Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial
We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial. The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are appli...
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| Veröffentlicht in: | Catheterization and cardiovascular interventions 2009-11, Vol.74 (5), p.719-727 |
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| creator | Lansky, Alexandra J Ng, Vivian G Mutlu, Halil Cristea, Ecaterina Guiran, Julian Benetato Midei, Mark Newman, William Sanz, Mark Sood, Poornima Doostzadeh, Julie Su, Xiaolu White, Roseann Cao, Sherry Sudhir, Krishnankutty Stone, Gregg W |
| description | We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.
The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.
A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.
A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.
Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women. |
| doi_str_mv | 10.1002/ccd.22067 |
| format | Article |
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The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.
A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.
A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.
Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.22067</identifier><identifier>PMID: 19530147</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Angioplasty, Balloon, Coronary - adverse effects ; Angioplasty, Balloon, Coronary - instrumentation ; Angioplasty, Balloon, Coronary - mortality ; Cardiovascular Agents - administration & dosage ; Cardiovascular Diseases - diagnostic imaging ; Cardiovascular Diseases - etiology ; Cardiovascular Diseases - mortality ; Coronary Angiography ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - mortality ; Coronary Artery Disease - therapy ; Coronary Restenosis - diagnostic imaging ; Coronary Restenosis - etiology ; Drug-Eluting Stents ; Everolimus ; Female ; Humans ; Kaplan-Meier Estimate ; Linear Models ; Logistic Models ; Male ; Middle Aged ; Myocardial Infarction - diagnostic imaging ; Myocardial Infarction - etiology ; Paclitaxel - administration & dosage ; Prospective Studies ; Prosthesis Design ; Risk Assessment ; Risk Factors ; Sex Factors ; Single-Blind Method ; Sirolimus - administration & dosage ; Sirolimus - analogs & derivatives ; Thrombosis - diagnostic imaging ; Thrombosis - etiology ; Time Factors ; Treatment Outcome ; Women's Health</subject><ispartof>Catheterization and cardiovascular interventions, 2009-11, Vol.74 (5), p.719-727</ispartof><rights>Copyright 2009 Wiley-Liss, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c244t-fcd1597cd370fdb8a3ac99e41706a4384fbae911c99c1051579ab13892be1ad23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27928,27929</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19530147$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lansky, Alexandra J</creatorcontrib><creatorcontrib>Ng, Vivian G</creatorcontrib><creatorcontrib>Mutlu, Halil</creatorcontrib><creatorcontrib>Cristea, Ecaterina</creatorcontrib><creatorcontrib>Guiran, Julian Benetato</creatorcontrib><creatorcontrib>Midei, Mark</creatorcontrib><creatorcontrib>Newman, William</creatorcontrib><creatorcontrib>Sanz, Mark</creatorcontrib><creatorcontrib>Sood, Poornima</creatorcontrib><creatorcontrib>Doostzadeh, Julie</creatorcontrib><creatorcontrib>Su, Xiaolu</creatorcontrib><creatorcontrib>White, Roseann</creatorcontrib><creatorcontrib>Cao, Sherry</creatorcontrib><creatorcontrib>Sudhir, Krishnankutty</creatorcontrib><creatorcontrib>Stone, Gregg W</creatorcontrib><title>Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.
The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.
A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.
A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.
Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.</description><subject>Aged</subject><subject>Angioplasty, Balloon, Coronary - adverse effects</subject><subject>Angioplasty, Balloon, Coronary - instrumentation</subject><subject>Angioplasty, Balloon, Coronary - mortality</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Cardiovascular Diseases - diagnostic imaging</subject><subject>Cardiovascular Diseases - etiology</subject><subject>Cardiovascular Diseases - mortality</subject><subject>Coronary Angiography</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - mortality</subject><subject>Coronary Artery Disease - therapy</subject><subject>Coronary Restenosis - diagnostic imaging</subject><subject>Coronary Restenosis - etiology</subject><subject>Drug-Eluting Stents</subject><subject>Everolimus</subject><subject>Female</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Linear Models</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - diagnostic imaging</subject><subject>Myocardial Infarction - etiology</subject><subject>Paclitaxel - administration & dosage</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Sex Factors</subject><subject>Single-Blind Method</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - analogs & derivatives</subject><subject>Thrombosis - diagnostic imaging</subject><subject>Thrombosis - etiology</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Women's Health</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkU1LJDEQhoO4qKse_AOSm3hoN5X-mniTYRwbxF3WD7w16aR6jKQ7Y5JecH-JP9eoAx6KKqoeXqrqJeQI2Bkwxn8ppc84Z1W9Rfag5DyrefW4valBFNUu-RnCM2NMVFzskF0QZc6gqPfI2xJHjT7rZEBN8Z-0k4zGjdT1ND4hfWwWN_MFfUgj9M6aYQoZ2imacUWV826U_pWGiGOk4TXl4Zwqa0ajpKVy1ClWxq28XD8ZRT2GycZAe--GT_XbP83f5o42TUN9ot1g_qctojfSHpAfvbQBDzd5n9xfLu7mV9n172Uzv7jOFC-KmPVKQylqpfOa9bqbyVwqIbCAmlWyyGdF30kUAKmpgJVQ1kJ2kM8E7xCk5vk-OfnSXXv3MmGI7WCCQmvliG4KbZ0XAIJxSOTpF6m8C8Fj3669GdL9LbD2w4c2-dB--pDY443q1A2ov8nN4_N3An2FIg</recordid><startdate>20091101</startdate><enddate>20091101</enddate><creator>Lansky, Alexandra J</creator><creator>Ng, Vivian G</creator><creator>Mutlu, Halil</creator><creator>Cristea, Ecaterina</creator><creator>Guiran, Julian Benetato</creator><creator>Midei, Mark</creator><creator>Newman, William</creator><creator>Sanz, Mark</creator><creator>Sood, Poornima</creator><creator>Doostzadeh, Julie</creator><creator>Su, Xiaolu</creator><creator>White, Roseann</creator><creator>Cao, Sherry</creator><creator>Sudhir, Krishnankutty</creator><creator>Stone, Gregg W</creator><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>7X8</scope></search><sort><creationdate>20091101</creationdate><title>Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial</title><author>Lansky, Alexandra J ; Ng, Vivian G ; Mutlu, Halil ; Cristea, Ecaterina ; Guiran, Julian Benetato ; Midei, Mark ; Newman, William ; Sanz, Mark ; Sood, Poornima ; Doostzadeh, Julie ; Su, Xiaolu ; White, Roseann ; Cao, Sherry ; Sudhir, Krishnankutty ; Stone, Gregg W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c244t-fcd1597cd370fdb8a3ac99e41706a4384fbae911c99c1051579ab13892be1ad23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Aged</topic><topic>Angioplasty, Balloon, Coronary - adverse effects</topic><topic>Angioplasty, Balloon, Coronary - instrumentation</topic><topic>Angioplasty, Balloon, Coronary - mortality</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Cardiovascular Diseases - diagnostic imaging</topic><topic>Cardiovascular Diseases - etiology</topic><topic>Cardiovascular Diseases - mortality</topic><topic>Coronary Angiography</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - mortality</topic><topic>Coronary Artery Disease - therapy</topic><topic>Coronary Restenosis - diagnostic imaging</topic><topic>Coronary Restenosis - etiology</topic><topic>Drug-Eluting Stents</topic><topic>Everolimus</topic><topic>Female</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Linear Models</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - diagnostic imaging</topic><topic>Myocardial Infarction - etiology</topic><topic>Paclitaxel - administration & dosage</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Sex Factors</topic><topic>Single-Blind Method</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - analogs & derivatives</topic><topic>Thrombosis - diagnostic imaging</topic><topic>Thrombosis - etiology</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Women's Health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lansky, Alexandra J</creatorcontrib><creatorcontrib>Ng, Vivian G</creatorcontrib><creatorcontrib>Mutlu, Halil</creatorcontrib><creatorcontrib>Cristea, Ecaterina</creatorcontrib><creatorcontrib>Guiran, Julian Benetato</creatorcontrib><creatorcontrib>Midei, Mark</creatorcontrib><creatorcontrib>Newman, William</creatorcontrib><creatorcontrib>Sanz, Mark</creatorcontrib><creatorcontrib>Sood, Poornima</creatorcontrib><creatorcontrib>Doostzadeh, Julie</creatorcontrib><creatorcontrib>Su, Xiaolu</creatorcontrib><creatorcontrib>White, Roseann</creatorcontrib><creatorcontrib>Cao, Sherry</creatorcontrib><creatorcontrib>Sudhir, Krishnankutty</creatorcontrib><creatorcontrib>Stone, Gregg W</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lansky, Alexandra J</au><au>Ng, Vivian G</au><au>Mutlu, Halil</au><au>Cristea, Ecaterina</au><au>Guiran, Julian Benetato</au><au>Midei, Mark</au><au>Newman, William</au><au>Sanz, Mark</au><au>Sood, Poornima</au><au>Doostzadeh, Julie</au><au>Su, Xiaolu</au><au>White, Roseann</au><au>Cao, Sherry</au><au>Sudhir, Krishnankutty</au><au>Stone, Gregg W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2009-11-01</date><risdate>2009</risdate><volume>74</volume><issue>5</issue><spage>719</spage><epage>727</epage><pages>719-727</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.
The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.
A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.
A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.
Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.</abstract><cop>United States</cop><pmid>19530147</pmid><doi>10.1002/ccd.22067</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1522-1946 |
| ispartof | Catheterization and cardiovascular interventions, 2009-11, Vol.74 (5), p.719-727 |
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| subjects | Aged Angioplasty, Balloon, Coronary - adverse effects Angioplasty, Balloon, Coronary - instrumentation Angioplasty, Balloon, Coronary - mortality Cardiovascular Agents - administration & dosage Cardiovascular Diseases - diagnostic imaging Cardiovascular Diseases - etiology Cardiovascular Diseases - mortality Coronary Angiography Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - mortality Coronary Artery Disease - therapy Coronary Restenosis - diagnostic imaging Coronary Restenosis - etiology Drug-Eluting Stents Everolimus Female Humans Kaplan-Meier Estimate Linear Models Logistic Models Male Middle Aged Myocardial Infarction - diagnostic imaging Myocardial Infarction - etiology Paclitaxel - administration & dosage Prospective Studies Prosthesis Design Risk Assessment Risk Factors Sex Factors Single-Blind Method Sirolimus - administration & dosage Sirolimus - analogs & derivatives Thrombosis - diagnostic imaging Thrombosis - etiology Time Factors Treatment Outcome Women's Health |
| title | Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial |
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