Abstract
Background
More evidence is needed on the optimal antithrombotic regimen in elderly patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI).
Hypothesis
Octogenarian patients (aged ≥80 years) with AF who underwent PCI have worse 12‐month clinical outcome, compared with younger patients.
Methods
We performed a post‐hoc analysis of data from the prospective, multicenter AFCAS registry, which enrolled consecutive patients with AF who underwent PCI and stenting. Outcome measures included major adverse cardiac/cerebrovascular events (MACCE; all‐cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack) and bleeding events at 12‐month follow‐up.
Results
Out of 925 AF patients enrolled in AFCAS registry, 195 (21.1%) were ≥80 years. Mean age was 82.9 ± 2.6 years; 41.5% were women; 32.3% had diabetes mellitus. Compared with patients aged <80 years, there were more females among the octogenarians (P < 0.001). Compared with younger patients, octogenarians smoked and had dyslipidemia less often, and presented more frequently with acute coronary syndrome. The frequency and duration of antithrombotic regimens prescribed at discharge were comparable. At 12‐month follow‐up, overall MACCE rate was higher in octogenarians compared with younger patients (27.7% vs 20.1%, P = 0.02). The rate of acute myocardial infarction was higher in octogenarians (9.2% vs 4.9%, P = 0.02), but the rates of all bleeds and BARC >2 bleeds were similar (P = 0.13, P = 0.29, respectively).
Conclusions
In real‐world patients with AF undergoing PCI, patients aged ≥80 years had higher incidence of MACCE at 12‐month follow‐up compared with younger patients, although they received comparable antithrombotic treatment. The rates of bleeding events were similar.
Keywords: Atrial Fibrillation, Octogenarians, Oral Anticoagulation, Percutaneous Coronary Intervention
1. INTRODUCTION
Life expectancy has increased in the Western world, and more octogenarian patients (aged ≥80 years) now undergo percutaneous coronary intervention (PCI) with stent implantation. Octogenarians have a high‐risk clinical profile and more complex coronary disease compared with younger patients.1 Expectedly, older age is associated with worse short‐term and long‐term clinical outcomes following PCI.2, 3 Yet limited evidence is available on the efficacy and safety of PCI in both elderly and female patients, because they are underrepresented in clinical trials.4
Prevalence of atrial fibrillation (AF) increases with age.5 Nearly 5% of patients undergoing PCI and stenting have an indication for long‐term oral anticoagulation (OAC) due to AF.6 The current management guidelines recommend triple therapy (dual antiplatelet therapy [DAPT] on top of OAC), at least for a short period after PCI.7 However, the optimal antithrombotic regimen in this particularly high‐risk group of older patients remains unclear, and there is a need for more data on antithrombotic treatment and outcomes of octogenarian patients with AF undergoing PCI.
We performed a post‐hoc analysis of data from the prospective Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS) Registry to explore the 12‐month clinical outcome of patients aged ≥80 years undergoing PCI in comparison with younger patients, with gender‐based analysis of outcome.
2. METHODS
2.1. Patient selection and study design
The AFCAS Registry is a prospective, multicenter, observational study that enrolled consecutive patients with AF undergoing PCI and stenting.8 The inclusion criterion was ongoing AF or a history of AF (paroxysmal, persistent, or permanent). The only exclusion criterion was unwillingness or inability to participate in the study or to give informed consent. In each participating center, PCI was performed according to local practice, and follow‐up time was 12 months. Periprocedural and postprocedural antithrombotic regimens were at the operators' discretion. Follow‐up was performed by phone calls or clinical controls at 1, 3, 6, and 12 months after PCI. Patients were asked about clinical outcome endpoints (described below), hospitalization, and medications. CHA2DS2‐VASc and HAS‐BLED scores were calculated before PCI to evaluate the individual risks for stroke and bleeding events, respectively.
This investigator‐driven study was conducted according to the guidelines of the 1964 Declaration of Helsinki as revised in 2013. The study protocol was approved by the ethics committees of the participating centers. Informed written consent was obtained from every patient after full explanation of the study protocol. The AFCAS Registry is registered under http://www.ClinicalTrials.gov at NCT00596570.
2.2. Study definitions and endpoints
The primary outcome measures were (1) major adverse cardiac/cerebrovascular events (MACCE) and (2) bleeding events. The composite endpoint of MACCE was defined as the first occurrence of all‐cause death, myocardial infarction (MI), repeat revascularization, stent thrombosis (ST), or stroke/transient ischemic attack. MI was defined according to the Third Universal Definition.9 Repeat revascularization was defined as PCI or coronary bypass surgery to treat significant stenosis (>50%) in the previously treated vessel. ST was adjudicated according to the criteria of definite or probable ST described by the Academic Research Consortium (ARC).10 TIA was defined as a transient (<24 hours) focal neurological deficit adjudicated by a neurologist, whereas stroke was defined as a permanent focal neurological deficit confirmed by computed tomography or magnetic resonance imaging and adjudicated by a neurologist. Bleeding events were defined according to the BARC criteria and included events adjudicated as minor (BARC 2) and major (BARC 3a, 3b, 3c, and 5).11
2.3. Statistical analysis
Continuous variables were reported as the mean ± SD or median (interquartile range [IQR]). Categorical variables were described with absolute and relative (percentage) frequencies. Comparisons were performed using the unpaired 2‐tailed t test for continuous variables and the Pearson χ2 test or Fisher exact test for categorical variables, as appropriate. Kaplan–Meier estimates of MACCE and all bleeding events were used to construct time‐to‐event curves. These estimates were based on all the available data for MACCE and all bleeding events, with follow‐up data censored at the time of first event or latest known follow‐up. All tests were 2‐sided, and statistical significance was set at 5%. Statistical analysis was performed using SPSS software, version 20 (IBM Corp., Armonk, NY).
3. RESULTS
3.1. Baseline clinical and procedural data
Out of 925 AF patients enrolled in the AFCAS registry, a total of 195 (21.1%) patients were ≥80 years: 189 (96.9%) were octogenarians and 6 (3.1%) nonagenarians (aged ≥90 years). Their mean age was 82.9 ± 2.6 years (median, 82; range, 80–92 years). Eighty‐one patients (41.5%) were females, and 63 (32.3%) had diabetes mellitus. Mean CHA2DS2‐VASC score was 5.1 ± 1.2 (median [IQR] 5 [2]) and mean HAS‐BLED score was 3.1 ± 0.7 (median [IQR] 3 [0]).
The octogenarians were more often females. They smoked and had dyslipidemia less often in comparison with younger patients, and their body mass index and glomerular filtration rate were lower (P < 0.01 for all). Patients aged ≥80 years had a higher risk of thromboembolism and bleeding (P < 0.001 both). The 2 groups were comparable regarding prior coronary and cerebrovascular events, prior bleeding events, as well as prior heart failure and mean left ventricular ejection fraction (P > 0.05 for all). These findings were almost consistent in both gender subgroups (Table 1).
Table 1.
Baseline characteristics
| Variable | Whole Cohort, N = 925 | Males, n = 650 | Females, n = 275 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| OG, n = 195 | Younger, n = 730 | P Value | OG, n = 114 | Younger, n = 536 | P Value | OG, n = 81 | Younger, n = 194 | P Value | |
| Age, y, mean ± SD | 82.9 ± 2.6 | 70.4 ± 6.7 | <0.001 | 83.0 ± 2.8 | 69.7 ± 7.1 | <0.001 | 82.9 ± 2.4 | 72.3 ± 5.3 | <0.001 |
| Age, y, median (IQR) | 82 (3) | 72 (8) | 82 (4) | 71 (9) | 83 (3) | 74 (6) | |||
| Female sex | 81 (41.5) | 194 (26.6) | <0.001 | ||||||
| BMI | 26.2 ± 3.5 | 28.8 ± 4.7 | <0.001 | 26.2 ± 23.2 | 28.7 ± 4.5 | <0.001 | 26.2 ± 3.9 | 29.1 ± 5.1 | <0.001 |
| Preprocedural GFR (ml/min/1.73m2) | 53 ± 19 | 80 ± 35 | <0.001 | 55.3 ± 19.4 | 84.1 ± 35.9 | <0.001 | 49.5 ± 18.5 | 69.3 ± 28.0 | <0.001 |
| LVEF, % | 49 ± 14 | 50 ± 14 | 0.41 | 48.4 ± 14.8 | 48.5 ± 14.0 | 0.95 | 49.2 ± 11.9 | 53.3 ± 13.6 | 0.041 |
| DM | 63 (32.3) | 274 (37.5) | 0.18 | 36 (31.6) | 189 (35.3) | 0.45 | 27 (33.3) | 85 (43.8) | 0.11 |
| HTN | 160 (82.1) | 616 (84.4) | 0.43 | 88 (77.2) | 447 (83.4) | 0.12 | 72 (88.9) | 169 (87.1) | 0.68 |
| Dyslipidemia | 114 (58.5) | 502 (68.8) | 0.007 | 62 (54.4) | 361 (67.4) | 0.008 | 52 (64.2) | 141 (72.7) | 0.16 |
| Smoking | 9 (4.6) | 83 (11.4)% | 0.005 | 7 (6.1) | 73 (13.6) | 0.027 | 2 (2.5) | 10 (5.2) | 0.32 |
| Prior MI | 57 (29.2) | 179 (24.5) | 0.18 | 35 (30.7) | 140 (26.1) | 0.32 | 22 (27.2) | 39 (20.1) | 0.20 |
| Prior PCI | 25 (12.8) | 135 (18.5) | 0.063 | 16 (14.0) | 99 (18.5) | 0.26 | 9 (11.1) | 36 (18.6) | 0.13 |
| Prior CABG | 21 (10.8) | 113 (15.5) | 0.097 | 19 (16.7) | 97 (18.1) | 0.72 | 2 (2.5) | 16 (8.2) | 0.08 |
| Prior HF | 43 (22.1) | 142 (19.5) | 0.42 | 29 (25.4) | 110 (20.5) | 0.25 | 14 (17.3) | 32 (16.5) | 0.87 |
| Prior stroke | 26 (13.3) | 85 (11.6) | 0.52 | 16 (14.0) | 64 (11.9) | 0.54 | 10 (12.3) | 21 (10.9) | 0.72 |
| Prior TIA | 9 (4.6) | 37 (5.1) | 0.80 | 4 (3.5) | 30 (5.6) | 0.36 | 5 (6.2) | 7 (3.6) | 0.34 |
| Prior hemorrhage | 9 (4.6) | 29 (4.0) | 0.70 | 6 (5.3) | 22 (4.1) | 0.59 | 3 (3.7) | 7 (3.6) | 0.98 |
| CHA2DS2‐VASc score | 5.1 ± 1.2 | 4.2 ± 1.5 | <0.001 | 4.7 ± 1.1 | 3.8 ± 1.4 | <0.001 | 5.8 ± 1.1 | 5.1 ± 1.3 | <0.001 |
| CHA2DS2‐VASc ≥2 | 195 (100) | 716 (98.1) | <0.001 | 114 (100) | 522 (97.4) | 0.081 | 81 (100) | 194 (100) | 1.0 |
| HAS‐BLED score | 3.1 ± 0.7 | 2.9 ± 0.7 | <0.001 | 3.1 ± 0.8 | 2.9 ± 0.8 | 0.007 | 3.2 ± 0.6 | 3.0 ± 0.7 | 0.030 |
| HAS‐BLED ≥3 | 167 (85.6) | 540 (74.0) | 0.001 | 92 (80.7) | 384 (71.6) | 0.047 | 75 (92.6) | 156 (80.4) | 0.012 |
Abbreviations: BMI, body mass index; CABG, coronary artery bypass grafting; CHA2DS2‐VASc, congestive HF, HTN, age > 75 y, DM, stroke/TIA, vascular disease, age 65–74 y, sex category (female); DM, diabetes mellitus; GFR, glomerular filtration rate; HAS‐BLED, HTN, abnormal renal and liver function, stroke, bleeding history or predisposition, labile INR, elderly age > 65 years; HF, heart failure; HTN, hypertension; INR, international normalized ratio; IQR, interquartile range; LVEF, left ventricular ejection fraction; MI, myocardial infarction; OG, octogenarians; PCI, percutaneous coronary intervention; SD, standard deviation; TIA, transient ischemic attack.
Categorical variables are presented as n (%) and continuous variables as mean ± SD or median (IQR).
Compared with younger patients, the patients aged ≥80 years presented more often with acute coronary syndrome (ACS). This was consistent in males (P < 0.001), but not in females (P = 0.23). There was no significant difference in the use of drug‐eluting stents or other periprocedural data between the 2 groups (Table 2).
Table 2.
Procedural data
| Variable | Whole Cohort, N = 925 | Males, n = 650 | Females, n = 275 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| OG, n = 195 | Younger, n = 730 | P Value | OG, n = 114 | Younger, n = 536 | P Value | OG, n = 81 | Younger, n = 194 | P Value | |
| Presentation by ACS | 135 (69.6) | 392 (53.7) | <0.001 | 81 (71.1) | 276 (51.5) | <0.001 | 54 (67.5) | 116 (59.8) | 0.23 |
| STEMI | 32 (16.5) | 93 (12.7) | 0.18 | 17 (14.9) | 68 (12.7) | 0.52 | 15 (18.5) | 25 (12.9) | 0.23 |
| Lesions per patient | 1.2 ± 0.4 | 1.2 ± 0.4 | 0.64 | 1.2 ± 0.5 | 1.2 ± 0.4 | 0.15 | 1.1 ± 0.3 | 1.2 ± 0.4 | 0.30 |
| DES | 38 (20.3) | 181 (25.8) | 0.12 | 20 (17.9) | 138 (26.3) | 0.061 | 18 (22.8) | 44 (23.0) | 0.96 |
| Total stent length (mm) | 24.6 ± 16.8 | 25.0 ± 16.3 | 0.75 | 26.4 ± 19.1 | 25.1 ± 16.9 | 0.47 | 22.2 ± 12.7 | 25.0 ± 14.3 | 0.13 |
| Procedural success | 190 (97.4) | 707 (96.8) | 0.67 | 110 (96.5) | 515 (96.1) | 0.84 | 80 (98.8) | 192 (99.0) | 0.88 |
| Radial access | 57 (29.2) | 201 (27.5) | 0.64 | 39 (34.2) | 149 (27.8) | 0.17 | 18 (22.2) | 52 (26.8) | 0.43 |
| Hospital stay (days) | |||||||||
| Mean ± SD | 5.9 ± 7.8 | 4.8 ± 7.5 | 0.050 | 5.4 ± 6.9 | 5.0 ± 8.2 | 0.61 | 6.7 ± 8.9 | 4.0 ± 4.6 | 0.001 |
| Median (IQR) | 4 (5) | 2 (5) | 3 (5) | 2 (5) | 4 (6) | 2 (5) | |||
| TTR (%) | 68 ± 34 | 68 ± 34 | 0.87 | 71 ± 33 | 68 ± 32 | 0.38 | 64 ± 34 | 68 ± 33 | 0.46 |
Abbreviations: ACS, acute coronary syndrome; DES, drug‐eluting stents; IQR, interquartile range; OG, octogenarians; PCI, percutaneous coronary intervention; SD, standard deviation; STEMI, ST‐segment elevation myocardial infarction; TTR, time in therapeutic range.
Categorical variables are presented as n (%) and continuous variables as mean ± SD or median (IQR).
3.2. Antithrombotic regimens
Among patients aged ≥80 years, triple therapy (OAC + clopidogrel + aspirin) was the most common antithrombotic regimen prescribed at discharge (70.3%), followed by DAPT (clopidogrel + aspirin; 19.5%). The mean duration of clopidogrel use was 5.7 ± 4.8 months. The frequency of antithrombotic regimens prescribed at discharge was comparable between octogenarians and younger patients (Table 3). The proportions of patients on clopidogrel were comparable between patients aged ≥80 years and younger patients at 3, 6, 9, and 12 months (61.8% vs 64.9%, 45.3% vs 44.7%, 35.3% vs 33.7%, and 33.5% vs 30.4%, respectively); similarly, the proportions of patients on aspirin were comparable (75.4% vs 77.3%, 67.7% vs 70.1%, 64.1% vs 64.9%, and 60.0% vs 61.4%, respectively).
Table 3.
Antithrombotic and cardiac medications
| Variable | Whole Cohort, N = 925 | Males, n = 650 | Females, n = 275 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| OG, n = 195 | Younger, n = 730 | P Value | OG, n = 114 | Younger, n = 536 | P Value | OG, n = 81 | Younger, n = 194 | P Value | |
| Periprocedural INR | 1.9 ± 0.6 | 1.9 ± 0.7 | 0.98 | ||||||
| GPI | 41 (21.0) | 139 (19.0) | 0.53 | 25 (21.9) | 107 (20.0) | 0.64 | 16 (19.8) | 32 (16.5) | 0.52 |
| VKA + Clop + ASA | 137 (70.3) | 541 (74.1) | 0.28 | 80 (70.2) | 401 (74.8) | 0.31 | 57 (70.4) | 140 (72.2) | 0.76 |
| VKA + Clop/ASA | 20 (10.3) | 66 (9.0) | 0.60 | 14 (12.3) | 51 (9.5) | 0.37 | 6 (7.4) | 15 (7.7) | 0.93 |
| Clop + ASA | 38 (19.5) | 123 (16.8) | 0.39 | 20 (17.5) | 84 (15.7) | 0.62 | 18 (22.2) | 39 (20.1) | 0.69 |
| Clop duration (months) | 5.7 ± 4.8 | 5.7 ± 4.7 | 1.0 | 5.7 ± 4.7 | 5.7 ± 4.7 | 1.0 | 5.8 ± 5.0 | 5.8 ± 4.7 | 0.96 |
| Median (IQR) (months) | 3 (11) | 3 (11) | 3 (11) | 3 (11) | 3 (11) | 3 (11) | |||
| β‐Blockers | 163 (83.6) | 640 (87.7) | 0.19 | 98 (86.0) | 468 (87.3) | 0.51 | 65 (80.2) | 172 (88.7) | 0.18 |
| Lipid‐lowering agents | 154 (79.0) | 637 (87.3) | 0.013 | 89 (78.1) | 465 (86.8) | 0.059 | 65 (80.2) | 172 (88.7) | 0.18 |
| ACEIs/ARBs | 158 (84.9) | 573 (80.5) | 0.16 | 89 (81.7) | 419 (80.1) | 0.71 | 69 (89.6) | 154 (81.5) | 0.10 |
Abbreviations: ACEI, angiotensin‐converting enzyme inhibitors; ARB, angiotensin receptor blockers; ASA, acetylsalicylic acid (aspirin); Clop, clopidogrel; GPI, glycoprotein IIb/IIIa inhibitors; INR, international normalized ratio; IQR, interquartile range; OG, octogenarians; SD, standard deviation; VKA, vitamin K antagonists.
Categorical variables are presented as n (%) and continuous variables as mean ± SD or median (IQR).
3.3. Short‐term and long‐term outcome
Adverse outcome events are summarized in Table 4. The cumulative incidence of MACCE in patients aged ≥80 years was comparable during hospital stay and at 30 days, but significantly higher at 12 months (P = 0.02), in comparison with younger patients. There was a similar trend in both gender subgroups (P = 0.09 both). This was mainly driven by a higher incidence of MI shortly after index PCI and at 12 months. A trend to higher all‐cause mortality rate was evident at 12‐month follow‐up only. Despite a higher incidence of MI, the rate of repeat revascularization was not different between octogenarians and younger patients. The cumulative rates of BARC >2 bleeds were 12.3% vs 9.7% (P = 0.29) in patients ≥80 years compared with younger patients, respectively, and this was consistent in both gender subgroups.
Table 4.
Clinical outcome at 12‐month follow‐up
| Variable | Whole Cohort, N = 925 | Males, n = 650 | Females, n = 275 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| OG, n = 195 | Younger, n = 730 | P Value | OG, n = 114 | Younger, n = 536 | P Value | OG, n = 81 | Younger, n = 194 | P Value | |
| MACCE | |||||||||
| 12 months | 54 (27.7) | 147 (20.1) | 0.023 | 32 (28.1) | 112 (20.9) | 0.09 | 22 (27.2) | 35 (18.0) | 0.09 |
| 30 days | 14 (7.2) | 51 (7.0) | 0.93 | 9 (7.9) | 36 (6.7) | 0.65 | 5 (6.2) | 15 (7.7) | 0.65 |
| In‐hospital | 7 (3.6) | 31 (4.3) | 0.67 | 4 (3.5) | 24 (4.5) | 0.64 | 3 (3.7) | 7 (3.7) | 0.99 |
| Death | |||||||||
| 12 months | 29 (14.9) | 74 (10.1) | 0.06 | 18 (15.8) | 56 (10.4) | 0.10 | 11 (13.6) | 18 (9.3) | 0.29 |
| 30 days | 6 (3.1) | 26 (3.6) | 0.74 | 4 (3.5) | 17 (3.2) | 0.85 | 2 (2.5) | 9 (4.6) | 0.40 |
| In‐hospital | 5 (2.6) | 14 (1.9) | 0.58 | 2 (1.8) | 10 (1.9) | 0.93 | 3 (3.7) | 4 (2.1) | 0.44 |
| MI | |||||||||
| 12 months | 18 (9.2) | 36 (4.9) | 0.023 | 11 (9.6) | 23 (4.3) | 0.020 | 7 (8.6) | 13 (6.7) | 0.57 |
| In‐hospital | 6 (3.4) | 9 (1.3) | 0.062 | 3 (2.9) | 6 (1.2) | 0.20 | 3 (4.0) | 3 (1.6) | 0.25 |
| Re‐revascularization | 59 (8.1) | 14 (7.2) | 0.68 | 8 (7.0) | 43 (8.0) | 0.72 | 6 (7.4) | 16 (8.2) | 0.82 |
| ST | 5 (2.6) | 10 (1.4) | 0.24 | 3 (2.6) | 7 (1.3) | 0.30 | 2 (2.5) | 3 (1.5) | 0.60 |
| Stroke/TIA | 8 (4.1) | 15 (2.1) | 0.10 | 4 (3.5) | 12 (2.2) | 0.42 | 4 (4.9) | 3 (1.5) | 0.10 |
| All TE | 10 (5.1) | 20 (2.7) | 0.09 | 5 (4.4) | 16 (3.0) | 0.44 | 5 (6.2) | 4 (2.1) | 0.08 |
| All bleeding | |||||||||
| 12 months | 51 (26.2) | 154 (21.1) | 0.13 | 31 (27.2) | 102 (19.0) | 0.050 | 20 (24.7) | 52 (26.8) | 0.72 |
| In‐hospital | 26 (13.3) | 77 (10.5) | 0.27 | 14 (12.3) | 55 (10.3) | 0.53 | 12 (14.8) | 22 (11.3) | 0.43 |
| BARC >2 | |||||||||
| 12 months | 24 (12.3) | 71 (9.7) | 0.29 | 15 (13.2) | 44 (8.2) | 0.10 | 9 (11.1) | 27 (13.9) | 0.53 |
| In‐hospital | 9 (4.6) | 31 (4.2) | 0.82 | 4 (3.5) | 22 (4.1) | 0.77 | 5 (6.2) | 9 (4.6) | 0.60 |
Abbreviations: BARC, Bleeding Academic Research Consortium; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial infarction; OG, octogenarians; ST, stent thrombosis; TE, thromboembolism; TIA, transient ischemic attack.
Data are presented as n (%).
4. DISCUSSION
The AFCAS Registry shows that octogenarians have a higher incidence of MACCE at 12 months despite comparable antithrombotic regimens, mainly driven by higher incidence of MI. On the other hand, the bleeding rates were not significantly different between octogenarians and younger patients.
Few data exist on the optimal antithrombotic regimen in older patients with AF who need lifelong OAC and undergo PCI. In the randomized trials What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary Stenting (WOEST), A Study Exploring Two Strategies of Rivaroxaban and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention (PIONEER AF‐PCI), and Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL‐PCI), the proportion of patients aged ≥80 years was not separately reported.12, 13, 14 In the WOEST and PIONEER AF‐PCI trials, a regimen of dual therapy with OAC (vitamin K antagonist and rivaroxaban, respectively) plus a P2Y12 inhibitor was associated with lower rates of clinically significant bleeding compared with triple therapy (OAC + P2Y12 inhibitor + aspirin).12, 13 In the recently reported REDUAL‐PCI trial, dual therapy with OAC (dabigatran 110 mg twice daily) plus P2Y12 inhibitor was associated with lower rates of clinically relevant bleeding compared with warfarin triple therapy (warfarin + P2Y12 inhibitor + aspirin for 1–3 months).14 In all 3 trials, the rates of thromboembolic events were not significantly different between the 2 comparison groups; however, the 3 trials were underpowered to examine thromboembolic events (composite efficacy endpoint).12, 13, 14 Moreover, in the WOEST trial (69% of patients had AF), reduction of bleeding was driven by reduction of minor, rather than major, bleeding events12; the PIONEER AF‐PCI trial excluded patients with prior stroke or transient ischemic attack and those with new‐onset AF13; and REDUAL‐PCI trial excluded those with severe renal impairment.14 In the current registry, the prescribed antithrombotic regimens (medications, dosage, and duration) were widely heterogeneous because they were based on local practice and operators' discretion.
Unanswered questions include the duration of each antithrombotic medication and the change of antithrombotic regimen over time. Our findings provide important clinical data in this setting. In real‐life practice, the duration of intensified antithrombotic therapy after PCI is often shortened in elderly patients because of a presumed higher bleeding risk. As expected, octogenarians in our cohort had a higher HAS‐BLED score. The higher bleeding risk did not, however, lead to a less intensive antithrombotic treatment in octogenarians; and, surprisingly, both the total and clinically significant bleeding event rates did not differ between the age groups. The comparable 12‐month bleeding rates, despite a higher bleeding risk in octogenarians, might by viewed in light of the similar periprocedural international normalized ratio, similar time in therapeutic range throughout the follow‐up period, and similar duration of clopidogrel usage in the 2 age groups. Comparably, in an unselected cohort of patients with AF undergoing PCI, octogenarians (higher bleeding and thrombotic risk scores) experienced more MACCE (mainly driven by higher rates of all‐cause death and embolism), higher major bleeding rates, and similar minor bleeding rates, compared with younger patients.15 In that cohort, OAC prescribed at discharge for octogenarian patients was associated with lower rates of MACCE.15 Notably, octogenarian women—often considered as “extra‐frail” patients—had bleeding rates comparable with octogenarian men, and with younger women. Given the higher rates of thrombotic events and the comparable rates of bleeding events in octogenarians, and the largely comparable distribution of prescribed antithrombotic medications between the 2 age groups, our study supports the view that longer antithrombotic treatment might be considered in octogenarians, especially in those presenting with ACS. This assumption, however, needs to be confirmed in adequately powered randomized trials.
In accordance with a previous study,16 octogenarians in the AFCAS registry presented more often with ACS compared with younger patients. In the same prior study, octogenarians (65.5% drug‐eluting stents vs 80.1% in younger patients) had higher rates of mortality, ST, and clinically driven in‐stent restenosis at 12‐month follow‐up, compared with younger patients.16 This may partly explain the higher incidence of MI events, and consequently the higher incidence of MACCE, at 12‐month follow‐up in octogenarians in our cohort. In the AFCAS study, older patients were not treated more frequently with bare‐metal stents, as is often recommended to enable shorter DAPT (Table 2). Octogenarians treated with PCI have more comorbidities compared with younger patients,16, 17 and this may affect noncardiac causes of mortality as well. Yet in a cohort of octogenarians who underwent PCI for ACS, cardiovascular death was responsible for 71% of all‐cause mortality at 5‐year follow‐up.18
Increasing age is a well‐known risk factor for mortality after PCI. Not surprisingly, the proportion of patients aged ≥80 years (21.1%) in the AFCAS registry was higher than recent reports from unselected patients (12%)19 and from patients who underwent primary PCI for ST‐segment elevation MI (10.3% and 11.6%).20, 21 This is comprehensible because the prevalence of AF increases progressively with age.
4.1. Study limitations
The current study has all the inherent limitations of an observational study design, including unmeasured confounders and individual decision‐making in treatment choice. Another limitation is the heterogeneity of cohort among the participating centers and some variations in periprocedural routines. The statistical power of our study is limited by the absolute low rates of ST and stroke and a relatively small sample size. Therefore, lack of significant difference between comparison groups might be due to type II statistical error. We could not provide data on adherence to OAC and antiplatelet medications in either group. The strength of the registry is enrollment of consecutive patients with the only exclusion criterion being unwillingness or inability to participate. In this sense, the registry cohort well represents real‐world patients with AF referred for PCI.
5. CONCLUSION
In a real‐world cohort of patients with AF who underwent PCI, patients aged ≥80 years had a higher incidence of MACCE at 12‐month follow‐up in comparison with younger patients, although they received comparable antithrombotic treatment. The bleeding events did not differ between octogenarians and younger patients, despite higher bleeding risk assessed by HAS‐BLED score.
ACKNOWLEDGMENTS
The authors thank the study coordinator, Tuija Vasankari, RN, for her valuable input in data management.
Conflicts of interest
The authors declare no potential conflicts of interest.
Author contributions
Heli M. Lahtela, MD, and Aissa Bah, MD, contributed equally to this work.
Lahtela HM, Bah A, Kiviniemi T, et al. Outcome of octogenarians with atrial fibrillation undergoing percutaneous coronary intervention: insights from the AFCAS registry. Clin Cardiol. 2017;40:1264–1270. 10.1002/clc.22821
Funding information This research was supported by the Finnish Foundation for Cardiovascular Research, Helsinki, Finland, and the Clinical Research Fund (EVO) of Turku University Hospital, Turku, Finland.
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