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Procedural resources utilization and clinical outcomes with bioresorbable everolimus‐eluting scaffolds and Pt‐Cr everolimus‐eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial
Objectives We sought to compare the procedural implications of using bioresorbable everolimus‐eluting scaffolds (BVS) and Pt‐Cr everolimus‐eluting stent with abluminal bioabsorbable polymer (Synergy). Background There are important differences in the respective platforms, which could impact on proce...
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| Published in: | Catheterization and cardiovascular interventions 2017-08, Vol.90 (2), p.E25-E30 |
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| container_title | Catheterization and cardiovascular interventions |
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| creator | de la Torre Hernandez, Jose M. Garcia Camarero, Tamara Lee, Dae‐Hyun Sainz Laso, Fermin Veiga Fernandez, Gabriela Pino, Tania Rubio, Silvia Legarra, Pablo Valdivia, Jorge R. Zueco Gil, Javier |
| description | Objectives
We sought to compare the procedural implications of using bioresorbable everolimus‐eluting scaffolds (BVS) and Pt‐Cr everolimus‐eluting stent with abluminal bioabsorbable polymer (Synergy).
Background
There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes.
Methods
A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose‐area product, contras agent volumen, and peri‐procedural troponin release.
Results
A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P |
| doi_str_mv | 10.1002/ccd.26843 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1836735004</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1928299643</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3533-d167d56f4098db1b6d9ea960da2874c46fdc83f46bd50e1a1879eb9ef98c403b3</originalsourceid><addsrcrecordid>eNp1kctu1DAUhiMEoqV0wQsgS2xgMVPf4tjLKlyKVIkuQOoucuwTcOXEg-1QTVd9hD4fS56kbjNchNSNbcmfv-Nz_qp6QfCaYEyPjLFrKiRnj6p9UlO6aqg4f7w7E8XFXvUspQuMsRJUPa32aCNxo7jcr36exWDAzlF7FCGFORpIaM7OuyudXZiQniwy3k3OFCTM2YSxEJcuf0O9C3dvYq97Dwh-QAzejXP6dX0DvjimrygZPQzB23TvOcvlqo0PoBmmvIj_sZZlHt1Uam-C344QkZv-_mcTtcnOwBodo1gqhNFdgUU5Ou2fV08G7RMc7vaD6sv7d5_bk9Xppw8f2-PTlWE1YytLRGNrMXCspO1JL6wCrQS2msqGGy4GayQbuOhtjYFoIhsFvYJBScMx69lB9XrxbmL4PkPK3eiSAe_1BGFOHZFMNKzGmBf01X_oRZl4aa5QikqqlOCsUG8WysSQUoSh20Q36rjtCO7uAu9K4N194IV9uTPO_Qj2D_k74QIcLcCl87B92NS17dtFeQvyBb6x</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1928299643</pqid></control><display><type>article</type><title>Procedural resources utilization and clinical outcomes with bioresorbable everolimus‐eluting scaffolds and Pt‐Cr everolimus‐eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial</title><source>Wiley-Blackwell Read & Publish Collection</source><creator>de la Torre Hernandez, Jose M. ; Garcia Camarero, Tamara ; Lee, Dae‐Hyun ; Sainz Laso, Fermin ; Veiga Fernandez, Gabriela ; Pino, Tania ; Rubio, Silvia ; Legarra, Pablo ; Valdivia, Jorge R. ; Zueco Gil, Javier</creator><creatorcontrib>de la Torre Hernandez, Jose M. ; Garcia Camarero, Tamara ; Lee, Dae‐Hyun ; Sainz Laso, Fermin ; Veiga Fernandez, Gabriela ; Pino, Tania ; Rubio, Silvia ; Legarra, Pablo ; Valdivia, Jorge R. ; Zueco Gil, Javier</creatorcontrib><description>Objectives
We sought to compare the procedural implications of using bioresorbable everolimus‐eluting scaffolds (BVS) and Pt‐Cr everolimus‐eluting stent with abluminal bioabsorbable polymer (Synergy).
Background
There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes.
Methods
A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose‐area product, contras agent volumen, and peri‐procedural troponin release.
Results
A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P < 0.001), postdilatation (64.8 vs. 38.4%: P < 0.01), and use of 2 wires (20.8 vs. 10%; P = 0.02) were more frequent with BVS. The BVS group showed a significant increase in fluoroscopy time (18%), dose‐area product (20%), and contrast volume (10%). Post‐procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri‐procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy.
Conclusions
The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.26843</identifier><identifier>PMID: 27807948</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Absorbable Implants ; Aged ; bioabsorbable stent ; Calcium-binding protein ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - adverse effects ; Clinical outcomes ; Coated Materials, Biocompatible ; Complications ; Contrast Media - administration & dosage ; Coronary Angiography ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - therapy ; Coronary Thrombosis - etiology ; Creatinine ; Drug-Eluting Stents ; drug‐eluting stent ; Everolimus - administration & dosage ; Everolimus - adverse effects ; Female ; Fluoroscopy ; Humans ; Implants ; Incidence ; Infarction ; Lesions ; Male ; Middle Aged ; Myocardial Infarction - etiology ; percutaneous coronary intervention ; Percutaneous Coronary Intervention - adverse effects ; Percutaneous Coronary Intervention - instrumentation ; Polymers - chemistry ; Prospective Studies ; Prosthesis Design ; Radiation ; Radiation Dosage ; Radiation Exposure ; Radiography, Interventional ; Risk Factors ; Spain ; Thromboembolism ; Thrombosis ; Time Factors ; Treatment Outcome ; Troponin</subject><ispartof>Catheterization and cardiovascular interventions, 2017-08, Vol.90 (2), p.E25-E30</ispartof><rights>2016 Wiley Periodicals, Inc.</rights><rights>2017 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3533-d167d56f4098db1b6d9ea960da2874c46fdc83f46bd50e1a1879eb9ef98c403b3</citedby><cites>FETCH-LOGICAL-c3533-d167d56f4098db1b6d9ea960da2874c46fdc83f46bd50e1a1879eb9ef98c403b3</cites></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/27807948$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de la Torre Hernandez, Jose M.</creatorcontrib><creatorcontrib>Garcia Camarero, Tamara</creatorcontrib><creatorcontrib>Lee, Dae‐Hyun</creatorcontrib><creatorcontrib>Sainz Laso, Fermin</creatorcontrib><creatorcontrib>Veiga Fernandez, Gabriela</creatorcontrib><creatorcontrib>Pino, Tania</creatorcontrib><creatorcontrib>Rubio, Silvia</creatorcontrib><creatorcontrib>Legarra, Pablo</creatorcontrib><creatorcontrib>Valdivia, Jorge R.</creatorcontrib><creatorcontrib>Zueco Gil, Javier</creatorcontrib><title>Procedural resources utilization and clinical outcomes with bioresorbable everolimus‐eluting scaffolds and Pt‐Cr everolimus‐eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Objectives
We sought to compare the procedural implications of using bioresorbable everolimus‐eluting scaffolds (BVS) and Pt‐Cr everolimus‐eluting stent with abluminal bioabsorbable polymer (Synergy).
Background
There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes.
Methods
A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose‐area product, contras agent volumen, and peri‐procedural troponin release.
Results
A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P < 0.001), postdilatation (64.8 vs. 38.4%: P < 0.01), and use of 2 wires (20.8 vs. 10%; P = 0.02) were more frequent with BVS. The BVS group showed a significant increase in fluoroscopy time (18%), dose‐area product (20%), and contrast volume (10%). Post‐procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri‐procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy.
Conclusions
The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc.</description><subject>Absorbable Implants</subject><subject>Aged</subject><subject>bioabsorbable stent</subject><subject>Calcium-binding protein</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Cardiovascular Agents - adverse effects</subject><subject>Clinical outcomes</subject><subject>Coated Materials, Biocompatible</subject><subject>Complications</subject><subject>Contrast Media - administration & dosage</subject><subject>Coronary Angiography</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - therapy</subject><subject>Coronary Thrombosis - etiology</subject><subject>Creatinine</subject><subject>Drug-Eluting Stents</subject><subject>drug‐eluting stent</subject><subject>Everolimus - administration & dosage</subject><subject>Everolimus - adverse effects</subject><subject>Female</subject><subject>Fluoroscopy</subject><subject>Humans</subject><subject>Implants</subject><subject>Incidence</subject><subject>Infarction</subject><subject>Lesions</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - etiology</subject><subject>percutaneous coronary intervention</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Percutaneous Coronary Intervention - instrumentation</subject><subject>Polymers - chemistry</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Radiation</subject><subject>Radiation Dosage</subject><subject>Radiation Exposure</subject><subject>Radiography, Interventional</subject><subject>Risk Factors</subject><subject>Spain</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Troponin</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp1kctu1DAUhiMEoqV0wQsgS2xgMVPf4tjLKlyKVIkuQOoucuwTcOXEg-1QTVd9hD4fS56kbjNchNSNbcmfv-Nz_qp6QfCaYEyPjLFrKiRnj6p9UlO6aqg4f7w7E8XFXvUspQuMsRJUPa32aCNxo7jcr36exWDAzlF7FCGFORpIaM7OuyudXZiQniwy3k3OFCTM2YSxEJcuf0O9C3dvYq97Dwh-QAzejXP6dX0DvjimrygZPQzB23TvOcvlqo0PoBmmvIj_sZZlHt1Uam-C344QkZv-_mcTtcnOwBodo1gqhNFdgUU5Ou2fV08G7RMc7vaD6sv7d5_bk9Xppw8f2-PTlWE1YytLRGNrMXCspO1JL6wCrQS2msqGGy4GayQbuOhtjYFoIhsFvYJBScMx69lB9XrxbmL4PkPK3eiSAe_1BGFOHZFMNKzGmBf01X_oRZl4aa5QikqqlOCsUG8WysSQUoSh20Q36rjtCO7uAu9K4N194IV9uTPO_Qj2D_k74QIcLcCl87B92NS17dtFeQvyBb6x</recordid><startdate>20170801</startdate><enddate>20170801</enddate><creator>de la Torre Hernandez, Jose M.</creator><creator>Garcia Camarero, Tamara</creator><creator>Lee, Dae‐Hyun</creator><creator>Sainz Laso, Fermin</creator><creator>Veiga Fernandez, Gabriela</creator><creator>Pino, Tania</creator><creator>Rubio, Silvia</creator><creator>Legarra, Pablo</creator><creator>Valdivia, Jorge R.</creator><creator>Zueco Gil, Javier</creator><general>Wiley Subscription Services, Inc</general><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>20170801</creationdate><title>Procedural resources utilization and clinical outcomes with bioresorbable everolimus‐eluting scaffolds and Pt‐Cr everolimus‐eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial</title><author>de la Torre Hernandez, Jose M. ; Garcia Camarero, Tamara ; Lee, Dae‐Hyun ; Sainz Laso, Fermin ; Veiga Fernandez, Gabriela ; Pino, Tania ; Rubio, Silvia ; Legarra, Pablo ; Valdivia, Jorge R. ; Zueco Gil, Javier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3533-d167d56f4098db1b6d9ea960da2874c46fdc83f46bd50e1a1879eb9ef98c403b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Absorbable Implants</topic><topic>Aged</topic><topic>bioabsorbable stent</topic><topic>Calcium-binding protein</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Cardiovascular Agents - adverse effects</topic><topic>Clinical outcomes</topic><topic>Coated Materials, Biocompatible</topic><topic>Complications</topic><topic>Contrast Media - administration & dosage</topic><topic>Coronary Angiography</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - therapy</topic><topic>Coronary Thrombosis - etiology</topic><topic>Creatinine</topic><topic>Drug-Eluting Stents</topic><topic>drug‐eluting stent</topic><topic>Everolimus - administration & dosage</topic><topic>Everolimus - adverse effects</topic><topic>Female</topic><topic>Fluoroscopy</topic><topic>Humans</topic><topic>Implants</topic><topic>Incidence</topic><topic>Infarction</topic><topic>Lesions</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - etiology</topic><topic>percutaneous coronary intervention</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Percutaneous Coronary Intervention - instrumentation</topic><topic>Polymers - chemistry</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Radiation</topic><topic>Radiation Dosage</topic><topic>Radiation Exposure</topic><topic>Radiography, Interventional</topic><topic>Risk Factors</topic><topic>Spain</topic><topic>Thromboembolism</topic><topic>Thrombosis</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Troponin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de la Torre Hernandez, Jose M.</creatorcontrib><creatorcontrib>Garcia Camarero, Tamara</creatorcontrib><creatorcontrib>Lee, Dae‐Hyun</creatorcontrib><creatorcontrib>Sainz Laso, Fermin</creatorcontrib><creatorcontrib>Veiga Fernandez, Gabriela</creatorcontrib><creatorcontrib>Pino, Tania</creatorcontrib><creatorcontrib>Rubio, Silvia</creatorcontrib><creatorcontrib>Legarra, Pablo</creatorcontrib><creatorcontrib>Valdivia, Jorge R.</creatorcontrib><creatorcontrib>Zueco Gil, Javier</creatorcontrib><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>de la Torre Hernandez, Jose M.</au><au>Garcia Camarero, Tamara</au><au>Lee, Dae‐Hyun</au><au>Sainz Laso, Fermin</au><au>Veiga Fernandez, Gabriela</au><au>Pino, Tania</au><au>Rubio, Silvia</au><au>Legarra, Pablo</au><au>Valdivia, Jorge R.</au><au>Zueco Gil, Javier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Procedural resources utilization and clinical outcomes with bioresorbable everolimus‐eluting scaffolds and Pt‐Cr everolimus‐eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2017-08-01</date><risdate>2017</risdate><volume>90</volume><issue>2</issue><spage>E25</spage><epage>E30</epage><pages>E25-E30</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Objectives
We sought to compare the procedural implications of using bioresorbable everolimus‐eluting scaffolds (BVS) and Pt‐Cr everolimus‐eluting stent with abluminal bioabsorbable polymer (Synergy).
Background
There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes.
Methods
A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose‐area product, contras agent volumen, and peri‐procedural troponin release.
Results
A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P < 0.001), postdilatation (64.8 vs. 38.4%: P < 0.01), and use of 2 wires (20.8 vs. 10%; P = 0.02) were more frequent with BVS. The BVS group showed a significant increase in fluoroscopy time (18%), dose‐area product (20%), and contrast volume (10%). Post‐procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri‐procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy.
Conclusions
The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>27807948</pmid><doi>10.1002/ccd.26843</doi><tpages>6</tpages></addata></record> |
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| ispartof | Catheterization and cardiovascular interventions, 2017-08, Vol.90 (2), p.E25-E30 |
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| language | eng |
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| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Absorbable Implants Aged bioabsorbable stent Calcium-binding protein Cardiovascular Agents - administration & dosage Cardiovascular Agents - adverse effects Clinical outcomes Coated Materials, Biocompatible Complications Contrast Media - administration & dosage Coronary Angiography Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - therapy Coronary Thrombosis - etiology Creatinine Drug-Eluting Stents drug‐eluting stent Everolimus - administration & dosage Everolimus - adverse effects Female Fluoroscopy Humans Implants Incidence Infarction Lesions Male Middle Aged Myocardial Infarction - etiology percutaneous coronary intervention Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - instrumentation Polymers - chemistry Prospective Studies Prosthesis Design Radiation Radiation Dosage Radiation Exposure Radiography, Interventional Risk Factors Spain Thromboembolism Thrombosis Time Factors Treatment Outcome Troponin |
| title | Procedural resources utilization and clinical outcomes with bioresorbable everolimus‐eluting scaffolds and Pt‐Cr everolimus‐eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial |
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