TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multi

Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).

Kedhi E ，Rroku A ，Hermanides RS ，Dambrink JH ，Singh S ，Berg JT ，van Ginkel DJ ，Hudec M ，Amoroso G ，Amat-Santos IJ ，Andreas M ，Teles RC ，Bonnet G ，Van Belle E ，Conradi L ，van Garsse L ，Wojakowski W ，Voudris V ，Sacha J ，Cervinka P ，Lipsic E ，Somi S ，Nombela-Franco L ，Postma S ，Piayda K ，De Luca G ，Malinofski K ，Modine T ... -  《-》

Trends and outcomes of combined percutaneous (TAVI+PCI) and surgical approach (SAVR+CABG) for patients with aortic valve and coronary artery disease: A National Readmission Database (NRD) analysis.

In patients with severe aortic stenosis (AS) and concomitant severe coronary artery disease (CAD), the relative merits of a combined percutaneous (transcatheter aortic valve implantation [TAVI] and percutaneous coronary intervention [PCI]] versus surgical approach (surgical aortic valve replacement [SAVR] and coronary artery bypass graft [CABG]) remain unknown. To determine the utility of combined percutaneous versus surgical approaches in patients with severe AS and CAD. The National Readmission Database (NRD) (2015-2019) was queried to identify all cases of TAVI+PCI and SAVR+CABG. The adjusted odds ratios (aOR) of mortality, stroke, and its composite (major adverse cardiovascular events [MACE]) were calculated using a propensity-score matched (PSM) analysis. A total of 89,314 (5358 TAVI+PCI, 83,956 SAVR+CABG) patients were included in the crude analysis. There was a gradual increase in the utilization of TAVI+PCI from 2016 to 2019 by 2%-4% per year. Using PSM, a subset of 11,361 (5358 TAVI+PCI, 6003 SAVR+CABG) patients with a balanced set of demographics and baseline comorbidities was selected. During index hospitalization, the adjusted odds of MACE (aOR 0.72, 95% confidence interval [CI] 0.62-0.83), and all-cause mortality (aOR 0.68, 95% CI 0.57-0.81) were significantly lower in patients undergoing TAVI+PCI compared with SAVR+CABG. However, patients undergoing TAVI+PCI had a higher incidence of MACE (aOR 1.40, 95% CI 1.05-1.87), and mortality (aOR 1.75, 95% CI 1.22-2.50) at 30-days. The risk of index-admission (aOR 0.82, 95% CI 0.62-1.09) and 30-day (aOR 0.88, 95% CI 0.51-1.51) stroke was similar between the two groups. In selected patients with severe AS and concomitant CAD, a combined percutaneous approach (TAVR+PCI) compared with SAVR+CABG may confer a lower risk of MACE and mortality during index admission but a higher incidence of 30-day complications.

Ullah W ，Sarvepalli D ，Kumar A ，Zahid S ，Saleem S ，Muhammadzai HZU ，Khattak F ，Block PC ，Jaber WA ，Shishehbor MH ，Filby SJ ，Devireddy C ... -  《-》

A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial.

Ribichini F ，Pesarini G ，Fabris T ，Lunardi M ，Barbierato M ，D'Amico G ，Zanchettin C ，Gregori D ，Piva T ，Nicolini E ，Gandolfo C ，Fineschi M ，Petronio AS ，Berti S ，Caprioglio F ，Saia F ，Sclafani R ，Esposito G ，D'Ascenzo F ，Tarantini G ... -  《-》

Coronary revascularization during treatment of severe aortic stenosis: A meta-analysis of the complete percutaneous approach (PCI plus TAVR) versus the complete surgical approach (CABG plus SAVR).

The management of patients with coexisting severe aortic stenosis (AS) and coronary artery disease (CAD) is still facing a great deal of uncertainty when it comes to choosing between the entire surgical versus the complete percutaneous approaches, after accurately balancing risks versus outcomes. To evaluate clinical outcomes and mortality of transcatheter aortic valve replacement (TAVR) plus percutaneous coronary intervention (PCI) compared with surgical aortic valve replacement (SAVR) plus coronary arteries bypass grafting (CABG) procedures in patients with concomitant AS and CAD. Electronic databases of PubMed, EMBASE, and SCOPUS were searched for relevant articles assessing outcome parameters of interest. The study endpoints were the rate of overall myocardial infarction and stroke within 30 days and the rate of 30-day mortality and 2-year mortality between patients with TAVR/PCI and those with SAVR/CABG. Random-effect meta-analysis did not reveal any significant difference between 30-day safety outcomes: myocardial infarction (TAVR/PCI vs SAVR/CABG: odds ratio [OR]: 0.52; 95% confidence interval [CI]: 0.20-1.33; I2  = 0%), stroke (TAVR/PCI vs SAVR/CABG: OR: 0.88; 95% CI: 0.45-1.73; I2  = 0%). No significant difference in 30-day mortality (OR: 0.72; 95% CI: 0.43-1.21; I2  = 0%) and 2-year mortality (OR: 1.50; 95% CI: 0.77-2.94; I2  = 81%) rate was noted between patients with TAVR/PCI and those with SAVR/CABG. When comparing the total percutaneous and total surgical treatment, no significant difference in short-term safety outcomes or early and late mortality was observed. More evidence is needed to guide the clinical decision.

Tarus A ，Tinica G ，Bacusca A ，Artene B ，Popa IV ，Burlacu A ... -  《-》

Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation - the third nordic aortic valve intervention trial - NOTION-3.

Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes. The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI. NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.

Sabbah M ，Veien K ，Niemela M ，Freeman P ，Linder R ，Ioanes D ，Terkelsen CJ ，Kajander OA ，Koul S ，Savontaus M ，Karjalainen P ，Erglis A ，Minkkinen M ，Jørgensen T ，Sondergaard L ，De Backer O ，Engstrøm T ，Lønborg J ... -  《-》