The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial

Table 2 Endpoint definitions

End-point	Definition
Mortality	All-cause death
Cardiovascular mortality	All deaths unless otherwise clearly documented to be related to another cause (for example, trauma, cancer, suicide etcetera)
Myocardial infarction (MI)	Peri-procedural MI related to TAVI (≤72 h after the TAVI)
	Spontaneous MI (>72 h after TAVI)
	MI related to PCI (type 4a)
	MI related to PCI due to stent thrombosis (type 4b)
Cerebrovascular event	Stroke
Cerebrovascular event	Transient ischemic attack
Bleeding complication	Life-threatening or disabling
	Major
	Minor
Access site complication	Major
Access site complication	Minor
Acute kidney injury As per AKIN classification in VARC2 [34]	Stage 1
	Stage 2
	Stage 3
Major adverse cardiac and cerebrovascular events (MACCE)	Combined cardiovascular mortality, MI, stroke and further revascularization

TAVI, transcatheter aortic valve implantation; PCI, percutaneous coronary intervention, AKIN, acute kidney injury network; VARC2, Valve Academic Research Consortium second guidelines [34].

ISSN: 1745-6215