In Stent Restenosis
Conditions
Brief summary
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.
Interventions
Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)
Sponsors
Study design
Eligibility
Inclusion criteria
• All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.
Exclusion criteria
* PCI with DES struts thickness \>100μm * PCI with DEB and thin-DES in the same procedure * PCI of other vascular territories during the same procedure * PCI in saphenous vain graft or internal mammary artery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TLR | 3 years | target lesion revascularisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOCE | 3 years | composite of cardiac death, TLR, and target vessel MI |
| TVR | 3 years | target vessel revascularization |
| TV-MI | 3 years | target vessel myocardial infarction |
| cardiac death | 3 years | — |
| myocardial infarction | 3 years | — |
Countries
Poland