Table 1.
Eligibility criteria for the percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial
| Inclusion criteria | |
|---|---|
| Definition | |
| • Patients ≥18 years of age | |
| • Severe aortic stenosis, as defined by | • Peak transvalvular gradient of ≥40 mmHg on transthoracic echocardiography (TTE), transesophageal echocardiography (TOE) or dobutamine stress echocardiography (DSE) |
| • Aortic valve area of <1.0 cm2 | |
| • Symptoms suggestive of aortic stenosis | Dyspnea, syncope etc. but not pre-dominantly angina |
| • Deemed of prohibitive risk for open aortic valve replacement by a TAVI multidisciplinary team (MDT) and accepted for TAVI by said TAVI MDT. | |
| Significant coronary artery disease | • ≥1 stenosis of ≥70% in a major epicardial artery deemed suitable for PCI (≥50% if protected left main stem or vein graft) |
| • Undergoing TAVI via any accepted approach | Transfemoral, transapical, subclavian or transaortic |
| • Written informed consent | |
| Exclusion Criteria | Definition |
| • Recent acute coronary syndrome | Within 30 days of randomization |
| • Unprotected left main stem disease | |
| • Significant angina | CCS class ≥3 |
| • Pregnancy | |
| • Active internal bleeding (except menstruation) | |
| • Allergy to heparin or GPIIb/IIIa inhibitors | |
| • Thrombocytopenia cells/mm3) | Platelet count <100,000 |
| • Patients who have previously been enrolled in this study | |
| • Patients who are currently enrolled in any other study where involvement in ACTIVATION would involve deviation from either protocol | |
TAVI, transcatheter aortic valve implantation; CCS, Canadian Cardiac Society; GpIIb/IIIa, glycoprotein IIb/IIIa.