Research Article: Second-generation drug-eluting stents in the elderly patients with acute coronary syndrome: the in-hospital and 12-month follow-up of the all-comer registry

Date Published: November 10, 2016

Publisher: Springer International Publishing

Author(s): Wojciech Wańha, Damian Kawecki, Tomasz Roleder, Beata Morawiec, Sylwia Gładysz, Adam Kowalówka, Tomasz Jadczyk, Barbara Adamus, Tomasz Pawłowski, Grzegorz Smolka, Maciej Kaźmierski, Andrzej Ochała, Ewa Nowalany-Kozielska, Wojciech Wojakowski.

http://doi.org/10.1007/s40520-016-0649-8

Abstract

Katowice–Zabrze registry provides data that can be used to evaluate clinical outcomes of percutaneous coronary interventions in elderly patients (≥70 y/o) treated with either first- (DES-I) or second-generation (DES-II) drug-eluting stents (DES).

The registry consisted of data from 1916 patients treated with coronary interventions using either DES-I or DES-II stents. For our study, we defined patients ≥70 years of age as elderly. We evaluated any major adverse cardiac and cerebral events (MACCE) at 12-month follow-up.

Coronary angiography revealed a higher incidence of multivessel coronary artery disease in this elderly patient population. There were no differences in acute and subacute stent thrombosis (0.4 vs. 0.6%, p = 0.760; 0.4 vs. 0.4%; p = 0.712). Elderly patients experienced more in-hospital bleeding complications requiring blood transfusion (2.0 vs. 0.9%; p = 0.003). Resuscitated cardiac arrests (2.0 vs. 0.9%; p = 0.084) were observed more often in this elderly patients during hospitalization. The composite in-hospital MACCE rates did not differ statistically between both groups (1.4 vs. 1.1%; p = 0.567). Data from a twelve-month follow-up disclosed that mortality was higher (7.1 vs. 1.8%; p < 0.001) in the elderly, with no difference in TVR (7.2 vs. 9.9%, p = 0.075), MI (6.0 vs. 4.8%, p = 0.300), stroke (0.8 vs. 0.6%, p = 0.600) and composite MACCE (15.0 vs. 13.4%, p = 0.324). The age of 70 years or over was an independent predictor of death [HR = 2.55 (95% CI 1.49–4.37); p < 0.001]. The use of DES-II reduced the risk of MI [HR = 0.40 (95% CI 0.19–0.82); p = 0.012] in the elderly. This elderly patient population had an increased risk of in-hospital bleeding complications requiring blood transfusion and a higher risk of death at 12-month follow-up. The use of new-generation DES reduced the risk of MI in the elderly population.

Partial Text

Elderly patients represent an increasing percentage of the population undergoing percutaneous coronary interventions (PCI) [1]. This trend is due, in part, to a prolonged life expectancy and better access to medical care. However, advanced age is associated with poor outcomes in patients with acute coronary syndromes (ACS), stable coronary artery disease (CAD) treated with PCI and bypass surgery as well as in patients with heart failure [2–4]. Elderly patients undergoing PCI have a significantly higher burden of comorbidities.

The Katowice–Zabrze registry contains data that included 1916 patients treated with either first- (paclitaxel and sirolimus eluting; 33.6%) or second-generation (everolimus, zotarolimus, biolimus A9 eluting, 66.4%) DES in two tertiary Silesian cardiology centers. We obtained and recorded retrospective data which included baseline characteristics, cardiac history, risk factors, medications, angiographic and procedural data. For our study, we defined patients ≥70 years of age as elderly. Angiographic data were collected in all patients undergoing PCI and recorded in the cardiovascular information registry. SYNTAX scores were calculated for all patients except these with prior CABG (coronary artery bypass graft). For patients with the occluded infarct-related artery, SYNTAX scores were calculated based on baseline angiography. Two observers estimated the SYNTAX scores, in cases where the SYNTAX score consensus could not be made; the angiography was excluded from this analysis. The primary efficacy endpoint was a composite of major adverse cardiac and cerebral events (MACCE), including all-cause death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and stroke during the in-hospital stay and at 12-month follow-up. The secondary endpoints were individual components of the primary endpoint (all-cause death, MI, TVR, stroke) and in-hospital bleeding complications. The safety of DES was defined as definite stent thrombosis (acute, subacute, late). TVR, definite stent thrombosis, acute, subacute and late stent thrombosis were defined according to the definitions of endpoints for clinical trials [9]. Gastrointestinal bleeding was considered an endpoint if it fulfilled criteria for type 3 or type 5 bleeding complication according to proposed definitions [10]. Data regarding outcomes (MACCE and gastrointestinal bleeding) at 12-month were obtained from the database of the National Health Fund Service (Ministry of Health).

Statistical analysis was performed using MedCalc Software (v.12 Belgium). Continuous data were presented as mean ± standard deviation and median with interquartile range (Q1–Q3). Qualitative data were expressed as crude values and/or percentages. Between-group differences for quantitative variables were assessed using Mann–Whitney U test for non-normally distributed data and one-way ANOVA for normally distributed data. Chi-square test was used for qualitative variables. Data distribution was verified with Smirnov–Kolmogorov test. The univariable analysis was performed to determine the risk factors for death at 12-month follow-up. Variables with p values less than 0.05 entered the multivariate analysis model to estimate independent risk factors of death at 12-month follow-up. Kaplan–Meier curves were used to present the unadjusted time-to-event data for investigated end-points. A value of 2-tailed p < 0.05 was considered significant. The registry included 1916 patients referred for PCI because of unstable angina (UA) [1500 (78.2%)], non-ST-segment elevation myocardial infarction (NSTEMI) [285 (14.8%)] and ST-segment elevation myocardial infarction (STEMI/LBBB) [131(6.8%)] (Table 1). Five hundred sixty-three patients (29.4%) were ≥70 years of age compared to one thousand, three hundred and fifty-three patients (70.6%) ≤70 years of age. There were fewer men in the elderly group, and elderly patients had a higher prevalence of hypertension, diabetes, chronic kidney disease, anemia, chronic obstructive pulmonary disease, carotid artery disease and neoplasm, as compared to the younger group. The elderly patients were more often hospitalized because of NSTEMI and had a higher prevalence of GRACE risk score over 140. The length of hospital stay was also longer in elderly patients (5.0 IQR 4–7 vs. 4.0 IQR 3–6, p < 0.001). Younger patients had more dyslipidemia, family history of CAD, and were more often current smokers. There were no differences regarding the history of myocardial infarction, previous PCI and CABG between the elderly and younger patients’ groups. Elderly patients had a lower LVEF (50% IQR 44.0–58.0 vs. 55% IQR 46.0–60.0; p = 0.001) when compared to the younger group (Table 1).Table 1Patients characteristics, risk factors and clinical presentation according to the ageAge <70n = 1353 (70.6%)Age ≥70n = 563 (29.4%)pDemographic data Male, n (%)944 (69.7)292 (51.8)<0.001 BMI (kg/m2), median (IQR)28.7 (25.8–31.6)28.4 (25.5–31.4)0.623Discharge diagnosis UA, n (%)1074 (79.4)426 (75.6)0.082 NSTEMI, n (%)178 (13.2)107 (19.0)0.001 STEMI/LBBB, n (%)101 (7.5)30 (5.3)0.112CAD history Previous MI, n (%)638 (47.2)277 (49.2)0.443 Previous PCI, n (%)744 (55.0)320 (56.8)0.489 Previous CABG, n (%)277 (20.5)121 (21.4)0.660CAD risk factors Hypertension, n (%)1137 (84.0)506 (89.9)0.001 Dyslipidemia, n (%)946 (69.9)318 (56.5)<0.001 CKD, n (%)141 (10.4)190 (33.7)<0.001 Anemia, n (%)113 (8.4)104 (18.5)<0.001 Diabetes mellitus, n (%)440 (32.5)277 (49.2)<0.001 Current smoking, n (%)418 (30.9)46 (8.2)<0.001 Family history of CAD, n (%)501 (37.0)127 (22.6)<0.001Concomitant disease Cancer, n (%)63 (4.7)54 (9.6)<0.001 COPD, n (%)64 (4.7)53 ( (9.4)<0.001 PAD, n (%)147 (10.9)71 (12.6)0.308 Carotid artery disease, n (%)64 (4.7)49 (8.7)0.002 Obesity, n (%)319 (23.6)122 (21.7)0.398 Length of hospital stay (day), median (IQR)4.0 (3–6)5.0 (4–7)<0.001Left ventricular function, n (%) <30%81 (6.0)32 (5.7)0.890 30–50%292 (21.6)162 (28.8)<0.001 >50%964 (71.2)361 (64.1)0.002 LVEF, median (IQR)55.0 (46.0–60.0)50.0 (44.0–58.0)0.001Laboratory (on admission) GFR (ml/min/1.73 m2), median (IQR)88.2 (73.5–97.3)67.7 (55.1–82.3)<0.001 Hemoglobin, (g/dl), median (IQR)14.4 (13.5–15.2)13.6 (12.7–14.5)<0.001Clinical status on admission HR, (bpm), median (IQR)70 (60–80)70 (60–76)0.935 SBP, (mmHg), median (IQR)130 (120–145)140 (125–150)<0.001 GRACE score > 140, n (%)84 (6.2)52 (9.2)0.007CKD was defined as estimated GFR (eGFR) <60 60 ml/min/1.73 m2 calculated using the modification of diet in renal disease (MDRD) methodBMI body mass index, UA unstable angina, NSTEMI non-ST-segment elevation myocardial infarction, STEMI ST-segment elevation myocardial infarction, CAD coronary artery disease, MI myocardial infarction, PCI percutaneous coronary intervention, CABG coronary artery bypass graft, CKD chronic kidney disease, COPD chronic obstructive pulmonary disease, PAD peripheral artery disease, HR heart rate, SBP systolic blood pressure We were able to observe during this study that a high proportion of patients hospitalized with ACS were age 70 or over. ACS is known as an important risk factor for cardiovascular events. The main results from our current analysis obtained from Katowice–Zabrze registry’ data are that elderly patients have higher rates of death in a one-year follow-up study, more bleeding complications post-PCI, requiring blood transfusions despite the fact that they do not have a higher risk of acute, subacute and late stent thrombosis. The presence of both risk factors (age and acute presentation) identified a cohort of patients with a high risk of complications after PCI [4, 11, 12]. The current study demonstrated some significant differences between patients representing these two age ranges. Similarly to results observed in other analysis, elderly patients from our registry carry a higher risk of adverse events. They have a higher percentage of comorbidities: hypertension, diabetes, chronic kidney disease, chronic obstructive pulmonary disease, heart failure and higher GRACE risk score as compared to younger group [13, 14]. Our elderly group did not manifest typical angina as would be expected since time to reperfusion in ACS is longer [15, 16]. Analysis of available angiographic data demonstrated that this population of elderly patients differed regarding the complex coronary atherosclerotic lesions when compared to our younger patient groups. As observed in a study by Rosengren et al. [14], these patients have more often multivessel disease and more complex PCI such as left main or saphenous vein graft interventions. Moreover, there were also differences in the efficacy of PCI. Dziewierz et al. [5] analyzed 1650 patients with STEMI and analyzed the outcomes in age strata (<65, 65–74, 75–84 and ≥85 years). They demonstrated that elderly patients were less likely to achieve TIMI 3 flow and ST-segment resolution after PCI and were more likely to have PCI complications. Patients were not randomized as to a choice of stent implantation (DES first or second generation), so there was no balance between DES-I and DES-II. There was no information on drugs used before admission to the hospital, especially those with a known impact on the occurrence of bleeding. There was no information about the duration of medication (e.g., patients taking clopidogrel, prasugrel) after PCI. Elderly patients had an increased risk of in-hospital bleeding requiring blood transfusion and had a higher risk of death at 12-month follow-up. The use of the new generation of DES reduced the risk of MI in the elderly at 12-month follow-up.   Source: http://doi.org/10.1007/s40520-016-0649-8

 

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