Bruno Scheller1, Davor Vukadinovic2, Raban Jeger3, Tuomas T Rissanen4, Sean S Scholz2, Robert Byrne5, Franz X Kleber6, Azeem Latib7, Yvonne P Clever2, Sebastian Ewen2, Michael Böhm2, Yiping Yang8, Alexandra Lansky8, Felix Mahfoud2. 1. Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Hospital, Saarland University, Homburg/Saar, Germany; Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany. Electronic address: bruno.scheller@uks.eu. 2. Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Hospital, Saarland University, Homburg/Saar, Germany. 3. University Hospital Basel, University of Basel, Basel, Switzerland. 4. Heart Center, North Karelia Central Hospital, Siun Sote, Joensuu, Finland. 5. Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 6. Evangelisches Krankenhaus Paul Gerhardt Stift, Paul-Gerhardt-Straße 42-45, Lutherstadt Wittenberg, Germany. 7. Montefiore Medical Center, New York, New York. 8. Section of Cardiology, Yale University School of Medicine, New Haven, Connecticut.
Abstract
BACKGROUND: Drug-coated balloons (DCBs) are accepted treatment strategies for coronary in-stent restenosis and are under clinical investigation for lesions without prior stent implantation. A recently published meta-analysis suggested an increased risk of death associated with the use of paclitaxel-coated devices in the superficial femoral artery. The reasons are incompletely understood as potential underlying pathomechanisms remain elusive, and no relationship to the administered dose has been documented. OBJECTIVES: The purpose of this analysis was to investigate the available data on survival after coronary intervention with paclitaxel-coated balloons from randomized controlled trials (RCTs). METHODS: PubMed, Web of science, and the Cochrane library database were searched, and a meta-analysis from RCT was performed comparing DCB with non-DCB devices (such as conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) for the treatment of coronary in-stent restenosis or de novo lesions. The primary outcome was all-cause death. The number of patients lost to follow-up was observed at different time points. Risk estimates are reported as risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: A total of 4,590 patients enrolled in 26 RCTs published between 2006 and 2019 were analyzed. At follow-up of 6 to 12 months, no significant difference in all-cause mortality was found, however, with numerically lower rates after DCB treatment (RR: 0.74; 95% CI: 0.51 to 1.08; p = 0.116). Risk of death at 2 years (n = 1,477, 8 RCTs) was similar between the 2 groups (RR: 0.84; 95% CI: 0.51 to 1.37; p = 0.478). After 3 years of follow-up (n = 1,775, 9 RCTs), all-cause mortality was significantly lower in the DCB group when compared with control treatment (RR: 0.73; 95% CI: 0.53 to 1.00; p = 0.047) with a number needed to treat of 36 to prevent 1 death. A similar reduction was seen in cardiac mortality (RR: 0.53; 95% CI: 0.33 to 0.85; p = 0.009). CONCLUSIONS: In this meta-analysis, the use of paclitaxel DCBs for treatment of coronary artery disease was not associated with increased mortality, as has been suggested for peripheral arteries. On the contrary, use of coronary paclitaxel-coated balloons was associated with a trend toward lower mortality when compared with control treatments.
BACKGROUND:Drug-coated balloons (DCBs) are accepted treatment strategies for coronary in-stent restenosis and are under clinical investigation for lesions without prior stent implantation. A recently published meta-analysis suggested an increased risk of death associated with the use of paclitaxel-coated devices in the superficial femoral artery. The reasons are incompletely understood as potential underlying pathomechanisms remain elusive, and no relationship to the administered dose has been documented. OBJECTIVES: The purpose of this analysis was to investigate the available data on survival after coronary intervention with paclitaxel-coated balloons from randomized controlled trials (RCTs). METHODS: PubMed, Web of science, and the Cochrane library database were searched, and a meta-analysis from RCT was performed comparing DCB with non-DCB devices (such as conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) for the treatment of coronary in-stent restenosis or de novo lesions. The primary outcome was all-cause death. The number of patients lost to follow-up was observed at different time points. Risk estimates are reported as risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: A total of 4,590 patients enrolled in 26 RCTs published between 2006 and 2019 were analyzed. At follow-up of 6 to 12 months, no significant difference in all-cause mortality was found, however, with numerically lower rates after DCB treatment (RR: 0.74; 95% CI: 0.51 to 1.08; p = 0.116). Risk of death at 2 years (n = 1,477, 8 RCTs) was similar between the 2 groups (RR: 0.84; 95% CI: 0.51 to 1.37; p = 0.478). After 3 years of follow-up (n = 1,775, 9 RCTs), all-cause mortality was significantly lower in the DCB group when compared with control treatment (RR: 0.73; 95% CI: 0.53 to 1.00; p = 0.047) with a number needed to treat of 36 to prevent 1 death. A similar reduction was seen in cardiac mortality (RR: 0.53; 95% CI: 0.33 to 0.85; p = 0.009). CONCLUSIONS: In this meta-analysis, the use of paclitaxelDCBs for treatment of coronary artery disease was not associated with increased mortality, as has been suggested for peripheral arteries. On the contrary, use of coronary paclitaxel-coated balloons was associated with a trend toward lower mortality when compared with control treatments.
Authors: Abraham R Tzafriri; Benny Muraj; Fernando Garcia-Polite; Antonio G Salazar-Martín; Peter Markham; Brett Zani; Anna Spognardi; Mazen Albaghdadi; Steve Alston; Elazer R Edelman Journal: Biomaterials Date: 2020-08-20 Impact factor: 12.479
Authors: Felix Mahfoud; Ahmed Farah; Marc-Alexander Ohlow; Norman Mangner; Jochen Wöhrle; Sven Möbius-Winkler; Daniel Weilenmann; Gregor Leibundgut; Florim Cuculi; Nicole Gilgen; Christoph Kaiser; Marco Cattaneo; Bruno Scheller; Raban V Jeger Journal: Clin Res Cardiol Date: 2022-02-27 Impact factor: 6.138
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