دورية أكاديمية
Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial.
| العنوان: | Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial. |
|---|---|
| المؤلفون: | Eriksen E; Department of Heart Disease, Haukeland University Hospital.; Department of Clinical Science, University of Bergen, Bergen, Norway., Neghabat O; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Saeed S; Department of Heart Disease, Haukeland University Hospital., Herstad J; Department of Heart Disease, Haukeland University Hospital., Nordrehaug JE; Department of Clinical Science, University of Bergen, Bergen, Norway., Tuseth V; Department of Heart Disease, Haukeland University Hospital.; Department of Clinical Science, University of Bergen, Bergen, Norway., Holm NR; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Holck EN; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Sejr-Hansen M; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Maule CF; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Barkholt TØ; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Andreasen LN; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Christiansen EH; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Bleie Ø; Department of Heart Disease, Haukeland University Hospital. |
| المصدر: | Coronary artery disease [Coron Artery Dis] 2023 Jan 01; Vol. 34 (1), pp. 1-10. Date of Electronic Publication: 2022 Nov 22. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: England NLM ID: 9011445 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-5830 (Electronic) Linking ISSN: 09546928 NLM ISO Abbreviation: Coron Artery Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: London : Lippincott Williams & Wilkins Original Publication: Philadelphia, Pa. : Current Science, c1990- |
| مواضيع طبية MeSH: | ST Elevation Myocardial Infarction*/diagnostic imaging , ST Elevation Myocardial Infarction*/therapy , Drug-Eluting Stents* , Percutaneous Coronary Intervention*/adverse effects, Humans ; Everolimus ; Prospective Studies |
| مستخلص: | Background: Primary percutaneous coronary intervention with implantation of a metallic drug-eluting stent (DES) is the standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Implantation of a bioresorbable scaffold (BRS) during STEMI represents a novel strategy without intravascular metal. Objective: The aim of the study was to investigate 12-month healing response in an STEMI population after implantation of either the Absorb BRS or Xience DES (Abbott Vascular, USA). Methods: The present trial was a prospective, randomized, controlled, nonblinded, noninferiority study with planned inclusion of 120 patients with STEMI. Patients were randomly assigned 1:1 to treatment with Absorb BRS or Xience DES. Implantation result and healing response were evaluated by angiography and optical coherence tomography (OCT) at baseline and 12-month follow-up. The primary endpoint was minimum flow area (MFA) assessed at 12 months. Coronary stent healing index (CSHI) was calculated from OCT images. Results: Out of 66 included patients, 58 had follow-up OCT after 12 months, and 49 entered matched analysis. One death occurred in each group; none were stent-related. MFA was 5.13 ± 1.70 mm2 (95% CI, 4.44-5.82) in the BRS group compared with 6.30 ± 2.49 mm2 (95% CI, 5.22-7.37) (P = 0.06) in the DES group. Noninferiority could not be evaluated. CSHI for both groups had a median score of 3. Conclusion: The DES group performed numerically better in primary and secondary endpoints, but the CSHI showed good stent healing in both groups. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.) |
| References: | Davies MJ, Woolf N, Robertson WB. Pathology of acute myocardial infarction with particular reference to occlusive coronary thrombi. Br Heart J 1976; 38:659–664. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et alESC Scientific Document Group. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019; 40:87–165. Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Rev Esp Cardiol (Engl Ed) 2017; 70:1082. Kereiakes DJ. The TWENTE trial in perspective: stents and stent trials in evolution. JAMA Cardiol 2017; 2:235–237. Simsek C, Karanasos A, Magro M, Garcia-Garcia HM, Onuma Y, Regar E, et al. Long-term invasive follow-up of the everolimus-eluting bioresorbable vascular scaffold: five-year results of multiple invasive imaging modalities. EuroIntervention 2016; 11:996–1003. Karanasos A, Simsek C, Gnanadesigan M, van Ditzhuijzen NS, Freire R, Dijkstra J, et al. OCT assessment of the long-term vascular healing response 5 years after everolimus-eluting bioresorbable vascular scaffold. J Am Coll Cardiol 2014; 64:2343–2356. Picard F, de Hemptinne Q, Avram R, Ly HQ, L’Allier PL, Tanguay JF. Bioresorbable vascular scaffold during ST-elevation myocardial infarction: a systematic review. Can J Cardiol 2017; 33:515–524. Kajiya T, Liang M, Sharma RK, Lee CH, Chan MY, Tay E, et al. Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). EuroIntervention 2013; 9:501–504. Wiebe J, Mollmann H, Most A, Dorr O, Weipert K, Rixe J, et al. Short-term outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with an everolimus-eluting bioresorbable vascular scaffold. Clin Res Cardiol 2014; 103:141–148. Fam JM, Felix C, van Geuns RJ, Onuma Y, Van Mieghem NM, Karanasos A, et al. Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: a propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study. EuroIntervention 2016; 12:30–37. Chakraborty R, Patra S, Banerjee S, Pande A, Khan A, Mandol PC, et al. Outcome of everolimus eluting bioabsorbable vascular scaffold (BVS) compared to non BVS drug eluting stent in the management of ST-segment elevation myocardial infarction (STEMI) - a comparative study. Cardiovasc Revasc Med 2016; 17:151–154. Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, et al. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv 2015; 8:189–197. Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, et al. ABSORB bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in ST-segment elevation myocardial infarction (BVS EXAMINATION study): 2-year results from a propensity score matched comparison. Int J Cardiol 2016; 214:483–484. Sabate M, Windecker S, Iniguez A, Okkels-Jensen L, Cequier A, Brugaletta S, et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. Eur Heart J 2016; 37:229–240. Lipinski MJ, Escarcega RO, Baker NC, Benn HA, Gaglia MA Jr, Torguson R, et al. Scaffold thrombosis after percutaneous coronary intervention with ABSORB bioresorbable vascular scaffold: a systematic review and meta-analysis. JACC Cardiovasc Interv 2016; 9:12–24. Onuma Y, Thuesen L, van Geuns RJ, van der Ent M, Desch S, Fajadet J, et al. Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study–TROFI trial. Eur Heart J 2013; 34:1050–1060. Barkholt TO, Neghabat O, Holck EN, Andreasen LN, Christiansen EH, Holm NR. Bioresorbable magnesium scaffold in the treatment of simple coronary bifurcation lesions: the BIFSORB pilot II study. Catheter Cardiovasc Interv 2022; 99:1075–1083. Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, et al. Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for intravascular optical coherence tomography standardization and validation. J Am Coll Cardiol 2012; 59:1058–1072. Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Fourth universal definition of myocardial infarction (2018). Eur Heart J 2019; 40:237–269. Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, et al. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European association of cardiovascular imaging. Eur Heart J Cardiovasc Imaging 2015; 16:233–270. Nakatani S, Sotomi Y, Ishibashi Y, Grundeken MJ, Tateishi H, Tenekecioglu E, et al. Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up. EuroIntervention 2016; 12:1498–1509. Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, et al. 3-year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: the ABSORB III trial. J Am Coll Cardiol 2017; 70:2852–2862. Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, et al. Three-year outcomes with the absorb bioresorbable scaffold: individual-patient-data meta-analysis from the ABSORB randomized trials. Circulation 2018; 137:464–479. Tousek P, Kocka V, Maly M, Lisa L, Budesinsky T, Widimsky P. Neointimal coverage and late apposition of everolimus-eluting bioresorbable scaffolds implanted in the acute phase of myocardial infarction: OCT data from the PRAGUE-19 study. Heart Vessels 2016; 31:841–845. Waksman R, Lipinski MJ, Acampado E, Cheng Q, Adams L, Torii S, et al. Comparison of acute thrombogenicity for metallic and polymeric bioabsorbable scaffolds: magmaris versus absorb in a porcine arteriovenous shunt model. Circ Cardiovasc Interv 2017; 10:e004762. Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, et al. Magnesium-based resorbable scaffold versus permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: the MAGSTEMI randomized clinical trial. Circulation 2019; 140:1904–1916. de Hemptinne Q, Xaplanteris P, Guedes A, Demeure F, Vandeloo B, Dugauquier C, et al. Magmaris resorbable magnesium scaffold versus conventional drug-eluting stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison. Cardiovasc Revasc Med 2022; 43:28–35. Zong J, He Q, Liu Y, Qiu M, Wu J, Hu B. Advances in the development of biodegradable coronary stents: a translational perspective. Mater Today Bio 2022; 16:100368. Guagliumi G, Sirbu V, Musumeci G, Gerber R, Biondi-Zoccai G, Ikejima H, et al. Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. JACC Cardiovasc Interv 2012; 5:12–20. Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, et al. 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; 118:1138–1145. Parodi G, La Manna A, Di Vito L, Valgimigli M, Fineschi M, Bellandi B, et al. Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the Mechanism Of Stent Thrombosis (MOST) study. EuroIntervention 2013; 9:936–944. Cuesta J, Rivero F, Bastante T, Garcia-Guimaraes M, Antuna P, Alvarado T, et al. Optical coherence tomography findings in patients with stent thrombosis. Rev Esp Cardiol (Engl Ed) 2017; 70:1050–1058. Adriaenssens T, Joner M, Godschalk TC, Malik N, Alfonso F, Xhepa E, et al. Optical coherence tomography findings in patients with coronary stent thrombosis: a report of the PRESTIGE consortium (prevention of late stent thrombosis by an interdisciplinary global European effort). Circulation 2017; 136:1007–1021. Widimsky P, Petr R, Tousek P, Maly M, Linkova H, Vrana J, et al. One-year clinical and computed tomography angiographic outcomes after bioresorbable vascular scaffold implantation during primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction: the PRAGUE-19 study. Circ Cardiovasc Interv 2015; 8:e002933. Tousek P, Kocka V, Maly M, Kozel M, Robert P, Hajsl M, et al. Two-year follow-up after bioresorbable vascular scaffold implantation in STEMI patients - results from PRAGUE-19 study. Int J Cardiol 2016; 209:20–21. Tousek P, Kocka V, Maly M, Kozel M, Petr R, Hajsl M, et al. Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update. EuroIntervention 2016; 12:23–29. Serruys PW, Ormiston J, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, et al. A polylactide bioresorbable scaffold eluting everolimus for treatment of coronary stenosis: 5-year follow-up. J Am Coll Cardiol 2016; 67:766–776. |
| المشرفين على المادة: | 9HW64Q8G6G (Everolimus) |
| تواريخ الأحداث: | Date Created: 20221209 Date Completed: 20221215 Latest Revision: 20221220 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1097/MCA.0000000000001202 |
| PMID: | 36484214 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1473-5830 |
|---|---|
| DOI: | 10.1097/MCA.0000000000001202 |