Polymer-free sirolimus-eluting stents in a large-scale all-comers population
Status PubMed-not-MEDLINE Jazyk angličtina Země Anglie, Velká Británie Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
28761678
PubMed Central
PMC5515132
DOI
10.1136/openhrt-2017-000592
PII: openhrt-2017-000592
Knihovny.cz E-zdroje
- Klíčová slova
- ACUTE CORONARY SYNDROME, CORONARY ARTERY DISEASE, CORONARY INTERVENTION (PCI),
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied. METHODS: Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated. RESULTS: A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001). CONCLUSIONS: PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575). TRIAL REGISTRATION NUMBER: NCT02629575.
Ambulantes Herzzentrum Kassel Kassel Germany
Cardiocentre of Teaching Hospital of J A Reiman Prešov Slovakia
Department of Cardiology Gil Hospital Gachon University Incheon Republic of Korea
Department of Cardiology SUSCCH a s Banská Bystrica Slovakia
Department of Cardiology University Hospital Královské Vinohrady Prague Czech Republic
Department of Kardiologie Elblandklinikum Riesa Riesa Germany
Department of Kardiologie Helmut G Walther Klinikum Lichtenfels Lichtenfels Germany
Department of Kardiologie Sudharz Klinikum Nordhausen gGmbH Nordhausen Thüringen Germany
Department of Medical Scientific Affairs B Braun Melsungen AG Berlin Germany
Division Cardiology Department of Medicine University Malaya Medical Centre Kuala Lumpur Malaysia
Division of Cardiology Chonnam National University Hospital Gwangju Republic of Korea
Kardiologie Campus Virchow Klinikum Charité Berlin Germany
Klinik für Kardiologie Angiologie Pneumologie Klinikum Esslingen Esslingen Baden Württemberg Germany
Zobrazit více v PubMed
Palmerini T, Benedetto U, Biondi-Zoccai G, et al. . Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2015;65:2496–507.10.1016/j.jacc.2015.04.017 PubMed DOI
Mauri L, Kereiakes DJ, Yeh RW, et al. . Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med Overseas Ed 2014;371:2155–66.10.1056/NEJMoa1409312 PubMed DOI PMC
Urban P, Meredith IT, Abizaid A, et al. . Polymer-free drug-coated coronary stents in patients at high bleeding risk. N Engl J Med 2015;373:2038–47.10.1056/NEJMoa1503943 PubMed DOI
Massberg S, Byrne RA, Kastrati A, et al. . Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents (ISAR-TEST 5) trial. Circulation 2011;124:624–32.10.1161/CIRCULATIONAHA.111.026732 PubMed DOI
Cutlip DE, Windecker S, Mehran R, et al. . Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51.10.1161/CIRCULATIONAHA.106.685313 PubMed DOI
Leschke M, Waliszewski M, Pons M, et al. . Thin strut bare metal stents in patients with atrial fibrillation: is there still a need for BMS? Catheter Cardiovasc Interv 2016;88:358–66.10.1002/ccd.26261 PubMed DOI
Kufner S, Sorges J, Mehilli J, et al. . Randomized trial of polymer-free sirolimus- and probucol-eluting stents versus durable polymer zotarolimus-eluting stents: 5-year results of the ISAR-TEST-5 trial. JACC Cardiovasc Interv 2016;9:784–92.10.1016/j.jcin.2016.01.009 PubMed DOI
Colleran R, Kufner S, Harada Y, et al. . Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction. Catheter Cardiovasc Interv 2017;89:367–74.10.1002/ccd.26597 PubMed DOI
Harada Y, Colleran R, Kufner S, et al. . Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial. Cardiovasc Diabetol 2016;15:124.10.1186/s12933-016-0429-y PubMed DOI PMC
Windecker S, Kolh P, Alfonso F, et al. . 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35:2541–619.10.1093/eurheartj/ehu278 PubMed DOI
Wöhrle J, Zadura M, Möbius-Winkler S, et al. . SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol 2012;60:1733–8.10.1016/j.jacc.2012.07.040 PubMed DOI
Garot P, Morice MC, Tresukosol D, et al. . 2-year outcomes of high bleeding risk patients after polymer-free drug-coated stents. J Am Coll Cardiol 2017;69:162–71.10.1016/j.jacc.2016.10.009 PubMed DOI
Nakamura M, Muramatsu T, Yokoi H, et al. . Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT). Cardiovasc Interv Ther 2015;30:103–14.10.1007/s12928-014-0279-z PubMed DOI
Iqbal J, Serruys PW, Silber S, et al. . Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv 2015;8(6):e002230.10.1161/CIRCINTERVENTIONS.114.002230 PubMed DOI PMC
Colombo A, Godino C, Donahue M, et al. . One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients: insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTre rEgistry). Int J Cardiol 2016;214:113–20.10.1016/j.ijcard.2016.03.088 PubMed DOI
Stefanini GG, Behan M, Valgimigli M, et al. . Will LEADERS-FREE change my practice? A randomised double-blind comparison of the BioFreedom™ drug-coated stent vs. the Gazelle™ bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy. EuroIntervention 2016;12:798–800.10.4244/EIJV12I6A129 PubMed DOI
D'Ascenzo F, Moretti C, Bianco M, et al. . Meta-analysis of the duration of dual antiplatelet therapy in patients treated with second-generation drug-eluting stents. Am J Cardiol 2016;117:1714–23.10.1016/j.amjcard.2016.03.005 PubMed DOI
Savarese G, Savonitto S, Lund LH, et al. . Efficacy and safety of prolonged dual antiplatelet therapy: a meta-analysis of 15 randomized trials enrolling 85 265 patients. Eur Heart J Cardiovasc Pharmacother 2016;2:218–28.10.1093/ehjcvp/pvw011 PubMed DOI
Bønaa KH, Mannsverk J, Wiseth R, et al. . Drug-eluting or bare-metal stents for coronary artery disease. N Engl J Med 2016;375:1242–52.10.1056/NEJMoa1607991 PubMed DOI
Yeh RW, Secemsky EA, Kereiakes DJ, et al. . Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 year after percutaneous coronary intervention. JAMA 2016;315:1735–49.10.1001/jama.2016.3775 PubMed DOI PMC
Waliszewski M, Rittger H. Surrogate and clinical endpoints in interventional cardiology: are statistics the brakes? Ther Adv Cardiovasc Dis 2016;10:314–26.10.1177/1753944716656150 PubMed DOI PMC
Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice
ClinicalTrials.gov
NCT02629575