NCT03135275

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

6.6 years

First QC Date

April 10, 2017

Last Update Submit

January 9, 2024

Conditions

ST-elevation Myocardial InfarctionMultivessel Coronary Disease

Keywords

ST-elevation Myocardial InfarctionMultivessel coronary diseaseImmediate complete coronary revascularizationStaged complete coronary revascularizationPercutaneous coronary interventionBiodegradable-polymer everolimus-eluting stent

Outcome Measures

Primary Outcomes (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

    1-year

Secondary Outcomes (18)

  • All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke

    6 months

  • All-cause death

    6 months, 1 year

  • Non-fatal myocardial infarction

    6 months, 1 year

  • Unplanned ischemia-driven revascularization

    6 months, 1 year

  • Hospitalization for heart failure

    6 months, 1 year

  • +13 more secondary outcomes

Other Outcomes (1)

  • Cost-effectiveness analysis

    1 year

Study Arms (2)

Staged complete PCI

ACTIVE COMPARATOR

Patients 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.

Procedure: Staged complete PCIDevice: Synergy™ stent

Immediate complete PCI

EXPERIMENTAL

Patients 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.

Procedure: Immediate complete PCIDevice: Synergy™ stent

Interventions

Staged complete PCIPROCEDURE

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.

Staged complete PCI
Immediate complete PCIPROCEDURE

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.

Immediate complete PCI
Synergy™ stentDEVICE

Bioabsorbable Polymer Drug-Eluting Stent

Immediate complete PCIStaged complete PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to give informed consent
  • Cardiogenic shock
  • Prolonged resuscitation \>10 min
  • General unsuitability for PCI
  • Need for emergency CABG
  • Previous CABG
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zürich, Cardiology Department

Zurich, 8091, Switzerland

Location

Related Publications (11)

  • 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.

    PMID: 23991625BACKGROUND

  • 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.

    PMID: 25766941BACKGROUND

  • 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.

    PMID: 26347918BACKGROUND

  • 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.

    PMID: 21816305BACKGROUND

  • 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.

    PMID: 19660603BACKGROUND

  • 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.

    PMID: 21118854BACKGROUND

  • 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.

    PMID: 22922416BACKGROUND

  • 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.

    PMID: 25173339BACKGROUND

  • 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.

    PMID: 24332419BACKGROUND

  • 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.

    PMID: 37634190RESULT

  • 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.

    PMID: 40928512DERIVED

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Barbara E. Stähli, MD, eMBA

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

May 1, 2017

Study Start

October 1, 2016

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)