Author + information
- Philip Urban1,
- John Gregson2,
- Philipp Lurz3,
- Bernard Chevalier4,
- Marie-Claude Morice5,
- Janusz Lipiecki6,
- Franz-Josef Neumann7,
- Stephen Lee8,
- Andrejs Erglis9,
- Samantha Greene10 and
- Stuart Pocock11
- 1La Tour Hospital, Geneva, Switzerland
- 2London School of Hygiene and Tropical Medicine, London, United Kingdom
- 3Heart Center Leipzig, Leipzig, Germany
- 4Institut Cardiovasculaire Paris Sud, Massy, France
- 5CERC, Massy, France
- 6Clinique Des Domes-Pole Sante Republique, Clermont-Ferrand, France
- 7Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
- 8Queen Mary Hospital, The University of Hong K, Hong Kong, Hong Kong, China
- 9P. Stradins Clinical University Hospital, Riga, Latvia
- 10MVRx, Inc., San Mateo, California, United States
- 11London School of Hygiene and Tropical Medicine, London, United Kingdom
The LEADERS FREE trial has shown that a Biolimus A9 coated polymer-free metallic stent (DCS) was both safer and more effective than a bare metal stent (BMS) when used with one month dual antiplatelet therapy (DAPT) only in patients at high bleeding risk (HBR). It remains unknown whether individual adjustments of DAPT duration might be justified in such patients. The aim of this study was to design a trade-off score encompassing the risks for both coronary thrombotic events (CTE) and major bleeding events (MB) after percutaneous coronary intervention (PCI) in HBR patients treated with one month DAPT, in order to identify those patients with either an excess thrombotic risk or an excess bleeding risk.
Using data from 2423 HBR patients treated with either a DCS or a BMS and enrolled in the LEADERS FREE trial, independent predictors of CTE (defined as the composite of stent thrombosis or myocardial infarction) and MB (defined as the occurrence of a Bleeding Academic Research Consortium type 3, 4 or 5 bleed) were identified.
Between 3 and 365 days post PCI, 137 patients (5.6%) sustained a CTE, and 132 (5.4%) suffered a MB. Subsequent mortality after CTE and MB was 23.0% and 21.2% respectively at one year. Advanced age and renal insufficiency were predictors of both CTE and MB, especially the former. Multivessel coronary disease, a history of prior MI or presentation with ACS, and the use of a BMS were associated only with an increased risk of CTE. The need for long-term oral anticoagulation, and a low hemoglobin level at baseline were predictors of an increased risk of MB. Using an integer score, we identified a group (21.2% of patients) for whom the thrombosis risk was at least twice the bleeding risk and another (7.5% of patients) for whom the bleeding risk was at least twice the thrombosis risk. The former group might benefit from a DAPT course > 1 month, while the latter might benefit from maximal bleeding avoidance strategies.
A simple trade-off score, applicable shortly after PCI, may assist in optimizing individual anti-thrombotic regimens for HBR patients.