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

NCT ID: NCT02579031

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-05-31

Brief 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.

Detailed 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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orsiro

Novel biodegradable-polymer sirolimus-eluting stent Orsiro

Group Type: ACTIVE_COMPARATOR

Orsiro

Intervention Type: DEVICE

Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention

Xience

Durable-polymer everolimus-eluting stent Xience

Group Type: ACTIVE_COMPARATOR

Xience

Intervention Type: DEVICE

Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention

Interventions

Orsiro

Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention

Intervention Type: DEVICE

Xience

Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pilgrim, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Cardiology, Bern University Hospital

Locations

Kantonsspital Aarau

Aarau, , Switzerland

Universitätsspital Basel

Basel, , Switzerland

Bern University Hospital, Dep. of Cardiology

Bern, , Switzerland

Universität Freiburg

Fribourg, , Switzerland

HUG

Geneva, , Switzerland

Lausanne University Hospital

Lausanne, , Switzerland

Kantonsspital Luzern

Lucerne, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Spital Wallis

Sion, , Switzerland

Triemli

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 12517460 (View on PubMed)

Kolh P, Windecker S, 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; European Society of Cardiology Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; EACTS Clinical Guidelines Committee; Sousa Uva M, Achenbach S, Pepper J, Anyanwu A, Badimon L, Bauersachs J, Baumbach A, Beygui F, Bonaros N, De Carlo M, Deaton C, Dobrev D, Dunning J, Eeckhout E, Gielen S, Hasdai D, Kirchhof P, Luckraz H, Mahrholdt H, Montalescot G, Paparella D, Rastan AJ, Sanmartin M, Sergeant P, Silber S, Tamargo J, ten Berg J, Thiele H, van Geuns RJ, Wagner HO, Wassmann S, Wendler O, Zamorano JL; Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery; European Association of Percutaneous Cardiovascular Interventions. 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 J Cardiothorac Surg. 2014 Oct;46(4):517-92. doi: 10.1093/ejcts/ezu366. Epub 2014 Aug 29. No abstract available.

Reference Type: RESULT

PMID: 25173601 (View on PubMed)

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;1(2):103-10. doi: 10.1161/CIRCINTERVENTIONS.108.787762. Epub 2008 Sep 3.

Reference Type: RESULT

PMID: 20031664 (View on PubMed)

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 myocardial infarction: a 15-year single-center experience. JACC Cardiovasc Interv. 2011 Jan;4(1):30-8. doi: 10.1016/j.jcin.2010.11.004.

Reference Type: RESULT

PMID: 21251626 (View on PubMed)

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 and non-ST-segment myocardial infarction). Am J Cardiol. 2014 Jun 1;113(11):1794-801. doi: 10.1016/j.amjcard.2014.03.007. Epub 2014 Mar 15.

Reference Type: RESULT

PMID: 24837256 (View on PubMed)

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: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.

Reference Type: RESULT

PMID: 18725485 (View on PubMed)

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;9(1):62-9. doi: 10.4244/EIJV9I1A10.

Reference Type: RESULT

PMID: 23685296 (View on PubMed)

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 primary intervention in patients with acute myocardial infarction: an intravascular ultrasound substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. Circulation. 2010 Sep 14;122(11):1077-84. doi: 10.1161/CIRCULATIONAHA.109.906040. Epub 2010 Aug 30.

Reference Type: RESULT

PMID: 20805433 (View on PubMed)

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 follow-up from randomized trials. Circ Cardiovasc Interv. 2013 Aug;6(4):378-90. doi: 10.1161/CIRCINTERVENTIONS.113.000415. Epub 2013 Aug 6.

Reference Type: RESULT

PMID: 23922145 (View on PubMed)

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. Circulation. 2014 Jan 14;129(2):211-23. doi: 10.1161/CIRCULATIONAHA.113.001790. Epub 2013 Oct 25.

Reference Type: RESULT

PMID: 24163064 (View on PubMed)

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 Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.

Reference Type: RESULT

PMID: 17692740 (View on PubMed)

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 in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.

Reference Type: RESULT

PMID: 10607811 (View on PubMed)

Haner JD, Rohla M, Losdat S, Iglesias JF, Muller O, Eeckhout E, Kurz D, Weilenmann D, Kaiser C, Tapponnier M, Roffi M, Heg D, Windecker S, Pilgrim T. Ultrathin-strut vs thin-strut drug-eluting stents for multi and single-stent lesions: A lesion-level subgroup analysis of 2 randomized trials. Am Heart J. 2023 Sep;263:73-84. doi: 10.1016/j.ahj.2023.05.004. Epub 2023 May 14.

Reference Type: DERIVED

PMID: 37192697 (View on PubMed)

Iglesias JF, Muller O, Losdat S, Roffi M, Kurz DJ, Weilenmann D, Kaiser C, Heg D, Windecker S, Pilgrim T. Complex primary percutaneous coronary intervention with ultrathin-strut biodegradable versus thin-strut durable polymer drug-eluting stents in patients with ST-segment elevation myocardial infarction: A subgroup analysis from the BIOSTEMI randomized trial. Catheter Cardiovasc Interv. 2023 Mar;101(4):687-700. doi: 10.1002/ccd.30600. Epub 2023 Feb 19.

Reference Type: DERIVED

PMID: 36807456 (View on PubMed)

Iglesias JF, Muller O, Losdat S, Roffi M, Kurz DJ, Weilenmann D, Kaiser C, Heg D, Valgimigli M, Windecker S, Pilgrim T. Multivessel percutaneous coronary intervention with thin-strut biodegradable versus durable polymer drug-eluting stents in ST-segment elevation myocardial infarction: A subgroup analysis of the BIOSTEMI randomized trial. Int J Cardiol. 2021 Jul 1;334:37-41. doi: 10.1016/j.ijcard.2021.04.034. Epub 2021 Apr 20.

Reference Type: DERIVED

PMID: 33887341 (View on PubMed)

Pilgrim T, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, Weilenmann D, Kaiser C, Tapponnier M, Losdat S, Eeckhout E, Valgimigli M, Juni P, Windecker S, Iglesias JF. Biodegradable- Versus Durable-Polymer Drug-Eluting Stents for STEMI: Final 2-Year Outcomes of the BIOSTEMI Trial. JACC Cardiovasc Interv. 2021 Mar 22;14(6):639-648. doi: 10.1016/j.jcin.2020.12.011.

Reference Type: DERIVED

PMID: 33727005 (View on PubMed)

Iglesias JF, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, Weilenmann D, Kaiser C, Tapponnier M, Stortecky S, Losdat S, Eeckhout E, Valgimigli M, Odutayo A, Zwahlen M, Juni P, Windecker S, Pilgrim T. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial. Lancet. 2019 Oct 5;394(10205):1243-1253. doi: 10.1016/S0140-6736(19)31877-X. Epub 2019 Sep 2.

Reference Type: DERIVED

PMID: 31488372 (View on PubMed)

Iglesias JF, Roffi M, Degrauwe S, Secco GG, Aminian A, Windecker S, Pilgrim T. Orsiro cobalt-chromium sirolimus-eluting stent: present and future perspectives. Expert Rev Med Devices. 2017 Oct;14(10):773-788. doi: 10.1080/17434440.2017.1378091. Epub 2017 Sep 19.

Reference Type: DERIVED

PMID: 28889769 (View on PubMed)

Other Identifiers

288/15

Identifier Type: -

Identifier Source: org_study_id