TY - JOUR
T1 - Survival After Coronary Revascularization With Paclitaxel-Coated Balloons
AU - Scheller, Bruno
AU - Vukadinovic, Davor
AU - Jeger, Raban
AU - Rissanen, Tuomas T.
AU - Scholz, Sean S.
AU - Byrne, Robert
AU - Kleber, Franz X.
AU - Latib, Azeem
AU - Clever, Yvonne P.
AU - Ewen, Sebastian
AU - Böhm, Michael
AU - Yang, Yiping
AU - Lansky, Alexandra
AU - Mahfoud, Felix
N1 - Funding Information:
Dr. Scheller is a shareholder of InnoRa GmbH; and has been named as a coinventor on patent applications submitted by Charit? University Hospital. Dr. Jeger has received research grant support and speaker honoraria from B.Braun; and has received speaker honoraria from Cardionovum. Dr. Rissanen has received research grant support and speaker honoraria from B.Braun. Dr. Scholz has received speaker honoraria from Pfizer. Dr. Byrne has received speaker fees from B. Braun, Melsungen AG, and Biotronik. Dr. Kleber has served as a consultant for and received speaker honoraria from B.Braun. Dr. Latib has served on the Advisory Board for Medtronic. Dr. B?hm has received support from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Servier, and Vifor. Dr. Mahfoud is supported by Deutsche Gesellschaft f?r Kardiologie (DGK) and Deutsche Forschungsgemeinschaft (SFB TRR219); and has received research grants/honoraria from Berlin Chemie, Boehringer Ingelheim, Medtronic, and Recor. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 American College of Cardiology Foundation
PY - 2020/3/10
Y1 - 2020/3/10
N2 - 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.
AB - 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.
KW - drug-coated balloon
KW - paclitaxel
KW - percutaneous coronary intervention
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U2 - 10.1016/j.jacc.2019.11.065
DO - 10.1016/j.jacc.2019.11.065
M3 - Article
C2 - 32138961
AN - SCOPUS:85079843035
SN - 0735-1097
VL - 75
SP - 1017
EP - 1028
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 9
ER -