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ST-elevation Myocardial InfarctionMULTISTARS AMINCT03135275

MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial

A study testing Staged complete PCI, Immediate complete PCI and Synergy™ stent in people with ST-elevation Myocardial Infarction and Multivessel Coronary Disease, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Staged complete PCI, Immediate complete PCI and Synergy™ stent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
1 siteSwitzerland
Study dates
Oct 2016to May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset)
  • Suitability for PCI from femoral or radial access
  • Coronary anatomy suitable for complete coronary revascularization with Synergy® stent implantation
  • Identifiable culprit lesion/artery
  • At least one non-culprit coronary stenosis ≥ 70% in at least two projections, in a vessel with a lumen diameter ≥2.25 - ≤5.75 mm, other than the culprit artery
  • TIMI Flow 3 or TIMI flow 2 after revascularization of the culprit artery
  • Stable hemodynamics at the end of the culprit vessel revascularization

Who cannot join

  • Inability to give informed consent
  • Cardiogenic shock
  • Prolonged resuscitation >10 min
  • General unsuitability for PCI
  • Need for emergency CABG
  • Previous CABG
Show all 21Show fewer
  • Planned hybrid revascularization
  • Coronary artery dissection
  • STEMI due to ST
  • Previous documented allergic reaction to everolimus or to any stent material
  • Severe mechanical complication of acute myocardial infarction
  • Pre-existing severe renal failure (eGFR <30 mL/min) or renal replacement therapy
  • Chronic total occlusion of a major coronary artery
  • Left main stem stenosis ≥50% or left main stem equivalent (ostial left anterior descending and ostial circumflex stenosis ≥70%)
  • In-stent restenosis
  • Panned coronary, cerebrovascular, or peripheral arterial revascularization
  • Planned cardiac or major surgery
  • Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 Inhibitor for at least 90 days, except for patients on oral anticoagulation
  • Known pregnancy at the time of inclusion
  • Participation in another clinical study with an investigational product
  • Life expectancy <1 year

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Zürich, Cardiology Department

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial

The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention (PCI) of all significant coronary lesions (within 19 to 45 days), in a non-inferiority trial using a third generation, biodegradable-polymer, everolimus-eluting stent.

Read the detailed description

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions, undergoing after successful PCI of the culprit lesion either (1:1 randomization) immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions (within 19 to 45 days) using the Boston Scientific Synergy™ stent.

The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice: immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD.

Patients randomized to immediate complete revascularization will have treated during the index procedure, after revascularization of the culprit lesion, all significant non-culprit coronary lesions.

Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions.

For both groups, lesion are considered significant when causing a ≥70% diameter stenosis by visual estimation in at least two projections on the coronary angiogram.

Being tested
Staged complete PCI, Immediate complete PCI, Synergy™ stent
Keywords
ST-elevation Myocardial Infarction, Multivessel coronary disease, Immediate complete coronary revascularization, Staged complete coronary revascularization, Percutaneous coronary intervention, Biodegradable-polymer everolimus-eluting stent
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staged complete PCIProcedure or surgery

    During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

  • Immediate complete PCIProcedure or surgery

    During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

  • Synergy™ stentDevice

    Bioabsorbable Polymer Drug-Eluting Stent

Study groups in NCT03135275
Study groupRoleWhat they receive
Staged complete PCIActive comparatorPatients randomized to staged complete PCI will have treated during the index admission only the culprit lesion and they will be hospitalized after 19-45 days, to complete the coronary revascularization on all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.
Receives: Procedure: Staged complete PCI; Device: Synergy™ stent
Immediate complete PCIExperimentalPatients randomized to immediate complete PCI will have treated immediately after the revascularization of the culprit lesion during the index procedure all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.
Receives: Procedure: Immediate complete PCI; Device: Synergy™ stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year

    Measured: 1-year

Secondary outcomes (18)
  1. All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke

    Primary endpoint

    Measured: 6 months

  2. All-cause death

    Single components of the primary endpoint

    Measured: 6 months, 1 year

  3. Non-fatal myocardial infarction

    Single components of the primary endpoint

    Measured: 6 months, 1 year

  4. Unplanned ischemia-driven revascularization

    Single components of the primary endpoint

    Measured: 6 months, 1 year

  5. Hospitalization for heart failure

    Single components of the primary endpoint

    Measured: 6 months, 1 year

  6. Stroke

    Single components of the primary endpoint

    Measured: 6 months, 1 year

  7. Target lesion revascularization (TLR)

    Measured: 6 months, 1 year

  8. Target vessel revascularization (TVR)

    Measured: 6 months, 1 year

  9. Non-cardiovascular death

    Measured: 6 months, 1 year

  10. Cardiac death

    Measured: 6 months, 1 year

  11. Cardiovascular death

    Measured: 6 months, 1 year

  12. Cardiac death or myocardial infarction

    Measured: 6 months, 1 year

  13. All-cause death or myocardial infarction

    Measured: 6 months, 1 year

  14. Stent thrombosis

    Measured: 6 months, 1 year

  15. Acute renal insufficiency or dialysis

    Measured: 6 months, 1 year

  16. Procedural success

    Measured: 6 months, 1 year

  17. Bleeding event (BARC definition)

    Measured: 6 months, 1 year

  18. Quality of life (EQ-5D questionnaire)

    Measured: 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study startOct 2016
  3. Primary completionMay 2023
  4. Study completionMay 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03135275
Sponsor's protocol ID
MULTISTARS_USZ
Acronym
MULTISTARS AMI
Status last verified
Jan 2024
First submitted
10 Apr 2017
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23991625
  • Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.

    PubMed 25766941
  • 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.

    PubMed 26347918
  • Kornowski R, Mehran R, Dangas G, Nikolsky E, Assali A, Claessen BE, Gersh BJ, Wong SC, Witzenbichler B, Guagliumi G, Dudek D, Fahy M, Lansky AJ, Stone GW; HORIZONS-AMI Trial Investigators. Prognostic impact of staged versus "one-time" multivessel percutaneous intervention in acute myocardial infarction: analysis from the HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial. J Am Coll Cardiol. 2011 Aug 9;58(7):704-11. doi: 10.1016/j.jacc.2011.02.071.

    PubMed 21816305
  • Cavender MA, Milford-Beland S, Roe MT, Peterson ED, Weintraub WS, Rao SV. Prevalence, predictors, and in-hospital outcomes of non-infarct artery intervention during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (from the National Cardiovascular Data Registry). Am J Cardiol. 2009 Aug 15;104(4):507-13. doi: 10.1016/j.amjcard.2009.04.016. Epub 2009 Jun 18.

    PubMed 19660603
  • Widimsky P, Holmes DR Jr. How to treat patients with ST-elevation acute myocardial infarction and multi-vessel disease? Eur Heart J. 2011 Feb;32(4):396-403. doi: 10.1093/eurheartj/ehq410. Epub 2010 Nov 30.

    PubMed 21118854
  • Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.

    PubMed 22922416
  • Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

    PubMed 25173339
  • Sabate M, Raber L, Heg D, Brugaletta S, Kelbaek H, Cequier A, Ostojic M, Iniguez A, Tuller D, Serra A, Baumbach A, von Birgelen C, Hernandez-Antolin R, Roffi M, Mainar V, Valgimigli M, Serruys PW, Juni P, Windecker S. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials. JACC Cardiovasc Interv. 2014 Jan;7(1):55-63. doi: 10.1016/j.jcin.2013.07.012. Epub 2013 Dec 11.

    PubMed 24332419
  • Stahli BE, Varbella F, Linke A, Schwarz B, Felix SB, Seiffert M, Kesterke R, Nordbeck P, Witzenbichler B, Lang IM, Kessler M, Valina C, Dibra A, Rohla M, Moccetti M, Vercellino M, Gaede L, Bott-Flugel L, Jakob P, Stehli J, Candreva A, Templin C, Schindler M, Wischnewsky M, Zanda G, Quadri G, Mangner N, Toma A, Magnani G, Clemmensen P, Luscher TF, Munzel T, Schulze PC, Laugwitz KL, Rottbauer W, Huber K, Neumann FJ, Schneider S, Weidinger F, Achenbach S, Richardt G, Kastrati A, Ford I, Maier W, Ruschitzka F; MULTISTARS AMI Investigators. Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2023 Oct 12;389(15):1368-1379. doi: 10.1056/NEJMoa2307823. Epub 2023 Aug 27.

    PubMed 37634190
  • Jakob P, Varbella F, Linke A, Felix SB, Seiffert M, Kesterke R, Nordbeck P, Witzenbichler B, Lang IM, Kessler M, Valina C, Dibra A, Rohla M, Moccetti M, Vercellino M, Gaede L, Bott-Flugel L, Stehli J, Candreva A, Wurdinger M, Paneni F, Templin C, Schindler M, Wischnewsky M, Zanda G, Quadri G, Mangner N, Toma A, Magnani G, Clemmensen P, Munzel T, Schulze PC, Laugwitz KL, Rottbauer W, Huber K, Neumann FJ, Schneider S, Riemer T, Weidinger F, Achenbach S, Richardt G, Kastrati A, Ford I, Ruschitzka F, Stahli BE. Killip class at presentation and immediate versus staged multivessel PCI in patients with STEMI. Sci Rep. 2026 Jun 26. doi: 10.1038/s41598-026-58258-8. Online ahead of print.

    PubMed 42362625
  • Rohla M, Huber K, Varbella F, Linke A, Schwarz B, Felix SB, Seiffert M, Kesterke R, Nordbeck P, Witzenbichler B, Lang IM, Kessler M, Valina C, Dibra A, Jakob P, Moccetti M, Vercellino M, Gaede L, Bott-Flugel L, Stehli J, Candreva A, Paneni F, Templin C, Schindler M, Wischnewsky M, Zanda G, Quadri G, Mangner N, Toma A, Magnani G, Clemmensen P, Luscher TF, Munzel T, Schulze PC, Laugitz KL, Rottbauer W, Neumann FJ, Schneider S, Riemer T, Weidinger F, Achenbach S, Richardt G, Kastrati A, Ford I, Ruschitzka F, Stahli BE; MULTISTARS AMI Investigators. Impact of renal dysfunction on immediate versus staged revascularization of non-culprit lesions in patients with ST segment elevation myocardial infarction: a pre-specified subgroup analysis of the randomized MULTISTARS AMI trial. Clin Res Cardiol. 2026 Mar 9. doi: 10.1007/s00392-026-02875-w. Online ahead of print.

    PubMed 41801439
  • Jakob P, Varbella F, Linke A, Schwarz B, Felix SB, Seiffert M, Kesterke R, Nordbeck P, Witzenbichler B, Lang IM, Kessler M, Valina C, Dibra A, Rohla M, Moccetti M, Vercellino M, Gaede L, Bott-Flugel L, Stehli J, Candreva A, Paneni F, Templin C, Schindler M, Wischnewsky M, Zanda G, Quadri G, Mangner N, Toma A, Magnani G, Clemmensen P, Luscher TF, Munzel T, Schulze PC, Laugwitz KL, Rottbauer W, Huber K, Neumann FJ, Schneider S, Riemer T, Weidinger F, Achenbach S, Richardt G, Kastrati A, Ford I, Ruschitzka F, Stahli BE; MULTISTARS A. M. I. Investigators. Impact of diabetes on outcomes of patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease undergoing percutaneous coronary intervention. Clin Res Cardiol. 2025 Sep 10. doi: 10.1007/s00392-025-02745-x. Online ahead of print.

    PubMed 40928512

Questions about this trial

What is this clinical trial studying?

A study testing Staged complete PCI, Immediate complete PCI and Synergy™ stent in people with ST-elevation Myocardial Infarction and Multivessel Coronary Disease, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03135275, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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