A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V Pilot Study
The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia. Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative...
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| Veröffentlicht in: | Journal of the American College of Cardiology 2007-05, Vol.49 (17), p.1763-1769 |
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| creator | Poldermans, Don Schouten, Olaf Vidakovic, Radosav Bax, Jeroen J Thomson, Ian R Hoeks, Sanne E Feringa, Harm H H Dunkelgrün, Martin de Jaegere, Peter Maat, Alexander van Sambeek, Marc R H M Kertai, Miklos D Boersma, Eric |
| description | The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia.
Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy.
One thousand eight hundred eighty patients were screened, and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (> or =5 segments or > or =3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up.
Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48).
In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome. |
| doi_str_mv | 10.1016/j.jacc.2006.11.052 |
| format | Article |
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Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy.
One thousand eight hundred eighty patients were screened, and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (> or =5 segments or > or =3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up.
Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48).
In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2006.11.052</identifier><identifier>PMID: 17466225</identifier><language>eng</language><publisher>United States: Elsevier Limited</publisher><subject>Aged ; Angina pectoris ; Angioplasty, Balloon, Coronary ; Cardiology ; Coronary Artery Bypass ; Coronary vessels ; Drug therapy ; Exercise Test ; Feasibility Studies ; Female ; Follow-Up Studies ; Heart attacks ; Humans ; Male ; Middle Aged ; Mortality ; Myocardial Ischemia - etiology ; Myocardial Ischemia - prevention & control ; Myocardial Ischemia - surgery ; Pilot Projects ; Risk Factors ; Stents ; Treatment Outcome ; Vascular Surgical Procedures</subject><ispartof>Journal of the American College of Cardiology, 2007-05, Vol.49 (17), p.1763-1769</ispartof><rights>Copyright Elsevier Limited May 1, 2007</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17466225$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Poldermans, Don</creatorcontrib><creatorcontrib>Schouten, Olaf</creatorcontrib><creatorcontrib>Vidakovic, Radosav</creatorcontrib><creatorcontrib>Bax, Jeroen J</creatorcontrib><creatorcontrib>Thomson, Ian R</creatorcontrib><creatorcontrib>Hoeks, Sanne E</creatorcontrib><creatorcontrib>Feringa, Harm H H</creatorcontrib><creatorcontrib>Dunkelgrün, Martin</creatorcontrib><creatorcontrib>de Jaegere, Peter</creatorcontrib><creatorcontrib>Maat, Alexander</creatorcontrib><creatorcontrib>van Sambeek, Marc R H M</creatorcontrib><creatorcontrib>Kertai, Miklos D</creatorcontrib><creatorcontrib>Boersma, Eric</creatorcontrib><creatorcontrib>DECREASE Study Group</creatorcontrib><title>A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V Pilot Study</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia.
Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy.
One thousand eight hundred eighty patients were screened, and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (> or =5 segments or > or =3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up.
Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48).
In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.</description><subject>Aged</subject><subject>Angina pectoris</subject><subject>Angioplasty, Balloon, Coronary</subject><subject>Cardiology</subject><subject>Coronary Artery Bypass</subject><subject>Coronary vessels</subject><subject>Drug therapy</subject><subject>Exercise Test</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Myocardial Ischemia - etiology</subject><subject>Myocardial Ischemia - prevention & control</subject><subject>Myocardial Ischemia - surgery</subject><subject>Pilot Projects</subject><subject>Risk Factors</subject><subject>Stents</subject><subject>Treatment Outcome</subject><subject>Vascular Surgical Procedures</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkM2O1DAQhC3Eih0WXoADagmJW4LtxPnhNhqGH2mlXe0C16jH7pk4JPas7Yw0PA2PSgTLhVOrWl-VuouxV4Lngovq3ZAPqHUuOa9yIXKu5BO2Eko1WaHa-ilb8bpQmeBtfcmexzjwBWxE-4xdirqsKinViv1agx6tsxpHCOiMn-xPMpCCXRbJA51wnDERpJ4g4p7SGfweEJx31p0w2hMBHo_Bo-7BOujtoc-CjT_giMmSSxFmZygcvHUHmHDwARabnkcMEOdwoHB-_yf9w3Zzt13fb7PvcGtHn-A-zeb8gl3scYz08nFesW8ft183n7Prm09fNuvrrJd1kTI0hRG70uC-0CQqqjTyshaykItq5U5xaqTYCV6TlK1slcGKm4aXyElXyIsr9vZv7vLKw0wxdZONmsYRHfk5djUvSyHLYgHf_AcOfg5uua0TileiqVUjFur1IzXvJjLdMdgJw7n713zxG_gPh-o</recordid><startdate>20070501</startdate><enddate>20070501</enddate><creator>Poldermans, Don</creator><creator>Schouten, Olaf</creator><creator>Vidakovic, Radosav</creator><creator>Bax, Jeroen J</creator><creator>Thomson, Ian R</creator><creator>Hoeks, Sanne E</creator><creator>Feringa, Harm H H</creator><creator>Dunkelgrün, Martin</creator><creator>de Jaegere, Peter</creator><creator>Maat, Alexander</creator><creator>van Sambeek, Marc R H M</creator><creator>Kertai, Miklos D</creator><creator>Boersma, Eric</creator><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20070501</creationdate><title>A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V Pilot Study</title><author>Poldermans, Don ; 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Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy.
One thousand eight hundred eighty patients were screened, and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (> or =5 segments or > or =3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up.
Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48).
In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.</abstract><cop>United States</cop><pub>Elsevier Limited</pub><pmid>17466225</pmid><doi>10.1016/j.jacc.2006.11.052</doi><tpages>7</tpages></addata></record> |
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| subjects | Aged Angina pectoris Angioplasty, Balloon, Coronary Cardiology Coronary Artery Bypass Coronary vessels Drug therapy Exercise Test Feasibility Studies Female Follow-Up Studies Heart attacks Humans Male Middle Aged Mortality Myocardial Ischemia - etiology Myocardial Ischemia - prevention & control Myocardial Ischemia - surgery Pilot Projects Risk Factors Stents Treatment Outcome Vascular Surgical Procedures |
| title | A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V Pilot Study |
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