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Long‐term outcome after drug‐eluting stent implantation in unselected population: ROME and UDINE Experience (The RUDI Registry)
Author(s) -
Sardella Gennaro,
Conti Giulia,
Bisceglia Teodoro,
Canali Emanuele,
Mancone Massimo,
De Carlo Carlotta,
Spedicato Leonardo,
Morocutti Giorgio,
Fedele Francesco,
Bernardi Guglielmo
Publication year - 2011
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.23050
Subject(s) - medicine , incidence (geometry) , population , drug eluting stent , revascularization , stent , surgery , myocardial infarction , cardiology , percutaneous coronary intervention , physics , environmental health , optics
Objectives : 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. © 2011 Wiley Periodicals, Inc.