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First Romanian registry of safety and effectiveness of drug eluting stent implantation in the real world scenario (RODESINO registry)
Background. Medium-term outcome of patients with percutaneous coronary interventions (PCIs) is related to in-stent restenosis, which represents the main drawback for PCIs. Recent clinical studies have shown a decrease of restenosis rate from 25% to less than 10%, using sirolimus eluting stents (DES). However, “real-life” DES restenosis, by comparison with similar patients receiving BMS, has not been enough reported.
Methods. We performed a controlled registry study (“case control study”) over a period of 44 months, including all patients who received ≥ 1 sirolimus eluting stent, comparing them to a control group of patients who received ≥ 1 bare metal stent (BMS). Primary end-point was the clinical restenosis (defined clinically and/or by ECG exercise test); when clinical restenosis was suspected, coronary angiography was repeated. Secondary end-points were major adverse cardiac events (MACE).
Results. 448 patients were included into the controlled registry study: 224 DES patients (58±10 years, 75% males), compared to 224 age- and sex-matched BMS patients. 268 DES were used in 260 lesions, versus (vs.) 298 BMS used in 278 lesions. Major cardiovascular risk factors prevalence was: diabetes mellitus 26% vs. 11%, p=0.0001; arterial hypertension 79% vs. 72%, p=0.065; hypercholesterolemia 90% vs. 79%, p=0.001, in DES and BMS groups, respectively. 52% vs. 40% patients (p=0.005) associated at least 3 risk factors, and 16% vs. 3.5% patients had four major risk factors. 71% vs. 43% patients (p=0.0001) had previous myocardial infarction. 8% vs. 0.3% (p=0.001) stents were used for intrastent restenosis. Target vessel was LAD in 66% vs. 45% patients (p=0.003); left circumflex in 12% vs. 24% (p=0.012); and RCA in 20% vs. 31% (p=0.05). 71% vs. 41% (p= 0.0001) were lesions with RVD ≤ 3 mm, and 88% vs. 51% (p= 0.0001) were lesions longer than 15 mm. 3 cases of clinical restenosis were suspected in the DES group, confirmed by coronary angiography in 2 patients (0.9%), whereas 20 cases of clinical restenosis were suspected in the BMS group, confirmed by coronary angiography in 16 patients (7.0%) (p=0.001). 2.7% patients from the DES group had MACE, compared with 8.9% from the BMS group (p= 0.007). Myocardial infarction and total death did not differ significantly between the two groups.
Conclusions. By comparison with patients receiving BMS, patients who benefit from DES had more diabetes mellitus, more than 3 major cardiovascular risk factors, mainly LAD lesions, small and/or long vessel lesions. Clinically-driven in-stent restenosis was reduced from 7% to less than 1%, with a significant decrease of MACE.