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?
OBJECTIVE
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.


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).


CONCLUSIONS
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).
Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany.
Martin
M
Unverdorben
Franz X
FX
Kleber
Hubertus
H
Heuer
Hans-Reiner
HR
Figulla
Christian
C
Vallbracht
Matthias
M
Leschke
Bodo
B
Cremers
Stefan
S
Hardt
Michael
M
Buerke
Hanns
H
Ackermann
Michael
M
Boxberger
Ralf
R
Degenhardt
Bruno
B
Scheller
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D002317:Cardiovascular Agents / Q000627:therapeutic use; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D017239:Paclitaxel