title: Long-term outcome after drug-eluting stent implantation in unselected population: ROME and UDINE experience (the RUDI registry).
abstract: OBJECTIVE
  The aim of our study is to evaluate the safety and efficacy of DES implantation in an unselected, "real world," high-risk population.
  
  
  BACKGROUND
  Several clinical trials showed that drug-eluting stents (DESs) implantation is safe and effective in selected population. In spite of these encouraging results, there are some concerns about "real world" utilization of these stents.
  
  
  METHODS
  One thousand four hundred and fifty-five off-label patients have been included in our registry. Primary end-points were: long-term clinical incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombosis (ST). We detected the difference between uniDES vs. multiDES implantation in terms of MACCE, death, nonfatal-MI, the composite of death/nonfatal-MI and target lesion revascularization (TLR) and the difference between DES type in term of MACCE.
  
  
  RESULTS
  At 36 months follow-up we found: cardiac death occurred in 20 patients (1.6%); 33 patients (2.6%) had a nonfatal MI and 81 patients (6.3%) had a TLR. We observed one (0.1%) acute, 9 subacute (0.6%), 6 late (0.6%), and 1 (0.5%) very late definite ST. No difference were found in terms of overall MACCE, MI, death and composite of death/nonfatal-MI between uni- and multiDES implantation but multiDES group had a higher incidence of TLR. No difference between DES type in term of MACCE was detected.
  
  
  CONCLUSIONS
  DES utilization shows their safety and efficacy in off-label patients with complex clinical and angiographic profile in terms of long-term incidence of MACCE. MultiDES implantation is associated with a higher risk of long-term TLR. No difference between DES type was found.
authors.affiliation: Nephrologic and Respiratory Sciences Department, Cardiovascular, Sapienza University of Rome, Geriatric, Umberto I Hospital, Italy. rino.sardella@uniroma1.it
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.forename: Giulia
authors.initials: G
authors.lastname: Conti
authors.forename: Teodoro
authors.initials: T
authors.lastname: Bisceglia
authors.forename: Emanuele
authors.initials: E
authors.lastname: Canali
authors.forename: Massimo
authors.initials: M
authors.lastname: Mancone
authors.forename: Carlotta
authors.initials: C
authors.lastname: De Carlo
authors.forename: Leonardo
authors.initials: L
authors.lastname: Spedicato
authors.forename: Giorgio
authors.initials: G
authors.lastname: Morocutti
authors.forename: Francesco
authors.initials: F
authors.lastname: Fedele
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Bernardi
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002561:Cerebrovascular Disorders / Q000209:etiology; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome