title: Clinical outcome of percutaneous treatment of in-stent restenosis with drug-eluting stents: results from the first phase of the prospective multicentre German DES.DE registry.
abstract: OBJECTIVE
  Treatment of in-stent restenosis (ISR) was historically considered the Achilles heel of percutaneous coronary intervention (PCI) and has been associated with worse clinical outcome than PCI of de novo lesions. However, comparative data on ISR and de novo lesions using drug-eluting stents (DES) are scarce. Therefore, we aimed to assess the impact of ISR on procedural and long-term outcome in patients treated with DES.
  
  
  RESULTS
  We analysed data from 5,144 patients enrolled in the prospective multicentre German Drug-Eluting Stent Registry (DES.DE). The registry included 872 patients (17%) treated for ISR with follow-up data (median 12.4 months) available for 817 patients (94%). Of the ISR patients, 37.1% (n=323) presented with acute coronary syndromes. In total, 1,027 DES were used (528 sirolimus-eluting stents and 499 paclitaxel-eluting stents), with successful implantation in 97.7% of patients. In the ISR cohort, myocardial infarction (MI) during hospitalisation was observed in 1.6% of patients (n=14) and in-hospital mortality was only 0.3% (n=3). Major adverse cardiac and cerebrovascular events (MACCE) rate at follow-up (defined as a composite of death, MI and stroke) was 8.7% (n=71) versus 8.2% (n=325) in patients treated for de novo lesions (p=0.63). Target vessel revascularisation (TVR) rate was 12.7% (n=100), numerically higher than in patients with de novo lesions (10.5%, p=0.07). Ten patients (1.3%) suffered from ARC definite stent thrombosis versus 0.7% observed in patients with de novo lesions (p=0.13). After adjustment for differences in baseline characteristics, TVR rates were statistically higher in the ISR cohort (OR 1.27, 95%CI 1.01-1.61, p=0.04), while MACCE rates remained comparable (OR 1.10, 95%CI 0.83-1.44, p=0.51). The type of stent used (sirolimus vs. paclitaxel-eluting stent) did not impact the rate of MACCE, TVR or definite stent thrombosis at one year.
  
  
  CONCLUSIONS
  Results from this large prospective multicentre registry confirm that treatment of ISR with DES is effective and safe, with similar procedural outcome but slightly higher revascularisation rates at one year compared to patients treated for de novo lesions, with no differences in outcome between sirolimus- and paclitaxel-eluting stents.
authors.affiliation: Heart and Vascular Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany. mohamed.abdel-wahab@segebergerkliniken.de
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.forename: Christoph A
authors.initials: CA
authors.lastname: Nienaber
authors.forename: Ahmad E
authors.initials: AE
authors.lastname: Mostafa
authors.forename: Georg
authors.initials: G
authors.lastname: Sabin
authors.forename: Ulrich
authors.initials: U
authors.lastname: Tebbe
authors.forename: Matthias
authors.initials: M
authors.lastname: Hochadel
authors.forename: Jochen
authors.initials: J
authors.lastname: Senges
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Akin
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome