Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial
Summary Background Optimum duration of dual antiplatelet treatment (DAPT) after coronary stenting remains uncertain, with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice. We assessed whether DAPT continuation b...
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| Veröffentlicht in: | The Lancet (British edition) 2014-11, Vol.384 (9954), p.1577-1585 |
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| creator | Collet, Jean-Philippe, Prof Silvain, Johanne, MD Barthélémy, Olivier, MD Rangé, Grégoire, MD Cayla, Guillaume, Prof Van Belle, Eric, Prof Cuisset, Thomas, Prof Elhadad, Simon, MD Schiele, François, Prof Lhoest, Nicolas, MD Ohlmann, Patrick, Prof Carrié, Didier, Prof Rousseau, Hélène, MSc Aubry, Pierre, MD Monségu, Jacques, Prof Sabouret, Pierre, MD O'Connor, Stephen A, MD Abtan, Jérémie, MD Kerneis, Mathieu, MD Saint-Etienne, Christophe, MD Beygui, Farzin, Prof Vicaut, Eric, Prof Montalescot, Gilles, Prof |
| description | Summary Background Optimum duration of dual antiplatelet treatment (DAPT) after coronary stenting remains uncertain, with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice. We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial. Methods This analysis was a planned extension of the previously published ARCTIC-Monitoring trial, in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent (DES). We recruited patients (aged 18 years or older) scheduled for planned DES implantation at 38 centres in France. After 1 year of follow-up, patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study (ARCTIC-Interruption). Using a computer-generated randomisation sequence (1:1; stratified by centre), we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained (interruption group) or a strategy of DAPT continuation for 6–18 months (continuation group). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularisation, analysed by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00827411. Findings Between Jan 4, 2011, and March 3, 2012, 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption: 624 to the interruption group and 635 to the continuation group. After a median follow-up of 17 months (IQR 15–18), the primary endpoint occurred in 27 (4%) patients in the interruption group and 24 (4%) patients in the continuation group (hazard ratio [HR] 1·17 [95% CI 0·68–2·03]; p=0·58). STEEPLE major bleeding events occurred more often in the continuation group (seven [1%] patients) compared with the interruption group (one [ |
| doi_str_mv | 10.1016/S0140-6736(14)60612-7 |
| format | Article |
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We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial. Methods This analysis was a planned extension of the previously published ARCTIC-Monitoring trial, in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent (DES). We recruited patients (aged 18 years or older) scheduled for planned DES implantation at 38 centres in France. After 1 year of follow-up, patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study (ARCTIC-Interruption). Using a computer-generated randomisation sequence (1:1; stratified by centre), we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained (interruption group) or a strategy of DAPT continuation for 6–18 months (continuation group). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularisation, analysed by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00827411. Findings Between Jan 4, 2011, and March 3, 2012, 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption: 624 to the interruption group and 635 to the continuation group. After a median follow-up of 17 months (IQR 15–18), the primary endpoint occurred in 27 (4%) patients in the interruption group and 24 (4%) patients in the continuation group (hazard ratio [HR] 1·17 [95% CI 0·68–2·03]; p=0·58). STEEPLE major bleeding events occurred more often in the continuation group (seven [1%] patients) compared with the interruption group (one [<0·5%] patient; HR 0·15 [0·02–1·20]; p=0·073). Major or minor bleedings were also more common in the continuation group compared with the interruption group (12 [2%] patients vs three [1%] patients; HR 0·26 [0·07–0·91]; p=0·04). Interpretation Our finding suggests no apparent benefit but instead harm with extension of DAPT beyond 1 year after stenting with DES when no event has occurred within the first year after stenting. No conclusion can be drawn for high-risk patients who could not be randomised. The consistency between findings from all trials of such interruption suggests the need for a reappraisal of guidelines for DAPT after coronary stenting towards shorter duration of treatment. Funding Allies in Cardiovascular Trials Initiatives and Organized Networks (ACTION Study Group), Fondation de France, Sanofi-Aventis, Cordis, Medtronic, Boston Scientific, Fondation SGAM.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(14)60612-7</identifier><identifier>PMID: 25037988</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Acute coronary syndromes ; Adolescent ; Adult ; Aged ; Aspirin ; Aspirin - administration & dosage ; Aspirin - adverse effects ; Aspirin - therapeutic use ; Biological and medical sciences ; Coronary Artery Disease - therapy ; Drug Administration Schedule ; Drug therapy ; Drug Therapy, Combination ; Drug-Eluting Stents ; Female ; General aspects ; Heart attacks ; Hemorrhage - chemically induced ; Humans ; Internal Medicine ; Kaplan-Meier Estimate ; Male ; Medical sciences ; Middle Aged ; Myocardial infarction ; Percutaneous Coronary Intervention - methods ; Platelet Aggregation Inhibitors - administration & dosage ; Platelet Aggregation Inhibitors - adverse effects ; Platelet Aggregation Inhibitors - therapeutic use ; Platelet Function Tests - methods ; Prospective Studies ; Pyridines - administration & dosage ; Pyridines - adverse effects ; Pyridines - therapeutic use ; Stents ; Stroke ; Studies ; Survival analysis ; Thromboembolism ; Thrombosis ; Treatment Outcome ; Young Adult</subject><ispartof>The Lancet (British edition), 2014-11, Vol.384 (9954), p.1577-1585</ispartof><rights>Elsevier Ltd</rights><rights>2014 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Nov 1, 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c548t-bdaf81116353a523688cf37331830b51f7c6df5bda539a72bf638a3e80680c3a3</citedby><cites>FETCH-LOGICAL-c548t-bdaf81116353a523688cf37331830b51f7c6df5bda539a72bf638a3e80680c3a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673614606127$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28880459$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25037988$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Collet, Jean-Philippe, Prof</creatorcontrib><creatorcontrib>Silvain, Johanne, MD</creatorcontrib><creatorcontrib>Barthélémy, Olivier, MD</creatorcontrib><creatorcontrib>Rangé, Grégoire, MD</creatorcontrib><creatorcontrib>Cayla, Guillaume, Prof</creatorcontrib><creatorcontrib>Van Belle, Eric, Prof</creatorcontrib><creatorcontrib>Cuisset, Thomas, Prof</creatorcontrib><creatorcontrib>Elhadad, Simon, MD</creatorcontrib><creatorcontrib>Schiele, François, Prof</creatorcontrib><creatorcontrib>Lhoest, Nicolas, MD</creatorcontrib><creatorcontrib>Ohlmann, Patrick, Prof</creatorcontrib><creatorcontrib>Carrié, Didier, Prof</creatorcontrib><creatorcontrib>Rousseau, Hélène, MSc</creatorcontrib><creatorcontrib>Aubry, Pierre, MD</creatorcontrib><creatorcontrib>Monségu, Jacques, Prof</creatorcontrib><creatorcontrib>Sabouret, Pierre, MD</creatorcontrib><creatorcontrib>O'Connor, Stephen A, MD</creatorcontrib><creatorcontrib>Abtan, Jérémie, MD</creatorcontrib><creatorcontrib>Kerneis, Mathieu, MD</creatorcontrib><creatorcontrib>Saint-Etienne, Christophe, MD</creatorcontrib><creatorcontrib>Beygui, Farzin, Prof</creatorcontrib><creatorcontrib>Vicaut, Eric, Prof</creatorcontrib><creatorcontrib>Montalescot, Gilles, Prof</creatorcontrib><creatorcontrib>for the ARCTIC investigators</creatorcontrib><creatorcontrib>ARCTIC investigators</creatorcontrib><title>Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Optimum duration of dual antiplatelet treatment (DAPT) after coronary stenting remains uncertain, with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice. We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial. Methods This analysis was a planned extension of the previously published ARCTIC-Monitoring trial, in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent (DES). We recruited patients (aged 18 years or older) scheduled for planned DES implantation at 38 centres in France. After 1 year of follow-up, patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study (ARCTIC-Interruption). Using a computer-generated randomisation sequence (1:1; stratified by centre), we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained (interruption group) or a strategy of DAPT continuation for 6–18 months (continuation group). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularisation, analysed by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00827411. Findings Between Jan 4, 2011, and March 3, 2012, 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption: 624 to the interruption group and 635 to the continuation group. After a median follow-up of 17 months (IQR 15–18), the primary endpoint occurred in 27 (4%) patients in the interruption group and 24 (4%) patients in the continuation group (hazard ratio [HR] 1·17 [95% CI 0·68–2·03]; p=0·58). STEEPLE major bleeding events occurred more often in the continuation group (seven [1%] patients) compared with the interruption group (one [<0·5%] patient; HR 0·15 [0·02–1·20]; p=0·073). Major or minor bleedings were also more common in the continuation group compared with the interruption group (12 [2%] patients vs three [1%] patients; HR 0·26 [0·07–0·91]; p=0·04). Interpretation Our finding suggests no apparent benefit but instead harm with extension of DAPT beyond 1 year after stenting with DES when no event has occurred within the first year after stenting. No conclusion can be drawn for high-risk patients who could not be randomised. The consistency between findings from all trials of such interruption suggests the need for a reappraisal of guidelines for DAPT after coronary stenting towards shorter duration of treatment. Funding Allies in Cardiovascular Trials Initiatives and Organized Networks (ACTION Study Group), Fondation de France, Sanofi-Aventis, Cordis, Medtronic, Boston Scientific, Fondation SGAM.</description><subject>Acute coronary syndromes</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aspirin</subject><subject>Aspirin - administration & dosage</subject><subject>Aspirin - adverse effects</subject><subject>Aspirin - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Coronary Artery Disease - therapy</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Drug-Eluting Stents</subject><subject>Female</subject><subject>General aspects</subject><subject>Heart attacks</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Percutaneous Coronary Intervention - methods</subject><subject>Platelet Aggregation Inhibitors - administration & dosage</subject><subject>Platelet Aggregation Inhibitors - adverse effects</subject><subject>Platelet Aggregation Inhibitors - therapeutic use</subject><subject>Platelet Function Tests - methods</subject><subject>Prospective Studies</subject><subject>Pyridines - administration & dosage</subject><subject>Pyridines - adverse effects</subject><subject>Pyridines - therapeutic use</subject><subject>Stents</subject><subject>Stroke</subject><subject>Studies</subject><subject>Survival analysis</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Treatment Outcome</subject><subject>Young 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syndromes</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aspirin</topic><topic>Aspirin - administration & dosage</topic><topic>Aspirin - adverse effects</topic><topic>Aspirin - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Coronary Artery Disease - therapy</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Drug-Eluting Stents</topic><topic>Female</topic><topic>General aspects</topic><topic>Heart attacks</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Myocardial infarction</topic><topic>Percutaneous Coronary Intervention - methods</topic><topic>Platelet Aggregation Inhibitors - administration & dosage</topic><topic>Platelet Aggregation Inhibitors - adverse 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Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Collet, Jean-Philippe, Prof</au><au>Silvain, Johanne, MD</au><au>Barthélémy, Olivier, MD</au><au>Rangé, Grégoire, MD</au><au>Cayla, Guillaume, Prof</au><au>Van Belle, Eric, Prof</au><au>Cuisset, Thomas, Prof</au><au>Elhadad, Simon, MD</au><au>Schiele, François, Prof</au><au>Lhoest, Nicolas, MD</au><au>Ohlmann, Patrick, Prof</au><au>Carrié, Didier, Prof</au><au>Rousseau, Hélène, MSc</au><au>Aubry, Pierre, MD</au><au>Monségu, Jacques, Prof</au><au>Sabouret, Pierre, MD</au><au>O'Connor, Stephen A, MD</au><au>Abtan, Jérémie, MD</au><au>Kerneis, Mathieu, MD</au><au>Saint-Etienne, Christophe, MD</au><au>Beygui, Farzin, Prof</au><au>Vicaut, Eric, Prof</au><au>Montalescot, Gilles, Prof</au><aucorp>for the ARCTIC investigators</aucorp><aucorp>ARCTIC investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>384</volume><issue>9954</issue><spage>1577</spage><epage>1585</epage><pages>1577-1585</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Optimum duration of dual antiplatelet treatment (DAPT) after coronary stenting remains uncertain, with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice. We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial. Methods This analysis was a planned extension of the previously published ARCTIC-Monitoring trial, in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent (DES). We recruited patients (aged 18 years or older) scheduled for planned DES implantation at 38 centres in France. After 1 year of follow-up, patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study (ARCTIC-Interruption). Using a computer-generated randomisation sequence (1:1; stratified by centre), we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained (interruption group) or a strategy of DAPT continuation for 6–18 months (continuation group). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularisation, analysed by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00827411. Findings Between Jan 4, 2011, and March 3, 2012, 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption: 624 to the interruption group and 635 to the continuation group. After a median follow-up of 17 months (IQR 15–18), the primary endpoint occurred in 27 (4%) patients in the interruption group and 24 (4%) patients in the continuation group (hazard ratio [HR] 1·17 [95% CI 0·68–2·03]; p=0·58). STEEPLE major bleeding events occurred more often in the continuation group (seven [1%] patients) compared with the interruption group (one [<0·5%] patient; HR 0·15 [0·02–1·20]; p=0·073). Major or minor bleedings were also more common in the continuation group compared with the interruption group (12 [2%] patients vs three [1%] patients; HR 0·26 [0·07–0·91]; p=0·04). Interpretation Our finding suggests no apparent benefit but instead harm with extension of DAPT beyond 1 year after stenting with DES when no event has occurred within the first year after stenting. No conclusion can be drawn for high-risk patients who could not be randomised. The consistency between findings from all trials of such interruption suggests the need for a reappraisal of guidelines for DAPT after coronary stenting towards shorter duration of treatment. Funding Allies in Cardiovascular Trials Initiatives and Organized Networks (ACTION Study Group), Fondation de France, Sanofi-Aventis, Cordis, Medtronic, Boston Scientific, Fondation SGAM.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>25037988</pmid><doi>10.1016/S0140-6736(14)60612-7</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2014-11, Vol.384 (9954), p.1577-1585 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1629968908 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Acute coronary syndromes Adolescent Adult Aged Aspirin Aspirin - administration & dosage Aspirin - adverse effects Aspirin - therapeutic use Biological and medical sciences Coronary Artery Disease - therapy Drug Administration Schedule Drug therapy Drug Therapy, Combination Drug-Eluting Stents Female General aspects Heart attacks Hemorrhage - chemically induced Humans Internal Medicine Kaplan-Meier Estimate Male Medical sciences Middle Aged Myocardial infarction Percutaneous Coronary Intervention - methods Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - therapeutic use Platelet Function Tests - methods Prospective Studies Pyridines - administration & dosage Pyridines - adverse effects Pyridines - therapeutic use Stents Stroke Studies Survival analysis Thromboembolism Thrombosis Treatment Outcome Young Adult |
| title | Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-31T18%3A55%3A28IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Dual-antiplatelet%20treatment%20beyond%201%20year%20after%20drug-eluting%20stent%20implantation%20(ARCTIC-Interruption):%20a%20randomised%20trial&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Collet,%20Jean-Philippe,%20Prof&rft.aucorp=for%20the%20ARCTIC%20investigators&rft.date=2014-11-01&rft.volume=384&rft.issue=9954&rft.spage=1577&rft.epage=1585&rft.pages=1577-1585&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(14)60612-7&rft_dat=%3Cproquest_cross%3E3476981761%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1618908092&rft_id=info:pmid/25037988&rft_els_id=1_s2_0_S0140673614606127&rfr_iscdi=true |