LONG-TERM FOLLOW-UP AFTER TREATMENT OF DRUG-ELUTING STENT RESTENOSIS AND DE NOVO LESIONS USING SEQUENT PLEASE PACLITAXEL-COATED BALLOONS

Drug-eluting balloons currently constitute a therapeutic tool used in percutaneous coronary interventions (PCI). Long-term results remain unknown. We evaluated the prognosis of PCI using a second generation paclitaxel-eluting balloon (PEB) in real-world patients. We included all PCI with PEB in de novo or in-stent restenosis coronary lesions performed in our unit from March 2009 to March 2019. We assessed the composite of major adverse cardiovascular events (MACE) rate after a median follow-up of 42 months. Consecutive patients (n = 320) with 386 lesions were included; 46.9% presented with stable angina and 53.1% acute coronary syndromes; 52.6% of the lesions were in-stent restenosis and 47.3% de novo lesions with a mean diameter of 2.4 ± 0.5 mm. A bare metal stent was implanted in 6.7% and a drug-eluting stent in 8.5% of patients. The MACE rate was 8%: 10 (2.6%) cardiovascular deaths, 13 (3.4%) myocardial infarctions, and 16 (4.1%) target lesion revascularization. The all-cause death rate was 5.2%. No cases of thrombosis were recorded. In conclusion, PEB was a safe and effective tool to treat in-stent restenosis and de novo coronary lesions, especially small vessel disease, during long-term follow-up.

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Long-Term Follow-Up After Treatment of Drug-Eluting Stent Restenosis and De Novo Lesions Using SeQuent Please Paclitaxel-Coated Balloons

Angiology ◽

10.1177/0003319718809423 ◽

2018 ◽

Vol 70 (5) ◽

pp. 414-422

Author(s):

Dai Zhang ◽

Yan Sun ◽

Xiaoli Liu ◽

Fang Liu ◽

Yujing Cheng ◽

...

Keyword(s):

De Novo ◽

Coronary Vessels ◽

Target Lesion ◽

Drug Eluting Stent ◽

Cardiac Events ◽

Stent Restenosis ◽

Significant Difference ◽

Drug Eluting

Managing patients with in-stent restenosis (ISR) remains an important clinical challenge. In particular, large, randomized trials assessing the effect of drug-eluting balloons (DEB) in patients with de novo lesions are warranted. We investigated the effect of DEB on procedural complications, target lesion revascularization (TLR), and major adverse cardiac and cerebrovascular events in patients with drug-eluting stent ISR and de novo lesions. The clinical profiles of 238 consecutive patients treated for coronary ISR (n = 174) and de novo lesions (n = 64) using SeQuent Please paclitaxel-coated balloon were analyzed. Study end points were major adverse cardiac events (MACEs). At 1-year follow-up, TLR and MACEs occurred with acceptably low rates (5.0% and 6.3%, respectively). At 2.00 (0.74) years of follow-up, there was a significant difference in the rates of TLR between the ISR and the de novo lesions groups (14.4% [ISR] vs 3.1% [de novo], P = .028), and the occurrence of MACEs distinctly increased in the ISR group compared to the de novo lesions group (21.8% vs 6.2%, P = .009). The long-term outcomes of the ISR group were inferior to those of the de novo group (TLR, log-rank P = .019; MACEs, log-rank P = .010). Drug-eluting balloon for ISR and de novo lesions of small coronary vessels is effective and safe.

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