In-hospital Versus After-discharge Complete Revascularization

NCT04743154 | Completed

• 1 other identifier: HGUValencia
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with STEMI and multivessel disease in whom the culprit lesion has been successfully revascularized during prmimary PCI, will be randomized to in-hospital or after-discharge complete revascularization. The purpose of this study is to evaluate the impact of these two different strategies in terms of hospital stay.

Conditions

STEMI - ST Elevation Myocardial Infarction; Multivessel Coronary Artery Disease

Keywords

STEMI; Multivessel; PCI

Outcome Measures

Primary Outcomes (1)

• Impact in hospital stay

  To evaluate the impact of two different revascularization strategies (in-hospital versus after-discharge) in terms of hospital stay (days) in patients with a STEMI and multivessel disease.

  6 months

Secondary Outcomes (2)

• Cardiovascular death, acute myocardial infarction or revascularization.

  1 year

• Fractional flow reserve of angiographically moderate stenosis

  6 months

Study Arms (2)

In-hospital complete revascularization group.

OTHER

Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.

Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)

After-discharge complete revascularization group.

OTHER

Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.

Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)

Interventions

In-hospital nonculprit-lesions percutaneous coronary intervention (PCI) OTHER

To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.

In-hospital complete revascularization group.

After-discharge nonculprit-lesions percutaneous coronary intervention (PCI) OTHER

To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.

After-discharge complete revascularization group.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute onset of chest pain \<12 hours duration.
• ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
• Culprit lesion in a major native vessel, with successful primary PCI.
• Presence of at least one non-culprit lesion more than or equal to 70% of stenosis in a vessel more than 2mm of diameter or more than or equal to 50% stenosis in proximal segments.
• The patient is able to give written consent for participation in the study.

You may not qualify if:

• Pregnancy.
• Significant left main stenosis.
• Stent thrombosis.
• Chronic total occlusion.
• Severe stenosis of non-culprit vessels with distal flow less than TIMI3.
• Significant non-culprit stenosis no candidate to revascularization.
• Presence of valvulopathy candidate for cardiac surgery.
• Cardiogenic shock status at admission.
• The patient is not able to give written consent for participation in the study.

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, Spain

Location

Related Publications (16)

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• Vlaar PJ, Mahmoud KD, Holmes DR Jr, van Valkenhoef G, Hillege HL, van der Horst IC, Zijlstra F, de Smet BJ. Culprit vessel only versus multivessel and staged percutaneous coronary intervention for multivessel disease in patients presenting with ST-segment elevation myocardial infarction: a pairwise and network meta-analysis. J Am Coll Cardiol. 2011 Aug 9;58(7):692-703. doi: 10.1016/j.jacc.2011.03.046.

  PMID: 21816304 BACKGROUND

• Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG; PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013 Sep 19;369(12):1115-23. doi: 10.1056/NEJMoa1305520. Epub 2013 Sep 1.

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  PMID: 25766941 BACKGROUND

• Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.

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• Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

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• Rumiz E, Valero E, Fernandez C, Vilar JV, Pellicer M, Cubillos A, Berenguer A, Facila L, Vano J, Nunez J. In-hospital versus after-discharge complete revascularization in patients with ST segment elevation myocardial infarction and multivessel disease. REVIVA-ST trial. PLoS One. 2024 May 14;19(5):e0303284. doi: 10.1371/journal.pone.0303284. eCollection 2024.

  PMID: 38743727 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Eva Rumiz Gonzalez, MD, PhD

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: January 20, 2018
• Primary Completion: November 25, 2021
• Study Completion: December 21, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)