Vol.47 - Número 3, Julio/Septiembre 2018 Imprimir sólo la columna central

Percutaneous coronary interventions in very elderly patients
referred for symptomatic coronary disease

ADOLFO FERRERO GUADAGNOLI, ALEJANDRO E. CONTRERAS,
MIGUEL A. BALLARINO, CARLOS R. LEONARDI,
JONATHAN MIARA, RENZO NUÑEZ, EDUARDO J. BRENNA
Hospital Privado Universitario de Córdoba.
(5016) Córdoba, Argentina.
E-mail
Recibido 15-ENE-18 – ACEPTADO despues de revision el 28-FEBRERO-2018.
There are no conflicts of interest to disclose.

 

ABSTRACT

The elderly population is increasing and has a high cardiovascular risk. This population has been systematically excluded from clinical trials. So much so, the evidence about the best treatment to offer them is unknown.
Methods: We analyzed data from 63 consecutive patients> 85 years who underwent percutaneous coronary intervention in order to obtain the results for those patients who were offered percutaneous treatment for their symptomatic coronary disease. They were divided into 3 clinical groups (unstable angina, NSTEMI or STEMI) and for monitoring into 2 groups (hospitalization until the first month and up to 1 year).
Results: The average age of patients was 87.5 (SD 3), 66.7% men and 33.3% women. 33.3% presented with STEMI, 38% with NSTEMI and 28.7% with unstable angina. There were 1.3 (SD 1) PCI performed on average. Radial access was 36%. Complications related to the procedure were 24% acute renal failure or preexisting failure worsening, and 2% required dialysis. 12% of major bleeding, 5% periprocedural MI. There were no strokes. The overall cardiovascular mortality was 17% during hospitalization in up to one month (with 5%, 13% and 33% respectively for unstable angina, NSTEMI or STEMI) and 20% at one year. The average hospital stay was 5.44 days (SD 6).
Conclusions:
Acute coronary syndrome in the elderly can be treated invasively with acceptable risks. The chronological age should not be the main determining factor in the decision of invasive treatment.
Key words: Coronary interventions. Angioplasty. Elderly. Coronary syndrome.

 

INTRODUCTION
With the increase in life expectancy, the elderly population is in progressive increase. According to the 2010 Census, Argentina presents 10.2% of people ≥65 years when in year 1970 they were 7% [1]. An advanced age per se is one of the major cardiovascular risk factors and CAD is the most frequent cause of death in the elderly [2]. This context makes evident the need of implementing an effective treatment dedicated to older patients presenting CAD. However, little is known about the management and results of CAD treatment in this age group, as these patients have been systematically excluded from clinical studies [3].

This population represents a double challenge; on one side, they are a group with high risk of coronary intervention [4], due to a high risk profile given the associated co-morbidities, physical fragility, polypharmacy, a high ischemic load because of multiple vessel coronary disease and the significant calcification of coronary vessels; but on the other hand, they could also benefit from percutaneous coronary intervention, so the risk-benefit balance should be carefully taken into account [5].

This study in “very old” patients (>85 years) has as a goal to evaluate the results of coronary angioplasty in our Hospital in the subset of patients called elderly by us.

 

MATERIAL AND METHODS
Retrospective, observational and descriptive study for which data from the computer database of the service of hemodynamics and cardioangiography in our Hospital and their respective clinical histories. Data were extracted of consecutive patients who underwent coronary angioplasty and who were older than 85 years at the time of the procedure. The patients selected were subdivided according to the clinical presentation mode into: ST-segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI) and unstable angina (UA).

The patients were diagnosed with STEMI or NSTEMI according to the third universal definition of myocardial infarction in 2012 [6]. The group with UA was constituted by “ambulatory” patients with recent-onset angina (≤2 months) or that progressed recently (≤2 months) in spite of the use of at least two antianginal agents and that may or may not had demonstrable angina in a positive noninvasive test, such as stress echo or myocardial perfusion scintigraphy.

The decisions of the procedure, including the site of access, the use of adjuvant pharmacotherapy and the type of stent were chosen by the operator. For patients who underwent procedures in “stages”, so they had to come back for an elective percutaneous coronary intervention (PCI) after having had the culprit vessel previously treated, only the index event was included.

All patients who underwent PCI received heparin in an 80 mg/kg dose, aspirin, ticlopidine, or clopidogrel according to current guidelines. The patients that received pharmaco-active stents received minimum dual antiplatelet therapy for 1 year.          

The follow-up was divided in 2: in-hospital evolution up to the subsequent 30 days and from there to one year. All patients were indicated and instructed about standard therapy for secondary prevention at discharge according to what is recommended by the current guidelines.

Adverse events that presented in the follow-up periods after angioplasty were in-hospital mortality, that was defined as the appearance of death during the hospitalization phase after the procedure, at 30 days and one year. It was defined as having a cardiac cause when death occurred by arrhythmias, mechanical complications (myocardial rupture or severe valve compromise) or refractory heart failure. Other causes were defined as noncardiogenic ones.

Myocardial reinfarction (REAMI) was defined as the presence of at least two of the following three: changes in ECG, precordial pain (or another angina equivalent) or increase in biomarkers after PCI.

Stroke was defined as the permanent loss of neurological function (including coma) caused by an ischemic or hemorrhagic vascular event verified by tomography or brain magnetic resonance imaging.

Acute renal failure (ARF) after the procedure was defined as oliguria (urine production of less than 30 ml/h) or anuria associated to a daily increase in serum creatinine and urea nitrogen in blood of 0.1 mg/dl and 0.10 mg/dl, respectively, or the need for hemodialysis or peritoneal dialysis at any time after coronary intervention and up to the subsequent 10 days.

Patients were considered smokers because they smoked presently or in the past. There was no differentiation by amount.

Patients were deemed hypertensive (HTN) when they had a previous history of systemic hypertension or medicated for such pathology, and with blood pressure greater than 140 mmHg.

Patients were deemed dyslipidemic (DLP) when they had previous history of hypertriglyceridemia, hypercholesterolemia, or both, and lab results for triglycerides higher than 150 mg/dL and cholesterol higher than 200 mg/dL.

Patients were considered diabetic (DBT) when they had previous history of diabetes or were medicated with insulin or anti-diabetic agents.

Major bleeding was defined as the requirement for transfusion of at least 2 units of blood after the procedure.

Statistical estimations were made with the statistical Infostat system (Universidad Nacional de Córdoba, 2014, free version). Categorical variables were expressed as percentage and continuous variables as mean and range.

 

RESULTS
From January 1994 to June 2016, coronary angioplasties were performed in our center, on 63 patients older than 85 years, with an average age of 87.5 (SD 3), 66.7% women and 33.3% men. 33.3% presented STEMI (anterior 57%, inferior 29%, lateral 14%). 38% presented NSTEMI and 28.7% UA.

As to the cardiovascular risk factors (Table 1), known at the time of performing PCI, it was observed that 84% presented HTN, 29% DBT, and from the latter, 6% used insulin. There was 29% of patients with previous myocardial infarction (AMI), 17% of patients with previous PCI, as well as 10% of surgical revascularization (coronary bypass).

Table 1. General characteristics of the population
  UNSTABLE ANGINA NSTEMI STEMI OVERALL
   Total Pts
  Age
  Women
  Men
  HTN
  Smoking 
  DLP
  DBT
  Insulin
  CKD
  Creat
  HB
  COPD
  Isch stroke
  Previous PCI  
  Previous AF    
  Previous AMI
  DHF
  CVS
  CABG
  Valve R
  PM
  ASA
  Statins
  Clopi
  OAC
  LVEF pre
  LVEF post
  Sinus
  Post-AF
  CRBBB
18
86.5(DE2,2)
13
6
17
2
14
5
0
5
1.06 (D.E 0,40)
11.5 (D.E 3,3)
0
1
6
4
10
6
2
2
0
2
16
8
4
2
54% (D.E 12)
53% (D.E 14)
17
2
0


72,0%
33,0%
94,0%
11,0%
77,0%
27,0%
0,0%
27,0%


0,0%
5,0%
33,0%
24,0%
55,0%
33,0%
11,0%
11,0%
0,0%
11,0%
88,0%
44,0%
22,0%
11,0%

94,0%
11,0%
0,0%

24
88 (DE3)
15
9
21
11
11
9
2
6
1.12(DE 0.42)
12.2 (DE 1,93)
4
1
2
4
6
6
4
3
1
3
14
6
5
2
56,4% (D.E 11)
52% (DE13)
19
4
3


62,5%
37,5%
88,0%
46,0%
46,0%
38,0%
8,0%
25,0%


17,0%
4,0%
8,0%
17,0%
25,0%
25,0%
17,0%
13,0%
4,0%
13,0%
58,0%
25,0%
21,0%
8,0%

79,0%
17,0%
13,0%

21
88.2(DE3)
14
7
15
9
9
4
2
3
1,03 (D.E 0,25)
12.2 (D.E 2,32)
3
1
3
3
2
1
1
1
0
1
8
1
0
0
57 % (D.E 12
47,7% (D.E 13)
18
1
0


67,0%
33,0%
68,0%
43,0%
43,0%
19,0%
10,0%
14,0%


4,0%
5,0%
14,0%
14,0%

10,0%

5,0%
5,0%
5,0%
0,0%
5,0%
38,0%
5,0%
0,0%
0,0% 86,0%
5,0%
0,0%
63
87.5(DE3)
42
22
53
22
34
18
4
14
1.12 (D.E 0,42)
12.2 (D.E 1,9)
7
3
11
11
18
13
7
6
1
6
38
15
9
4
56,4%  (D.E 11)
52% (D.E 13)
54
7
3


66,7%
33,3%
84,0%
35,0%
54,0%
29,0%
6,0%
22,0%


12,0%
5,0%
17,0%
17,0%
29,0%
21,0%
12,0%
10,0%
2,0%
10,0%
60,0%
24,0%
14,0%
6,0%


85,0%
12,0%
5,0%

AF: Chronic atrial fibrillation; AMI: Acute myocardial infarction; ASA: Aspirin; CABG: Coronary artery bypass grafting; CKD: Chronic kidney disease; Clopi: Clopidogrel; COPD: Chronic obstructive pulmonary disease; CRBBB: Complete right bundle branch block; Creat: Creatinine; CVS: Cardiovascular surgery; DBT: Diabetes; DHF: Decompensated heart failure; DLP: Dyslipidemia; HB: Hemoglobin; HTN: Hypertension; LVEF post: Left ventricular ejection fraction after the event; LVEF pre: Left ventricular ejection fraction previous to the event; OAC: Oral anticoagulation; PCI: Percutaneous coronary intervention; PM: Pacemaker; Pts: Patients; Valve R: Valve replacement.


54% was in sinus rhythm, 2% presented atrial fibrillation, and 10% had a pacemaker implanted and presented rhythms associated to it.

In coronary angiography, 10% presented significant disease of left main coronary artery, 52% of anterior descending artery, 40% of right coronary artery and 30% of circumflex artery. The number of vessels significantly affected (≥70%) in average was 1.9 (SD 1), the number of PCI performed in average was 1.3 (SD 1). Access was radial in 36% of cases (Table 2), a practice that was becoming more frequent from year 2011, to reach 95% in years 2015 and 2016.

Table 2. Percutaneous coronary intervention
  UNSTABLE ANGINA NSTEMI STEMI OVERALL
  LMCA
  ADA
  Cx
  RCA
  N° of vessels
  N° of PCI
  N° of Stents
  Bleed >
  ARF
  Dialysis
  Post-isch stroke
  Post-hem stroke
  Post-AMI
  CV death Hosp/30   days
  CV death 1 year
  Discharge ASA
  Discharge Clopi/ticlo
  Discharge statins
  Discharge BB
  Discharge ACEI/ARB
  Discharge diuretics
  Hosp days
1
16
8
13
1.9 (D.E 0,94)
1.3% (D.E 0,58)
1.15% (0,76)
3
4
1
0
0
1
1

1
18
18
17
17
17
13
2.6 (D.E 3,24)
5,0%
88,0%
44,0%
72,0%



16,0%
22,0%
5,0%
0,0%
0,0%
5,0%
5,0%

5,0%
100,0%
100,0%
94,0%
94,0%
94,0%
72,0%
2
18
12
16
1.9 (D.E 1)
1.3 (D.E 1)
1.2 (D.E 1)
2
4
0
0
0
0
3

4
23
24
24
22
23
15
5.4 (D.E 6)

8,0%
75,0%
50,0%
67,0%



8,0%
17,0%
0,0%
0,0%
0,0%
0,0%
13,0%

16,0%
96,0%
100,0%
100,0%
92,0%
96,0%
63,0%

3
18
10
11
1.9 (D.E 1)
1.4 (D.E 1)
1.4 (D.E 1)
2
7
0
0
0
2
7

8
19
20
20
20
20
18
8.2 (D.E 9)

14,0%
86,0%
48,0%
52,0%



10,0%
33,0%
0,0%
0,0%
0,0%
10,0%
33,0%
38,0%
91,0%
95,0%
95,0%
95,0%
95,0%
86,0%

6
52
30
40
1.9  (D.E 1)
1.3  (D.E 1)
1.2  (D.E 1)
7
15
1
0
0
3
11

13
61
62
61
59
60
46
5.4 (D.E 6)

10,0%
83,0%
48,0%
63,0%



12,0%
24,0%
2,0%
0,0%
0,0%
5,0%
17,0%

20,0%
97,0%
98,0%
97,0%
93,0%
95,0%
73,0%

ACEI: Angiotensin converting enzyme inhibitors; ADA: Anterior descending artery; AMI: Acute myocardial infarction; ARB: Angiotensin II receptor blockers; ARF: Acute renal failure; ASA: Aspirin; BB: Beta blockers; Bleed >: Major bleeding; CKD: Chronic kidney disease; Clopi: Clopidogrel; CV: Cardiovascular; Cx: Circumflex artery; Hem stroke: Hemorrhagic stroke; Hosp: Hospitalization; Isch stroke: Ischemic stroke; LMCA: Left main coronary artery; N°: Number; PM: Pacemaker; RCA: Right coronary artery; Ticlo: Ticlopidine.


About complications (Figure 1) related to the procedure, we may say that 24% of patients developed ARF or new worsening of preexisting failure, and 2% required dialysis. 12% of patients presented major bleeding. 5% presented periprocedural AMI during admission. There were no periprocedural ischemic or hemorrhagic strokes.

Overall cardiovascular mortality rate was 17% during admission and at one month (being 5%, 13%, and 33% respectively, considering the modality of presentation, whether UA, NSTEMI or STEMI) and 20% at one year.

The average time of admission was 5.4 days (SD 6).


Figure 1. Abbreviations: ARF: Acute renal failure; NSTEMI: Non-ST segment elevation myocardial infarction; STEMI: ST-segment elevation myocardial infarction.

 

DISCUSSION
In daily clinical practice, it is habitual for patients with an advanced age, to receive pharmacological or conservative treatment instead of PCI [7]. This is partly because this population presents many challenges, such as atypical clinical presentation and of later onset, greater probability of presenting concomitant diseases, cognitive impairment, physical fragility, polypharmacy, and a more complex CAD (multiple vessels, tortuosity and significant calcification) and with a greater ischemic load [8]. Often, it is thought that these challenges decrease the benefits and increase the risk of invasive treatment complications. Consequently, the treatment of patients with a very advanced age has traditionally been more conservative than what guidelines recommend, with suboptimal access to angiography and early revascularization, and even to optimal pharmacological treatment [9]. However, there is strong evidence that patients in high risk obtain a benefit from PCI, which should lower the threshold at the time of deciding more aggressive strategies in this age group, with certain high risk [10].

Currently, primary PCI, performed within the times recommended is the preferred therapy for patients presenting STEMI. Very old patients who present STEMI and undergo PCI have a lower rate of morbidity and mortality compared with those treated with pharmacological treatment or thrombolytic agents [11]. In our case load, in-hospital mortality of patients with STEMI was 33%, all by cardiovascular cause and due to refractory heart failure. This mortality is similar to that reported by other studies in which 80-year-old and 90-year-old patients (average age of 88 years) were included, as in ours [12]. The complications occurred in 20%, 2% related to major bleeding, 0% of periprocedural AMI, and ARF 33%.

In the case of very old patients that present NSTEMI, the situation is similar in terms of them receiving a suboptimal therapy in comparison to current recommendations [12]. However, this subgroup of patients benefits in the sense of mortality and mainly of morbidity when treated with percutaneous revascularization, and even more when supplemented with optimal pharmacological treatment [13]. The CRUSADE study observed, in elderly patients similar to ours, a lower in-hospital mortality in patients that undergo invasive strategy [14]. Another recent study based on data from the Nationwide Inpatient Sample showed that, in comparison with an initial conservative approach, an early invasive strategy in 80-year-old patients with NSTEMI was associated to a lower in-hospital mortality, acute ischemic stroke, intracranial bleeding, gastrointestinal bleeding and less time to admission duration [15]. In our experience, elderly patients with this syndrome presented 13% of mortality during hospitalization with 6% of overall complications, of which 8% of major bleeding and 17% of ARF were related to the procedure.

The European Society of Cardiology, American College of Cardiology and the American Heart Association advise for the treatment of patients with an advanced age to be based in individual characteristics, with a proper balance between risks and benefits, taking into account ischemia and the risk of bleeding, life expectancy, co-morbidities, including cognitive function, quality of life, and the wishes of the patient before deciding on the proper treatment strategy [16,17,18].

In the subset of patients in whom PCI was performed electively because they presented UA, the complications were low; only 6% (the most frequent being: renal failure 22% and major bleeding 16%) and mortality of 1 patient, in whom there were complications with retroperitoneal bleeding, and his death was due to septic shock from an infection associated to the ventilator. Studies comparing invasive strategy versus the conservative one in these patients, conclude that there is an improvement in angina, quality of life [19] and major absolute reduction in mortality [20].

As to stents to be chosen when dealing with coronary artery lesions of elderly patients we could say that, as with the rest of the patients, the benefit of using pharmaco-active stents are given by the lower rate of revascularization of the treated vessel and less acute myocardial infarction in follow-up, although it seems there was no significant impact in terms of mortality and strokes [21].

We should also mention prevention of complications in these patients, as they impact on survival. With this purpose in mind, the last 5 years we used radial access in all our patients (unless not available), and this enabled a remarkable reduction in bleeding associated to the access site, to the point in which no case presented major bleeding among those treated with this technique.

The limitations of this study are those proper of its observational and retrospective character, so there is a latent possibility of bias in selection and the possibility of confounding factors not being entirely removed. Another important limitation is the number of patients added for a long period, which represents a small sample. But we believe that before the scarcity of data from large randomized trials, observational studies like ours, acquire a great value by providing evidence.

The study was made following the current recommendations for human investigation and legal regulations. Given that the information of the study was obtained by reviewing medical recordings, not reporting on the identification data of patients, the informed consent of patients was not required.

 

CONCLUSIONS
Acute coronary syndrome in an elderly population entails an extreme severity, and it could be treated invasively with acceptable risks. Chronological age should not be the most important conditioning factor when deciding on invasive treatments.


BIBLIOGRAPHY

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Publication: September 2018



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