Abstract
In 2013, a drug-coated balloon catheter (DCB) (SeQuent Please) for the treatment of coronary in-stent restenosis (ISR) was approved in Japan. The pre-marketing Japan domestic NP001 study demonstrated better outcomes of the DCB (n = 138) compared to plain balloon angioplasty (n = 72). After the introduction to marketing, a post-marketing surveillance (PMS) (n = 396) was conducted to evaluate the safety and efficacy of the DCB in Japanese routine clinical practice. The aim of this paper was to assess differences between the pre-marketing NP001 study and the PMS. Compared to the NP001 study, more complex lesions were treated in the PMS (type B2/C: 69.0% vs 20.4%, total occlusion: 11.2% vs 0%, p < 0.001, respectively) and target lesion was more frequently ISR related to drug-eluting stent (DES) (79.5% vs 39.4%, p < 0.001). Regarding clinical outcomes, the rate of target lesion revascularization (TLR) was higher in the PMS than in the NP001 study (TLR: 12.9% at 7 months and 17.6% at 12 months vs 2.8% at 6 months, p = 0.001, p < 0.001, respectively). Multivariable logistic regression analysis revealed that DES-ISR was a risk factor of TLR after DCB treatment for ISR (odds ratio: 5.77, 95% CI 1.75–18.95, p = 0.004). Among representative published trials using DCB for ISR, clinical outcomes are often worse in DES-ISR trials than those in bare metal stent-ISR trials. The rates of TLR in previous DES-ISR trials are similar to that in the current PMS (TLR at 12 months: 22.1% for ISAR-DESIRE 3, 15.3% for PEPCAD-DES, and 13.0% for RIBS IV). The effectiveness and safety of DCB for coronary ISR have been confirmed in the Japanese real-world survey. PMS would be useful to evaluate the safety and effectiveness of medical products throughout their total life cycles.
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Abbreviations
- BMS:
-
Bare metal stents
- BR:
-
Binary restenosis
- CABG:
-
Coronary artery bypass grafting
- CI:
-
Confidence intervals
- DAPT:
-
Dual antiplatelet therapy
- DCB:
-
Drug-coated balloon
- DES:
-
Drug-eluting stents
- DS:
-
Diameter stenosis
- GPSP:
-
Good post-marketing surveillance practice
- ISR:
-
In-stent restenosis
- LAD:
-
Left anterior descending artery
- LCX:
-
Left circumflex artery
- LMT:
-
Left main trunk
- LLL:
-
Late lumen loss
- MACE:
-
Major adverse cardiac events
- MI:
-
Myocardial infarction
- OR:
-
Odds ratio
- PCI:
-
Percutaneous coronary intervention
- PMDA:
-
Pharmaceuticals and Medical Devices Agency
- PMS:
-
Post-marketing surveillance
- POBA:
-
Plain old balloon angioplasty
- QCA:
-
Quantitative coronary angiography
- RCA:
-
Right coronary artery
- RVD:
-
Reference vessel diameter
- TLR:
-
Target lesion revascularization
- TVF:
-
Target vessel failure
- TVR:
-
Target vessel revascularization
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We thank the members of the PMDA review team for their input and Editage (https://www.editage.com) for English editing. The views expressed in this article are those of the authors and do not necessarily reflect the official views of the PMDA.
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Mitsutake, Y., Konishi, A., Shiba, T. et al. Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint. Heart Vessels 36, 155–162 (2021). https://doi.org/10.1007/s00380-020-01676-z
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DOI: https://doi.org/10.1007/s00380-020-01676-z