Supervisors info:
Σιάσος Γεράσιμος, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ, Επιβλέπων
Κυρίτση Ελένη, Καθηγήτρια, Τμήμα Νοσηλευτικής, Πανεπιστήμιο Δυτικής Αττικής
Τούσουλης Δημήτριος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Summary:
Hypothesis: Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is the cornerstone of secondary prevention of thrombotic events in patients undergoing percutaneous coronary intervention (PCI) and angioplasty, either in the context of acute coronary syndromes (ACS) or of stable coronary disease (CAD).
Purpose: To study the effect of long-term DAPT for 24 months compared to short-term DAPT ≤ 12 months in the prognosis of patients who have undergone PCI and angioplasty.
Methods: 469 patients [423 (90.2%) men], with a median age of 63.46 ± 10.33 years who underwent PCI and angioplasty, either in the context of ACS [104 (22.6%)] or stable CAD, participated into our prospective, non-invasive study. Patients received DAPT with a maintenance dose of aspirin 80-160mg and clopidogrel 75mg daily and they were categorized in Group A for DAPT ≤ 12 months and Group B for DAPT 24 months, based on the duration of DAPT they received. Patients were prospectively followed up for an average of 37 (25- 46) months for the onset of primary and secondary endpoints.
Results: There were no differences between the two groups regarding age, gender, history of diabetes mellitus, arterial hypertension, dyslipidemia, family history, atherosclerotic burden, previous PCI history, coronary artery bypass gradient (CABG). Patient who received DAPT for 24 months were more likely smokers (83.9% for DAPT 24 months, 74.2% for DAPT ≤12 months, p = 0.02). The extension of DAPT did not appear to affect the likelihood of a new ACS or cardiovascular death (HR = 0.57, p = 0.25). When we contacted a regression analysis model, family history (OR: 1.98, p = 0.04), history of previous PCI (OR: 1.98, p = 0.01), CABG history (OR: 3.48, p = ) and DAPT for 24 months (OR: 0.43, p = 0.001 DAPT≤12 months) were independent predictors of total morbidity and mortality after adjustment for age, gender, arterial hypertension, diabetes mellitus, dyslipidemia, smoking history, history of previous ACS and increased atherosclerotic burden. According to the Cox analysis, long-term DAPT remained an independent, favorable, prognostic indicator for total morbidity and mortality [HR: 0.67 (95% CI: 0.48-0.94) for 24 months DAPT, p = 0,02) after adjustment for the aforementioned factors. At the same time, family history (HR: 1.55, p = 0.02), history of previous PCI (HR: 1.59, p = 0.01) and CABG history (HR: 1.97, p = 0.01) remained independent, adverse prognostic factors for total morbidity and mortality. Survival analysis by Kaplan Meier showed that group survival with DAPT 24 months was significantly elevated [48 (44-53) vs. 44 (40-49) months, LogRank test p = 0.01] in comparison to the DAPT≤12 month group. The two groups did not differ in the incidence of major bleeding (HR: 0.48, p = 0.19) or bleeding of any severity (HR: 1.08, p = 0.76).
Conclusions: Extending the duration of dual antiplatelet administration to 24 months has a more favorable clinical efficacy on total morbidity and mortality than the administration over a shorter period, without compromising on the safety of the administered regimen.
