Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction.

Humans Coronary Artery Disease / complications Coronary Vessels / surgery Europe Heart Failure / etiology Myocardial Infarction / etiology Myocardial Revascularization / adverse effects Percutaneous Coronary Intervention / adverse effects ST Elevation Myocardial Infarction / etiology Stroke / etiology Time Factors Treatment Outcome Time-to-Treatment

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
12 Oct 2023

Historique:

medline: 4 1 2024

pubmed: 27 8 2023

entrez: 27 8 2023

Statut: ppublish

Résumé

In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year.

RESULTS RESULTS

We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event.

CONCLUSIONS CONCLUSIONS

Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).

Identifiants

DOI: 10.1056/NEJMoa2307823 PMID: 37634190

pubmed: 37634190

doi: 10.1056/NEJMoa2307823

doi:

Banques de données

ClinicalTrials.gov

['NCT03135275']

Types de publication

Comparative Study Equivalence Trial Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

Pagination

1368-1379

Subventions

Organisme : Boston Scientific Corporation

ID : ISROTH10277

Investigateurs

Barbara E Stähli (BE)

Willibald Maier (W)

Frank Ruschitzka (F)

Jasmina Alibegovic (J)

Ronald Binder (R)

Alessandro Candreva (A)

Maciej Cieslik (M)

Marko Gajic (M)

Oliver Gämperli (O)

Thomas Gilhofer (T)

Alexander Gotschy (A)

Erik Holy (E)

Thomas Lüscher (T)

Giulia Magnani (G)

Robert Manka (R)

Susanne Markendorf (S)

Jonathan Michel (J)

Fabian Nietlispach (F)

Slayman Obeid (S)

Evelyn Regar (E)

Patrick Siegrist (P)

Julia Stehli (J)

Gabor Sütsch (G)

Christian Templin (C)

Miriam Brinkert (M)

Ercüment Ercin (E)

Marco Giacchi (M)

Igal Moarof (I)

Martin Steiner (M)

Andre Vuilliomenet (A)

Christoph Kaiser (C)

Gregor Fahrni (G)

Raban Jeger (R)

Stephane Cook (S)

Gerard Baeriswyl (G)

Serban Puricel (S)

Mario Togni (M)

Marco Moccetti (M)

Marco Araco (M)

Luigi Biasco (L)

Elena Binda (E)

Carmela Crljenica (C)

Tiziano Moccetti (T)

Cristina Monti (C)

Elena Pasotti (E)

Giovanni Pedrazzini (G)

Iveta Petrova-Slater (I)

Angelo Quagliana (A)

Mariagrazia Rossi (M)

Daniel Sürder (D)

Christian Valina (C)

Franz-Josef Neumann (FJ)

Michael Amann (M)

Mohamed Ayoub (M)

Philipp Breitbart (P)

Johannes Bremicker (J)

Thomas Comberg (T)

Miroslaw Ferenc (M)

Michael Gick (M)

Willibald Hochholzer (W)

Nikolaus Löffelhardt (N)

Kambis Mashayekhi (K)

Thomas Nührenberg (T)

Faridun Rahimi (F)

Juergen Rothe (J)

Aurel Toma (A)

Ralph Tölg (R)

Bettina Schwarz (B)

Gert Richardt (G)

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Mohamed Abdel-Wahab (M)

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Martin Desaga (M)

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Axel Linke (A)

Stephan Haußig (S)

Robert Höllriegel (R)

Manja Hubald (M)

Stefanie Jellinghaus (S)

Norman Mangner (N)

Christian Pflücke (C)

Peter Sick (P)

Ephraim Winzer (E)

Felix Woitek (F)

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Commentaires et corrections

Type : CommentIn