Claudiu STOICESCU, Vlad VINTILA, Cristian UDROIU, Nicolae FLORESCU, Aws DAWOOD, Mircea CINTEZA and Dragos VINEREANU

ABSTRACT

Background: Stent thrombosis (ST) is a rare, but extremely severe complication of PCI. Outside clinical trials, data are limited regarding the risks and the impact of this phenomenon.

Aims: To assess prevalence, predictors, and clinical outcome of ST after implantation of drug eluting stents (DES) compared with bare metal stents (BMS), in a large case-control study in a real world scenario, as well as the relation between ST and duration of combined antiplatelet treatment.

Methods: In a case-control registry we included 475 patients who received at least 1 DES (sirolimus, zotarolimus, everolimus, paclitaxel), compared with a group of 475 patients who received at least 1 BMS. We used 1.22 DES/patient vs. 1.26 BMS/patient (p=ns), treating 1.02 DES/lesion vs. 1.05 BMS/ lesion (p=ns). Main outcome was ST defined by the Academic Research Consortium (ARC) as definite (acute, sub-acute, late), probable, and possible.

Results: At 15 months we found 0.8% (4) patients in the DES group vs. 1.1% (5) patients in the BMS group with definite ST (ns); 0.4% (2) patients from each group had acute ST, while 0.4% (2) vs. 0.7% (3) patients had sub-acute ST (both comparisons were ns). None of the patients from the DES group died, whereas two patients with definite ST from the BMS group died, with a case fatality rate of 40% (2/5). 0.2% (1) patient from each group had probable ST (ns) and 0.6% (3) vs. 0.4% (2) patients had possible ST (ns). Independent predictors of stent thrombosis in merged groups were antiplatelet therapy discontinuation (HR 3.8; 95%CI 1.9-7.6; p<0.01), diabetes (HR 2.15; 95%CI 1.4-5.1; p<0.01), a lower left ventricular ejection fraction (EF) (HR 1.1; 95%CI 1.0-1.9; p<0.01 for each 10% decrease), and LAD lesions (HR 1.0; 95%CI, 0.93-1.9; P<0.01).

Conclusions: ST is a rare complication (0.95%), similar after DES or BMS implantation. Premature discontinuation of antiplatelet therapy, followed by diabetes and a lower LVEF, are the independent predictors of ST.

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Claudiu STOICESCU, Alexandru BURLACU, Vlad VINTILA, Cristian UDROIU, Nicolae FLORESCU, Octavian PARVU, Mircea CINTEZA and Dragos VINEREANU

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.

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