Survival After Coronary Revascularization With Paclitaxel-Coated Balloons
Key result
Paclitaxel-coated balloons reduce 3-year all-cause mortality ~27% vs non-DCB devices in coronary revascularization.
- RR 0.73
- 95% CI 0.53-1.00
- P=0.047
- NNT 36
- n=4,590
Why the study?
A meta-analysis suggested an increased mortality risk with paclitaxel-coated devices in the superficial femoral artery, prompting investigation into survival after coronary intervention with paclitaxel-coated balloons.
Does coronary revascularization with paclitaxel-coated balloons affect all-cause mortality compared to non-DCB devices in patients with coronary in-stent restenosis or de novo lesions?
Key Points
- To evaluate survival outcomes following coronary intervention with paclitaxel-coated balloons compared with non-drug-coated devices using randomized controlled trial data.
- Systematic search of PubMed, Web of Science, and Cochrane Library databases for randomized controlled trials comparing paclitaxel-coated balloons to non-drug-coated devices (conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) for in-stent restenosis or de novo lesions.
- Meta-analysis of 26 randomized controlled trials published between 2006 and 2019 encompassing 4,590 patients, evaluating all-cause death as the primary outcome alongside cardiac mortality over up to 3 years of follow-up.
- All-cause mortality showed no significant difference at 6 to 12 months (RR: 0.74; 95% CI: 0.51 to 1.08; p = 0.116) or at 2 years across 8 trials (n = 1,477; RR: 0.84; 95% CI: 0.51 to 1.37; p = 0.478).
- At 3 years of follow-up across 9 trials (n = 1,775), all-cause mortality was significantly lower in the drug-coated balloon group than in controls (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.
- Cardiac mortality was also significantly reduced in the drug-coated balloon arm at 3 years compared with control therapy (RR: 0.53; 95% CI: 0.33 to 0.85; p = 0.009).
Study Design
Type
Meta-Analysis (n=4,590)
Randomization
Randomized controlled trials
Structured PICO
Does coronary revascularization with paclitaxel-coated balloons affect all-cause mortality compared to non-DCB devices in patients with coronary in-stent restenosis or de novo lesions?
P
Population
4,590 patients across 26 RCTs undergoing coronary revascularization for in-stent restenosis or de novo lesions, followed for up to 3 years.
I
Intervention
Paclitaxel-coated balloons (drug-coated balloons, DCBs) for coronary revascularization
C
Comparator
Non-DCB control devices (such as conventional balloon angioplasty, bare-metal stents, or drug-eluting stents)
O
Outcome
All-cause death at 6 to 12 months, 2 years, and 3 years follow-uphard clinical
Main Result
Relative Risk: 0.73 (95% CI 0.53–1)
Number Needed to Treat: 36
p-value: p=0.047
Contrary to safety concerns raised in peripheral artery interventions, paclitaxel-coated balloons used for coronary revascularization are not associated with increased mortality and demonstrate significantly lower all-cause and cardiac mortality at 3 years compared to non-DCB devices.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“One may speculate that this is related to a significant reduction in the number and length of permanent implants, which should lead to a reduction in stent-associated short- and long-term events”
BEBimmer E. ClaessenInterventional cardiologist, Icahn School of Medicine at Mount Sinai
“One of the limitations of the current study that it's a very selected population of mostly patients with in-stent restenosis. At 3-year follow up only about one-third of patients remain, which again makes it more of a selected group.”
FAFernando AlfonsoInterventional cardiologist, Hospital Universitario de La Princesa, Madrid
“could have provided additional granularity and perhaps novel insights on factors affecting both the safety and efficacy of [paclitaxel-coated balloons].”
Implication
Reassures on coronary paclitaxel-coated balloon safety; challenges peripheral mortality signals and supports dedicated long-term outcome trials.
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.
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Cite This Study
Scheller et al. (2020) conducted a meta-analysis in Coronary artery disease (in-stent restenosis or de novo lesions) (n=4,590). Paclitaxel-coated balloons (DCBs) vs. Non-DCB devices (conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) was evaluated on All-cause death at 3 years (RR 0.73, 95% CI 0.53-1.00, p=0.047). Paclitaxel-coated balloons reduced 3-year all-cause mortality vs non-DCB devices in coronary revascularization (RR 0.73; 95% CI 0.53-1.00; p=0.047; NNT=36).