Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease

NCT03621501 | Active Not Recruiting DMC

• 1 other identifier: BioVasc protocol definitive
• Study Type: interventional
• Target: 1,525
• Locations: 1 country
• Sites: 1

Brief Summary

To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in Patients presenting with ACS, including Non-ST-elevation ACS (NSTEACS) and ST-elevation myocardial infarction (STEMI), with multivessel disease accepted for PCI

Conditions

Acute Coronary Syndrome

Keywords

Percutaneous coronary intervention; Multivessel disease

Outcome Measures

Primary Outcomes (1)

• MACCE

  a composite clinical outcome of all-cause mortality, myocardial infarction, any unplanned ischemia driven revascularization, and cerebrovascular events

  1 year

Secondary Outcomes (22)

• MACCE

  30 days

• MACCE

  2 years

• MACCE

  5 years

• All cause mortality

  30 days

• All cause mortality

  1 year

Study Arms (2)

Staged complete revascularization

PLACEBO COMPARATOR

• Culprit only + staged (within six weeks after index procedure) complete revascularization in all vessels ≥ 2.5mm with ≥ 70% stenosis by visual estimation or positive coronary physiology test per operator's discretion (Control arm)

Device: Percutaneous coronary intervention

Immediate complete revascularization

ACTIVE COMPARATOR

• Immediate complete revascularization in all vessels ≥ 2.5mm with ≥ 70% stenosis by visual estimation or positive coronary physiology test per operator's discretion (Experimental arm)

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

At the index procedure, the culprit lesion (cause of complaints/acute coronary syndrome) will be treated according to standard of care with a Biotronik Orsiro DES (Sirolimus-Eluting stent). If there are additional significant lesions besides the culprit lesion, patients will be randomized to direct complete revascularization or staged complete revascularization. In the direct complete revascularization group all lesions will be treated during the index procedure. In the staged complete revascularization group, only the culprit lesion will be treated during the index procedure. The remaining significant lesions will be treated later but within six weeks after the index procedure. In both arms the additional lesions will also be treated with Biotronik Orsiro DES (Sirolimus-Eluting stent).

Also known as: PCI

Immediate complete revascularization; Staged complete revascularization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chest pain for more than 20 minutes with an electrocardiographic ST-segment elevation of 1 mm or greater in two or more contiguous leads, or with a new left bundle-branch block
• Admission either within 12 hours of symptom onset or between 12 and 24 hours after onset with evidence of continuing ischemia.
• History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
• Coronary angiography with indication to PCI
• Troponin T or I or creatine kinase MB above the upper limit of normal
• Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts) 0 Unstable Angina (UA)
• At least two of the following must be present in the absence of cardiomyocyte necrosis (i.e. Troponin T or I and creatine kinase MB must be within normal limits):
• History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
• Coronary angiography with indication to PCI
• Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts)
• Age ≥ 18 years ≤ 85 years
• The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
• Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Biotronik Orsiro (Sirolimus-Eluting stent) system.
• The patient is willing and able to cooperate with study procedures and the required follow up visits
• The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization

You may not qualify if:

• Age \<18 years and \> 85 years
• Single coronary vessel disease or multivessel disease without clear culprit
• Patients in cardiogenic shock
• Patients who cannot give informed consent or have a life expectancy of less than 1year
• Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
• Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint . The patient may only be enrolled once in the BioVAsc study
• PCI in the previous 30 days.
• Presence of a chronic total occlusion
• Previous CABG
• Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding.
• Planned surgery within 6 months after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (22)

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• Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.

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  PMID: 17320742 RESULT

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MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Roberto Diletti, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Nicolas Van Mieghem, Prof.

  Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the patients to avoid a potential bias in the adjudication process of events
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This study is a prospective, multicenter, randomized, two-arm, international, open-label, non-inferiority study. Due to the design characteristics of the study, the study investigators and operators cannot be blinded.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: August 8, 2018
• Study Start: June 22, 2018
• Primary Completion: October 31, 2022
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)