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Long term outcome of elective day case percutaneous coronary intervention in patients with stable angina
International Journal of Cardiology 128 (2008) 272 – 274 www.elsevier.com/locate/ijcard
Letter to the Editor
Long term outcome of elective day case percutaneous coronary intervention in patients with stable angina William J. van Gaal ⁎, Jayanth R. Arnold, Italo Porto, Barton Jennings, Vaishali Ashar, Ryan G. Schrale, Adrian P. Banning Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom Received 26 February 2007; accepted 19 May 2007 Available online 10 August 2007
Abstract Patients undergoing elective PCI are traditionally admitted overnight, however day case PCI cuts costs and has been proposed as a safe method for selected patients. We evaluated the success and long term clinical outcomes of day case percutaneous coronary intervention (PCI) for outpatients with stable angina. In total, 484 consecutive patients treated over a five year period with planned day case PCI were studied and followed up for 12 months. Successful PCI with same day discharge was performed in 463 patients (95.7%). There were 21 patients (4.3%) who required hospital admission. Reasons for failed discharge were hematoma formation (n = 7, 1.4%), coronary dissection (n = 4, 0.8%), post-procedural chest pain (n = 3, 0.6%), prolonged procedure (n = 2, 0.4%), and 1 each of acute stent thrombosis, coronary perforation, anaphylaxis, minor drug reaction and a functional study for untreated disease. One year follow up was complete for 439/484 (90.7%). At 12 months there were 6 hospitalizations for angina (1.2%, 95% CI 0.6–3.0%), 20 repeat revascularisations (4.1%, 95% CI 2.7–6.3%), 3 myocardial infarctions (0.6%, 95% CI 0.2–2.1%) and 2 deaths (0.4%, 95% CI 0.1–1.6%). Event free survival at 1 year follow up was 93.6% (95% CI 90.7–95.6%). Selecting patients for day case PCI is safe, and can achieve a high rate of success with excellent long term outcomes. © 2007 Elsevier Ireland Ltd. All rights reserved. Keywords: Angioplasty; Day care; Safety; Outcomes assessment
1. Introduction
2. Methods
Previous reports of our initial day case percutaneous coronary intervention (PCI) experience demonstrated favorable short term outcomes [1,2]. No literature is available on longer term outcomes and safety. This is of particular importance as day case PCI limits the use of glycoprotein IIb/IIIa inhibitors, other adjunctive therapies and potentially more complicated PCI strategies. The aim of this study was to evaluate the long term results and safety (12 month outcome) of day case PCI.
A retrospective cohort study of patients undergoing planned day case PCI between January 2000 and December 2004, performed by a single consultant team. Participants were identified using the cardiology catheterization database, and followed up by mailed questionnaire. Inclusion and exclusion criteria for day case PCI are shown in Table 1. Troponin I measurement at 6 h post-PCI was performed from 2002 onwards. Routine treatment on discharge included long term aspirin and clopidogrel for at least four weeks, or six months in the case of drug eluting stents. Procedural success was defined as a residual stenosis of b 30% with TIMI 3 flow. Successful day case angioplasty was defined as any patient discharged on the same day of admission and PCI. Repeat revascularisation was defined as repeat PCI or coronary artery bypass surgery, and was further divided into target lesion revascularisation
⁎ Corresponding author. Interventional Cardiology Fellow, Department of Cardiology, Level 2, The John Radcliffe, Headley Way, Headington, OX3 9DU, United Kingdom. Tel.: +44 1865 220255; fax: +44 1865 220585. E-mail address: [email protected] (W.J. van Gaal). 0167-5273/$ - see front matter © 2007 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2007.05.054
W.J. van Gaal et al. / International Journal of Cardiology 128 (2008) 272–274 Table 1 Patient selection criteria Patient selection Inclusion criteria Elective PCI Stable angina Age b 80 years Normal renal function Exclusion criteria Long lesion (N30 mm) Obligate need for GP IIb/IIIa Heart failure Requirement for I.A.B.P. Unfavorable social circumstances GP = Glycoprotein. IABP = Intra aortic balloon pulsation. Patients met all inclusion criteria without the presence of any exclusion criteria.
(TLR), target vessel revascularisation (TVR) or non-TVR. Myocardial infarction was defined as chest pain associated with elevation of creatine kinase 2 times the normal limit. Continuous data are expressed as the mean ± standard deviation. Categorical data are expressed as frequency (percent). Event free survival was analysed using the Kaplan–Meier method, and 12 month event rates reported as frequency (percent, 95% confidence interval). 3. Results During the study period, 484/968 (50%) of outpatient procedures were admitted for planned day case PCI. Mean age Table 2 Procedural variables among the 484 patients undergoing day case PCI
273
was 63.1 ± 8.9 years (males 77.3%). In 527 treated vessels, procedural success was 96.0% and successful day case PCI occurred in 463/484 (95.7%). For procedural variables see Table 2. Follow up was complete for 439/484 (90.7%) patients. Twenty-one patients (4.3%) failed same day discharge due to hematoma formation (n = 7, 1.4%), coronary dissection (n = 4, 0.8%), post-procedural chest pain (n = 3, 0.6%), prolonged procedure (n = 2, 0.4%), and one each of acute stent thrombosis, coronary perforation, anaphylaxis, and a minor drug reaction. One patient was admitted overnight for a functional study to assess a second, untreated lesion. In total, 17/273 patients (6.2%) had an elevated 6 h troponin I (≥ 1.0 μg/L), and two of these failed same day discharge due to procedural LAD dissection and coronary perforation. The remaining 15 patients had troponin elevations b 4.0 μg/L and were discharged the same day. No patient with an elevated troponin I experienced any adverse 12 month outcome following discharge. There was no in-hospital or 30-day mortality. At 12 months there were 2/484 deaths (0.4%, 95% CI 0.1–1.6%), one due to heart failure and one MI in a non-treated vessel, both confirmed at autopsy. Readmission for angina (not requiring repeat revascularisation) occurred in 6/484 patients (1.2%, 95% CI 0.6–3.0%). Twenty patients underwent repeat revascularisation (4.1%, 95% CI 2.7–6.3%). Of these, 10 patients underwent TLR with PCI for instent restenosis. These patients had originally been treated with bare metal stents (8) or balloon angioplasty only (2). Ten patients underwent nonTLR (8 PCI, 2 CABG). There were 3/484 patients who had an MI at 12 months (0.6%, 95% CI 0.2–2.1%). One year event free survival was 93.6% (95% CI 90.7–95.6%). See Fig. 1.
Procedural variables Non-femoral access Sheath size N 6Fr Arterial closure device (angioseal) Vessels treated Left anterior descending Right coronary artery Circumflex Intermediate Arterial graft Saphenous vein graft Unprotected left main stem Protected left main stem Multi-vessel PCI Bifurcation Total occlusions Procedural success Number of stents Bare metal stents Drug eluting stents Stents per lesion Stents per patient Stent length per patient (mm) POBA only POBA = balloon angioplasty. Non-femoral access included radial or brachial access.
6 (1.2%) 6 (1.2%) 25 (5.2%) 527 230 (43.6%) 164 (31.1%) 117 (22.2%) 7 (1.3%) 4 (0.8%) 3 (0.6%) 1 (0.2%) 1 (0.2%) 53 (11.0%) 107 (20.3%) 76 (14.4%) 506 (96.0%) 623 532 (85.4%) 91 (14.6%) 1.2 1.3 20.0 ± 12.2 8 (1.6%)
Fig. 1. Kaplan Meier curve demonstrating 12 month event free survival from the combined endpoint of readmission for angina, revascularisation, MI or death.
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4. Discussion Our study shows that day case PCI for select patients can achieve very high same day discharge rates whilst maintaining excellent procedural success and long term safety, with event free survival greater than 90% at 12 months. Previous studies of day case PCI by other groups have demonstrated same day discharge rates of 53–77% with no prior studies reporting long term outcomes [3–7]. By design, our patient cohort was a select group in order to maximise successful same day discharge and patient safety, and minimize disruption of inpatient bed access due to unexpected discharge failures. Nevertheless, the selected group represented one half of all patients undergoing elective PCI, and using our selection criteria these results should be applicable to other interventional practices. We have previously published on the incidence of troponin elevation following day case PCI in a smaller cohort which was 3.0% [2]. The incidence of troponin elevation was slightly higher in the current study, however the majority of troponin elevations were minimal (b4.0 μg/L), and not associated with longer term MACE in our cohort. The increased incidence of peri-procedural troponin elevation probably represents the inclusion of more complex lesions, with over one third of cases being bifurcations, total occlusions or multi-vessel PCI. Despite the increase in complexity and peri-procedural troponin elevation, the current cohort experienced a high success rate for day case PCI and low 12 month event rate. In patients undergoing day case PCI, minor troponin elevations at 6 h probably should not postpone discharge if the patient is mobilized uneventfully and there is an optimal angiographic result. Our study is retrospective and potentially prone to data collection bias. Whilst we cannot rule out patient recall bias for non-fatal events, all recorded events were checked with the patient's hospital medical record and/or the referring physician. Day case PCI is advantageous for patients with earlier discharge from hospital, and as such is highly cost effective. Furthermore, such a strategy frees up hospital beds for acute admissions, facilitates ward admissions from the emergency department and reduces waiting lists for PCI. This study
demonstrates that using our inclusion criteria, 50% of all elective patients undergoing PCI can be discharged the same day, whilst maintaining procedural success and long term safety. Acknowledgements None Author Disclosures/Competing Interests William J. van Gaal, none Jayanth R. Arnold, none Italo Porto, none Barton Jennings, none Vaishali Ashar, none Ryan G. Schrale, none Adrian P. Banning, none Funding None References [1] Banning AP, Ormerod OJ, Channon K, et al. Same day discharge following elective percutaneous coronary intervention in patients with stable angina. Heart 2003;89(6):665. [2] Porto I, Blackman DJ, Nicolson D, et al. What is the incidence of myocardial necrosis in elective patients discharged on the same day following percutaneous coronary intervention? Heart 2004;90(12):1489–90. [3] Kiemeneij F, Laarman GJ, Slagboom T, van der Wieken R. Outpatient coronary stent implantation. J Am Coll Cardiol 1997;29(2):323–7. [4] Knopf WD, Cohen-Bernstein C, Ryan J, et al. Outpatient PTCA with same day discharge is safe and produces high patient satisfaction level. J Invasive Cardiol 1999;11(5):290–5. [5] Dalby M, Davies J, Rakhit R, et al. Feasibility and safety of day-case transfemoral coronary stenting. Catheter Cardiovasc Interv 2003;60 (1):18–24. [6] Wilentz JR, Mishkel G, McDermott D, et al. Outpatient coronary stenting: femoral approach with vascular sealing. Herz 1999;24(8):624–33. [7] Slagboom T, Kiemeneij F, Laarman GJ, van der Wieken R, Odekerken D. Actual outpatient PTCA: results of the OUTCLAS pilot study. Catheter Cardiovasc Interv 2001;53(2):204–8.
Letter to the Editor
Long term outcome of elective day case percutaneous coronary intervention in patients with stable angina William J. van Gaal ⁎, Jayanth R. Arnold, Italo Porto, Barton Jennings, Vaishali Ashar, Ryan G. Schrale, Adrian P. Banning Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom Received 26 February 2007; accepted 19 May 2007 Available online 10 August 2007
Abstract Patients undergoing elective PCI are traditionally admitted overnight, however day case PCI cuts costs and has been proposed as a safe method for selected patients. We evaluated the success and long term clinical outcomes of day case percutaneous coronary intervention (PCI) for outpatients with stable angina. In total, 484 consecutive patients treated over a five year period with planned day case PCI were studied and followed up for 12 months. Successful PCI with same day discharge was performed in 463 patients (95.7%). There were 21 patients (4.3%) who required hospital admission. Reasons for failed discharge were hematoma formation (n = 7, 1.4%), coronary dissection (n = 4, 0.8%), post-procedural chest pain (n = 3, 0.6%), prolonged procedure (n = 2, 0.4%), and 1 each of acute stent thrombosis, coronary perforation, anaphylaxis, minor drug reaction and a functional study for untreated disease. One year follow up was complete for 439/484 (90.7%). At 12 months there were 6 hospitalizations for angina (1.2%, 95% CI 0.6–3.0%), 20 repeat revascularisations (4.1%, 95% CI 2.7–6.3%), 3 myocardial infarctions (0.6%, 95% CI 0.2–2.1%) and 2 deaths (0.4%, 95% CI 0.1–1.6%). Event free survival at 1 year follow up was 93.6% (95% CI 90.7–95.6%). Selecting patients for day case PCI is safe, and can achieve a high rate of success with excellent long term outcomes. © 2007 Elsevier Ireland Ltd. All rights reserved. Keywords: Angioplasty; Day care; Safety; Outcomes assessment
1. Introduction
2. Methods
Previous reports of our initial day case percutaneous coronary intervention (PCI) experience demonstrated favorable short term outcomes [1,2]. No literature is available on longer term outcomes and safety. This is of particular importance as day case PCI limits the use of glycoprotein IIb/IIIa inhibitors, other adjunctive therapies and potentially more complicated PCI strategies. The aim of this study was to evaluate the long term results and safety (12 month outcome) of day case PCI.
A retrospective cohort study of patients undergoing planned day case PCI between January 2000 and December 2004, performed by a single consultant team. Participants were identified using the cardiology catheterization database, and followed up by mailed questionnaire. Inclusion and exclusion criteria for day case PCI are shown in Table 1. Troponin I measurement at 6 h post-PCI was performed from 2002 onwards. Routine treatment on discharge included long term aspirin and clopidogrel for at least four weeks, or six months in the case of drug eluting stents. Procedural success was defined as a residual stenosis of b 30% with TIMI 3 flow. Successful day case angioplasty was defined as any patient discharged on the same day of admission and PCI. Repeat revascularisation was defined as repeat PCI or coronary artery bypass surgery, and was further divided into target lesion revascularisation
⁎ Corresponding author. Interventional Cardiology Fellow, Department of Cardiology, Level 2, The John Radcliffe, Headley Way, Headington, OX3 9DU, United Kingdom. Tel.: +44 1865 220255; fax: +44 1865 220585. E-mail address: [email protected] (W.J. van Gaal). 0167-5273/$ - see front matter © 2007 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2007.05.054
W.J. van Gaal et al. / International Journal of Cardiology 128 (2008) 272–274 Table 1 Patient selection criteria Patient selection Inclusion criteria Elective PCI Stable angina Age b 80 years Normal renal function Exclusion criteria Long lesion (N30 mm) Obligate need for GP IIb/IIIa Heart failure Requirement for I.A.B.P. Unfavorable social circumstances GP = Glycoprotein. IABP = Intra aortic balloon pulsation. Patients met all inclusion criteria without the presence of any exclusion criteria.
(TLR), target vessel revascularisation (TVR) or non-TVR. Myocardial infarction was defined as chest pain associated with elevation of creatine kinase 2 times the normal limit. Continuous data are expressed as the mean ± standard deviation. Categorical data are expressed as frequency (percent). Event free survival was analysed using the Kaplan–Meier method, and 12 month event rates reported as frequency (percent, 95% confidence interval). 3. Results During the study period, 484/968 (50%) of outpatient procedures were admitted for planned day case PCI. Mean age Table 2 Procedural variables among the 484 patients undergoing day case PCI
273
was 63.1 ± 8.9 years (males 77.3%). In 527 treated vessels, procedural success was 96.0% and successful day case PCI occurred in 463/484 (95.7%). For procedural variables see Table 2. Follow up was complete for 439/484 (90.7%) patients. Twenty-one patients (4.3%) failed same day discharge due to hematoma formation (n = 7, 1.4%), coronary dissection (n = 4, 0.8%), post-procedural chest pain (n = 3, 0.6%), prolonged procedure (n = 2, 0.4%), and one each of acute stent thrombosis, coronary perforation, anaphylaxis, and a minor drug reaction. One patient was admitted overnight for a functional study to assess a second, untreated lesion. In total, 17/273 patients (6.2%) had an elevated 6 h troponin I (≥ 1.0 μg/L), and two of these failed same day discharge due to procedural LAD dissection and coronary perforation. The remaining 15 patients had troponin elevations b 4.0 μg/L and were discharged the same day. No patient with an elevated troponin I experienced any adverse 12 month outcome following discharge. There was no in-hospital or 30-day mortality. At 12 months there were 2/484 deaths (0.4%, 95% CI 0.1–1.6%), one due to heart failure and one MI in a non-treated vessel, both confirmed at autopsy. Readmission for angina (not requiring repeat revascularisation) occurred in 6/484 patients (1.2%, 95% CI 0.6–3.0%). Twenty patients underwent repeat revascularisation (4.1%, 95% CI 2.7–6.3%). Of these, 10 patients underwent TLR with PCI for instent restenosis. These patients had originally been treated with bare metal stents (8) or balloon angioplasty only (2). Ten patients underwent nonTLR (8 PCI, 2 CABG). There were 3/484 patients who had an MI at 12 months (0.6%, 95% CI 0.2–2.1%). One year event free survival was 93.6% (95% CI 90.7–95.6%). See Fig. 1.
Procedural variables Non-femoral access Sheath size N 6Fr Arterial closure device (angioseal) Vessels treated Left anterior descending Right coronary artery Circumflex Intermediate Arterial graft Saphenous vein graft Unprotected left main stem Protected left main stem Multi-vessel PCI Bifurcation Total occlusions Procedural success Number of stents Bare metal stents Drug eluting stents Stents per lesion Stents per patient Stent length per patient (mm) POBA only POBA = balloon angioplasty. Non-femoral access included radial or brachial access.
6 (1.2%) 6 (1.2%) 25 (5.2%) 527 230 (43.6%) 164 (31.1%) 117 (22.2%) 7 (1.3%) 4 (0.8%) 3 (0.6%) 1 (0.2%) 1 (0.2%) 53 (11.0%) 107 (20.3%) 76 (14.4%) 506 (96.0%) 623 532 (85.4%) 91 (14.6%) 1.2 1.3 20.0 ± 12.2 8 (1.6%)
Fig. 1. Kaplan Meier curve demonstrating 12 month event free survival from the combined endpoint of readmission for angina, revascularisation, MI or death.
274
W.J. van Gaal et al. / International Journal of Cardiology 128 (2008) 272–274
4. Discussion Our study shows that day case PCI for select patients can achieve very high same day discharge rates whilst maintaining excellent procedural success and long term safety, with event free survival greater than 90% at 12 months. Previous studies of day case PCI by other groups have demonstrated same day discharge rates of 53–77% with no prior studies reporting long term outcomes [3–7]. By design, our patient cohort was a select group in order to maximise successful same day discharge and patient safety, and minimize disruption of inpatient bed access due to unexpected discharge failures. Nevertheless, the selected group represented one half of all patients undergoing elective PCI, and using our selection criteria these results should be applicable to other interventional practices. We have previously published on the incidence of troponin elevation following day case PCI in a smaller cohort which was 3.0% [2]. The incidence of troponin elevation was slightly higher in the current study, however the majority of troponin elevations were minimal (b4.0 μg/L), and not associated with longer term MACE in our cohort. The increased incidence of peri-procedural troponin elevation probably represents the inclusion of more complex lesions, with over one third of cases being bifurcations, total occlusions or multi-vessel PCI. Despite the increase in complexity and peri-procedural troponin elevation, the current cohort experienced a high success rate for day case PCI and low 12 month event rate. In patients undergoing day case PCI, minor troponin elevations at 6 h probably should not postpone discharge if the patient is mobilized uneventfully and there is an optimal angiographic result. Our study is retrospective and potentially prone to data collection bias. Whilst we cannot rule out patient recall bias for non-fatal events, all recorded events were checked with the patient's hospital medical record and/or the referring physician. Day case PCI is advantageous for patients with earlier discharge from hospital, and as such is highly cost effective. Furthermore, such a strategy frees up hospital beds for acute admissions, facilitates ward admissions from the emergency department and reduces waiting lists for PCI. This study
demonstrates that using our inclusion criteria, 50% of all elective patients undergoing PCI can be discharged the same day, whilst maintaining procedural success and long term safety. Acknowledgements None Author Disclosures/Competing Interests William J. van Gaal, none Jayanth R. Arnold, none Italo Porto, none Barton Jennings, none Vaishali Ashar, none Ryan G. Schrale, none Adrian P. Banning, none Funding None References [1] Banning AP, Ormerod OJ, Channon K, et al. Same day discharge following elective percutaneous coronary intervention in patients with stable angina. Heart 2003;89(6):665. [2] Porto I, Blackman DJ, Nicolson D, et al. What is the incidence of myocardial necrosis in elective patients discharged on the same day following percutaneous coronary intervention? Heart 2004;90(12):1489–90. [3] Kiemeneij F, Laarman GJ, Slagboom T, van der Wieken R. Outpatient coronary stent implantation. J Am Coll Cardiol 1997;29(2):323–7. [4] Knopf WD, Cohen-Bernstein C, Ryan J, et al. Outpatient PTCA with same day discharge is safe and produces high patient satisfaction level. J Invasive Cardiol 1999;11(5):290–5. [5] Dalby M, Davies J, Rakhit R, et al. Feasibility and safety of day-case transfemoral coronary stenting. Catheter Cardiovasc Interv 2003;60 (1):18–24. [6] Wilentz JR, Mishkel G, McDermott D, et al. Outpatient coronary stenting: femoral approach with vascular sealing. Herz 1999;24(8):624–33. [7] Slagboom T, Kiemeneij F, Laarman GJ, van der Wieken R, Odekerken D. Actual outpatient PTCA: results of the OUTCLAS pilot study. Catheter Cardiovasc Interv 2001;53(2):204–8.