In-hospital Versus After-discharge Complete Revascularization

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— REVIVA-ST  

Official title:

In-hospital Versus After-discharge Complete Revascularization in STEMI Patients With Multivessel Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743154
• Other study ID #: HGUValencia
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: December 21, 2022

Study information

• Verified date: April 2023
• Source: Hospital General Universitario de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

STEMI patients with mutivessel disease are, after successful primary angioplasty, randomized 1:1 ratio to either in-hospital complete revascularization or after-discharge complete revascularization strategy.

Eligible non-culprit coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between ≥50% and <70 in proximal segments can be randomized.

Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial infarction. On the other hand, patients in the after-discharge group will undergo to non-culprit PCI within 4-6 weeks after STEMI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 21, 2022
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Multivessel Coronary Artery Disease
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Other:
• In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.
• After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Andersen HR, Nielsen TT, Vesterlund T, Grande P, Abildgaard U, Thayssen P, Pedersen F, Mortensen LS; DANAMI-2 Investigators. Danish multicenter randomized study on fibrinolytic therapy versus acute coronary angioplasty in acute myocardial infarction: rationale and design of the DANish trial in Acute Myocardial Infarction-2 (DANAMI-2). Am Heart J. 2003 Aug;146(2):234-41. doi: 10.1016/S0002-8703(03)00316-8. — View Citation

Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Ornato JP. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004 Aug 4;44(3):E1-E211. doi: 10.1016/j.jacc.2004.07.014. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Grines CL, Marsalese DL, Brodie B, Griffin J, Donohue B, Costantini CR, Balestrini C, Stone G, Wharton T, Esente P, Spain M, Moses J, Nobuyoshi M, Ayres M, Jones D, Mason D, Sachs D, Grines LL, O'Neill W. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998 Apr;31(5):967-72. doi: 10.1016/s0735-1097(98)00031-x. — View Citation

Hannan EL, Samadashvili Z, Walford G, Holmes DR Jr, Jacobs AK, Stamato NJ, Venditti FJ, Sharma S, King SB 3rd. Culprit vessel percutaneous coronary intervention versus multivessel and staged percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel disease. JACC Cardiovasc Interv. 2010 Jan;3(1):22-31. doi: 10.1016/j.jcin.2009.10.017. — View Citation

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. — View Citation

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7. — View Citation

Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available. Erratum In: J Am Coll Cardiol. 2016 Mar 29;67(12):1506. — View Citation

O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available. — View Citation

Politi L, Sgura F, Rossi R, Monopoli D, Guerri E, Leuzzi C, Bursi F, Sangiorgi GM, Modena MG. A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up. Heart. 2010 May;96(9):662-7. doi: 10.1136/hrt.2009.177162. Epub 2009 Sep 23. Erratum In: Heart. 2014 Feb;100(4):350. — View Citation

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. — View Citation

Sorajja P, Gersh BJ, Cox DA, McLaughlin MG, Zimetbaum P, Costantini C, Stuckey T, Tcheng JE, Mehran R, Lansky AJ, Grines CL, Stone GW. Impact of multivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction. Eur Heart J. 2007 Jul;28(14):1709-16. doi: 10.1093/eurheartj/ehm184. Epub 2007 Jun 7. — View Citation

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. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular death, acute myocardial infarction or revascularization.	Composite of cardiovascular death, myocardial infarction, or ischemia driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two strategies.	1 year
Secondary	Fractional flow reserve of angiographically moderate stenosis	Evaluate the presence of ischemia by analyzing the fractional flow reserve of angiographically moderate stenoses (=50% and <70) in proximal segments of the anterior descending, circumflex, or right coronary artery.	6 months