Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
The primary objective of this study is to compare, in patients with severe aortic stenosis
 and concomitant coronary artery disease accepted for transcatheter aortic valve implantation
 (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the
 safety and efficacy of fractional flow reserve (FFR)-guided complete revascularization
 performed after (within 1-40 days) with FFR-guided complete revascularization performed
 before (within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
The prevalence of coronary artery disease in patients with severe aortic stenosis is high.
 About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal
 timing of coronary revascularization in patients with severe aortic stenosis and concomitant
 coronary artery disease undergoing TAVI is uncertain.

 The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label,
 non-inferiority trial is to compare two treatment strategies that are currently performed in
 clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic
 stenosis and concomitant coronary artery disease.

 In this trial, consecutive patients with severe aortic stenosis and concomitant coronary
 artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio
 to either FFR-guided complete coronary revascularization before (within 1-40 days) or after
 (within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.

 For both treatment groups, suitable lesions with FFR≤0.80 or >90% diameter stenosis on
 coronary angiography in a coronary artery ≥2.5 mm in diameter are considered significant.

 TAVI and PCI will be performed according to current guidelines.
Inclusion Criteria:

 -  Age ≥18 years

 -  Patients with severe aortic stenosis and concomitant coronary artery disease accepted
 for TAVI and PCI by a multidisciplinary Heart Team

 -  Severe symptomatic aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or
 ≥40 mmHg (echocardiography) and at least one of the following:

 1. Dyspnea

 2. Angina symptoms

 3. Syncope

 4. Decline in left ventricular ejection fraction <50%, symptoms or fall in blood
 pressure on exercise testing, or presence of high-risk criteria (peak transaortic
 velocity >5.5 m/s, severe valve calcification, peak transaortic velocity
 progression ≥0.3 m/s per year, and severe pulmonary hypertension with systolic
 pulmonary artery pressure >60 mmHg) according to current guidelines

 Exclusion Criteria:

 -  Inability to give informed consent

 -  No PCI-eligible coronary artery stenosis

 -  Admission with acute coronary syndromes within 30 days before randomization

 -  Previous coronary artery bypass grafting (CABG)

 -  Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12
 inhibitors (clopidogrel, ticagrelor, prasugrel)

 -  Planned cardiac or major surgery

 -  Known pregnancy at the time of inclusion

 -  Participation in another clinical study with an investigational product

 -  Life expectancy <1 year due to other severe non-cardiac disease