Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial
BACKGROUND:The use of poly-L-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being t...
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| Published in | Circulation (New York, N.Y.) Vol. 140; no. 23; pp. 1904 - 1916 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
by the American College of Cardiology Foundation and the American Heart Association, Inc
03.12.2019
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0009-7322 1524-4539 1524-4539 |
| DOI | 10.1161/CIRCULATIONAHA.119.043467 |
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| Abstract | BACKGROUND:The use of poly-L-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment–elevation myocardial infarction patients.
METHODS:This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment–elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69).
RESULTS:Between June 2017 and June 2018, 150 ST-segment–elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (−8.3±3.5% versus −2.4±1.3% in the SES group, P=0.003).
CONCLUSIONS:When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT03234348. |
|---|---|
| AbstractList | The use of poly-
-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients.
This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69).
Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%;
=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm,
<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm;
<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%],
=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group;
=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group,
=0.003).
When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348. The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients.BACKGROUNDThe use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients.This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69).METHODSThis investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69).Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003).RESULTSBetween June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003).When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns.CONCLUSIONSWhen compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns.URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.CLINICAL TRIAL REGISTRATIONURL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348. BACKGROUND:The use of poly-L-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment–elevation myocardial infarction patients. METHODS:This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment–elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS:Between June 2017 and June 2018, 150 ST-segment–elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (−8.3±3.5% versus −2.4±1.3% in the SES group, P=0.003). CONCLUSIONS:When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT03234348. |
| Author | Gomez-Lara, Josep Alfonso, Fernando Serra, Antonio Bordes, Pascual Hernández-Antolín, Rosana Ortega-Paz, Luis Iñiguez, Andrés García del Blanco, Bruno Goicolea, Javier Romaní, Sebastián Salinas, Pablo Brugaletta, Salvatore Cequier, Angel Sabaté, Manel Cuesta, Javier Gómez-Hospital, Joan Antoni |
| AuthorAffiliation | Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.). Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.). Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.). Hospital San Pedro de Alcántara, Cáceres, Spain (S.R.). Hospital General de Alicante, Alicante, Spain (P.B.). Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S.). Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.). Hospital Clínico San Carlos, Madrid, Spain (P.S.). Hospital Vall d’Hebrón, Barcelona, Spain (B.G.D.B.). Hospital Puerta de Hierro-Majadahonda, Madrid, Spain (J.G.). Hospital Ramón y Cajal, Madrid, Spain (R.H.A.). Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.) |
| AuthorAffiliation_xml | – name: Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.). Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.). Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.). Hospital San Pedro de Alcántara, Cáceres, Spain (S.R.). Hospital General de Alicante, Alicante, Spain (P.B.). Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S.). Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.). Hospital Clínico San Carlos, Madrid, Spain (P.S.). Hospital Vall d’Hebrón, Barcelona, Spain (B.G.D.B.). Hospital Puerta de Hierro-Majadahonda, Madrid, Spain (J.G.). Hospital Ramón y Cajal, Madrid, Spain (R.H.A.). Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.) |
| Author_xml | – sequence: 1 givenname: Manel surname: Sabaté fullname: Sabaté, Manel organization: Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.). Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.). Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.). Hospital San Pedro de Alcántara, Cáceres, Spain (S.R.). Hospital General de Alicante, Alicante, Spain (P.B.). Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S.). Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.). Hospital Clínico San Carlos, Madrid, Spain (P.S.). Hospital Vall d’Hebrón, Barcelona, Spain (B.G.D.B.). Hospital Puerta de Hierro-Majadahonda, Madrid, Spain (J.G.). Hospital Ramón y Cajal, Madrid, Spain (R.H.A.). Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.) – sequence: 2 givenname: Fernando surname: Alfonso fullname: Alfonso, Fernando – sequence: 3 givenname: Angel surname: Cequier fullname: Cequier, Angel – sequence: 4 givenname: Sebastián surname: Romaní fullname: Romaní, Sebastián – sequence: 5 givenname: Pascual surname: Bordes fullname: Bordes, Pascual – sequence: 6 givenname: Antonio surname: Serra fullname: Serra, Antonio – sequence: 7 givenname: Andrés surname: Iñiguez fullname: Iñiguez, Andrés – sequence: 8 givenname: Pablo surname: Salinas fullname: Salinas, Pablo – sequence: 9 givenname: Bruno surname: García del Blanco fullname: García del Blanco, Bruno – sequence: 10 givenname: Javier surname: Goicolea fullname: Goicolea, Javier – sequence: 11 givenname: Rosana surname: Hernández-Antolín fullname: Hernández-Antolín, Rosana – sequence: 12 givenname: Javier surname: Cuesta fullname: Cuesta, Javier – sequence: 13 givenname: Joan surname: Gómez-Hospital middlename: Antoni fullname: Gómez-Hospital, Joan Antoni – sequence: 14 givenname: Luis surname: Ortega-Paz fullname: Ortega-Paz, Luis – sequence: 15 givenname: Josep surname: Gomez-Lara fullname: Gomez-Lara, Josep – sequence: 16 givenname: Salvatore surname: Brugaletta fullname: Brugaletta, Salvatore |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31553204$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2019 by the American College of Cardiology Foundation and the American Heart Association, Inc. |
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| Keywords | STEMI vascular endothelium-dependent relaxation stents, drug-eluting tissue scaffolds |
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| Snippet | BACKGROUND:The use of poly-L-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of... The use of poly- -lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological... The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological... |
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| SubjectTerms | Absorbable Implants Acetylcholine - pharmacology Aged Angioplasty, Balloon, Coronary Coronary Angiography Coronary Restenosis - epidemiology Drug-Eluting Stents Endothelium, Vascular - drug effects Endothelium, Vascular - physiopathology Female Humans Incidence Magnesium Male Middle Aged Nitroglycerin - pharmacology Polyesters Risk Factors Sample Size Sirolimus - administration & dosage Sirolimus - therapeutic use ST Elevation Myocardial Infarction - drug therapy ST Elevation Myocardial Infarction - surgery Thrombectomy Tissue Scaffolds Vasodilation - drug effects Vasodilator Agents - therapeutic use Vasomotor System - physiopathology |
| Title | Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial |
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