Dissertation committee:
Ελένη Πετρίδου, Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Κωνσταντίνος Τούτουζας, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Μαρία Καντζανού, Επίκ. Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Κωνσταντίνος Τσιούφης, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ελευθέριος Τσιάμης, Αναπλ. Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Κωνσταντίνα Αγγέλη, Αναπλ. Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Δημήτριος Αλεξόπουλος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Summary:
In this Thesis, long-term outcomes of 600 patients with chronic stable angina and an isolated de-novo lesion in the pLAD that underwent PCI with Endeavor-zotarolimus eluting stents (E-ZES) (Ν=180) and everolimus eluting stents (EES) (Ν=420) were compared. Mean clinical follow-up was 54,9 + 25,6 months. The study's primary endpoint was Target Lesion Failure (TLF), defined by its composites in hierarchical order: cardiac death, non-fatal MI not clearly attributed to a non-target vessel and clinically-driven revascularization of the target lesion (Target Lesion Revascularization - TLR). Secondary endpoints were Patient-Related Outcome (PRO – a composite index of all-cause mortality, any myocardial infarction related to any coronary artery, any revascularization conducted to any coronary artery), stent thrombosis and the components of TLF (cardiac death, non-fatal myocardial infarction and TLR). The use of EES in isolated de-novo pLAD lesions, led to substantially reduced clinical events in comparison to E-ZES. At 5 years, statistically significant differences between the two groups in the cumulative probability for TLF (13.8% for the E-ZES group versus 7.5% for the EES group, p=0.025) and for TLR (10% for the E-ZES group versus 3.3% for the EES group, p=0.003) were observed. No difference was observed concerning the remaining clinical outcomes. Differences between stents regarding TLF increased after 30 months. In multivariate analysis predictors of TLF adjusted for stent type were Diabetes mellitus and impaired estimated Glomerular Filtration Rate (eGFR).
We also compared the long-term outcomes of PCI-DES and CABG with the left internal mammary artery in stable angina patients with isolated single-vessel pLAD disease. We included 631 PCI-DES patients and 379 CABG patients. The study’s primary endpoint was the occurrence of MACEs, namely, cardiac death, myocardial infarction not attributed to a non-target vessel and target lesion revascularization (using either the percutaneous or surgical technique) as a composite index. Secondary endpoints were Patient-Related Outcome, individual components of MACEs, recurrence of stable or unstable angina or a nonfatal arrhythmia (atrial fibrillation, atrial flutter or nonsustained ventricular tachycardia), duration of hospitalization, any complication (periprocedural or in-hospital) and CAD progression of other lesions (namely, nontarget vessel myocardial infarction, new onset of a nontarget vessel/lesion attributed stable angina determined by cardiac scintigraphy stress-test and/or angiography). Unadjusted and adjusted hazard ratios (HRs) were derived for all main outcomes. The main finding of the comparison was that long-term MACE rates were comparable between the two groups, despite a borderline significantly lower risk of repeat revascularization in the CABG group than in the PCI group. Moreover, no significant difference was observed between the two cohorts with respect to the risk of MACEs, PRO, cardiac death and nonfatal myocardial infarction. Compared with CABG, PCI-DES had a borderline significantly greater risk of repeat revascularization (HR:1.99, 95% CI:1.00-3.94, p=0.05; HR:1.95, 95% CI:0.98-3.9, p=0.06). The risk for the recurrence of stable angina was significantly increased in the PCI group compared to the CABG group (p<0.001), but the risk for non fatal arrhythmia occurrence (atrial fibrillation, atrial flutter or nonsustained ventricular tachycardia) was greater in the surgery group than in the PCI group (p=0.02). The surgical approach was associated with higher rates of in-hospital complications (p<0.001) and longer duration of hospitalization (p<0.001) compared with those in the PCI group.
In conclusion, both EES and E-ZES stents provided a favorable safety profile, with EES demonstrating better effectiveness regarding TLF and TLR. The long-term clinical outcomes of second-generation PCI-DES and CABG in patients with stable angina and isolated pLAD disease were comparable, highlighting the excellent long-term outcomes of both the surgical and DES-PCI approaches. A similar cardiac mortality rate and myocardial infarction risk might be slightly offset by an increased risk of repeat revascularization with second-generation DES-PCI in the treatment of isolated pLAD disease, although overall MACEs were similar.
Keywords:
Coronary artery bypass graft surgery, Coronary artery disease, Percutaneous coronary intervention, Coronary stent, Drug eluting stents (DES), Clinical effectiveness
