Extended, standard, or De-escalation antiplatelet therapy for patients with coronary artery disease undergoing percutaneous coronary intervention? A trial-sequential, bivariate, influential, and network meta-analysis

Author:

Ullah Waqas1ORCID,Zahid Salman2,Sandhyavenu Harigopal3,Faisaluddin Mohammed2,Khalil Fouad4,Pasha Ahmad K5,Alraies M Chadi6,Cuisset Thomas7,Rao Sunil V8,Sabouret Pierre9,Savage Michael P1,Fischman David L1

Affiliation:

1. Division of Cardiology, Thomas Jefferson University Hospitals , 111 S 11th Street, Philadelphia , PA 19107, USA

2. Rochester General Hospital , 1425 Portland Ave, Rochester, NY 14621 , USA

3. Weiss Memorial Hospital , 4646 N Marine Dr, Chicago, IL 60640 , USA

4. Sanford School of Medicine, University of South Dakota , 1400 West 22nd Street, Sioux Falls, SD 57105, USA

5. UHS Wilson Hospital, 33-57 Harrison Street , Johnson City, NY 13790, USA

6. Detroit Medical Center, Heart Hospital , 311 Mack Ave, Detroit, MI 48201 , USA

7. Aix-Marseille University , 58 Boulevard Charles Livon, 13007 Marseille, France

8. The Duke Clinical Research Institute , Durham, NC , USA

9. Collège National des Cardiologues Français , 13 Rue Niépce, 75014 Paris , France

Abstract

Abstract Aims The relative safety and efficacy of de-escalation, extended duration (ED) (>12-months), and standard dual antiplatelet therapy for 12-months (DAPT-12) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) remains controversial. Methods and results Online databases were queried to identify relevant randomized control trials (RCTs). ED-DAPT, high-potency (HP) DAPT, shorter duration (SD) DAPT, and low-dose (LD) DAPT were compared with DAPT-12. A trial sequential, bivariate, influential, and frequentist network meta-analysis (NMA) was performed to determine the pooled estimates. A total of 30 RCTs comprising 81 208 (40 839 experimental, 40 369 control arm) patients with CAD were included in the quantitative analysis. On NMA, compared with DAPT-12, all types of de-escalation, HP-DAPT-12, and ED-DAPT strategies had a statistically non-significant difference in the incidence of MACE at a median follow-up of 1-year. Similarly, there was no significant difference in the incidence of stroke, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and all-cause mortality between DAPT-12 and all other strategies. The network estimates showed a significantly lower incidence of major bleeding with DAPT for 3-months followed by P2Y12-inhibitor monotherapy (RR 0.62, 95% CI 0.45–0.84), while a higher risk of bleeding with HP-DAPT for 12 months (RR 1.55, 95% CI 1.16–2.06). The net clinical benefit and rankograms also favoured DAPT-3 (P2Y12) and discouraged the use of HP-DAPT-12 and ED-DAPT. A subgroup analysis of 19 RCTs restricted to patients who presented with acute coronary syndrome (ACS) mirrored the findings of pooled analysis. A sensitivity analysis revealed no influence of any individual study or individual strategy on net ischemic estimates. The trial sequential analysis (TSA) illustrated a consistently non-significant difference at the interim analysis of trials, reaching the futility area for MACE, while the cumulative Z-values line surpassed the monitoring boundary as well as the required information size for major bleeding favouring de-escalation strategy. Conclusion DAPT for three months followed by ticagrelor-only and use of aspirin + clopidogrel after a short period of high potency DAPT appears to be a safe strategy for treating post-PCI patients. However, given the methodological limitations and inclusion of a small number of trials in novel de-escalation strategies, these findings need validation by future large scale RCTs.

Funder

Amgen

AZ

Boehringer Ingelheim

Sanofi

Servier

Novartis

Vifor Pharma

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Cardiology and Cardiovascular Medicine

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