion revascularisation 1 (0.2) 5 (1.1) 7 (1.5)
 Target vessel revascularisation 1 (0.2) 10 (2.2) 14 (3.0)
Non target vessel revascularisation 2 (0.4) 4 (0.8) 6 (1.2)
 Stent thrombosis 1 (0.2) 3 (0.6) 4 (0.9)
 Definite ST 0 (0.0) 0 (0.0) 0 (0.0)
 Probable ST 1 (0.2) 1 (0.2) 1 (0.2)
 Possible ST 0 (0.0) 2 (0.4) 3 (0.6)

MACE, major adverse cardiac events (composite of cardiac death, any MI, emergent or repeat revascularisation); MI, myocardial Infarction; ST, stent thrombosis; TLF, target lesion failure (composite of cardiac death, target vessel MI or clinically driven TLR); TVF, target vessel failure (composite of cardiac death, target vessel MI and TVR); TVR, target vessel revascularisation.