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. (c) 2011 Wiley Periodicals, Inc.
Long-term outcome after drug-eluting stent implantation in unselected population: ROME and UDINE Experience (The RUDI Registry) / Sardella, Gennaro; Conti, Giulia; Teodoro, Bisceglia; Canali, Emanuele; Mancone, Massimo; DE CARLO, Carlotta; Leonardo, Spedicato; Giorgio, Morocutti; Fedele, Francesco; Guglielmo, Bernardi. - In: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. - ISSN 1522-1946. - STAMPA. - 78:7(2011), pp. 1068-1075. [10.1002/ccd.23050]
Long-term outcome after drug-eluting stent implantation in unselected population: ROME and UDINE Experience (The RUDI Registry)
SARDELLA, Gennaro;CONTI, GIULIA;CANALI, EMANUELE;MANCONE, Massimo;DE CARLO, CARLOTTA;FEDELE, Francesco;
2011
Abstract
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. (c) 2011 Wiley Periodicals, Inc.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.