Clinical safety and efficacy of a novel thin‐strut cobalt–chromium coronary stent system: Results of the real world Coroflex Blue Registry
Identifieur interne : 000266 ( Main/Exploration ); précédent : 000265; suivant : 000267Clinical safety and efficacy of a novel thin‐strut cobalt–chromium coronary stent system: Results of the real world Coroflex Blue Registry
Auteurs : Wolfgang Bocksch [Allemagne] ; Francisco Pomar [Espagne] ; Mieczyslaw Dziarmaga ; Damras Tresukosol [Thaïlande] ; Omar Ismail [Malaisie] ; Bronislav Janek [République tchèque] ; Joerg Carlsson [Suède] ; Jean-Philippe Simon [France]Source :
- Catheterization and Cardiovascular Interventions [ 1522-1946 ] ; 2010-01-01.
English descriptors
- Teeft :
- Angiography, Angioplasty, Balloon angioplasty, Bifurcation, Blue registry, Blue stent, Cardiac, Cardiol, Cardiology, Cardiovascular, Cardiovascular angiography, Cardiovascular interventions, Catheterization, Central hospital, Coll, Coll cardiol, Coronary artery disease, Elective, Engl, Implantation, Infarction, Investigator, Late stent thrombosis, Lesion, Mace, Main stenosis, Myocardial infarction, Percutaneous, Popma, Procedural success, Procedural success rate, Randomized, Randomized comparison, Restenosis, Scai, Stenosis, Stent, Stent implantation, Stent system, Stent thrombosis, Stenting, Technical success rate, Thrombosis, Upper limit, Vision stent.
Abstract
Objectives: The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt–chromium stent in real‐world practice. Background: The development of cobalt–chromium bare‐metal stents (BMS) with thinner struts has lead to better deliverability and lower target‐lesion revascularization rates compared with stainless steel BMS. Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target‐lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in‐hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. Results: The registry included 2,315 patients (mean age 64.3 ± 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B2/C‐lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6‐month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event‐free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt–chromium stent platform in real‐world practice. In the era of drug‐eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.
Url:
DOI: 10.1002/ccd.22208
Affiliations:
- Allemagne, Espagne, France, Malaisie, République tchèque, Suède, Thaïlande
- Berlin, Bohême centrale
- Berlin, Prague
Links toward previous steps (curation, corpus...)
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Le document en format XML
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Virchow Klinikum, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Allemagne</country></affiliation><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Correspondence address: Head of Cardiac Catheterization Laboratories, Department of Cardiology, Universitaetsmedizin Berlin, Charité‐Campus Virchow‐Klinikum, Humboldt‐Universität zu Berlin, Augustenburger Platz 1, Berlin 13353</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Pomar, Francisco" sort="Pomar, Francisco" uniqKey="Pomar F" first="Francisco" last="Pomar">Francisco Pomar</name><affiliation wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Cardiology, Hospital General de Valencia, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Dziarmaga, Mieczyslaw" sort="Dziarmaga, Mieczyslaw" uniqKey="Dziarmaga M" first="Mieczyslaw" last="Dziarmaga">Mieczyslaw Dziarmaga</name><affiliation><wicri:noCountry code="subField">Poznan</wicri:noCountry></affiliation></author><author><name sortKey="Tresukosol, Damras" sort="Tresukosol, Damras" uniqKey="Tresukosol D" first="Damras" last="Tresukosol">Damras Tresukosol</name><affiliation wicri:level="1"><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Department of Cardiology, Siriraj Hospital, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Ismail, Omar" sort="Ismail, Omar" uniqKey="Ismail O" first="Omar" last="Ismail">Omar Ismail</name><affiliation wicri:level="1"><country xml:lang="fr">Malaisie</country><wicri:regionArea>Department of Cardiology, Penang General Hospital, Penang</wicri:regionArea><wicri:noRegion>Penang</wicri:noRegion></affiliation></author><author><name sortKey="Janek, Bronislav" sort="Janek, Bronislav" uniqKey="Janek B" first="Bronislav" last="Janek">Bronislav Janek</name><affiliation wicri:level="3"><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Cardiology, Klinika kardiologie IKEM, Praha</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Carlsson, Joerg" sort="Carlsson, Joerg" uniqKey="Carlsson J" first="Joerg" last="Carlsson">Joerg Carlsson</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Cardiology, Central Hospital of Kalmar, Kalmar</wicri:regionArea><wicri:noRegion>Kalmar</wicri:noRegion></affiliation></author><author><name sortKey="Simon, Jean Hilippe" sort="Simon, Jean Hilippe" uniqKey="Simon J" 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when="2010-01-01">2010-01-01</date></imprint><idno type="ISSN">1522-1946</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1522-1946</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Angiography</term><term>Angioplasty</term><term>Balloon angioplasty</term><term>Bifurcation</term><term>Blue registry</term><term>Blue stent</term><term>Cardiac</term><term>Cardiol</term><term>Cardiology</term><term>Cardiovascular</term><term>Cardiovascular angiography</term><term>Cardiovascular interventions</term><term>Catheterization</term><term>Central hospital</term><term>Coll</term><term>Coll cardiol</term><term>Coronary artery disease</term><term>Elective</term><term>Engl</term><term>Implantation</term><term>Infarction</term><term>Investigator</term><term>Late stent thrombosis</term><term>Lesion</term><term>Mace</term><term>Main stenosis</term><term>Myocardial infarction</term><term>Percutaneous</term><term>Popma</term><term>Procedural success</term><term>Procedural success rate</term><term>Randomized</term><term>Randomized comparison</term><term>Restenosis</term><term>Scai</term><term>Stenosis</term><term>Stent</term><term>Stent implantation</term><term>Stent system</term><term>Stent thrombosis</term><term>Stenting</term><term>Technical success rate</term><term>Thrombosis</term><term>Upper limit</term><term>Vision stent</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objectives: The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt–chromium stent in real‐world practice. Background: The development of cobalt–chromium bare‐metal stents (BMS) with thinner struts has lead to better deliverability and lower target‐lesion revascularization rates compared with stainless steel BMS. Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target‐lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in‐hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. Results: The registry included 2,315 patients (mean age 64.3 ± 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B2/C‐lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6‐month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event‐free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt–chromium stent platform in real‐world practice. In the era of drug‐eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Espagne</li><li>France</li><li>Malaisie</li><li>République tchèque</li><li>Suède</li><li>Thaïlande</li></country><region><li>Berlin</li><li>Bohême centrale</li></region><settlement><li>Berlin</li><li>Prague</li></settlement></list><tree><noCountry><name sortKey="Dziarmaga, Mieczyslaw" sort="Dziarmaga, Mieczyslaw" uniqKey="Dziarmaga M" first="Mieczyslaw" last="Dziarmaga">Mieczyslaw Dziarmaga</name></noCountry><country name="Allemagne"><region name="Berlin"><name sortKey="Bocksch, Wolfgang" sort="Bocksch, Wolfgang" uniqKey="Bocksch W" first="Wolfgang" last="Bocksch">Wolfgang Bocksch</name></region><name sortKey="Bocksch, Wolfgang" sort="Bocksch, Wolfgang" uniqKey="Bocksch W" first="Wolfgang" last="Bocksch">Wolfgang Bocksch</name><name sortKey="Bocksch, Wolfgang" sort="Bocksch, Wolfgang" uniqKey="Bocksch W" first="Wolfgang" last="Bocksch">Wolfgang Bocksch</name></country><country name="Espagne"><noRegion><name sortKey="Pomar, Francisco" sort="Pomar, Francisco" uniqKey="Pomar F" first="Francisco" last="Pomar">Francisco Pomar</name></noRegion></country><country name="Thaïlande"><noRegion><name sortKey="Tresukosol, Damras" sort="Tresukosol, Damras" uniqKey="Tresukosol D" first="Damras" last="Tresukosol">Damras Tresukosol</name></noRegion></country><country name="Malaisie"><noRegion><name sortKey="Ismail, Omar" sort="Ismail, Omar" uniqKey="Ismail O" first="Omar" last="Ismail">Omar Ismail</name></noRegion></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Janek, Bronislav" sort="Janek, Bronislav" uniqKey="Janek B" first="Bronislav" last="Janek">Bronislav Janek</name></region></country><country name="Suède"><noRegion><name sortKey="Carlsson, Joerg" sort="Carlsson, Joerg" uniqKey="Carlsson J" first="Joerg" last="Carlsson">Joerg Carlsson</name></noRegion></country><country name="France"><noRegion><name sortKey="Simon, Jean Hilippe" sort="Simon, Jean Hilippe" uniqKey="Simon J" first="Jean-Philippe" last="Simon">Jean-Philippe Simon</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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