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Efficacy of drug‐coated balloon angioplasty in early versus late occurring drug‐eluting stent restenosis: A pooled analysis from the randomized ISAR DESIRE 3 and DESIRE 4 trials
Author(s) -
Koch Tobias,
Cassese Salvatore,
Xhepa Erion,
Mayer Katharina,
Tölg Ralph,
Hoppmann Petra,
Laugwitz KarlLudwig,
Byrne Robert A.,
Kastrati Adnan,
Kufner Sebastian
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28638
Subject(s) - medicine , mace , restenosis , myocardial infarction , clinical endpoint , hazard ratio , drug eluting stent , stent , cardiology , angioplasty , incidence (geometry) , percutaneous coronary intervention , clinical trial , surgery , confidence interval , physics , optics
Background Whether there exist differences concerning clinical outcomes between patients presenting with early versus late DES‐ISR undergoing treatment with drug‐coated balloons (DCB) remains a scientific knowledge gap. Methods This is a pooled analysis including patients with DES‐ISR assigned to treatment with DCB in the setting of the ISAR DESIRE 3 and 4 trials. Clinical outcomes were evaluated according to time of occurrence of ISR after DES implantation, in patients presenting with early (≤12 months) versus late DES‐ISR (>12 months) undergoing treatment with DCB. The primary endpoint of this analysis was major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR) at 12 months after DCB treatment. Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment. Results This analysis included 352 patients, 199 patients presented with early‐ISR, 153 patients with late‐ISR. Concerning the primary endpoint, patients with early‐DES‐ISR as compared those with late‐DES‐ISR showed significant higher risk (25.9% vs. 17.0%; p = .04). In a multivariate analysis including diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis after DCB‐treatment, the adjusted hazard ratio showed significant higher risk for MACE of early‐DES‐ISR as compared to late‐DES‐ISR (HR adj = 1.8, [95% CI = 1.1–3.0], p = .02). Conclusion Clinical outcome at 12 months after treatment of DES‐ISR with DCB, showed significant higher clinical event rates in patients presenting with early DES restenosis, as compared with patients presenting with late DES restenosis.