the General Health Bureau of Taiwan are acute or threatened occlusion after POBA ... was integrated into our fluoroscopy system (INTEGRIS BH5000, Philip).
Clinical Studies
Transradial Approach Percutaneous Coronary Interventions in an Out-Patient Clinic Safety and Feasibility Trial of Same-Day Discharge Versus Hospital Admission Wen-Jung Chung,1 MD, Hsiu-Yu Fang,1 MD, Tzu-Hsien Tsai,1 MD, Cheng-Hsu Yang,1 MD, Chien-Jen Chen,1 MD, Shyh-Ming Chen,1 MD, Cheng-I Cheng,1 MD, Chih-Yuan Fang,1‡ MD, Yuan-Kai Hsieh,1 MD, Chi-Ling Hang,1 MD, Hon-Kan Yip,1§ MD, and Chiung-Jen Wu,1 MD Summary Same-day discharge transradial percutaneous coronary intervention (TRI) has been reported to be safe and feasible in Western countries. However, Asia has not produced any reports related to this matter. The present study explored the safety and feasibility of patients with indications for TR coronary angiography and ad hoc PCI with a same-day discharge protocol. Between October 1995 and December 2002, 660 adult patients were admitted to our hospital for ad hoc PCIs. Of these, 214 patients were discharged on the day of their PCI (group A), while the remaining 446 patients were referred for out-patient department (OPD) PCI with subsequent admission (group B). Periprocedural complications were not significantly different between the groups. There were no differences in 1-month major adverse cardiac events including death, myocardial infarction, and target vessel revascularization (1.4% versus 0.2% for groups A and B, respectively; P = 0.068). Three group A cases (1.4%) experienced peri- and post-PCI myocardial infarction and one group B case (0.2%) experienced a post-PCI myocardial infarction. No patient died or required emergency bypass surgery. In group A, 8 cases (3.7%) required cutting balloon angioplasty and 2 cases (0.9%) needed rotational atherectomy. TRI is safe and feasible on an outpatient basis. For select patients, even though PCI can carry the potential risk of subsequent cutting balloon angioplasty or rotational atherectomy, the procedure should still be considered. (Int Heart J 2010; 51: 371-376) Key words: Angioplasty, Out-patient, Transradial
T
he transradial (TR) approach for diagnostic coronary angiography was first reported in 1989,1) and the use of TR percutaneous coronary intervention (PCI) was reported in 1992.2) The benefits of TR intervention (TRI) include less bleeding complications,3) and earlier ambulation and better quality of care after the procedure.4) Accordingly, TRI has been increasingly adopted for out-patient department (OPD) procedures, with same-day discharge, with a variety of studies including randomized trials verifying the safety and feasibility of the approach in Western countries.5-7,12-20) Beginning in 1994, we and others introduced TRI in Asia.8-10) However, feasibility and safety issues of OPD TRI without admission have not been reported in Asia. The present study was undertaken to explore the safety and feasibility of OPD patients with indications for TR coronary angiography and ad hoc PCIs, who fulfilled predefined criteria for same-day discharge after TRI. Consecutive patients after OPD TRIs were selected by operators and were divided into two groups (admission for close observation or without admission), and the clinical outcomes of the two groups were compared prospectively.
Methods Between October 1995 and December 2002, 660 adult patients were admitted to our hospital for ad hoc PCIs. Of these, 214 patients were prepared for same-day discharge after PCIs and the other 446 patients were prepared for OPD PCI with subsequent admission. The TRI program in our hospital began in 1994.8) Informed consent was obtained prior to performing TRI. A 6F transradial kit (Terumo Corporation, Tokyo) was used for radial access. Radial puncture was made with a 20 G needle and a 0.025 inch straight or J-tip hydrophilic wire was introduced into a radial artery. The 6 F arterial sheath was advanced slowly into the radial artery with or without an incision at the puncture site. After sheath insertion, a cocktail solution was routinely administered via a sheath side arm (verapamil 2.5 mg, heparin 5,000 IU, and 100-200 μg nitroglycerine). Early in the TRI program, a diagnostic Judkins left or right catheter was used for coronary angiography. In later years, a proper guiding catheter was exchanged for TRIs. Still later, a Kimny-radial guiding catheter (Boston Scientific, Natick, MA, USA) was
From the 1 Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital- Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan, R.O.C. ‡ indicates equal contribution in this study compared with the first author. § indicates equal contribution in this study compared with corresponding author. Address for correspondence: Chiung-Jen Wu, MD, Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, No. 123, Ta Pei Road, Niao Sung Hsiang, Kaohsiung Hsien 83301, Taiwan, R.O.C. Received for publication April 16, 2010. Revised and accepted July 22, 2010. 371
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utilized for bilateral coronary angiography and subsequent ad hoc PCIs. If the Kimny guiding catheter could not provide proper back-up, an additional guiding catheter was selected for further PCIs. Before the PCI procedure, a second bolus of 5,000 IU heparin was administered through a guiding catheter into the ascending aorta. The PCI was performed as per the usual indications, and, prior to the implementation of the firstgeneration Palmaz-Shatz stent in 1995, plain old balloon angioplasty (POBA) was used. Radial access time was defined as the time from radial puncture to radial sheath insertion. The diagnostic time was defined as the time from radial sheath insertion to completion of bilateral coronary angiography. Total procedure time was defined as the time from radial sheath insertion to completion of PCI. The indications for bare-metal stent reimbursement by the General Health Bureau of Taiwan are acute or threatened occlusion after POBA, ST-elevation myocardial infarction or elective PCIs with suboptimal results after POBA (> 50% residual diameter stenosis), restenosis (3-6 months) post-POBA, chronic total occlusion with reference vessel diameter > 2.5 mm, saphenous vein graft or internal mammary artery graft stenosis, and ostial lesions at the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA). Drug-eluting stents were not available in Taiwan from 1995 to 2002. Exclusion criteria for enrollment were left main disease; congestive heart failure with a low left ventricular ejection fraction (< 30%); complications during PCIs such as acute/ threatened occlusion, side branch occlusion with symptoms, perforation, puncture site complications, or cardiac tamponade; chronic renal insufficiency (creatinine ≥ 2.0 mg/dL); inability to reach an emergency department (ED) within 40 minutes (home > 40 km from hospital); and refusal by either the patient or surgeon to enroll in the study. After the TRI, hemostasis was applied by adhesive tape fixation over the forearm with the “figure 8” method. At that time, patients could ambulate to use the washroom, although they were closely monitored for 4-6 hours. Patients who had fulfilled the enrollment criteria were randomly allocated to one of two groups: group A (same-day discharge) and group B (routine admission for close observation). Group A patients were discharged after receiving instructions to return to the ED in the event of any intolerable discomfort, and that interventional on-call fellows would be informed of the possibility. In the event of an ED visit, the decision concerning hospital admission or continued close observation while remaining in the ED was made by consulting the on-call physician. Following their discharge, patients visited the OPD according to a schedule, with the first visit being 1-2 weeks after TRI, and at 1-3 months thereafter. Patients were pretreated with oral aspirin (100 mg/day), as well as a loading dose of clopidogrel (300 mg) at 4 to 12 hours before the procedure. Clopidogrel (postprocedure loading dose of 300 mg, 75 mg/day thereafter) was administered to patients for at least 3 months after bare-metal stenting. Before clopidogrel was available, in addition to aspirin, the patients were pretreated with ticlodipine (250 mg) twice a day for 1 week. Ticlodipine (250 mg twice a day) was administered to patients for 1 month after bare-metal stenting. Study endpoints of OPD TRIs were major adverse cardi-
ac events (MACE) that included death, myocardial infarction (> 3 times of normal value of creatine phosphokinase-MB), and emergency coronary bypass surgery. Minor adverse events were stroke (either hemorrhagic or ischemic), bleeding complication requiring blood transfusion or return to an ED, readmission within 30 days due to any causes possibly related to TRI procedures, and vascular access site aneurysm, fistula, or local hematoma with ecchymosis (> 5 cm in diameter). Quantitative coronary analysis (QCA) was analyzed using CAAS QCA software (CAAS II, Pie Medical Imaging, FDA 510(k) number: K945540) which was integrated into our fluoroscopy system (INTEGRIS BH5000, Philip). It offered contour detection of coronary arteries as well as obstruction and segment analysis. Continuous variables are reported as the mean ± standard deviation, while categorical variables are reported as frequencies. Categorical variables were compared between groups using the chi-square test. A P value of < 0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 15.0 software (SPSS, Chicago, IL).
Results From October 1995 to December 2002, of the total of 660 patients who underwent TRIs, 214 patients were enrolled for same-day discharge after OPD TRIs (group A) and 446 patients were admitted routinely after TRIs (group B). The clinical characteristics of both groups of patients are summarized in Table I. Both groups were predominantly comprised of males; the age in group B (61.7 ± 10.5 years) was significantly older than in group A (59.7 ± 10.4 years). No significant differences were evident in the clinical characteristics between groups A and B with respect to diabetic mellitus (28.0% versus 26.9%, respectively; P = 0.76), hypertension (59.8% versus 58.3%, respectively; P = 0.711), and current smokers (47.7% versus 43.5%, respectively; P = 0.314). However, relatively higher incidences of previous myocardial infarction (50.0% versus 35.4%, respectively; P < 0.001) and lower left ventricular ejection fraction (62.6% versus 66.7%, respectively; P = 0.001) were evident in group A versus group B. The indications for
Table I. Clinical Characteristics Parameter
Group A (n = 214)
Group B (n = 446)
Sex (male) Age (years) Body height (cm) Body weight (kg) Diabetes mellitus Hypertension Smoker Previous MI Cath. indications PCIs F/U Non PCI F/U LVEF (%)
181 (84.6%) 59.7 ± 10.4 164.2 ± 7.1 68.6 ± 10.6 60 (28.0%) 128 (59.8%) 102 (47.7%) 107 (50.0%)
381 (85.4%) 61.7 ± 10.5 164.9 ± 17.7 67.8 ± 11.5 120 (26.9%) 260 (58.3%) 194 (43.5%) 158 (35.4%)
0.775 0.021 0.521 0.398 0.760 0.711 0.314 < 0.001
155 (72.4%) 59 (27.6%) 62.6 ± 14.8
227 (50.9%) 219 (49.1%) 66.7 ± 13.3
< 0.001
P
0.001
MI indicates myocardial infarction; Cath. Indications, indication of diagnostic coronary angiography; PCIs F/U, history of previous percutaneous coronary intervention (PCIs) for follow-up study; and LVEF, left ventricular ejection fraction.
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SAME-DAY DISCHARGE PCI IS FEASIBLE AND SAFE Table II. Transradial Diagnostic Coronary Angiography
Parameter
Group A (n = 214) Group B (n = 446)
Success rate of first 205 (95.8%) RA access LRA (n = 437) 164 (80.0%) RRA (n = 207) 41 (20.0%) RA access time (minutes) 3.54 ± 5.40 Diagnostic time (minutes) 22.95 ± 10.50 Total procedural time 63.13 ± 27.28 (minutes) Single catheter (486) 102 (47.7%) Kimny-radial 83 (81.4%) Amplatz-left 19 (18.6%) Two catheters (174) 112 (52.3%) JL/JR 90 (80.4%) AL/JR 14 (12.5%) Other combination 8 (7.1%) Extent of CAD Single vessel 208 (97.2%) Multivessel 6 (2.8%) Type A/B1 lesions 86 (40.2%) Type B2/C lesions 128 (59.8%) Lesion characteristics Restenosis lesion 105 (49.1%) New lesion 109 (50.9%) Size of guiding catheter 5-6 F 211 (98.6%) 7-8 F 3 (1.4%)
Table III. Percutaneous Coronary Intervention (PCI) Results P
439 (98.4%)
0.039
273 (62.2%) 166 (37.8%) 2.98 ± 4.30 21.5 ± 10.46 62.42 ± 25.30
< 0.001
384 (86.1%) 373 (97.1%) 11 (2.9%) 62 (13.9%) 41 (66.1%) 3 (4.8%) 18 (29.0%)
< 0.001 < 0.001
414 (92.8%) 32 (7.2%) 93 (20.9%) 353 (79.1%)
0.024
0.151 0.098 0.742
< 0.001 < 0.001
< 0.001
153 (34.3%) 293 (65.7%)
< 0.001
401 (89.9%) 45 (10.1%)
< 0.001
RA indicates radial artery; LRA, left radial artery; RRA, right radial artery; Diagnostic time, diagnostic coronary angiography time; JL/JR, Judkins left & right catheters; AL/JR, Amplatz left & Judkins right catheters; and CAD, coronary artery disease.
OPD TR catheterization were a higher incidence of follow-up study for restenosis after a previous PCI in group A patients (72.4%) compared with group B (50.9%), and a lower incidence of ad-hoc PCIs with unknown coronary anatomies for group A versus group B patients (27.6% versus 49.1%, P < 0.001). The transradial access and diagnostic coronary angiography results are summarized in Table II. The success rate of first radial access was significantly higher in group B patients than in group A patients (98.4% versus 95.8%, respectively; P = 0.039). Patients who experienced first access failure required a second radial access from the other arm. The use of left radial access was predominant overall, but the frequency was higher in group A than in group B (80.0% versus 62.2%, respectively; P < 0.001), and the mean radial access time, mean diagnostic time, and total procedure time were not different between the two groups. A single guiding catheter, predominantly a 6F Kimny-mini-radial (Boston Scientific), was used more frequently in group B patients (97.1% versus 81.4%, P < 0.001) and two guiding catheters, predominantly Judkins left and right, were used more often in group A patients (80.4% versus 66.1%, P < 0.001). In group A, the lesion characteristics were similar in restenosis (49.1%) or new lesions (50.9%). However, in group B, about 65.7% of the patients had new lesions. A significant difference in the incidence of new lesions was observed between groups A and B (50.9% versus 65.7%, P < 0.001). For both groups, 5 or 6F guiding catheters were used predominantly (group A 98.6%, group B 89.9%) and 7 or 8F guiding catheters were used for intravascular ultrasound guid-
Parameter Single vessel PCI LAD RCA LCX SVG Multivessel PCI LAD/LCX LAD/RCA LCX/RCA Pre-PCI D.S. (%) MLD (mm) Reference (mm) Post-PCI D.S. (%) MLD (mm) Reference (mm) Stenting POBA Cutting BA Rota-PCIs Success rate of PCI (percent)
Group A (n = 214) Group B (n = 446) 103 (48.1%) 61 (28.5%) 41 (19.2%) 3 (1.4%)
215 (48.2%) 106 (23.8%) 91 (20.4%) 2 (0.4%)
P 0.986 0.190 0.708 0.186
4 (1.9%) 2 (0.9%) 0 (0%) 84.15 ± 10.81 0.67 ± 3.14 2.85 ± 0.62
5 (1.1%) 14 (3.1%) 12 (2.7%) 82.97 ± 11.48 0.52 ± 0.37 3.08 ± 0.63
0.438 0.085 0.015 0.208 0.325 < 0.001
23.49 ± 26.01 2.34 ± 1.01 2.96 ± 0.67
15.95 ± 15.68 2.86 ± 1.18 3.30 ± 0.67
< 0.001 < 0.001 < 0.001
72 (33.6%) 133 (62.1%) 8 (3.7%) 2 (0.9%) 210 (98.1%)
218 (48.9%) 159 (35.7%) 81 (18.2%) 3 (0.7%) 444 (99.6%)
< 0.001 < 0.001 < 0.001 0.716 0.072
LAD indicates left anterior descending artery; RCA, right coronary artery; LCX, left circumflex; SVG, saphenous vein graft; D.S., diameter stenosis; MLD, minimal luminal diameter; Reference, reference vessel diameter; and Cutting BA, cutting balloon angioplasty.
ed PCIs with bare-metal in-stent restenosis (group A 1.4%, group B 10.1%). The treated lesions were relatively simple (A/ B1 lesion) for group A (40.2%) compared to group B (20.9%), and were more complex (B2/C lesion) for group B (79.1%) compared with group A (59.8%). The results are summarized in Table III and show a similar frequency for target lesions including single vessels and multiple vessels. There was no difference between the groups in pre-PCI stenotic percentage and minimal luminal diameter. A PCI strategy that included stent deployment was more common in group B (48.9%) than in group A (33.6%) (P < 0.001), while POBA was more common in group A (62.1%) than in group B (35.7%) (P < 0.001). Two group A patients and 3 group B patients required adjunctive rotablation. There was no significant difference in the PCI success rate between the two patient groups. The post-PCI quantitative coronary angiography results, including post-PCI percentage of stenosis, postPCI minimal luminal diameter, and post-PCI reference were better and somewhat larger in group B patients than in group A patients. Tables IV and V summarize data concerning periprocedural complications and 30-day clinical outcomes. Periprocedural complications such as side branch jailing, type B to type D dissection, periprocedural arrhythmia, and acute threatening occlusion displayed were not significantly different between the groups. Three group A patients suffered from periprocedural myocardial infarction, which was due to major side branch jailing in two patients and transient ST segment elevation in the remaining patient. Only one of the 3 patients returned to the emergency department due to chest pain with elevated cardiac enzymes; the patient was discharged within 24 hours with
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Int Heart J November 2010
CHUNG, ET AL Table IV. Periprocedural Complications
Parameter
Table V. 30-Day Clinical Outcome
Group A (n = 214) Group B (n = 446)
Jail of branch vessel Type B-D dissection* Arrythmia Periprocedure MI Acute occlusion
5 (2.3%) 22 (10.3%) 1 (0.5%) 3 (1.4%) 0 (0%)
6 (1.3%) 58 (13.0%) 4 (0.9%) 0 (0%) 2 (0.4%)
Parameter
P 0.352 0.316 0.551 0.012 0.327
* indicates NHLBI classification; Arrythmia, ventricular tachycardia or ventricular fibrillation; and MI, myocardial infarction.
Group A (n = 214) Group B (n = 446)
Death Emergent CABG Myocardial infarction Stroke Post-PCI angina Vascular access complication MACE (%)
P
0 (0%) 0 (0%) 3 (1.4%) 0 (0%) 11 (5.1%) 9 (4.2%)
0 (0%) 0 (0%) 1 (0.2%) 2 (0.4%) 26 (5.8%) 9 (2.0%)
1.000 1.000 0.068 0.327 0.719 0.106
3 (1.4%)
1 (0.2%)
0.068
CABG indicates coronary artery bypass graft surgery; PCI, percutaneous coronary intervention; and MACE, major adverse cardiac event. Table VI. Literature Review of PCI With Same-Day Discharge Eligible Discharge Anticoagulant patients patients
Reference
Year
Design
Access site
Kiemeneij, et al12) Netherlands Slagboom, et al5) Netherlands Gilchrist, et al13) U.S. Ziakas, et al14) Canada Slagboom, et al15) Netherlands Kumar, et al6) U.K. Bertrand, et al16, 17) Canada Wiper, et al18) U.K. Small A, et al.19) Canada Jabara R, et al.11) U.S.
1994
Registry
Radial
188
100
Heparin
2000
Registry
Radial
159
106
Heparin
1999-2001
Registry
Radial
_
26
943
811
Heparin & abciximab Heparin
644
375
Heparin Heparin & abciximab Heparin & abciximab Heparin
Wu, et al. Taiwan
1998-2001 2003
Registry Radial (Retrospective) Random Radial/Femoral
2003
Registry
Radial
150
120
2003-2005
Random
Radial
504
443
2001-2005
Registry
Radial
442
387
2005-2006
Registry
Radial
2189
1015
2004-2007
Registry
Radial
450
12
1995-2002
Registry
Radial
660
214
Heparin/GP IIb/ IIIa inhibitor Heparin/GP IIb/ IIIa inhibitor/ Bivalirudin Heparin
Procedure
Major 1 month complication (MACE) from discharge (%) to 24 hours
PTCA/stent (BMS) PTCA/stent (BMS) PTCA/stent (BMS) PTCA/stent (BMS) PTCA/stent (BMS) _
0
0%
0
_
0
_
0
0.2%
1
1.0%
0
0.67%
PTCA/stent (BMS & DES) PTCA/stent (BMS & DES) PTCA/stent
N/A
1.6%
0
0.68%
_
_
PTCA/stent
_
_
PTCA/stent (BMS)
1
1.4%
PTCA indicates percutaneous transluminal coronary angioplasty; BMS, bare metal stent; DES, drug eluting stent; MACE, major adverse cardiac event; and GP IIb/ IIIa inhibitor, glycoprotein IIb/IIIa inhibitor.
abatement of the symptoms. Only one patient in group B had postprocedure non-ST segment elevation myocardial infarction. In the study, no patients died or needed emergency bypass surgery. Only two patients in group B experienced ischemic stroke, which occurred on days 15 and 25. Other complications such as post-PCI angina and restricted vascular access did not differ significantly between the two patient groups. There was no statistical difference in 1-month MACE between group A (1.4%) and group B (0.2%) (P = 0.068).
Discussion While OPD TRI has been shown to be feasible and safe in Western studies,5-7,11-18) the situation in Asia is unclear. The present prospective nonrandomized comparison study involving acceptably large numbers of patients provides an indication
that, by careful selection criteria, same-day discharge after OPD TRIs is acceptable and without serious PCI related complications. Presently, no significant differences in terms of complications were evident between the same-day discharge and admission groups. In the group A cohorts, two cases of rotational ablation were performed for bare-metal in-stent restenosis, with no complications experienced by either patient, both of whom were discharged safely after 6 hours of close observation. TR stenting procedures were conducted in 33.6% of the group A patients and in 48.9% of the group B patients; others were treated either by cutting balloon angioplasty or POBA. Of the group A patients treated by stenting, after same-day discharge only one patient revisited the ED due to recurrent chest pain caused by jailing effect of a diagonal branch after crossover stenting at the proximal LAD. The patient was discharged from the ED after 1 day of observation without further symp-
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SAME-DAY DISCHARGE PCI IS FEASIBLE AND SAFE
toms. The 30-day follow-up for both groups also revealed no significant difference in the study endpoint. Salient points from a review of the literature from 19942005 are listed in Table VI. Compared with an earlier study,12) the present patients had been selected by another medical center and had been referred for intervention without ad-hoc PCIs. Moreover, the present patients underwent a greater variety of procedures that included POBA, stenting, cutting balloon angioplasty, and rotational atherectomy, instead of stenting alone. Another study enrolled same-day discharge patients, but without multivessel PCIs.5) Compared with the earlier studies, an extremely low 1-month MACE rate was observed in the sameday discharge patients in the present study. Out-patient TRI has the potential of reducing medical costs and increasing the efficiency of hospital bed utilization. The present results reinforce the view that the resulting cost reduction would not jeopardize patient safety. Clinical application of OPD-TRI would be highly possible when patient exclusion was based on evidence of a clinically higher risk of acute coronary syndrome and lower ejection fraction, complex anatomy such as distal left main, bifurcation, thrombus-containing lesions, or other complex lesions, or PCI-related complications (previously listed as the study exclusion criteria). Conversely, in patients clinically suspected of restenosis after POBA or stenting, those with stable angina for elective PCIs with known coronary anatomy, and preserved left ventricular function are most suitable for OPD TRI. In our experience, PCI complications mostly occur during cardiac catheterization, although acute occlusion within 24 hours can occur in 3-4% of patients after POBA treatment. However, the incidence of acute or subacute in-stent thrombosis (IST) in the modern era has become even lower (< 1-2%) after the advent of pretreatment with aspirin and careful loading of clopidogrel (8-12 hours prior to the procedure), and the ability to achieve superior apposition of stent struts by routine high pressure inflation could lower the incidence of IST even more than the level evident in the group A patients. Prudent steps include careful evaluation of patients before discharge, ensuring that a patient is able to return to the ED within a short period of time if necessary, providing clear and understandable instructions for continuing medications, and scheduling a brief OPD visit to evaluate access site complications. Since patients may manifest adverse events during PCI and during observation, discharge may need to be canceled and admittance for further management undertaken instead. Compared with the conventional femoral approach, TRIs result in much less access site vascular complications.3) Recent advancements of vascular closure devices for femoral PCIs achieve outcomes superior to those of conventional manual compression. However, same-day discharge can carry a relatively higher risk of re-bleeding or other groin complications, and the vascular closure devices would definitely increase the medical cost.19) Several pilot studies have compared manual compression and closure devices, with the latter proving disappointing due to the high incidence of hematoma and pseudoaneurysm formation.20,21) Thus, the TR approach to coronary artery interventions may be more appropriate for outpatient programs. The present study had several limitations, such as nonrandomized comparison with relatively longer study period and use of different PCI devices such as POBA, cutting balloon an-
375
gioplasty, rotablators, and bare-metal stents. Although the study patients were treated with POBA only in 62.1% of the group A patients, the TRI OPD program was proven to be safe in our Asian population. Drug-eluting stents were not available during the study period, but the effectiveness and safety of such stents in more complex lesions have expanded the indications of PCI, which allow us to treat more complex coronary anatomies and even multivessel disease.22) It is conceivable (and can be tested) that a combination of OPD TR with a routine drug-eluting stent would allow the treatment of more complex lesion subsets.
References
1. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989; 16: 3-7. 2. Kiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary stent implantation. Cathet Cardiovasc Diagn 1993; 30: 173-8. 3. Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol 1997; 29: 1269-75. 4. Louvard Y, Lefèvre T, Allain A, Morice M. Coronary angiography through the radial or the femoral approach: The CARAFE study. Catheter Cardiovasc Interv 2001; 52: 181-7. 5. 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: 204-8. 6. Kumar S, Anantharaman R, Das P, et al. Radial approach to day case intervention in coronary artery lesions (RADICAL): a single centre safety and feasibility study. Heart 2004; 90: 1340-1. 7. Small A, Klinke P, Della Siega A, et al. Day procedure intervention is safe and complication free in higher risk patients undergoing transradial angioplasty and stenting. The discharge study. Catheter Cardiovasc Interv 2007; 70: 907-12. 8. Wu CJ, Lo PH, Chang KC, Fu M, Lau KW, Hung JS. Transradial coronary angiography and angioplasty in Chinese patients. Cathet Cardiovasc Diagn 1997; 40: 159-63. 9. Saito S, Miyake S, Hosokawa G, et al. Transradial coronary intervention in Japanese patients. Catheter Cardiovasc Interv 1999; 46: 37-41. 10. Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv 1999; 46: 173-8. 11. Jabara R, Gadesam R, Pendyala L, et al. Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study). Am Heart J 2008; 156: 1141-6. 12. Kiemeneij F, Laarman GJ, Slagboom T, van der Wieken R. Outpatient coronary stent implantation. J Am Coll Cardiol 1997; 29: 323-7. 13. Gilchrist IC, Nickolaus MJ, Momplaisir T. Same-day transradial outpatient stenting with a 6-hr course of glycoprotein llb/llla receptor blockade: a feasibility study. Catheter Cardiovasc Interv 2002; 56: 10-3. 14. Ziakas AA, Klinke BP, Mildenberger CR, et al. Safety of sameday-discharge radial percutaneous coronary intervention: a retrospective study. Am Heart J 2003; 146: 699-704. 15. Slagboom T, Kiemeneij F, Laarman GJ, Van der Wieken R. Outpatient coronary angioplasty; feasible and safe. Catheter Cardiovasc Interv 2005; 64: 421-7. 16. Bertrand OF, De Larochellière R, Rodés-Cabau J, et al. A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation. Circulation
376
CHUNG, ET AL
2006; 114: 2636-43. 17. Bertrand OF, Rodés-Cabau J, Larose E, et al. One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study. Am Heart J 2008; 156: 135-40. 18. Wiper A, Kumar S, MacDonald J, Roberts DH. Day case transradial coronary angioplasty: a four-year single-center experience. Catheter Cardiovasc Interven 2006; 68: 549-53. 19. Carere RG, Webb JG, Buller CE, et al. Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge. Am Heart J 2000; 139: 52-8.
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20. Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA 2004; 291: 350-7. (Review) 21. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 2004; 44: 1200-9. (Review) 22. Khater M, Zureikat H, Alqasem A, Alnaber N, Alhaddad IA. Contemporary outpatient percutaneous coronary intervention: feasible and safe. Coron Artery Dis 2007; 18: 565-9.
