Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

• ClinicalTrials.gov Identifier: NCT02151929
• Recruitment Status: Completed
• First Posted: June 2, 2014
• Last Update Posted: June 2, 2014
• Sponsor: San Giuseppe Moscati Hospital
• Information provided by (Responsible Party): Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital

Study Description

Brief Summary:

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Condition or disease	Intervention/treatment	Phase
ST Elevation Acute Myocardial Infarction	Device: Bioresorbable vascular scaffold; Device: Everolimus eluting stent	Phase 4

Detailed Description:

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent
• Study Start Date: May 2013
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bioresorbable Vascular Scaffold; Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI	Device: Bioresorbable vascular scaffold; stenting of an acute thrombotic lesion in patient within STEMI; Other Name: BVS, ABSORB (Abbot Vascular)
Active Comparator: Everolimus Eluting stent; Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI	Device: Everolimus eluting stent; stenting of an acute thrombotic lesion in patient within STEMI; Other Name: Xience Prime (Abbott Vascular)

Outcome Measures

Primary Outcome Measures :

1. Procedural and Clinical success [ Time Frame: Patients will be followed for the duration of hospital stay (4-8 days) ]

   Procedural success: The deployment of BVS at the intended target lesion with a final residual stenosis ≤20% and a TIMI 2-3 coronary flow by visual estimation without major periprocedural complication (death, emergent CABG, coronary perforation, flow limiting coronary dissection).

   Clinical success: any major in-hospital events (deaths, reinfarction, urgent revascularization, stroke, major bleedings)

Secondary Outcome Measures :

1. The MACE [ Time Frame: six months ]
   cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization

Other Outcome Measures:

1. stent thrombosis [ Time Frame: six months ]
   cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. chest pain for more than 30 minutes;
2. ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

Exclusion Criteria:

1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
2. Contraindication to dual antiplatelet therapy for 12 months;
3. Known allergy to everolimus;
4. A history of stroke within 30 days or any history of hemorrhagic stroke;
5. History, symptoms, or findings suggestive of aortic dissection;
6. High-likelihood of death within BVS resorbtion time;
7. Cardiogenic shock;
8. Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes);
9. Pregnancy;
10. Participation in other trials

Contacts and Locations

Locations

Italy

Division of Cardiology Ao Moscati

Avellino, Italy, 83100

Sponsors and Collaborators

San Giuseppe Moscati Hospital

Investigators

• Principal Investigator: Emilio Di Lorenzo, MD PhD; Division of Cardiology AO Moscati Avellino ITALY

More Information

Publications:

Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. doi: 10.1007/s11886-011-0207-0. Review.

De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Díaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. doi: 10.1001/archinternmed.2012.758. Review.

Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.

Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial. JACC Cardiovasc Interv. 2009 Jun;2(6):515-23. doi: 10.1016/j.jcin.2009.03.012.

Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.

Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, García-García HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.

• Responsible Party: Emilio Di Lorenzo MD PhD, Dott. Emilio Di Lorenzo, San Giuseppe Moscati Hospital
• ClinicalTrials.gov Identifier: NCT02151929
• Other Study ID Numbers: AOM_BVS1
• First Posted: June 2, 2014
• Last Update Posted: June 2, 2014
• Last Verified: May 2014

Keywords provided by Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital:

myocardial infarction; primary PCI; stent

Additional relevant MeSH terms:

Ischemia; Myocardial Ischemia; Everolimus; Myocardial Infarction; Infarction; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs