Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta-analysis and critical examination of current methodologies
Background The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis...
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| Veröffentlicht in: | Catheterization and cardiovascular interventions 2014-05, Vol.83 (6), p.975-983 |
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| container_title | Catheterization and cardiovascular interventions |
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| creator | Vardi, Moshe Novack, Victor Pencina, Michael J. Doros, Gheorghe Burke, David A. Elmariah, Sammy Cutlip, Donald E. Mauri, Laura Yeh, Robert W. |
| description | Background
The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.
Methods and Results
We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve‐month primary patency (PP) rate was reported in five trials. The meta‐analytic 12‐month PP rate was 71.6% (95% confidence interval [CI] 66.4–76.7%). The meta‐analytic rate of 30‐day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0–90.0%).
Conclusion
Contemporary nitinol‐based bare‐metal stents performed well in controlled settings. Occurrence of the 1‐month composite safety endpoint was extremely uncommon. © 2013 Wiley Periodicals, Inc. |
| doi_str_mv | 10.1002/ccd.25179 |
| format | Article |
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The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.
Methods and Results
We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve‐month primary patency (PP) rate was reported in five trials. The meta‐analytic 12‐month PP rate was 71.6% (95% confidence interval [CI] 66.4–76.7%). The meta‐analytic rate of 30‐day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0–90.0%).
Conclusion
Contemporary nitinol‐based bare‐metal stents performed well in controlled settings. Occurrence of the 1‐month composite safety endpoint was extremely uncommon. © 2013 Wiley Periodicals, Inc.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.25179</identifier><identifier>PMID: 23996913</identifier><identifier>CODEN: CARIF2</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Alloys ; Constriction, Pathologic ; Endovascular Procedures - adverse effects ; Endovascular Procedures - instrumentation ; Femoral Artery - physiopathology ; Humans ; Peripheral Arterial Disease - diagnosis ; Peripheral Arterial Disease - physiopathology ; Peripheral Arterial Disease - therapy ; peripheral vascular disease ; Popliteal Artery - physiopathology ; Prosthesis Design ; restenosis ; Risk Factors ; stent structure ; Stents ; Treatment Outcome ; Vascular Patency</subject><ispartof>Catheterization and cardiovascular interventions, 2014-05, Vol.83 (6), p.975-983</ispartof><rights>Copyright © 2013 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4929-6235ebb3f69b50398b501845c1366bcd514527f51025ad5234a7c04fde4db8f93</citedby><cites>FETCH-LOGICAL-c4929-6235ebb3f69b50398b501845c1366bcd514527f51025ad5234a7c04fde4db8f93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.25179$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.25179$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23996913$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vardi, Moshe</creatorcontrib><creatorcontrib>Novack, Victor</creatorcontrib><creatorcontrib>Pencina, Michael J.</creatorcontrib><creatorcontrib>Doros, Gheorghe</creatorcontrib><creatorcontrib>Burke, David A.</creatorcontrib><creatorcontrib>Elmariah, Sammy</creatorcontrib><creatorcontrib>Cutlip, Donald E.</creatorcontrib><creatorcontrib>Mauri, Laura</creatorcontrib><creatorcontrib>Yeh, Robert W.</creatorcontrib><title>Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta-analysis and critical examination of current methodologies</title><title>Catheterization and cardiovascular interventions</title><addtitle>Cathet. Cardiovasc. Intervent</addtitle><description>Background
The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.
Methods and Results
We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve‐month primary patency (PP) rate was reported in five trials. The meta‐analytic 12‐month PP rate was 71.6% (95% confidence interval [CI] 66.4–76.7%). The meta‐analytic rate of 30‐day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0–90.0%).
Conclusion
Contemporary nitinol‐based bare‐metal stents performed well in controlled settings. Occurrence of the 1‐month composite safety endpoint was extremely uncommon. © 2013 Wiley Periodicals, Inc.</description><subject>Alloys</subject><subject>Constriction, Pathologic</subject><subject>Endovascular Procedures - adverse effects</subject><subject>Endovascular Procedures - instrumentation</subject><subject>Femoral Artery - physiopathology</subject><subject>Humans</subject><subject>Peripheral Arterial Disease - diagnosis</subject><subject>Peripheral Arterial Disease - physiopathology</subject><subject>Peripheral Arterial Disease - therapy</subject><subject>peripheral vascular disease</subject><subject>Popliteal Artery - physiopathology</subject><subject>Prosthesis Design</subject><subject>restenosis</subject><subject>Risk Factors</subject><subject>stent structure</subject><subject>Stents</subject><subject>Treatment Outcome</subject><subject>Vascular Patency</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1vFSEUhonR2Fpd-AcMiRtdTAvMABd3zdVeTa418SO6IwxzqFRmuMKMdv6NP1XuR7swcQNn8bzPCbwIPaXklBLCzqztThmnUt1Dx5QzVkkmvt0_zFQ14gg9yvmaEKIEUw_REauVEorWx-jPJ-NgnLEZOgzOeWvsjHsYk7cZu5jwJvnepBkPfvRDDDiPMJTpCvsBO-hjipu4CX4EE3C0NkzZ_wLc-Qwmwyt8vpWZygwmzNnn3R6bissWHm5M7wcz-jjg6LCdUirybeJ77GKIVx7yY_TAmZDhyeE-QV8u3nxevq3WH1bvlufryjaKqUqwmkPb1k6olpNaLcpJFw23tBaitR2nDWfScUoYNx1ndWOkJY3roOnahVP1CXqx925S_DlBHnXvs4UQzABxyppyuhCMSioK-vwf9DpOqbxwR0lV9kpWqJd7yqaYcwKnD1-pKdHb2nSpTe9qK-yzg3Fqe-juyNueCnC2B377APP_TXq5fH2rrPYJXxq7uUuY9EMLWUuuv16u9Gp90Vyu3n8si_4CraKzMA</recordid><startdate>20140501</startdate><enddate>20140501</enddate><creator>Vardi, Moshe</creator><creator>Novack, Victor</creator><creator>Pencina, Michael J.</creator><creator>Doros, Gheorghe</creator><creator>Burke, David A.</creator><creator>Elmariah, Sammy</creator><creator>Cutlip, Donald E.</creator><creator>Mauri, Laura</creator><creator>Yeh, Robert W.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>20140501</creationdate><title>Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta-analysis and critical examination of current methodologies</title><author>Vardi, Moshe ; Novack, Victor ; Pencina, Michael J. ; Doros, Gheorghe ; Burke, David A. ; Elmariah, Sammy ; Cutlip, Donald E. ; Mauri, Laura ; Yeh, Robert W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4929-6235ebb3f69b50398b501845c1366bcd514527f51025ad5234a7c04fde4db8f93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Alloys</topic><topic>Constriction, Pathologic</topic><topic>Endovascular Procedures - adverse effects</topic><topic>Endovascular Procedures - instrumentation</topic><topic>Femoral Artery - physiopathology</topic><topic>Humans</topic><topic>Peripheral Arterial Disease - diagnosis</topic><topic>Peripheral Arterial Disease - physiopathology</topic><topic>Peripheral Arterial Disease - therapy</topic><topic>peripheral vascular disease</topic><topic>Popliteal Artery - physiopathology</topic><topic>Prosthesis Design</topic><topic>restenosis</topic><topic>Risk Factors</topic><topic>stent structure</topic><topic>Stents</topic><topic>Treatment Outcome</topic><topic>Vascular Patency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vardi, Moshe</creatorcontrib><creatorcontrib>Novack, Victor</creatorcontrib><creatorcontrib>Pencina, Michael J.</creatorcontrib><creatorcontrib>Doros, Gheorghe</creatorcontrib><creatorcontrib>Burke, David A.</creatorcontrib><creatorcontrib>Elmariah, Sammy</creatorcontrib><creatorcontrib>Cutlip, Donald E.</creatorcontrib><creatorcontrib>Mauri, Laura</creatorcontrib><creatorcontrib>Yeh, Robert W.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vardi, Moshe</au><au>Novack, Victor</au><au>Pencina, Michael J.</au><au>Doros, Gheorghe</au><au>Burke, David A.</au><au>Elmariah, Sammy</au><au>Cutlip, Donald E.</au><au>Mauri, Laura</au><au>Yeh, Robert W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta-analysis and critical examination of current methodologies</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Cathet. Cardiovasc. Intervent</addtitle><date>2014-05-01</date><risdate>2014</risdate><volume>83</volume><issue>6</issue><spage>975</spage><epage>983</epage><pages>975-983</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><coden>CARIF2</coden><abstract>Background
The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.
Methods and Results
We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve‐month primary patency (PP) rate was reported in five trials. The meta‐analytic 12‐month PP rate was 71.6% (95% confidence interval [CI] 66.4–76.7%). The meta‐analytic rate of 30‐day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0–90.0%).
Conclusion
Contemporary nitinol‐based bare‐metal stents performed well in controlled settings. Occurrence of the 1‐month composite safety endpoint was extremely uncommon. © 2013 Wiley Periodicals, Inc.</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>23996913</pmid><doi>10.1002/ccd.25179</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1522-1946 |
| ispartof | Catheterization and cardiovascular interventions, 2014-05, Vol.83 (6), p.975-983 |
| issn | 1522-1946 1522-726X |
| language | eng |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | Alloys Constriction, Pathologic Endovascular Procedures - adverse effects Endovascular Procedures - instrumentation Femoral Artery - physiopathology Humans Peripheral Arterial Disease - diagnosis Peripheral Arterial Disease - physiopathology Peripheral Arterial Disease - therapy peripheral vascular disease Popliteal Artery - physiopathology Prosthesis Design restenosis Risk Factors stent structure Stents Treatment Outcome Vascular Patency |
| title | Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta-analysis and critical examination of current methodologies |
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