Long-term outcome after drug-eluting stent implantation in unselected population: ROME and UDINE experience (the RUDI registry).

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.