Coronary interventions - Mini focus on left main revascularisation

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial

EuroIntervention 2022;17:1467-1476. DOI: 10.4244/EIJ-D-21-00514

Robert-Jan van Geuns
Robert-Jan van Geuns1,2, MD, PhD; Chang Chun-Chin2,3, MD; Margaret B. McEntegart4, PhD; Evgeny Merkulov5, MD; Evgeny Kretov6, MD, PhD; Maciej Lesiak7, MD; Peter O’Kane8, MD; Colm G. Hanratty9, MD; Erwan Bressollette10, MD; Marc Silvestri11, MD; Adrian Wlodarczak12, MD; Paul Barragan13, MD; Richard Anderson14, MD; Aleksey Protopopov15, MD; Aaron Peace16, MD; Ian Menown17, MD; Paul Rocchiccioli4, MD; Yoshinobu Onuma2,18, MD, PhD; Keith G. Oldroyd4, MD
1. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands; 2. Department of Cardiology, Thorax Center, Erasmus Medical Center, Rotterdam, the Netherlands; 3. Division of Cardiology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; 4. Golden Jubilee National Hospital, Glasgow, United Kingdom; 5. Russian Cardiology Research Center, Moscow, Russian Federation; 6. E.N. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation; 7. 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland; 8. Department of Cardiology, Royal Bournemouth Hospital, Bournemouth, United Kingdom; 9. Belfast Health and Social Care Trust, Belfast, United Kingdom; 10. Hôpital Privé du Confluent, Nantes, France; 11. Clinique Axium, Aix-en-Provence, France; 12. Department of Cardiology, Miedziowe Centrum Zdrowia S.A., Lubin, Poland; 13. Department of Cardiology, Polyclinique les Fleurs, Ollioules, France; 14. University Hospital of Wales, Cardiff, United Kingdom; 15. Krasnoyarsk Regional Vascular Centre, Krasnoyarsk, Russia; 16. Altnagelvin Hospital, Londonderry, United Kingdom; 17. Craigavon Area Hospital, Craigavon, United Kingdom; 18. Cardialysis, Rotterdam, the Netherlands

Background: Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).

Aims: The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease.

Methods: This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years.

Results: Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02).

Conclusions: In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

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adjunctive pharmacotherapydrug-eluting stentintravascular ultrasoundleft main
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