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 (
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| Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2019-12, Vol.140 (23), p.1904-1916 |
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| creator | Sabaté, Manel Alfonso, Fernando Cequier, Angel Romaní, Sebastián Bordes, Pascual Serra, Antonio Iñiguez, Andrés Salinas, Pablo García del Blanco, Bruno Goicolea, Javier Hernández-Antolín, Rosana Cuesta, Javier Gómez-Hospital, Joan Antoni Ortega-Paz, Luis Gomez-Lara, Josep Brugaletta, Salvatore |
| description | 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 ( |
| doi_str_mv | 10.1161/CIRCULATIONAHA.119.043467 |
| format | Article |
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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.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.119.043467</identifier><identifier>PMID: 31553204</identifier><language>eng</language><publisher>United States: by the American College of Cardiology Foundation and the American Heart Association, Inc</publisher><subject>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</subject><ispartof>Circulation (New York, N.Y.), 2019-12, Vol.140 (23), p.1904-1916</ispartof><rights>2019 by the American College of Cardiology Foundation and the American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2738-ec25ee7f1816adb6a25b24d59d1a7324799071e0a4d7dd497f9ca20d877112de3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31553204$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sabaté, Manel</creatorcontrib><creatorcontrib>Alfonso, Fernando</creatorcontrib><creatorcontrib>Cequier, Angel</creatorcontrib><creatorcontrib>Romaní, Sebastián</creatorcontrib><creatorcontrib>Bordes, Pascual</creatorcontrib><creatorcontrib>Serra, Antonio</creatorcontrib><creatorcontrib>Iñiguez, Andrés</creatorcontrib><creatorcontrib>Salinas, Pablo</creatorcontrib><creatorcontrib>García del Blanco, Bruno</creatorcontrib><creatorcontrib>Goicolea, Javier</creatorcontrib><creatorcontrib>Hernández-Antolín, Rosana</creatorcontrib><creatorcontrib>Cuesta, Javier</creatorcontrib><creatorcontrib>Gómez-Hospital, Joan Antoni</creatorcontrib><creatorcontrib>Ortega-Paz, Luis</creatorcontrib><creatorcontrib>Gomez-Lara, Josep</creatorcontrib><creatorcontrib>Brugaletta, Salvatore</creatorcontrib><title>Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>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.</description><subject>Absorbable Implants</subject><subject>Acetylcholine - pharmacology</subject><subject>Aged</subject><subject>Angioplasty, Balloon, Coronary</subject><subject>Coronary Angiography</subject><subject>Coronary Restenosis - epidemiology</subject><subject>Drug-Eluting Stents</subject><subject>Endothelium, Vascular - drug effects</subject><subject>Endothelium, Vascular - physiopathology</subject><subject>Female</subject><subject>Humans</subject><subject>Incidence</subject><subject>Magnesium</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nitroglycerin - pharmacology</subject><subject>Polyesters</subject><subject>Risk Factors</subject><subject>Sample Size</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - therapeutic use</subject><subject>ST Elevation Myocardial Infarction - drug therapy</subject><subject>ST Elevation Myocardial Infarction - surgery</subject><subject>Thrombectomy</subject><subject>Tissue Scaffolds</subject><subject>Vasodilation - drug effects</subject><subject>Vasodilator Agents - therapeutic use</subject><subject>Vasomotor System - physiopathology</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUe1u1DAQjBCIHoVXQOYBUvyV-My_EB1tpAutLin8jJx4c2dwkspOqMqb8XY4OkDi1-7OzqxWM1H0juArQlLyPi8O-f0-q4vbz9lNFjB5hTnjqXgWbUhCecwTJp9HG4yxjAWj9CJ65f23MKZMJC-jC0aShFHMN9GvUh1H8GYZ4o_Kg0YH8JNrVWsBVZ3q-8lq9AWcXzy6AzeoEcYZlTAra02HKuMma4bFxzu7zGY8ompeCWZEd2o2ofXoq5lPqKrjCo7DuttZ-BF204jKp6lTThtlUTH2ynUr-gHVJ0Bldl3Vu7JABzXqaTA_w2u5NaPpArl2QfI6etEr6-HNn3oZ3X_a1flNvL-9LvJsH3dUsG0MHU0ARE-2JFW6TRVNWsp1IjVRwRoupMSCAFZcC625FL3sFMV6KwQhVAO7jOT5bucm7x30zYMzg3JPDcHNGkfzfxwBk805jqB9e9Y-LO0A-p_yr_-BwM-Ex8nOweXvdnkE15xA2fnUhMAww0TEFBNJaOjjFdqy3-1Smpc</recordid><startdate>20191203</startdate><enddate>20191203</enddate><creator>Sabaté, Manel</creator><creator>Alfonso, Fernando</creator><creator>Cequier, Angel</creator><creator>Romaní, Sebastián</creator><creator>Bordes, Pascual</creator><creator>Serra, Antonio</creator><creator>Iñiguez, Andrés</creator><creator>Salinas, Pablo</creator><creator>García del Blanco, Bruno</creator><creator>Goicolea, Javier</creator><creator>Hernández-Antolín, Rosana</creator><creator>Cuesta, Javier</creator><creator>Gómez-Hospital, Joan Antoni</creator><creator>Ortega-Paz, Luis</creator><creator>Gomez-Lara, Josep</creator><creator>Brugaletta, Salvatore</creator><general>by the American College of Cardiology Foundation and the American Heart Association, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20191203</creationdate><title>Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial</title><author>Sabaté, Manel ; Alfonso, Fernando ; Cequier, Angel ; Romaní, Sebastián ; Bordes, Pascual ; Serra, Antonio ; Iñiguez, Andrés ; Salinas, Pablo ; García del Blanco, Bruno ; Goicolea, Javier ; Hernández-Antolín, Rosana ; Cuesta, Javier ; Gómez-Hospital, Joan Antoni ; Ortega-Paz, Luis ; Gomez-Lara, Josep ; Brugaletta, Salvatore</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2738-ec25ee7f1816adb6a25b24d59d1a7324799071e0a4d7dd497f9ca20d877112de3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Absorbable Implants</topic><topic>Acetylcholine - pharmacology</topic><topic>Aged</topic><topic>Angioplasty, Balloon, Coronary</topic><topic>Coronary Angiography</topic><topic>Coronary Restenosis - epidemiology</topic><topic>Drug-Eluting Stents</topic><topic>Endothelium, Vascular - drug effects</topic><topic>Endothelium, Vascular - physiopathology</topic><topic>Female</topic><topic>Humans</topic><topic>Incidence</topic><topic>Magnesium</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nitroglycerin - pharmacology</topic><topic>Polyesters</topic><topic>Risk Factors</topic><topic>Sample Size</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - therapeutic use</topic><topic>ST Elevation Myocardial Infarction - drug therapy</topic><topic>ST Elevation Myocardial Infarction - surgery</topic><topic>Thrombectomy</topic><topic>Tissue Scaffolds</topic><topic>Vasodilation - drug effects</topic><topic>Vasodilator Agents - therapeutic use</topic><topic>Vasomotor System - physiopathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sabaté, Manel</creatorcontrib><creatorcontrib>Alfonso, Fernando</creatorcontrib><creatorcontrib>Cequier, Angel</creatorcontrib><creatorcontrib>Romaní, Sebastián</creatorcontrib><creatorcontrib>Bordes, Pascual</creatorcontrib><creatorcontrib>Serra, Antonio</creatorcontrib><creatorcontrib>Iñiguez, Andrés</creatorcontrib><creatorcontrib>Salinas, Pablo</creatorcontrib><creatorcontrib>García del Blanco, Bruno</creatorcontrib><creatorcontrib>Goicolea, Javier</creatorcontrib><creatorcontrib>Hernández-Antolín, Rosana</creatorcontrib><creatorcontrib>Cuesta, Javier</creatorcontrib><creatorcontrib>Gómez-Hospital, Joan Antoni</creatorcontrib><creatorcontrib>Ortega-Paz, Luis</creatorcontrib><creatorcontrib>Gomez-Lara, Josep</creatorcontrib><creatorcontrib>Brugaletta, Salvatore</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sabaté, Manel</au><au>Alfonso, Fernando</au><au>Cequier, Angel</au><au>Romaní, Sebastián</au><au>Bordes, Pascual</au><au>Serra, Antonio</au><au>Iñiguez, Andrés</au><au>Salinas, Pablo</au><au>García del Blanco, Bruno</au><au>Goicolea, Javier</au><au>Hernández-Antolín, Rosana</au><au>Cuesta, Javier</au><au>Gómez-Hospital, Joan Antoni</au><au>Ortega-Paz, Luis</au><au>Gomez-Lara, Josep</au><au>Brugaletta, Salvatore</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2019-12-03</date><risdate>2019</risdate><volume>140</volume><issue>23</issue><spage>1904</spage><epage>1916</epage><pages>1904-1916</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><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.</abstract><cop>United States</cop><pub>by the American College of Cardiology Foundation and the American Heart Association, Inc</pub><pmid>31553204</pmid><doi>10.1161/CIRCULATIONAHA.119.043467</doi><tpages>13</tpages></addata></record> |
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| ispartof | Circulation (New York, N.Y.), 2019-12, Vol.140 (23), p.1904-1916 |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete |
| subjects | 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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