Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months?
Selected in EuroIntervention by S. Brugaletta
Unverdorben M, Kleber F-X, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B
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The one-year outcome of lesions in small coronary arteries by using a paclitaxel-iopromide-coated (3 μg/mm²) balloon catheter (DCB) has yielded good six-month angiographic and one-year clinical data. We now report the three-year clinical follow-up.
Methods and results: One hundred and twenty patients with >70% stenoses <22 mm in length in small coronary vessels (vessel diameter: 2.25-2.8 mm) were treated with the DCB. The primary endpoint was angiographic in-segment late lumen loss. The secondary endpoints encompassed all other angiographic and clinical data up to three years post intervention. In total 82/120 (68.3%) patients with a vessel diameter of 2.35±0.19 mm were treated with the DCB only, and 32/120 (26.7%) patients required additional bare metal stent (BMS) deployment. Both the 12- and 36-month major adverse cardiac event rates were 5/82 (6.1%) for DCB only and 12/32 (37.5%) for DCB+BMS, primarily due to the need for target lesion revascularisation in 4/82 (4.9%) patients and 9/32 (28.1%) (p<0.001) patients, respectively. Total MACE rate after 36 months was 18/120 (15%; intention-to-treat).
Treatment of small vessel coronary artery disease with a paclitaxel-iopromide-coated balloon exhibited good six-month angiographic and one-year clinical data that persisted during the three-year follow-up period. Randomised trials will clarify its role as an alternative to drug-eluting stents in the treatment of small vessel coronary artery disease. (ClinicalTrials.gov Identifier: NCT00404144).
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What is known
Randomised trials and large registries, testing the efficacy of various drug-eluting balloon (DEB) for treatment of small vessel coronary lesions have shown conflicting results, depending of the DEB used. One of the main concerns is about the long-term durability of the angiographic result obtained after DEB use. The PEPCAD I study published in this issue of eurointervention reports the 3-year result.
- One hundred and twenty patients with > 70% stenosis > 22 mm in length in small coronary vessels (diameter 2.25-2.8 mm) were treated with paclitaxel eluting balloon (PEB).
- 68.3% patients were treated with PEB only, the remaining 26.7% required additional bare metal stent deployment.
- Both the 12- and 36-month major adverse cardiac event rates (combined of cardiac death, TLR and lesion-related myocardial infarction) were 6.1% and 37.5% for PEB only and PEB+BMS, respectively.
Two main messages can be derived from the present paper. The first is that between 1 and 3-year no additional events are present either in the patients treated by PEB or in those treated by PEB+BMS. This finding reinforces the fact that a permanent caging is not more required after 1-year, which is actually the concept for using bioresorbable devices. The second is that the combined use of PEB+BMS does not seem to have, at least in this analysis, an efficacy comparable to that of a DES, but conversely appears worse than PEB alone. In case a stent is needed to cover a dissection or o contrast recoil, DES could likely be a better option than BMS. It is noteworthy that all these findings are related to small vessel disease, where small amount of neointima has more impact than in a large vessel. A randomized trial comparing DEB with DES would be needed in order to clarify the role of DEB in the percutaneous treatment of small vessel disease.