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Published on: June 3, 2018
PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation
Jacob Lønborg1, Reza Jabbari1, Muhammad Sabbah1
1From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis).
Insights
Percutaneous coronary intervention (PCI) reduced major adverse cardiac events in patients undergoing transcatheter aortic-valve implantation (TAVI). This approach lowered risks of death, heart attack, or urgent revascularization compared to conservative treatment over two years.
Area of Science:
- Cardiology
- Interventional Cardiology
- Cardiac Surgery
Background:
- The role of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease undergoing transcatheter aortic-valve implantation (TAVI) is not well-defined.
- Severe aortic stenosis often coexists with coronary artery disease, necessitating complex treatment decisions.
Purpose of the Study:
- To evaluate the efficacy and safety of PCI in patients with severe symptomatic aortic stenosis and significant coronary artery disease undergoing TAVI.
- To compare a strategy of PCI plus TAVI versus TAVI with conservative treatment for coronary disease.
Main Methods:
- An international, randomized trial assigned 455 patients with severe aortic stenosis and coronary artery stenosis (FFR ≤0.80 or diameter stenosis ≥90%) to either PCI or conservative treatment, with all patients receiving TAVI.
- The primary endpoint was a composite of all-cause death, myocardial infarction, or urgent revascularization.
- Safety outcomes, including bleeding events and procedural complications, were assessed.
Main Results:
- At a median follow-up of 2 years, major adverse cardiac events occurred in 26% of the PCI group versus 36% of the conservative treatment group (HR, 0.71; 95% CI, 0.51 to 0.99; P=0.04).
- Bleeding events were more frequent in the PCI group (28%) compared to the conservative group (20%) (HR, 1.51; 95% CI, 1.03 to 2.22).
- PCI-related complications occurred in 3% of patients in the PCI group.
Conclusions:
- In patients with coronary artery disease undergoing TAVI, PCI was associated with a significantly lower risk of major adverse cardiac events at 2-year follow-up compared to conservative management.
- While PCI demonstrated improved clinical outcomes, increased bleeding events warrant consideration in patient selection and management.
Background:
The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear.
Methods:
In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed.
Results:
A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Predicted Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications.
Conclusions:
Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.).
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