Effectiveness of fixed minidose warfarin in the prevention of thromboembolism and vascular death in nonrheumatic atrial fibrillation
Adjusted-dose warfarin is effective for stroke prevention in patients with nonrheumatic atrial fibrillation (AF), but the risk of bleeding is high, especially among the elderly. Fixed minidose warfarin is effective in preventing venous thromboembolism with low risk of bleeding and no need for freque...
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| Veröffentlicht in: | The American journal of cardiology 1998-08, Vol.82 (4), p.433-437 |
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| creator | Pengo, Vittorio Zasso, Antonella Barbero, Fabio Banzato, Alberto Nante, Giovanni Parissenti, Lucia John, Nancy Noventa, Franco Dalla Volta, Sergio |
| description | Adjusted-dose warfarin is effective for stroke prevention in patients with nonrheumatic atrial fibrillation (AF), but the risk of bleeding is high, especially among the elderly. Fixed minidose warfarin is effective in preventing venous thromboembolism with low risk of bleeding and no need for frequent clinical monitoring. Patients >60 years with nonrheumatic AF were randomized in an open-labeled trial to receive fixed minidose warfarin (1.25 mg/day) or standard adjusted-dose warfarin (International Normalized Ratio [INR] between 2.0 and 3.0). Primary outcome events were ischemic stroke, peripheral or visceral embolism, cerebral or fatal bleeding, and vascular death. Secondary end points were major bleeding, myocardial infarction, and death. This study was discontinued before completion in light of publication of the Stroke Prevention in Atrial Fibrillation III trial, which indicated that low-intensity fixed-dose warfarin treatment (i.e., INR |
| doi_str_mv | 10.1016/S0002-9149(98)00357-9 |
| format | Article |
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Fixed minidose warfarin is effective in preventing venous thromboembolism with low risk of bleeding and no need for frequent clinical monitoring. Patients >60 years with nonrheumatic AF were randomized in an open-labeled trial to receive fixed minidose warfarin (1.25 mg/day) or standard adjusted-dose warfarin (International Normalized Ratio [INR] between 2.0 and 3.0). Primary outcome events were ischemic stroke, peripheral or visceral embolism, cerebral or fatal bleeding, and vascular death. Secondary end points were major bleeding, myocardial infarction, and death. This study was discontinued before completion in light of publication of the Stroke Prevention in Atrial Fibrillation III trial, which indicated that low-intensity fixed-dose warfarin treatment (i.e., INR <1.5) was insufficient for stroke prevention in high-risk patients with nonrheumatic AF. From a total of 1,209 considered patients, 303 were randomized to be studied (150 in the minidose group and 153 in the adjusted-dose group). Mean follow-up was 14.5 months. The rate of cumulative primary events was 11.1% (95% confidence intervals [CI] 4.0 to 18.2) in the fixed minidose group and 6.1% (95% CI 1.1 to 11.1) in the adjusted-dose group (p = 0.29). The rate of ischemic stroke was significantly higher in the minidose group (3.7% vs 0% per year, p = 0.025). Major bleedings were more frequent in standard treatment group (2.6% vs 1% per year, p = 0.19). Most thromboembolic complications occurred at INRs <1.2, whereas the majority of hemorrhages occurred at INRs >3.0. No significant difference in primary outcome events was observed in the abbreviated study. However, the significantly increased occurrence of ischemic stroke in the fixed minidose warfarin group suggests that this regimen does not protect patients with nonrheumatic AF.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/S0002-9149(98)00357-9</identifier><identifier>PMID: 9723629</identifier><identifier>CODEN: AJCDAG</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; Anticoagulants - administration & dosage ; Atrial Fibrillation - complications ; Atrial Fibrillation - drug therapy ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Cardiology ; Disease-Free Survival ; Drug therapy ; Female ; Humans ; International Normalized Ratio ; Intracranial Embolism and Thrombosis - etiology ; Intracranial Embolism and Thrombosis - prevention & control ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Stroke ; Treatment Outcome ; Warfarin - administration & dosage</subject><ispartof>The American journal of cardiology, 1998-08, Vol.82 (4), p.433-437</ispartof><rights>1998 Excerpta Medica Inc.</rights><rights>1998 INIST-CNRS</rights><rights>Copyright Elsevier Sequoia S.A. Aug 15, 1998</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0002-9149(98)00357-9$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2357226$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9723629$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pengo, Vittorio</creatorcontrib><creatorcontrib>Zasso, Antonella</creatorcontrib><creatorcontrib>Barbero, Fabio</creatorcontrib><creatorcontrib>Banzato, Alberto</creatorcontrib><creatorcontrib>Nante, Giovanni</creatorcontrib><creatorcontrib>Parissenti, Lucia</creatorcontrib><creatorcontrib>John, Nancy</creatorcontrib><creatorcontrib>Noventa, Franco</creatorcontrib><creatorcontrib>Dalla Volta, Sergio</creatorcontrib><title>Effectiveness of fixed minidose warfarin in the prevention of thromboembolism and vascular death in nonrheumatic atrial fibrillation</title><title>The American journal of cardiology</title><addtitle>Am J Cardiol</addtitle><description>Adjusted-dose warfarin is effective for stroke prevention in patients with nonrheumatic atrial fibrillation (AF), but the risk of bleeding is high, especially among the elderly. Fixed minidose warfarin is effective in preventing venous thromboembolism with low risk of bleeding and no need for frequent clinical monitoring. Patients >60 years with nonrheumatic AF were randomized in an open-labeled trial to receive fixed minidose warfarin (1.25 mg/day) or standard adjusted-dose warfarin (International Normalized Ratio [INR] between 2.0 and 3.0). Primary outcome events were ischemic stroke, peripheral or visceral embolism, cerebral or fatal bleeding, and vascular death. Secondary end points were major bleeding, myocardial infarction, and death. This study was discontinued before completion in light of publication of the Stroke Prevention in Atrial Fibrillation III trial, which indicated that low-intensity fixed-dose warfarin treatment (i.e., INR <1.5) was insufficient for stroke prevention in high-risk patients with nonrheumatic AF. From a total of 1,209 considered patients, 303 were randomized to be studied (150 in the minidose group and 153 in the adjusted-dose group). Mean follow-up was 14.5 months. The rate of cumulative primary events was 11.1% (95% confidence intervals [CI] 4.0 to 18.2) in the fixed minidose group and 6.1% (95% CI 1.1 to 11.1) in the adjusted-dose group (p = 0.29). The rate of ischemic stroke was significantly higher in the minidose group (3.7% vs 0% per year, p = 0.025). Major bleedings were more frequent in standard treatment group (2.6% vs 1% per year, p = 0.19). Most thromboembolic complications occurred at INRs <1.2, whereas the majority of hemorrhages occurred at INRs >3.0. No significant difference in primary outcome events was observed in the abbreviated study. However, the significantly increased occurrence of ischemic stroke in the fixed minidose warfarin group suggests that this regimen does not protect patients with nonrheumatic AF.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants - administration & dosage</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Cardiology</subject><subject>Disease-Free Survival</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Humans</subject><subject>International Normalized Ratio</subject><subject>Intracranial Embolism and Thrombosis - etiology</subject><subject>Intracranial Embolism and Thrombosis - prevention & control</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. 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Blood coagulation. Reticuloendothelial system</topic><topic>Cardiology</topic><topic>Disease-Free Survival</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Humans</topic><topic>International Normalized Ratio</topic><topic>Intracranial Embolism and Thrombosis - etiology</topic><topic>Intracranial Embolism and Thrombosis - prevention & control</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Stroke</topic><topic>Treatment Outcome</topic><topic>Warfarin - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pengo, Vittorio</creatorcontrib><creatorcontrib>Zasso, Antonella</creatorcontrib><creatorcontrib>Barbero, Fabio</creatorcontrib><creatorcontrib>Banzato, Alberto</creatorcontrib><creatorcontrib>Nante, Giovanni</creatorcontrib><creatorcontrib>Parissenti, Lucia</creatorcontrib><creatorcontrib>John, Nancy</creatorcontrib><creatorcontrib>Noventa, Franco</creatorcontrib><creatorcontrib>Dalla Volta, Sergio</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Physical Education Index</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biochemistry Abstracts 1</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pengo, Vittorio</au><au>Zasso, Antonella</au><au>Barbero, Fabio</au><au>Banzato, Alberto</au><au>Nante, Giovanni</au><au>Parissenti, Lucia</au><au>John, Nancy</au><au>Noventa, Franco</au><au>Dalla Volta, Sergio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of fixed minidose warfarin in the prevention of thromboembolism and vascular death in nonrheumatic atrial fibrillation</atitle><jtitle>The American journal of cardiology</jtitle><addtitle>Am J Cardiol</addtitle><date>1998-08-15</date><risdate>1998</risdate><volume>82</volume><issue>4</issue><spage>433</spage><epage>437</epage><pages>433-437</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><coden>AJCDAG</coden><abstract>Adjusted-dose warfarin is effective for stroke prevention in patients with nonrheumatic atrial fibrillation (AF), but the risk of bleeding is high, especially among the elderly. Fixed minidose warfarin is effective in preventing venous thromboembolism with low risk of bleeding and no need for frequent clinical monitoring. Patients >60 years with nonrheumatic AF were randomized in an open-labeled trial to receive fixed minidose warfarin (1.25 mg/day) or standard adjusted-dose warfarin (International Normalized Ratio [INR] between 2.0 and 3.0). Primary outcome events were ischemic stroke, peripheral or visceral embolism, cerebral or fatal bleeding, and vascular death. Secondary end points were major bleeding, myocardial infarction, and death. This study was discontinued before completion in light of publication of the Stroke Prevention in Atrial Fibrillation III trial, which indicated that low-intensity fixed-dose warfarin treatment (i.e., INR <1.5) was insufficient for stroke prevention in high-risk patients with nonrheumatic AF. From a total of 1,209 considered patients, 303 were randomized to be studied (150 in the minidose group and 153 in the adjusted-dose group). Mean follow-up was 14.5 months. The rate of cumulative primary events was 11.1% (95% confidence intervals [CI] 4.0 to 18.2) in the fixed minidose group and 6.1% (95% CI 1.1 to 11.1) in the adjusted-dose group (p = 0.29). The rate of ischemic stroke was significantly higher in the minidose group (3.7% vs 0% per year, p = 0.025). Major bleedings were more frequent in standard treatment group (2.6% vs 1% per year, p = 0.19). Most thromboembolic complications occurred at INRs <1.2, whereas the majority of hemorrhages occurred at INRs >3.0. No significant difference in primary outcome events was observed in the abbreviated study. However, the significantly increased occurrence of ischemic stroke in the fixed minidose warfarin group suggests that this regimen does not protect patients with nonrheumatic AF.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>9723629</pmid><doi>10.1016/S0002-9149(98)00357-9</doi><tpages>5</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Anticoagulants - administration & dosage Atrial Fibrillation - complications Atrial Fibrillation - drug therapy Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system Cardiology Disease-Free Survival Drug therapy Female Humans International Normalized Ratio Intracranial Embolism and Thrombosis - etiology Intracranial Embolism and Thrombosis - prevention & control Male Medical sciences Middle Aged Pharmacology. Drug treatments Stroke Treatment Outcome Warfarin - administration & dosage |
| title | Effectiveness of fixed minidose warfarin in the prevention of thromboembolism and vascular death in nonrheumatic atrial fibrillation |
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