Table 1 Eligibility criteria for the percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial
Inclusion criteria | Â |
|---|---|
| Â | 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 | |