1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial
We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg). Durable polymers in...
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| Veröffentlicht in: | JACC. Cardiovascular interventions 2009-05, Vol.2 (5), p.422-427 |
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| creator | Costa, Jr, J Ribamar Abizaid, Alexandre Costa, Ricardo Feres, Fausto Tanajura, Luiz Fernando Abizaid, Andréa Maldonado, Galo Staico, Rodolfo Siqueira, Dimytri Sousa, Amanda G M R Bonan, Raoul Sousa, J Eduardo |
| description | We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg).
Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.
A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and |
| doi_str_mv | 10.1016/j.jcin.2009.02.009 |
| format | Article |
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Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.
A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and <or=14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months.
Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 +/- 0.3 mm and 10 +/- 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 +/- 0.25 mm and 2.6 +/- 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 +/- 0.23 mm and 4.0 +/- 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up.
The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.</description><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2009.02.009</identifier><identifier>PMID: 19463465</identifier><language>eng</language><publisher>United States</publisher><subject>Angioplasty, Balloon, Coronary ; Aspirin ; Coronary Angiography ; Coronary Artery Bypass ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - drug therapy ; Coronary Artery Disease - therapy ; Coronary Restenosis ; Drug-Eluting Stents ; Durapatite ; Female ; Humans ; Intensive Care Units ; Male ; Middle Aged ; Platelet Aggregation Inhibitors - therapeutic use ; Polymers ; Prospective Studies ; Sirolimus - administration & dosage ; Sirolimus - therapeutic use ; Ticlopidine - analogs & derivatives ; Ticlopidine - therapeutic use ; Time Factors ; Ultrasonography</subject><ispartof>JACC. Cardiovascular interventions, 2009-05, Vol.2 (5), p.422-427</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19463465$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Costa, Jr, J Ribamar</creatorcontrib><creatorcontrib>Abizaid, Alexandre</creatorcontrib><creatorcontrib>Costa, Ricardo</creatorcontrib><creatorcontrib>Feres, Fausto</creatorcontrib><creatorcontrib>Tanajura, Luiz Fernando</creatorcontrib><creatorcontrib>Abizaid, Andréa</creatorcontrib><creatorcontrib>Maldonado, Galo</creatorcontrib><creatorcontrib>Staico, Rodolfo</creatorcontrib><creatorcontrib>Siqueira, Dimytri</creatorcontrib><creatorcontrib>Sousa, Amanda G M R</creatorcontrib><creatorcontrib>Bonan, Raoul</creatorcontrib><creatorcontrib>Sousa, J Eduardo</creatorcontrib><title>1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg).
Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.
A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and <or=14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months.
Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 +/- 0.3 mm and 10 +/- 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 +/- 0.25 mm and 2.6 +/- 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 +/- 0.23 mm and 4.0 +/- 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up.
The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.</description><subject>Angioplasty, Balloon, Coronary</subject><subject>Aspirin</subject><subject>Coronary Angiography</subject><subject>Coronary Artery Bypass</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - drug therapy</subject><subject>Coronary Artery Disease - therapy</subject><subject>Coronary Restenosis</subject><subject>Drug-Eluting Stents</subject><subject>Durapatite</subject><subject>Female</subject><subject>Humans</subject><subject>Intensive Care Units</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Platelet Aggregation Inhibitors - therapeutic use</subject><subject>Polymers</subject><subject>Prospective Studies</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - therapeutic use</subject><subject>Ticlopidine - analogs & derivatives</subject><subject>Ticlopidine - therapeutic use</subject><subject>Time Factors</subject><subject>Ultrasonography</subject><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kM1OwzAQhC0kREvhBTgg3zgl-CdxEm5VVaBSBYcWJE6Rk2yoKycOtoPIg_C-hFJOs9qZb6RdhK4oCSmh4nYf7kvVhoyQLCQsHOUETWmaiCARJJ6gc-f2hAiSJewMTWgWCR6JeIq-aTCAtNiC67V32NTY7wDvhsqar0F20isPuDN6aMAGtQXATlmjVdO7AHTvVfuOnYfW49rYA-stSN_8bsYyN_oacAW4NZ8Gl8aaVtoBa3DKtO7uQLwuN9v55u1pgVcjraS-QKe11A4ujzpDL_fL7eIxWD8_rBbzdbBjUeYDWZZAqriqMs4SIGWWVZylJGaijFJCC8ZExWsYhziiEYtFXAAZvSJL0pLRhM_QzV9vZ81HD87njXIlaC1bML3LE84pIZSLMXl9TPZFA1XeWdWMd-T_n-Q_ruZ2pQ</recordid><startdate>200905</startdate><enddate>200905</enddate><creator>Costa, Jr, J Ribamar</creator><creator>Abizaid, Alexandre</creator><creator>Costa, Ricardo</creator><creator>Feres, Fausto</creator><creator>Tanajura, Luiz Fernando</creator><creator>Abizaid, Andréa</creator><creator>Maldonado, Galo</creator><creator>Staico, Rodolfo</creator><creator>Siqueira, Dimytri</creator><creator>Sousa, Amanda G M R</creator><creator>Bonan, Raoul</creator><creator>Sousa, J Eduardo</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>200905</creationdate><title>1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial</title><author>Costa, Jr, J Ribamar ; Abizaid, Alexandre ; Costa, Ricardo ; Feres, Fausto ; Tanajura, Luiz Fernando ; Abizaid, Andréa ; Maldonado, Galo ; Staico, Rodolfo ; Siqueira, Dimytri ; Sousa, Amanda G M R ; Bonan, Raoul ; Sousa, J Eduardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h249t-acce0d5dd9327e0c99d3280526c4801b226d3fe1b254142565be06c4b978c2173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Angioplasty, Balloon, Coronary</topic><topic>Aspirin</topic><topic>Coronary Angiography</topic><topic>Coronary Artery Bypass</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - drug therapy</topic><topic>Coronary Artery Disease - therapy</topic><topic>Coronary Restenosis</topic><topic>Drug-Eluting Stents</topic><topic>Durapatite</topic><topic>Female</topic><topic>Humans</topic><topic>Intensive Care Units</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Platelet Aggregation Inhibitors - therapeutic use</topic><topic>Polymers</topic><topic>Prospective Studies</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - therapeutic use</topic><topic>Ticlopidine - analogs & derivatives</topic><topic>Ticlopidine - therapeutic use</topic><topic>Time Factors</topic><topic>Ultrasonography</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Costa, Jr, J Ribamar</creatorcontrib><creatorcontrib>Abizaid, Alexandre</creatorcontrib><creatorcontrib>Costa, Ricardo</creatorcontrib><creatorcontrib>Feres, Fausto</creatorcontrib><creatorcontrib>Tanajura, Luiz Fernando</creatorcontrib><creatorcontrib>Abizaid, Andréa</creatorcontrib><creatorcontrib>Maldonado, Galo</creatorcontrib><creatorcontrib>Staico, Rodolfo</creatorcontrib><creatorcontrib>Siqueira, Dimytri</creatorcontrib><creatorcontrib>Sousa, Amanda G M R</creatorcontrib><creatorcontrib>Bonan, Raoul</creatorcontrib><creatorcontrib>Sousa, J Eduardo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Costa, Jr, J Ribamar</au><au>Abizaid, Alexandre</au><au>Costa, Ricardo</au><au>Feres, Fausto</au><au>Tanajura, Luiz Fernando</au><au>Abizaid, Andréa</au><au>Maldonado, Galo</au><au>Staico, Rodolfo</au><au>Siqueira, Dimytri</au><au>Sousa, Amanda G M R</au><au>Bonan, Raoul</au><au>Sousa, J Eduardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2009-05</date><risdate>2009</risdate><volume>2</volume><issue>5</issue><spage>422</spage><epage>427</epage><pages>422-427</pages><eissn>1876-7605</eissn><abstract>We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg).
Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.
A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and <or=14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months.
Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 +/- 0.3 mm and 10 +/- 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 +/- 0.25 mm and 2.6 +/- 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 +/- 0.23 mm and 4.0 +/- 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up.
The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.</abstract><cop>United States</cop><pmid>19463465</pmid><doi>10.1016/j.jcin.2009.02.009</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | EISSN: 1876-7605 |
| ispartof | JACC. Cardiovascular interventions, 2009-05, Vol.2 (5), p.422-427 |
| issn | 1876-7605 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_733100136 |
| source | MEDLINE; Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Angioplasty, Balloon, Coronary Aspirin Coronary Angiography Coronary Artery Bypass Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - drug therapy Coronary Artery Disease - therapy Coronary Restenosis Drug-Eluting Stents Durapatite Female Humans Intensive Care Units Male Middle Aged Platelet Aggregation Inhibitors - therapeutic use Polymers Prospective Studies Sirolimus - administration & dosage Sirolimus - therapeutic use Ticlopidine - analogs & derivatives Ticlopidine - therapeutic use Time Factors Ultrasonography |
| title | 1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial |
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