A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

— BIOSTEMI  

Official title:

A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579031
• Other study ID #: 288/15
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2020

Study information

• Verified date: September 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in MACE among patients with STEMI undergoing primary PCI with newer generation stents with enhanced biocompatibility.

The present trial aims at filling the current gap of evidence by providing randomized data to establish the superior clinical outcome with an ultrathin strut third-generation DES with biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing primary PCI, compared to the current state-of-the art second-generation DES with permanent polymer.

Description:

Background

Primary percutaneous coronary intervention (PCI) is considered nowadays as the reperfusion strategy of choice for patients with acute ST-segment elevation myocardial infarction (STEMI, owing to a lower risk of myocardial re-infarction and improved short- and long-term survival compared to fibrinolysis. However, STEMI is still associated with poorer clinical outcomes after PCI, compared to stable CAD, with higher rates of stent thrombosis and an increased risk of myocardial re-infarction persisting throughout long-term follow-up. recent data from randomized controlled trials and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in major adverse cardiac events among patients with STEMI undergoing primary PCI with third-generation DESs, compared with both first-generation and second-generation DESs with durable polymer. Importantly, this signal suggesting superiority of third-generation DESs in patients with STEMI has never been demonstrated with second-generation DESs. Third-generation DESs with enhanced biocompatibility may therefore have a particular clinical benefit in high-risk subgroups of patients with delayed vascular healing but these data warrants confirmation in appropriately designed randomized controlled trials.

Objective

The purpose of the study is to compare the safety and efficacy of a novel biodegradable-polymer sirolimus-eluting stent (Orsiro®) with a durable-polymer everolimus-eluting stent (Xience Xpedition or Xience Alpine®) in a superiority trial among patients presenting with acute STEMI and undergoing primary PCI.

Methods

Eligible patients with acute STEMI presenting within 24 hours of symptom onset will undergo primary PCI. At PCI, the randomly allocated stent has to be implanted in the culprit lesion of the target vessel.

Patients will be followed-up with a hospital visit at 12 months. Patients will be followed-up for clinical endpoints by telephone at 30 days and 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: May 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• ST-segment elevation acute myocardial infarction

• Primary PCI occurring within 24 hours of symptom onset

• Presence of =1 acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple coronary stents

Exclusion Criteria

• Known allergy to aspirin, Ticagrelor, Prasugrel, Clopidogrel, Sirolimus, Everolimus or contrast media

• Planned surgery within 6 months of primary PCI, unless dual antiplatelet therapy could be maintained throughout the peri-surgical period

• Currently participating in another trial before reaching the primary endpoint

• Inability to provide informed consent

• Non-cardiac comorbid conditions with life expectancy of less than 1 year

• Mechanical complication of acute myocardial infarction

• Acute myocardial infarction due to stent thrombosis

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction

Intervention

Device:
• Orsiro
Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention
• Xience
Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Universitätsspital Basel	Basel
Switzerland	Bern University Hospital, Dep. of Cardiology	Bern
Switzerland	Universität Freiburg	Freiburg
Switzerland	HUG	Genf
Switzerland	Lausanne University Hospital	Lausanne
Switzerland	Kantonsspital Luzern	Luzern
Switzerland	Spital Wallis	Sion
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Triemli	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

Bangalore S, Amoroso N, Fusaro M, Kumar S, Feit F. Outcomes with various drug-eluting or bare metal stents in patients with ST-segment-elevation myocardial infarction: a mixed treatment comparison analysis of trial level data from 34 068 patient-years of — View Citation

Brodie B, Pokharel Y, Fleishman N, Bensimhon A, Kissling G, Hansen C, Milks S, Cooper M, McAlhany C, Stuckey T. Very late stent thrombosis after primary percutaneous coronary intervention with bare-metal and drug-eluting stents for ST-segment elevation my — View Citation

Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty — View Citation

Guo N, Maehara A, Mintz GS, He Y, Xu K, Wu X, Lansky AJ, Witzenbichler B, Guagliumi G, Brodie B, Kellett MA Jr, Dressler O, Parise H, Mehran R, Stone GW. Incidence, mechanisms, predictors, and clinical impact of acute and late stent malapposition after pr — View Citation

Iqbal J, Sumaya W, Tatman V, Parviz Y, Morton AC, Grech ED, Campbell S, Storey RF, Gunn J. Incidence and predictors of stent thrombosis: a single-centre study of 5,833 consecutive patients undergoing coronary artery stenting. EuroIntervention. 2013 May 20 — 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. Review. — View Citation

Kolh P, Windecker S, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni 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, Valgimi — View Citation

Kukreja N, Onuma Y, Garcia-Garcia H, Daemen J, van Domburg R, Serruys PW. Primary percutaneous coronary intervention for acute myocardial infarction: long-term outcome after bare metal and drug-eluting stent implantation. Circ Cardiovasc Interv. 2008 Oct; — View Citation

Loh JP, Pendyala LK, Kitabata H, Torguson R, Omar A, Minha S, Chen F, Satler LF, Pichard AD, Waksman R. Comparison of outcomes after percutaneous coronary intervention among different coronary subsets (stable and unstable angina pectoris and ST-segment an — View Citation

Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: — View Citation

Otsuka F, Vorpahl M, Nakano M, Foerst J, Newell JB, Sakakura K, Kutys R, Ladich E, Finn AV, Kolodgie FD, Virmani R. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans. Circul — View Citation

Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (Q-wave and non-Q-wave), or clinically driven target lesion revascularization		up to 12 months
Secondary	Number of patients with clinically indicated and not clinically indicated target lesion revascularization (TLR)		up to 30 days, 1 and 2 years
Secondary	Number of patients with clinically indicated and not clinically indicated target vessel revascularization (TVR)		up to 30 days, 1 and 2 years
Secondary	Number of patients with target vessel failure (TVF)		up to 30 days, 1 and 2 years
Secondary	Number of patients with cardiac death		up to 30 days, 1 and 2 years
Secondary	Number of patients with all-cause death (cardiac and non-cardiac)		up to 30 days, 1 and 2 years
Secondary	Number of patients with myocardial infarction (Q-wave and non-Q-wave)		up to 30 days, 1 and 2 years
Secondary	Number of patients with definite stent thrombosis		up to 30 days, 1 and 2 years