Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial
Summary Background Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (...
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| Veröffentlicht in: | LANCET 2011, Vol.377 (9775), p.1409-1420 |
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| creator | Jolly, Sanjit S, Dr Yusuf, Salim, Prof Cairns, John, Prof Niemelä, Kari, Prof Xavier, Denis, MD Widimsky, Petr, Prof Budaj, Andrzej, Prof Niemelä, Matti, MD Valentin, Vicent, MD Lewis, Basil S, Prof Avezum, Alvaro, MD Steg, Philippe Gabriel, Prof Rao, Sunil V, MD Gao, Peggy, MSc Afzal, Rizwan, MSc Joyner, Campbell D, Prof Chrolavicius, Susan, BScN Mehta, Shamir R, MD |
| description | Summary Background Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. Methods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , NCT01014273. Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38–0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76–1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43–1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, |
| doi_str_mv | 10.1016/S0140-6736(11)60404-2 |
| format | Article |
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We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. Methods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , NCT01014273. Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38–0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76–1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43–1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28–0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13–0·71; p=0·006). Interpretation Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach. Funding Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(11)60404-2</identifier><identifier>PMID: 21470671</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Acute Coronary Syndrome - diagnostic imaging ; Acute Coronary Syndrome - therapy ; Acute coronary syndromes ; Aged ; Angiography ; Angioplasty, Balloon, Coronary - adverse effects ; Angioplasty, Balloon, Coronary - methods ; Biological and medical sciences ; Bleeding ; Cardiovascular disease ; Cardiovascular system ; Catheterization, Peripheral - adverse effects ; Catheterization, Peripheral - methods ; Clinical trials ; Competition ; Coronary Angiography - adverse effects ; Coronary Angiography - methods ; Coronary Artery Bypass ; death ; Diseases of the cardiovascular system ; Fees & charges ; Female ; Femoral Artery ; Femur ; General aspects ; Health sciences ; Heart attacks ; Hematoma ; Hemorrhage - etiology ; Hospitals ; Humans ; Implants ; Internal Medicine ; Investigative techniques, diagnostic techniques (general aspects) ; Male ; Medical imaging ; Medical research ; Medical sciences ; Middle Aged ; Mortality ; Motivation ; Myocardial infarction ; Myocardial Reperfusion ; patients ; Radial Artery ; Radiodiagnosis. Nmr imagery. Nmr spectrometry ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Stents ; Stroke ; Thromboembolism ; Thrombosis ; Veins & arteries</subject><ispartof>LANCET, 2011, Vol.377 (9775), p.1409-1420</ispartof><rights>Elsevier Ltd</rights><rights>2011 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Apr 23-Apr 29, 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c622t-f0c7fce4d29cf9cf7c080ad5be88266df8232387d4e336da58fcc894a48e2ab33</citedby><cites>FETCH-LOGICAL-c622t-f0c7fce4d29cf9cf7c080ad5be88266df8232387d4e336da58fcc894a48e2ab33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/863827918?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,881,3536,4009,27902,27903,27904,64361,64363,64365,65309,72215</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24095248$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21470671$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:122483979$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Jolly, Sanjit S, Dr</creatorcontrib><creatorcontrib>Yusuf, Salim, Prof</creatorcontrib><creatorcontrib>Cairns, John, Prof</creatorcontrib><creatorcontrib>Niemelä, Kari, Prof</creatorcontrib><creatorcontrib>Xavier, Denis, MD</creatorcontrib><creatorcontrib>Widimsky, Petr, Prof</creatorcontrib><creatorcontrib>Budaj, Andrzej, Prof</creatorcontrib><creatorcontrib>Niemelä, Matti, MD</creatorcontrib><creatorcontrib>Valentin, Vicent, MD</creatorcontrib><creatorcontrib>Lewis, Basil S, Prof</creatorcontrib><creatorcontrib>Avezum, Alvaro, MD</creatorcontrib><creatorcontrib>Steg, Philippe Gabriel, Prof</creatorcontrib><creatorcontrib>Rao, Sunil V, MD</creatorcontrib><creatorcontrib>Gao, Peggy, MSc</creatorcontrib><creatorcontrib>Afzal, Rizwan, MSc</creatorcontrib><creatorcontrib>Joyner, Campbell D, Prof</creatorcontrib><creatorcontrib>Chrolavicius, Susan, BScN</creatorcontrib><creatorcontrib>Mehta, Shamir R, MD</creatorcontrib><creatorcontrib>for the RIVAL trial group</creatorcontrib><creatorcontrib>RIVAL trial group</creatorcontrib><title>Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial</title><title>LANCET</title><addtitle>Lancet</addtitle><description>Summary Background Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. Methods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , NCT01014273. Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38–0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76–1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43–1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28–0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13–0·71; p=0·006). Interpretation Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach. Funding Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.</description><subject>Acute Coronary Syndrome - diagnostic imaging</subject><subject>Acute Coronary Syndrome - therapy</subject><subject>Acute coronary syndromes</subject><subject>Aged</subject><subject>Angiography</subject><subject>Angioplasty, Balloon, Coronary - adverse effects</subject><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Biological and medical sciences</subject><subject>Bleeding</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular system</subject><subject>Catheterization, Peripheral - adverse effects</subject><subject>Catheterization, Peripheral - methods</subject><subject>Clinical trials</subject><subject>Competition</subject><subject>Coronary Angiography - adverse effects</subject><subject>Coronary Angiography - methods</subject><subject>Coronary Artery Bypass</subject><subject>death</subject><subject>Diseases of the cardiovascular system</subject><subject>Fees & charges</subject><subject>Female</subject><subject>Femoral Artery</subject><subject>Femur</subject><subject>General aspects</subject><subject>Health sciences</subject><subject>Heart attacks</subject><subject>Hematoma</subject><subject>Hemorrhage - etiology</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Implants</subject><subject>Internal Medicine</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Male</subject><subject>Medical imaging</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Motivation</subject><subject>Myocardial infarction</subject><subject>Myocardial Reperfusion</subject><subject>patients</subject><subject>Radial Artery</subject><subject>Radiodiagnosis. Nmr imagery. Nmr spectrometry</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Stents</subject><subject>Stroke</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Veins & arteries</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkl1rFDEUhgdR7Lr6E9QgiC10NMlkvrxQSvGjsCC0VrwL2eTMNu3MZExmtuxP8l96ZmfdQm8KgckZnvPmvMkbRS8Zfc8oyz5cUCZonOVJdsjYUUYFFTF_FM2YyEWcivz342i2Rw6iZyFcU0pFRtOn0QFHimY5m0V_z5WxqiZr8GEIpILGeSyV1hCwdJ5o512r_IaodmXdyqvuatwbYtse_Bra3roWC9Kp3mIVyK3tr1Bh6OGuOWxa410DgRyen_06WRx9JIp4lHGNDWCOsRvPraEmK--G7pg0Q91bjXoeSO9xxOfRk0rVAV7svvPo8uuXn6ff48WPb2enJ4tYZ5z3cUV1XmkQhpe6wpVrWlBl0iUUBc8yUxU84UmRGwFJkhmVFpXWRSmUKICrZZLMo3jSDbfQDUvZedugA-mUlbtfN7gDmYoUpZF_N_Gdd38GCL1ERxrqWrXghiBLKkTORZI9SBZZIhLGywLJN_fIazf4Fm2PUMHzko1QOkHauxA8VPtRGZVjRuQ2I3IMgGRMbjMiOfa92okPywbMvut_KBB4uwNU0Kqu8Jm0DXecoGXKxTjA64mrlJNq5ZG5vOCUpZSiiwQ9z6PPEwH4YGsLXgaNGdFgrAfdS-Psg8N-uqega9taHOsGNhD218Jk4JJOIqMGY1sFnvwDg-35zQ</recordid><startdate>2011</startdate><enddate>2011</enddate><creator>Jolly, Sanjit S, Dr</creator><creator>Yusuf, Salim, Prof</creator><creator>Cairns, John, Prof</creator><creator>Niemelä, Kari, Prof</creator><creator>Xavier, Denis, MD</creator><creator>Widimsky, Petr, Prof</creator><creator>Budaj, Andrzej, Prof</creator><creator>Niemelä, Matti, MD</creator><creator>Valentin, Vicent, MD</creator><creator>Lewis, Basil S, Prof</creator><creator>Avezum, Alvaro, MD</creator><creator>Steg, Philippe Gabriel, Prof</creator><creator>Rao, Sunil V, MD</creator><creator>Gao, Peggy, MSc</creator><creator>Afzal, Rizwan, MSc</creator><creator>Joyner, Campbell D, Prof</creator><creator>Chrolavicius, Susan, BScN</creator><creator>Mehta, Shamir R, MD</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TT</scope><scope>0TZ</scope><scope>0U~</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>KB~</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope><scope>ADTPV</scope><scope>AOWAS</scope></search><sort><creationdate>2011</creationdate><title>Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial</title><author>Jolly, Sanjit S, Dr ; Yusuf, Salim, Prof ; Cairns, John, Prof ; Niemelä, Kari, Prof ; Xavier, Denis, MD ; Widimsky, Petr, Prof ; Budaj, Andrzej, Prof ; Niemelä, Matti, MD ; Valentin, Vicent, MD ; Lewis, Basil S, Prof ; Avezum, Alvaro, MD ; Steg, Philippe Gabriel, Prof ; Rao, Sunil V, MD ; Gao, Peggy, MSc ; Afzal, Rizwan, MSc ; Joyner, Campbell D, Prof ; Chrolavicius, Susan, BScN ; Mehta, Shamir R, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c622t-f0c7fce4d29cf9cf7c080ad5be88266df8232387d4e336da58fcc894a48e2ab33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Acute Coronary Syndrome - diagnostic imaging</topic><topic>Acute Coronary Syndrome - therapy</topic><topic>Acute coronary syndromes</topic><topic>Aged</topic><topic>Angiography</topic><topic>Angioplasty, Balloon, Coronary - adverse effects</topic><topic>Angioplasty, Balloon, Coronary - methods</topic><topic>Biological and medical sciences</topic><topic>Bleeding</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular system</topic><topic>Catheterization, Peripheral - adverse effects</topic><topic>Catheterization, Peripheral - methods</topic><topic>Clinical trials</topic><topic>Competition</topic><topic>Coronary Angiography - adverse effects</topic><topic>Coronary Angiography - methods</topic><topic>Coronary Artery Bypass</topic><topic>death</topic><topic>Diseases of the cardiovascular system</topic><topic>Fees & charges</topic><topic>Female</topic><topic>Femoral Artery</topic><topic>Femur</topic><topic>General aspects</topic><topic>Health sciences</topic><topic>Heart attacks</topic><topic>Hematoma</topic><topic>Hemorrhage - etiology</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Implants</topic><topic>Internal Medicine</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Male</topic><topic>Medical imaging</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Motivation</topic><topic>Myocardial infarction</topic><topic>Myocardial Reperfusion</topic><topic>patients</topic><topic>Radial Artery</topic><topic>Radiodiagnosis. Nmr imagery. Nmr spectrometry</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Stents</topic><topic>Stroke</topic><topic>Thromboembolism</topic><topic>Thrombosis</topic><topic>Veins & arteries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jolly, Sanjit S, Dr</creatorcontrib><creatorcontrib>Yusuf, Salim, Prof</creatorcontrib><creatorcontrib>Cairns, John, Prof</creatorcontrib><creatorcontrib>Niemelä, Kari, Prof</creatorcontrib><creatorcontrib>Xavier, Denis, MD</creatorcontrib><creatorcontrib>Widimsky, Petr, Prof</creatorcontrib><creatorcontrib>Budaj, Andrzej, Prof</creatorcontrib><creatorcontrib>Niemelä, Matti, MD</creatorcontrib><creatorcontrib>Valentin, Vicent, MD</creatorcontrib><creatorcontrib>Lewis, Basil S, Prof</creatorcontrib><creatorcontrib>Avezum, Alvaro, MD</creatorcontrib><creatorcontrib>Steg, Philippe Gabriel, Prof</creatorcontrib><creatorcontrib>Rao, Sunil V, MD</creatorcontrib><creatorcontrib>Gao, Peggy, MSc</creatorcontrib><creatorcontrib>Afzal, Rizwan, MSc</creatorcontrib><creatorcontrib>Joyner, Campbell D, Prof</creatorcontrib><creatorcontrib>Chrolavicius, Susan, BScN</creatorcontrib><creatorcontrib>Mehta, Shamir R, MD</creatorcontrib><creatorcontrib>for the RIVAL trial group</creatorcontrib><creatorcontrib>RIVAL trial group</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>News PRO</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Global News & ABI/Inform Professional</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>Consumer Health Database (Alumni 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><collection>SwePub</collection><collection>SwePub Articles</collection><jtitle>LANCET</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jolly, Sanjit S, Dr</au><au>Yusuf, Salim, Prof</au><au>Cairns, John, Prof</au><au>Niemelä, Kari, Prof</au><au>Xavier, Denis, MD</au><au>Widimsky, Petr, Prof</au><au>Budaj, Andrzej, Prof</au><au>Niemelä, Matti, MD</au><au>Valentin, Vicent, MD</au><au>Lewis, Basil S, Prof</au><au>Avezum, Alvaro, MD</au><au>Steg, Philippe Gabriel, Prof</au><au>Rao, Sunil V, MD</au><au>Gao, Peggy, MSc</au><au>Afzal, Rizwan, MSc</au><au>Joyner, Campbell D, Prof</au><au>Chrolavicius, Susan, BScN</au><au>Mehta, Shamir R, MD</au><aucorp>for the RIVAL trial group</aucorp><aucorp>RIVAL trial group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial</atitle><jtitle>LANCET</jtitle><addtitle>Lancet</addtitle><date>2011</date><risdate>2011</risdate><volume>377</volume><issue>9775</issue><spage>1409</spage><epage>1420</epage><pages>1409-1420</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. Methods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , NCT01014273. Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38–0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76–1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43–1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28–0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13–0·71; p=0·006). Interpretation Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach. Funding Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>21470671</pmid><doi>10.1016/S0140-6736(11)60404-2</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | LANCET, 2011, Vol.377 (9775), p.1409-1420 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_904472436 |
| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Acute Coronary Syndrome - diagnostic imaging Acute Coronary Syndrome - therapy Acute coronary syndromes Aged Angiography Angioplasty, Balloon, Coronary - adverse effects Angioplasty, Balloon, Coronary - methods Biological and medical sciences Bleeding Cardiovascular disease Cardiovascular system Catheterization, Peripheral - adverse effects Catheterization, Peripheral - methods Clinical trials Competition Coronary Angiography - adverse effects Coronary Angiography - methods Coronary Artery Bypass death Diseases of the cardiovascular system Fees & charges Female Femoral Artery Femur General aspects Health sciences Heart attacks Hematoma Hemorrhage - etiology Hospitals Humans Implants Internal Medicine Investigative techniques, diagnostic techniques (general aspects) Male Medical imaging Medical research Medical sciences Middle Aged Mortality Motivation Myocardial infarction Myocardial Reperfusion patients Radial Artery Radiodiagnosis. Nmr imagery. Nmr spectrometry Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Stents Stroke Thromboembolism Thrombosis Veins & arteries |
| title | Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial |
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