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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staged complete PCI | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke | Primary endpoint | 6 months |
| All-cause death | Single components of the primary endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness analysis | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara E. Stähli, MD, eMBA | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zürich, Cardiology Department | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23991625 | 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. | |
| 25766941 | Background | 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. |
| Label | URL |
|---|---|
| Press release University Hospital Zurich | View source |
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|
| Immediate complete PCI | Procedure | 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™ stent | Device | Bioabsorbable Polymer Drug-Eluting Stent |
|
| 6 months, 1 year |
| Non-fatal myocardial infarction | Single components of the primary endpoint | 6 months, 1 year |
| Unplanned ischemia-driven revascularization | Single components of the primary endpoint | 6 months, 1 year |
| Hospitalization for heart failure | Single components of the primary endpoint | 6 months, 1 year |
| Stroke | Single components of the primary endpoint | 6 months, 1 year |
| Target lesion revascularization (TLR) | 6 months, 1 year |
| Target vessel revascularization (TVR) | 6 months, 1 year |
| Non-cardiovascular death | 6 months, 1 year |
| Cardiac death | 6 months, 1 year |
| Cardiovascular death | 6 months, 1 year |
| Cardiac death or myocardial infarction | 6 months, 1 year |
| All-cause death or myocardial infarction | 6 months, 1 year |
| Stent thrombosis | 6 months, 1 year |
| Acute renal insufficiency or dialysis | 6 months, 1 year |
| Procedural success | 6 months, 1 year |
| Bleeding event (BARC definition) | 6 months, 1 year |
| Quality of life (EQ-5D questionnaire) | 6 months, 1 year |
| 26347918 | 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. |
| 21816305 | Background | 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. |
| 19660603 | Background | 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. |
| 21118854 | Background | 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. |
| 22922416 | Background | 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. |
| 25173339 | Background | 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. |
| 24332419 | Background | 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. |
| 37634190 | Result | 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. |
| 42362625 | Derived | 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. |
| 41801439 | Derived | 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. |
| 40928512 | Derived | 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. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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