Polymer-free sirolimus-eluting stents in a large-scale all-comers population

Florian Krackhardt, Viktor Kočka, Matthias W Waliszewski, Andreas Utech, Meik Lustermann, Martin Hudec, Martin Studenčan, Markus Schwefer, Jiangtao Yu, Myung Ho Jeong, Taehoon Ahn, Wan Azman Wan Ahmad, Michael Boxberger, André Schneider, Matthias Leschke, Florian Krackhardt, Viktor Kočka, Matthias W Waliszewski, Andreas Utech, Meik Lustermann, Martin Hudec, Martin Studenčan, Markus Schwefer, Jiangtao Yu, Myung Ho Jeong, Taehoon Ahn, Wan Azman Wan Ahmad, Michael Boxberger, André Schneider, Matthias Leschke

Abstract

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.

Keywords: ACUTE CORONARY SYNDROME; CORONARY ARTERY DISEASE; CORONARY INTERVENTION (PCI).

Conflict of interest statement

Competing interests: FK received lecturing fees, and MWW and MB served full time employment at the Department of Medical Scientific Affairs, B. Braun Melsungen AG.

Figures

Figure 1
Figure 1
Kaplan-Meier curve for freedom from TLR of patients with stable CAD and those with ACS. ACS, acute coronary syndrome; CAD, coronary artery disease; TLR, target lesion revascularisation.
Figure 2
Figure 2
Kaplan-Meier curve for freedom from MACE of patients with stable CAD and those with ACS. ACS, acute coronary syndrome; CAD, coronary artery disease; MACE, major adverse cardiac events.
Figure 3
Figure 3
MACE rates in subgroups of the overall cohort. ACS, acute coronary syndrome; CAD, coronary artery disease; ISR, in-stent restenosis; MACE, major adverse cardiac events.

References

    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner