Ticagrelor With or Without Aspirin After Complex PCI.

Aged Aspirin / administration & dosage Double-Blind Method Drug Therapy, Combination Female Follow-Up Studies Hemorrhage / chemically induced Humans Male Middle Aged Percutaneous Coronary Intervention / adverse effects Platelet Aggregation Inhibitors / administration & dosage Postoperative Complications / chemically induced Purinergic P2Y Receptor Antagonists / administration & dosage Ticagrelor / administration & dosage

aspirin bleeding complex PCI dual antiplatelet therapy ticagrelor monotherapy

Journal

Journal of the American College of Cardiology

ISSN: 1558-3597

Titre abrégé: J Am Coll Cardiol

Pays: United States

ID NLM: 8301365

Informations de publication

Date de publication:
19 05 2020

Historique:

received: 05 02 2020

revised: 05 03 2020

accepted: 09 03 2020

pubmed: 3 4 2020

medline: 1 1 2021

entrez: 3 4 2020

Statut: ppublish

Résumé

Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown. The purpose of this study was to evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization. Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38 to 0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21 to 0.80). There were no significant between-group differences in death, myocardial infarction, or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52 to 1.15), nor in stent thrombosis. Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).

Sections du résumé

BACKGROUND

Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown.

OBJECTIVES

The purpose of this study was to evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial.

METHODS

In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization.

RESULTS

Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38 to 0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21 to 0.80). There were no significant between-group differences in death, myocardial infarction, or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52 to 1.15), nor in stent thrombosis.

CONCLUSIONS

Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).

Identifiants

DOI: 10.1016/j.jacc.2020.03.011 PMID: 32240761

pubmed: 32240761

pii: S0735-1097(20)34533-2

doi: 10.1016/j.jacc.2020.03.011

pii:

doi:

Substances chimiques

Platelet Aggregation Inhibitors 0

Purinergic P2Y Receptor Antagonists 0

Ticagrelor GLH0314RVC

Aspirin R16CO5Y76E

Banques de données

ClinicalTrials.gov

['NCT02270242']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

2414-2424

Subventions

Organisme : British Heart Foundation

ID : CS/15/7/31679

Pays : United Kingdom

Commentaires et corrections

Type : CommentIn