Treatment of Coronary In-Stent Restenosis
Condition: Restenosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy
      using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug
      eluting stents releasing everolimus.
    

Detailed description: 
      In-stent restenosis after coronary angioplasty is currently one of the main limitations of
      this method, leading to a recurrence of exertional angina pectoris or manifesting as acute
      coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal
      hyperplasia.

      Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of
      in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past,
      it has also abandoned. The current treatment of in-stent restenosis is the use of drug
      eluting stents. Local drug released from these stents prevents new neointimal
      hyperplasia.This treatment carries the risk of late thrombosis (due to delayed
      neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy
      with the risk of bleeding complications. The drug-coated balloon catheters provide short-term
      penetration of the active substance into the vascular wall, leading to the inhibition of
      hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not
      affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis
      therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel
      releasing stents, however, the development of drug eluting stents meanwhile progressed. The
      aim of our study is to compare efficacy of coronary in-stent restenosis therapy using drug
      eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents
      releasing everolimus. Primary endpoint of our study is late lumen loss, because it represents
      accurate angiographic parameter predicting the need for repeat revascularisation and thus the
      clinical benefit for the patient.

      The 3rd observational, non-randomised arm compares the treatment with seal-wing
      paclitaxel-eluting balloon with two randomised arms (PEB vs. EES).

      3-year long term clinical follow-up of iopromide-coated PEB and EES arms was performed. All
      clinical MACE (CV death, AMI and TVR) were recorded.

      Subanalysis of seal-wing PEB arm comparrng the treatment of BMS and DES-ISR was added.
    

Intervention name(s): paclitaxel-coated balloon catheter with Iopromide coating; drug eluting stent with everolimus; seal-wing paclitaxel-eluting balloon catheter
Intervention type(s): Device; Device; Device
Intervention description(s): Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter; Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus; Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter
Other intervention name(s): Sequent Please; Promus; Protege
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: iopromide coated paclitaxel-eluting balloon catheter
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary artery disease; stent; restenosis