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Australia same day discharge

Heart, Lung and Circulation (2015) 24, 368–376
1443-9506/04/$36.00
http://dx.doi.org/10.1016/j.hlc.2014.11.011
ORIGINAL ARTICLE
Safety and Efficacy of Same-Day
Discharge Following Elective Percutaneous
Coronary Intervention, Including
Evaluation of Next Day Troponin T Levels
Yousef Saad, MBChB a,b, Ibrahim M. Shugman, PhD a,b,
Manish Kumar, MBBS b, Iwona Pauk, RN b, Christian Mussap, PhD a,b,
Andrew P. Hopkins, MBBS a,b, Rohan Rajaratnam, MBBS a,b,
Sidney Lo, MBBS a,b, Craig P. Juergens, DMedSc a,b,
John K. French, PhD. a,b*
a
South Western Sydney Clinical School, The University of New South Wales, Sydney, NSW, Australia
Cardiology Department, Liverpool Hospital, Sydney, NSW, Australia
b
Received 20 December 2013; received in revised form 6 November 2014; accepted 11 November 2014; online published-ahead-of-print 26 November 2014
Background
As patients are increasingly undergoing elective percutaneous coronary intervention (PCI) with same-day
discharge (SDD), and as post-PCI troponin T (TnT) elevations are associated with increased rates of death/
myocardial infarction (MI) following elective PCI, we examined late outcomes with respect to post-PCI TnT
elevations in patients undergoing SDD.
Methods
and Results
We studied 303 patients (mean age 62 9years, 89% male) who underwent elective-PCI between October
2007 and September 2012, of whom 149 had SDD and 154 stayed overnight (ON) who were age-and sexmatched. Eligibility for SDD excluded patients with: multi-vessel PCI, proximal LAD lesions, chronic total
occlusions, side branch occlusions, or access site complications. Femoral access rates were 72% and 96%
among SDD and ON patients respectively. Post-PCI, SDD patients left at 4.40[4.13-5.30]hours, and ON
patients left at 23.44[21.50-25.41]hours (p < 0.001). Overall 8.45% met the 2012 universal MI definition. No
patients were re-hospitalised within 48 hours. At 30-days, unplanned cardiac re-hospitalisation rates were
3.4% and 0.7% among SDD and ON patients (p = 0.118); the only event was MI in an SDD patient. At 16[9-32]
months, rates of death, MI, target vessel revascularisation, stroke, were 1.3%,1.3%,2.7% and 1% respectively;
the composite rate was 6%(6.1% SDD; 6% ON; p = 0.965). Late death/MI rates among patients with, and
without, post-PCI TnT levels5xURL were 3.4% and 2.8% respectively (p = 0.588).
Conclusion
SDD following elective PCI among low risk patients appears to be safe and 5 fold post-PCI TnT elevations
did not appear to confer incremental short and long term risk. A larger cohort is required to confirm this
observation.
Keywords
Elective percutaneous coronary intervention Same-day discharge TroponinT.
*Corresponding author at: Cardiology Department, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170, Australia. Tel.: +61287383069; fax: +61287383341,
Email: j.french@unsw.edu.au
© 2014 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier
Inc. All rights reserved.
369
Same-Day Discharge Following PCI
Introduction
There is increasing evidence that it is feasible and safe, in the
short term, for patients with stable coronary heart disease
(CHD) who undergo elective percutaneous coronary intervention (PCI) to be discharged on the same day of the procedure [1–9]. Same-day discharge (SDD) has occurred
because of increased safety and reduced complications associated with PCI [10,11]. In addition to its safety in the short
term, SDD following PCI in comparison with overnight (ON)
stay, can lead to increased hospital bed availability and cost
saving [7,8,12].
Associations between post-PCI biomarker, including troponin T (TnT), elevations and late outcomes including death
and recurrent myocardial infarction (MI) have been reported
[13–17]. Whether such biomarker elevations were associated
with cardiovascular adverse events after elective PCI with
SDD is not known. To assess the safety and efficacy of
SDD strategy and examine the significance of TnT elevations
post-elective PCI, we studied patients who underwent elective PCI with SDD, who were age-and-sex matched with
patients who stayed in the hospital overnight.
Methods
Study population
The clinical, angiographic and procedural data of all patients
undergoing PCI are recorded prospectively in the cardiology
database at the Liverpool Hospital cardiac catheterisation
laboratory in Sydney, Australia [13]. Institutional criteria
were initiated in October 2007 to select patients with stable-CHD who are suitable for SDD after elective PCI. Patients
were eligible for SDD if they met all of the inclusion criteria
and none of the exclusion criteria (Table 1); they were compared to 154 age-and sex-matched patients with similar
characteristics who underwent PCI for stable-CHD and
stayed overnight. South Western Sydney Local Health
Table 1 Criteria for Same-day Discharge.
Inclusion criteria
Be a non inpatient undergoing a planned, non emergency procedure on Monday – Thursday.
Be willing to be discharged on the day of their PCI
Be considered suitable by the proceduralist
Procedures required completion and a > 4 hours observation period prior to 18:30 (latest time for discharge)
Have a 6F or 7F sheath used
Have an uncomplicated procedure (does not meet any angiographic exclusion criteria below)
Have a suitable social environment (does not meet any social exclusion criteria below)
Have no acute changes on post PCI ECG
Have adequate puncture site haemostasis (successfully deployed femoral closure device or radial
approach preferred but not essential)
Exclusion criteria
Angiographic
Exclusions
Be able to ambulate 4 hours post sheath removal without problems
Temporary vessel closure during PCI
Suboptimal angiographic result
Dissection type C to E
Residual dissection after successful stent implantation
Occlusion of major side branch
Angiographic thrombus
No reflow/slow flow phenomenon
Clinical Exclusion
Perforation with guide wire
Age 80 years or greater
Severe renal failure (GFR < 30ml/min)
Severe bleeding risk (eg on warfarin/LMWH etc)
Severe LV dysfunction (EF <30%) or symptomatic heart failure
Severe visual or hearing impairment
Multi-vessel stenting #
Use of GP IIb/IIIa inhibitors
Social Exclusions
Lives alone or has no telephone
Staying 30 minutes or more, by car, from Liverpool hospital on first night
Patient or co-habiting relative/friend cannot communicate with nursing/medical staff without the
need for an interpreter
# Multi-vessel disease was stenosis 50% in 2 major coronary arteries or a left main stenosis of 50%. Patients with MVD not undergoing multi-vessel PCI, were
not excluded.
370
District human research ethics committee provided approval
for PCI follow-up for quality assurance (QA2008/034).
All post-PCI patients (including those with SDD) returned
the next day to CCL and underwent clinical assessment, an
electrocardiogram (ECG), measurement of levels of: creatinine, TnT, platelets, haemoglobin, and estimated glomerular
filtration rate (eGFR). Patients stayed for overnight observation for the following reasons: 1) logistical issues, largely
residence 30 minutes drive from the hospital; 2) no overnight or English-speaking carer; 3) patients who were scheduled for elective PCI on Fridays; and/or 4) clinical concerns
such as mild chest pain post-PCI without ECG changes.
Percutaneous Coronary Intervention
Procedures
Patients, except those with allergies, received pre-PCI aspirin
100–150 mg daily, and clopidogrel loading 300-600 mg and
75 mg daily. A bolus of unfractionated heparin (60-100 U/
Kg) was given at the start of PCI procedures (performed via
either femoral or radial access). The use of stents, either bare
metal stents (BMS) or drug eluting stents (DES), was according to the institutional DES use criteria [18]. Angiographically successful procedures were defined as <20% residual
stenosis in cases post-stenting or to <50% stenosis following
balloon angioplasty in the presence of grade 3 Thrombolysis
In Myocardial Infarction (TIMI) flow [19].
Troponin T Measurements
Venous blood samples that were obtained post-PCI were
assayed for TnT (4th generation from October 2007 to June
2011 [upper reference limit (URL) = 0.03 mg/L] and high sensitivity from June 2011 to September 2012 [URL = 14ng/L];
both Roche Diagnostics, Mannheim, Germany). The primary
end point was the association between post-elective PCI TnT
levels and major adverse cardiac and cerebral events (MACE)
during follow up.
Definitions and Clinical Follow-up
Definitions used in this study were as follows: 1) Elective PCI
was any coronary revascularisation performed in a patient
with stable-CHD undergoing planned or ad-hoc PCI; 2)
Multi-vessel disease by convention in our CCL has been
reported as 50% stenosis in 2 major coronary arteries
or a left main stenosis of 50%; 3) Stroke was defined as
any neurological deficit occurring after PCI and CT-scan or
MRI findings of cerebral or cerebellar infarction and/or
haemorrhage; 4) Target vessel revascularisation (TVR) was
ischaemia-driven repeat revascularisation (either PCI or coronary artery bypass graft surgery); 5) MACE included cardiac death, MI, stroke, or TVR; 6) Re-hospitalisation was
defined as any unplanned re-admission potentially related
to the PCI procedure.
Clinical follow-up was performed by research staff (nurses
and/or doctors), either by reviewing the medical records, or
contacting the patients and/or their doctors by telephone.
Patients, their next of kin, primary physicians or specialists
Y. Saad et al.
were asked about recurrent cardiac symptoms requiring
hospitalisation, the need for further coronary revascularisation (including for stent thrombosis [ST]), MI, or stroke. Data
regarding mortality was obtained from department or hospital records, physicians, next of kin and the state death
registry.
Data Analysis
All statistical analyses were performed using SPSS (Inc, Chicago) version 17.0. Categorical variables are expressed as
numbers and percentages, and continuous variables as
mean standard deviations (SD) or medians and [25th75th centiles]. For groups comparisons Pearson’s chi square
(x2) test or Fisher’s exact test were used as appropriate for
unpaired categorical variables. The student’s t tests or the
Mann-Whitney U tests (for skewed distribution) were used
for continuous variables. Kaplan-Meier clinical outcomes
were compared using Log Rank test. All p-values<0.05 (2
sided) were considered statistically significant.
Results
Among 303 patients with stable-CHD who underwent PCI
between October 2007 and September 2012, 149 patients
underwent SDD post-PCI after median of 4.40[4.13-5.30]
hours of observation; the comparator group, who stayed
overnight were 154 age-and sex-matched patients who
stayed 23.44[21.50-25.41] hours after PCI (Figure 1).
Table 2 shows the baseline clinical characteristics of the
patients according to their hospital stay, either SDD or ON,
and also whether their post-PCI TnT levels, were normal
(<URL) or elevated (>URL). Ad-hoc PCI was performed in
36(24.2%) patients among SDD group compared with 9(5.8%)
patients among the ON stay group, p < 0.0001. There were no
significant differences between the SDD and ON stay groups
with respect to most clinical characteristics though SDD
patients were more likely to have prior PCI (50.3% vs
35.7%, p = 0.010).
PCI was performed via femoral access in 84%(72% in SDD
group vs. 96% in ON group, p = <0.0001), and via the radial
artery in 15.5% (and one underwent brachial access). In 83%
of patients, 6-French guiding catheters were used. The
median PCI duration for the SDD and ON patients were
50[40-65] minutes and 50[39-73.5] minutes respectively
(p = 0.615). In 18 patients (7.4% of SDD patients and 4.5%
of ON patients, p = 0.296) balloon angioplasty only was used.
SDD patients compared with ON patients were less likely to
have lesions in the left anterior descending (LAD) artery
(28.2% vs. 41.6%, p = 0.015). Angiographic and procedural
characteristics are shown in Table 3.
Among 284 patients with post-PCI TnT measurements, 167
(58.8%) patients (47.9% SDD) had normal post-PCI TnT levels,
and 117(41.1%) patients (43.6% SDD) had elevated post-PCI
TnT levels. Patients with elevated post-PCI TnT levels, compared with those with levels <URL were less likely to have
diabetes mellitus (25.6% vs. 38.3%, p = 0.025), to have a family
371
Same-Day Discharge Following PCI
Total PCIs
(October 2007 to September 2012)
n=4470
2863 PCIs are excluded for the following reasons:
- PCIs for ACS.
- PCI with complications.
- Failed PCI.
- Miscellaneous (CHD with severe heart Failure or renal
failure).
Elective PCIs
n=1607
Patients underwent
elective PCIs and stayed
overnight
n=1458
528 Procedural reasons b:
- Proximal LAD lesion = 378
- Extensive dissection = 10
- Multivessel intervention = 69
- CTO = 5
- Bifurcation = 59
-Glycoprotein IIb/IIIa inhibitor use = 7
568 Personal/Social reasons:
- Non English speaker = 343
- Lived ≥30 minutes drive from the
hospital = 210
- Age >80 = 15
70 PCI performed late in the day
292 not specified
Discharged on the
same day of PCI a
n=149
Age- and Sex- matched
patients stayed overnight c
n=154
Figure 1 Study Population. ACS = acute coronary syndrome; CHD = coronary heart disease; CTO = chronic total occlusions; LAD = left anterior descending; PCI = percutaneous coronary intervention.
a
Based on criteria (see Table 1).
b
Procedural reasons for overnight stay are listed in hierarchical order.
c
Age- and Sex- matched group who stayed overnight for further observation included those with one or more of the
following reasons; 1) logistical reasons such as those who live 30 minutes driving or more from the hospital, those who did
not have a person to look after them after hospital discharge, those who could not speak English, or patients who were
scheduled for elective PCI on Friday; and/or 2) clinical events such as mild atypical chest pain after procedure without ECG
changes.
history of CHD (11.1% vs. 24.6%, p = 0.004), to have a lower
body mass index (median 27.8 vs. 28.9, p = 0.048), and a lower
platelet count (median 218 vs. 244, p = 0.011). Patients with
elevated post-PCI TnT levels were less likely to have right
coronary artery stenosis (28.2% vs. 43.7%, p = 0.008), and more
likely to have class B2/C lesions (61.5% vs. 49.1%, p = 0.038)
and lesions at a bifurcation (20.5% vs. 11.4%, p = 0.035).
Among the study population, an elevation in post-PCI TnT
levels to >3 URL occurred in 53(18.7%) patients (14.5%
among SDD and 22.2% among ON, p = 0.096). Overall 30
(10.6%) patients (7.6% among SDD and 13.1% among ON,
p = 0.137) had elevation in post-PCI TnT levels to >5 URL,
of whom 24 patients met the 2012 universal MI definition
angiographic criteria (Figure 2); one ON patient with a postPCI TnT level of 3.1 mg/L(>70 URL) met the new post-PCI
MI definition of the Society for Cardiovascular Angiography
and Interventions (SCAI) [20].
Clinical Outcomes and Troponin after
Percutaneous Coronary Intervention
Aside from peri-procedural MI, no major events were
reported during the in-hospital observation periods, or in
the two-days post-PCI (including rehospitalisation). By 30
days there were no deaths, ST, urgent TVR, stroke, or bleeding. Overall 16 patients (5.4%) had been rehospitalised for
various reasons (6.8% among SDD group vs 4% among ON
group, p = 0.285). Among six patients (2%) who had
unplanned re-hospitalisation post-PCI because of cardiac
causes one patient had a non-culprit coronary artery MI
on day 5, one patient had a left common femoral artery
pseudo-aneurysm at day 9, one patient had an arrhythmia
on day 28 post PCI, and three patients were readmitted at
median of 21 days post-PCI due to recurrent chest pain (all
had TnT levels <URL and no interventions were performed).
372
Y. Saad et al.
Table 2 Baseline Clinical Characteristics.
All
n = 303
Same day
Overnight
TnT
discharge
stay
Normal
elevated
n = 149
n = 154
n = 167
n = 117
p-value
(49.2%)
(50.8%)
p-value
TnT
Same day discharge
-
-
-
-
80(47.9%)
51(43.6%)
0.473
Age (mean SD) years
62.4 (9.3)
62.5(9.3)
62.3(9.3)
0.810
62.3(9.3)
62.8(9)
0.647
- Age 75 years
30(9.9%)
15(10.1%)
15(9.7%)
0.924
20(12.0%)
9(7.7%)
0.241
-Age 65 years
108(35.6%)
53(35.6%)
55(35.7%)
0.979
61(36.5%)
40(34.2%)
0.685
271(89.4%)
134(89.9%)
137(89.0%)
0.783
148(88.6%)
104(88.9%)
0.944
28.4
[25.7-32.1]
28.7
[25.7-32.1]
28.4
[25.4-32.3]
0.946
28.9
[26.1-32.4]
27.8
[24.9-31.4]
0.048
Male gender
BMI (kg/m2)
a
Diabetes mellitus
98(32.3%)
51(34.2%)
47(30.5%)
0.490
64(38.3%)
30(25.6%)
0.025
Smoking
39(13.0%)
20(13.4%)
19(12.5%)
0.812
21(12.7%)
14(12.1%)
0.884
Hypertension
242(79.9%)
113(75.8%)
129(83.8%)
0.085
139(83.2%)
89(76.1%)
0.135
Family history of CHD
56(18.5%)
34(22.8%)
22(14.3%)
0.056
41(24.6%)
13(11.1%)
0.004
248(81.8%)
114(76.5%)
134(87.0%)
0.018
136(81.4%)
99(84.6%)
0.485
Prior Aspirin
277(91.4%)
139(93.3%)
138(89.6%)
0.253
155(92.8%)
104(88.9%)
0.250
Previous PCI
Previous CABG
130(42.9%)
34(11.2%)
75(50.3%)
12(8.1%)
55(35.7%)
22(14.3%)
0.010
0.086
69(41.3%)
19(11.4%)
54(46.2%)
13(11.1%)
0.418
0.944
228(87.7%)
117(85.4%)
111(90.2%)
127(88.8%)
85(85.9%)
32(12.3%)
20(14.6%)
12(9.8%)
16(11.2%)
14(14.1%)
144[134-151]
143.5[134-152]
146[133-151]
0.569
146 [135-151]
140[130-151]
0.107
7.5[6.2-9]
7.5[6.1-9.2]
7.5[6.2-8.9]
0.877
7.5[6.2-9.2]
7.5[6.1-8.9]
0.675
235[201-283]
227[198-280]
241[204-289]
0.235
244[209-283]
218[183-278]
0.011
30(9.9%)
45(14.9%)
19(12.8%)
36(24.2%)
11(7.1%)
9(5.8%)
17(10.2%)
26(15.6%)
9(7.7%)
16(13.7%)
0.474
0.658
Hyperlipidaemia
b
Pre-PCI eGFR
- eGFR >60
0.235
c
- eGFR 30-<60
Pre Hb
WBC
a
a
Platelet
a
Staged PCI
Ad hoc
c
0.102
<0.0001
0.493
BMI = body mass index; CABG = coronary artery bypass grafting; CHD = coronary heart disease; PCI = Percutaneous coronary intervention; TnT = troponin T.
a
Median [25 percentile-75 percentile].
b
Hyperlipidaemia defined as previous diagnosis of hypercholesterolaemia, including treatment with lipid-lowering agents or fasting low-density lipoprotein
cholesterol of 130 mg/dl or total cholesterol of 200 mg/dl.
c
eGFR = estimated glomerular filtration rate ml/min/1.73 m2. Calculated by the abbreviated MDRD equation.
Among the remainder of re-hospitalisations, four patients
underwent planned staged PCI, one patient had a chest
infection, one patient had a urinary tract infection, one
patient had haematuria and two patients had gastrointestinal
bleeding at a median of 24 days post-PCI, and one had
musculoskeletal chest pain.
Late outcomes at 16[9-32] months were obtained in 299
(98.7%) patients (Table 4). The respective rates of cardiac
death, MI, TVR, and stroke, comparing SDD with ON
groups, were: 1.4% vs. 1.3%, p = 0.999; 2.7% vs. 0%,
p = 0.059; 2%vs. 3.3%, p = 0.723 and 0.7% vs. 1.3%,
p = 0.999. Overall MACE occurred in 6% (6.1% among
SDD vs. 6% among ON, p = 0.965). Among SDD patients,
cardiac death or MI occurred in six patients only and none of
these had post-PCI TnT levels>X5 URL.
The rates of the composite of cardiac death/MI among
patients who had post-PCI TnT levels>5xURL (34.5% SDD
and 65.5% ON) compared with patients without these elevations (47.8% SDD and 52.2% ON) were 3.4% versus 2.8%
(p = 0.588). Three patients developed stroke; none of them
had post-PCI TnT levels>X5 URL.
Discussion
This study assessed the safety of a SDD strategy at 4-5 h
following elective PCI. We also examined an outcome surrogate of post-PCI TnT levels >5XURL among SDD patients
and those who stayed ON, as we and others have previously
reported elevated post-PCI cardiac marker levels are associated with higher rates of adverse clinical outcomes (death
and/or MI) among these patients [13–17,21]. There were no
significant differences in cardiac death/MI reported among
patients who had post-PCI TnT levels >5XURL, compared
with those without such post-PCI TnT levels, though this
relatively small study was likely underpowered to examine
associations with ‘hard’ clinical outcomes. The study found
that among low risk patients, SDD is safe after elective PCI,
373
Same-Day Discharge Following PCI
Table 3 Angiographic and Procedural Characteristics.
All
Same day discharge
Overnight stay
TnT
TnT elevated
n = 303
n = 149
n = 154
Normal
n = 117
49.2%
50.8%
n = 167
P value
P value
Site of Culprit lesion
- Left Main
6(2.0%)
1(0.7%)
5(3.2%)
0.214
2(1.2%)
4(3.4%)
0.234
- LAD
106(35.0%)
42(28.2%)
64(41.6%)
0.015
53(31.7%)
48(41.0%)
0.108
- RCA
112(37.0%)
58(38.9%)
54(35.1%)
0.486
73(43.7%)
33(28.2%)
0.008
- LCX
72(23.8%)
46(30.9%)
26(16.9%)
0.004
35(21.0%)
30(25.6%)
0.355
- Graft
7(2.3%)
2(1.3%)
5(3.2%)
0.448
4(2.4%)
2(1.7%)
0.999
Number of diseased vessels
- 1-Vessel disease
0.603
0.971
160(52.8%)
81(54.4%)
79(51.3%)
88(52.7%)
60(51.3%)
- 2-Vessel disease
109(36.0%)
54(36.2%)
55(35.7%)
60(35.9%)
43(36.8%)
- 3-Vessel disease
34(11.2%)
14(9.4%)
20(13.0%)
19(11.4%)
14(12.0%)
143(47.2%)
68(45.6%)
75(48.7%)
0.646
79(47.3%)
57(48.7%)
0.904
82[70-91]
90[74.5-90]
80[70-95]
0.730
88[70-95]
80[70-90]
0.402
255(84.2%)
107(71.8%)
148(96.1%)
<0.0001
140(83.8%)
99(84.6%)
0.859
47(15.5%)
42(28.2%)
5(3.2%)
<0.0001
<0.001
26(15.6%)
18(15.4%)
0.966
0.623
6-F
250(82.5%)
143(96.0%)
107(69.5%)
138(82.6%)
94(80.3%)
7-F
53(17.5%)
6(4.0%)
47(30.5%)
29(17.4%)
23(19.7%)
- Multi-vessel disease
Stenosis Before PCI
Access site
a
b
c
Femoral
Radial
Guiding catheter size
Lesion class (ACC/ AHA)
0.752
0.179
-A
46(15.2%)
25(16.8%)
21(13.6%)
24(14.4%)
14(12.0%)
- B1
97(32.0%)
44(29.5%)
53(34.4%)
61(36.5%)
31(26.5%)
- B2
68(22.4%)
35(23.5%)
33(21.4%)
33(19.8%)
33(28.2%)
-C
- B2&C
92(30.4%)
160(52.8%)
45(30.2%)
80(53.7%)
47(30.5%)
80(51.9%)
0.761
49(29.3%)
82(49.1%)
39(33.3%)
72(61.5%)
TIMI flow grad 3 after PCI
303(100%)
149(100%)
154(100%)
-
167(100%)
117(100%)
-
Ostial lesions
15(5.0%)
3(2.0%)
12(7.8%)
0.020
9(5.4%)
5(4.3%)
0.669
Culprit lesion at bifurcation
44(14.5%)
20(13.4%)
24(15.6%)
0.593
19(11.4%)
24(20.5%)
0.035
Lesion calcification
42(13.9%)
14(9.4%)
28(18.2%)
0.027
27(16.2%)
14(12.0%)
0.321
18[12-25]
16[12-24]
18[12-28]
0.290
18[12-24]
18[12-28]
0.187
- Lesion >20mm
104(34.6%)
46(31.3%)
58(37.7%)
0.245
53(31.9%)
48(41.4%)
0.103
DES
BMS
134(47.0%)
147(51.6%)
57(41.3%)
79(57.2%)
77(52.4%)
68(46.3%)
0.061
0.064
73(45.6%)
85(53.1%)
55(50.9%)
51(47.2%)
0.394
0.343
Ballon angioplasty
18(5.9%)
11(7.4%)
7(4.5%)
0.296
7(4.2%)
9(7.7%)
0.208
> 1 stent
71(24.9%)
30(21.7%)
41(27.9%)
0.230
41(25.6%)
30(27.8%)
0.695
2.75[2.5-3]
3[2.5-3]
2.75[2.5-3]
0.154
2.75[2.5-3]
2.75[2.5-3]
0.696
18[16-20]
18[16-20]
18[16-20]
0.093
18[16-19]
18[16-20]
0.013
22[15-30]
24[17-30]
20[15-30]
0.161
20[16-30]
24[15-30]
0.900
0.009
0.009
0.009
0.026
0.009
0.08
[0.009-0.03]
[0.009-0.01]
[0.009-0.048]
[0.009-0.009]
[0.045-0.12]
20[9-50]
18[10-46]
28.5[9-51]
0.440
8[4.9-11]
38[23-76]
117(41.2%)
51(38.9%)
66(43.1%)
0.473
-
-
Culprit Lesion length (mm)
Stent diameter (mm)
b
b
Inflation pressure max (atm)
b
Maximal duration of
deployed pressure (sec)
Post- PCI Troponin-T
- Conventional assay
0.038
b
b
- High Sensitivity assay
b
Elevated above URL
<0.0001
<0.0001
-
ACC/AHA = American College of Cardiology/American Heart Association; BMS = Bare metal stent; DES = Drug eluting stent; 6-F = 6 French; 7-F = 7 French;
LAD = Left anterior descending; LCX = Left circumflex; PCI = Percutaneous coronary intervention; RCA = Right coronary artery; TIMI = Thrombolysis in
myocardial infarction; TnT = Troponin T.
a
Multi vessels disease defined as 50% stenosis in 2 major epicardial vessels (left anterior descending, left circumflex and right coronary arteries) or 50%
stenosis of left main coronary artery (which is defined as 2 vessel disease).
b
c
Median [25 percentile-75 percentile].
There was only one patient who had PCI through brachial access among ON group.
374
Y. Saad et al.
Figure 2 Comparing TnT Criteria for Myocardial
Infarction Using 2007 and Third Universal Definition
of Myocardial Infarction. MI = myocardial infarction;
ON = overnight; SDD = same day discharge; TnT = troponin T; URL = upper reference limit.
a
2007 periprocedural MI definition
b
2012 periprocedural MI definition
c
24 patients met the universal MI definition angiographic criteria.
and that short and long term clinical outcomes were comparable between those who were discharged on the same day
and those who stayed ON.
The first study demonstrating the safety of a SDD strategy
was performed by Kiemeneij et al, in 1997 [22]. The feasibility
and safety of this strategy after elective PCI with a femoral or
radial access has also been established among low risk
patients [1–8,23–28]. Our study confirms that low risk
patients who undergo an elective PCI using mainly a femoral
approach can be safely discharged on the same day of the
procedure.
An average observation time of 4.5 hours post-PCI
appeared sufficient for effective triage of low risk patients
for the SDD. Although other studies show that some events
occur over the following day [23,25], none occurred in our
study; very late events were rare.
Indeed in our study of 300 patients, no events were
reported during the first 48 hrs after PCI, the period when
the majority of post-PCI complications, such as abrupt vessel
closure, bleeding, acute ST, and acute renal failure, have been
reported [29]. Despite 250 patients in this study undergoing
PCI via the femoral route, no major bleeding complications
occurred, which probably explains the low 30 days re-hospitalisation rate compared to other studies [5,28]. Importantly SDD did not contribute to an increased hospital
burden due to more un-planned re-admissions.
The relatively strict selection criteria implemented in our
study may explain the lower incidence of these adverse
events; these were somewhat different to selection criteria
used elsewhere for SDD [1,28,30]. Our study did not involve
patients receiving a glycoprotein IIb/IIIa inhibitors, patients
who lived >30 minutes drive from the hospital, and >7Fr
guiding catheter(s). The outpatient (SDD) PCI criteria from
SCAI and endorsed by the American College of Cardiology
Foundation (ACC) [31], are stricter as exclusions include
patients >70 years old, those with eGFR<60, and/or those
receiving multiple stents; none of these were exclusions from
our study. Gilchrist et al. [10] have assessed these SCAI
criteria by evaluating the SDD strategy on 100 patients
undergoing elective trans-radial PCI and were all discharged
safely on the same day of PCI. These authors (and others [32])
reported that following successful elective PCI without
angiographic complications, age and other pre-existing
Table 4 Clinical Outcomes.
30 days
All re-hospitalisation, n (%)
a
Unplanned cardiac re-hospitalisation, n(%)
b
All
Same day
Overnight
TnT
TnT
n = 299
discharge
stay
Normal
elevated
n = 148
n = 151
n = 164
n = 116
16(5.4%)
10(6.8%)
6(4%)
0.285
9(5.5%)
6(5.2%)
0.908
6(2%)
5(3.4%)
1(0.7%)
0.118
3(1.8%)
2(1.7%)
0.999
P value
P value
Late outcomes at 16[9-32] months
Cardiac death, n (%)
4(1.3%)
2(1.4%)
2(1.3%)
0.999
2(1.2%)
2(1.7%)
0.999
MI, n (%)
4(1.3%)
4(2.7%)
0(0%)
0.059
3(1.8%)
1(0.9%)
0.644
TVR, n (%)
8(2.7%)
3(2.0%)
5(3.3%)
0.723
5(3.0%)
3(2.6%)
0.999
Stroke, n (%)
3(1.0%)
1(0.7%)
2(1.3%)
0.999
2(1.2%)
1(0.9%)
0.999
18(6.0%)
8(2.7%)
9(6.1%)
6(4.1%)
9(6.0%)
2(1.3%)
0.965
0.170
11(6.7%)
5(3.0%)
7(6.0%)
3(2.6%)
0.821
0.999
Composite: cardiac death, MI, stroke, TVR, n (%)
Cardiac death /MI, n (%)
MI = myocardial infarction; TnT = troponin T; TVR = target vessel revascularisation.
a
n = 6 cardiac, n = 4 staged PCIs, n = 6 Non-cardiac (1 chest infection / 1 urinary tract infection / 1 haematuria / 2 GIT bleeding/ 1 musculoskeletal chest pain).
b
cardiac causes (n = 1 arrhythmia, n = 1 myocardial infarction,n = 1 left femoral pseudo aneurysm, n = 3 chest pain).
375
Same-Day Discharge Following PCI
conditions should not preclude SDD unless there is clinical
instability. Patients with ad-hoc PCI are included in our
analysis unlike those in a randomised trial [1]; this trial
included patients living up to 60 min distance but excluded
7Fr guiding catheter use. While none of our patients received
glycoprotein IIb-IIIa inhibitors, Bertrand et al. reported
that some SDD patients received an abciximab bolus [28].
Though some studies have shown that a SDD PCI is a safe
and feasible practice even among non-low risk patients
[12,22,33], this approach needs to be studied in larger randomised trials.
Troponin is the preferable cardiac biomarker to detect
myocardial injury/necrosis post-PCI, [34–38]. To our knowledge ours is the first report of the SDD patients who underwent measurement of post-PCI TnT levels. Prasad et al [39]
examined peri-procedural MI as a predictor of late mortality
among patients with, and without pre-PCI TnT elevations,
and pre-procedural TnT elevations have a greater prognostic
significance than post-procedural TnT levels. Post-PCI TnT
>5XURL occurred in 30 patients (10.6%) of whom 24 (8.45%)
had the additional criteria necessary for the 2012 PMI definition in our study; there was no significant difference in the
SDD and ON groups. The prognostic significance of hsTnT
elevations meeting PMI criteria, after elective PCI among low
risk patients including with SDD, would need clarification in
a larger study.
Our study has other limitations. The TnT data were retrospectively analysed and an unappreciated bias could have
occurred. As some patients with stable CHD have elevated
troponin T levels (including high sensitivity) [40–42],
assumption of normality of TnT levels pre-PCI may have
lead to an over-estimation of the frequency of elevated levels
post-PCI. Furthermore, other causes of TnT elevations [43]
were not evaluated in this study. As the numbers of SDD
patients, including those with post-PCI TnT>5xURL were
small, and event rates were low, a possible adverse effect
of SDD can’t be excluded due to reduced study power.
Conclusion
In this study the SDD strategy appears to be safe and feasible
among low risk patients following an elective PCI and 5fold post-PCI TnT elevations did not appear to confer incremental short and long-term risk. Randomised trials with
a larger population are required to further assess this
observation.
Conflicts of interest
There are no conflicts of interest to disclose.
Acknowledgments
The authors would like to acknowledge the contribution of
Karen Lintern (RN) in setting up the same day discharge
program. The secretarial assistance of Philomena Kaarma is
acknowledged.
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