Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates.

Aged Aged, 80 and over Coronary Angiography / trends Coronary Artery Disease / diagnostic imaging Drug-Eluting Stents / adverse effects Female Hemorrhage / diagnostic imaging Humans Internationality Male Myocardial Ischemia / diagnostic imaging Percutaneous Coronary Intervention / adverse effects Risk Factors Single-Blind Method Sirolimus / administration & dosage Stents / adverse effects Treatment Outcome

Bare-metal stent Ischemic events Randomized trial SYNTAX score Zotarolimus-eluting stent

Journal

International journal of cardiology

ISSN: 1874-1754

Titre abrégé: Int J Cardiol

Pays: Netherlands

ID NLM: 8200291

Informations de publication

Date de publication:
15 Feb 2019

Historique:

received: 07 08 2018

revised: 19 09 2018

accepted: 28 09 2018

pubmed: 9 10 2018

medline: 4 9 2019

entrez: 9 10 2018

Statut: ppublish

Résumé

The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0-8: n = 563; >8-19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44-1.13; tertile 2: HR 0.71, 95% CI 0.46-1.09; tertile 3: HR 0.83, 95% CI 0.61-1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year.

RESULTS RESULTS

The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0-8: n = 563; >8-19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44-1.13; tertile 2: HR 0.71, 95% CI 0.46-1.09; tertile 3: HR 0.83, 95% CI 0.61-1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints.

CONCLUSIONS CONCLUSIONS

The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Identifiants

DOI: 10.1016/j.ijcard.2018.09.120 PMID: 30293666

pubmed: 30293666

pii: S0167-5273(18)34840-X

doi: 10.1016/j.ijcard.2018.09.120

pii:

doi:

Substances chimiques

zotarolimus H4GXR80IZE

Sirolimus W36ZG6FT64

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

60-65

Commentaires et corrections

Type : CommentIn