- Email: [email protected]
Comparison of mid-term clinical outcomes between “complete full-metal jacket strategy” versus “incomplete full-metal jacket strategy” for diffuse right coronary artery stenosis with drug-eluting stents
G Model
JJCC-1400; No. of Pages 7 Journal of Cardiology xxx (2016) xxx–xxx
Contents lists available at ScienceDirect
Journal of Cardiology journal homepage: www.elsevier.com/locate/jjcc
Original article
Comparison of mid-term clinical outcomes between ‘‘complete fullmetal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents Kei Yamamoto (MD)*, Kenichi Sakakura (MD), Yusuke Adachi (MD), Yousuke Taniguchi (MD), Hiroshi Wada (MD, FJCC), Shin-ichi Momomura (MD, FJCC), Hideo Fujita (MD, FJCC) Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan
A R T I C L E I N F O
A B S T R A C T
Article history: Received 26 April 2016 Received in revised form 18 August 2016 Accepted 28 September 2016 Available online xxx
Background: The optimal strategy for diffuse right coronary artery (RCA) stenosis remains unclear. Objective: The objective of this study was to compare the mid-term outcomes of ‘‘complete full-metal jacket (c-FMJ) stenting strategy’’ with ‘‘incomplete full-metal jacket (i-FMJ) stenting strategy’’ for the diffuse long RCA lesion using drug-eluting stents (DES). Methods: Between July 2007 and October 2015, 121 patients underwent percutaneous coronary intervention (PCI) for diffuse RCA lesions using DES. Fifty-three patients underwent c-FMJ PCI, whereas 68 patients underwent i-FMJ. Thirty patients received angiographical follow-up in the c-FMJ group, while 34 patients received angiographical follow-up in the i-FMJ group. The primary endpoint was major adverse cardiac events (MACE): cardiac death, stent thrombosis (ST), target lesion revascularization (TLR), and target vessel revascularization (TVR). Results: The incidence of MACE was significantly lower in the c-FMJ group (13.3%) as compared to the iFMJ group (41.2%) (p = 0.013). There was no cardiac death in either group. The incidence of ST was comparable between the i-FMJ group (2.9%) and c-FMJ group (3.3%) (p = 1.00), while TLR was significantly less in the c-FMJ group (6.7%) compared to the i-FMJ group (32.4%) (p = 0.011). Conclusions: The mid-term MACE was significantly less in the c-FMJ group than in the i-FMJ group, indicating that c-FMJ stenting was a favorable strategy for the diffuse long RCA lesion. ß 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Keywords: Full metal jacket Right coronary artery Percutaneous coronary intervention Drug-eluting stent
Introduction The development of drug-eluting stents (DES) has expanded indications for percutaneous coronary intervention (PCI) [1–4]. However, PCI strategy for the diffuse long lesion remains controversial. Stenting for the diffuse long lesion often resulted in full lesion coverage with multiple stents, which is called fullmetal jacket (FMJ). FMJ was defined as total stent length > 60 mm without gap [5]. As compared to the diffuse long lesion of left anterior descending artery or left circumflex artery, the diffuse long lesion
* Corresponding author at: Division of Cardiology, Department of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-city, Saitama 330-8503, Japan. Fax: +81 48 648 5188/252 0375. E-mail address: [email protected] (K. Yamamoto).
of right coronary artery (RCA) more frequently requires complete coverage by multiple stents from the aorto-ostium [6]. However, the current definition of FMJ does not refer to the complete whole vessel coverage by multiple stents, but only to stent length > 60 mm without gap. Therefore, incomplete vessel coverage with multiple stents such as from the proximal segment of RCA (not ostium) to the distal segment of RCA is also called FMJ, which we consider as incomplete FMJ (i-FMJ). Since previous studies revealed that stent gap or incomplete lesion coverage was the risk factor for future cardiovascular events [7,8], we hypothesized that the clinical outcomes would be worse in the lesion treated by i-FMJ strategy as compared to complete FMJ (c-FMJ) strategy, which we defined as complete coverage with multiple stents (>60 mm without gap) from the ostium to around the distal bifurcation of RCA. The purpose of this study was to compare the mid-term clinical outcomes between c-FMJ and i-FMJ strategies for the diffuse long lesion of RCA.
http://dx.doi.org/10.1016/j.jjcc.2016.09.014 0914-5087/ß 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
2
non-ST-segment elevation myocardial infarction, or unstable angina. Left ventricular ejection fraction was calculated by Mmode in echocardiography. The calcified lesions were classified as none/mild, moderate, and severe [13].
Methods Study design The present study was a retrospective and single center study. The inclusion criteria were the patients who received PCI to the RCA diffuse lesion and needed multiple DES. The stent site was located from segment 1 to segment 3 or more distal according to American College of Cardiology/American Heart Association (ACC/ AHA) classification [9]. The type of DES included both firstgeneration sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) and second-generation zotarolimus-eluting stent (ZES), everolimus-eluting stent (EES), biolimus-eluting stent (BES), and biodegradable-polymer SES (BP-SES). The exclusion criteria were the patients who underwent PCI with bare metal stent (BMS). We also excluded the patients who received multiple stents in several sessions.
Quantitative coronary angiography Quantitative coronary angiography (QCA) parameters were measured using a cardiovascular angiography analysis system (QAngio XA 7.3, GOODMAN, Aichi, Japan). The values of minimum lumen diameter, percent diameter stenosis, and reference diameter were obtained at 3 time points: pre-procedural, postprocedural, and follow-up. In addition, we calculated the acute gain, late loss, and stent/artery ratio. We also analyzed incomplete site by QCA; the parameters were reference diameter, minimum lumen diameter, and diameter stenosis at the post-procedural and follow-up times.
Definitions
Statistics
In the present study, a diffuse RCA lesion was defined as a continuous lesion from the proximal segment to the distal bifurcation of the RCA. C-FMJ was defined as full stent coverage from the ostium to around the distal bifurcation of RCA (beyond acute marginal branch), whereas i-FMJ was defined as incomplete stent coverage. Uncovered site was classified as proximal (ostium), middle, and distal of RCA (Fig. 1). Major adverse cardiac events (MACE) were defined as the occurrence of cardiac death, stent thrombosis (ST), target lesion revascularization (TLR), and target vessel revascularization (TVR). TLR and TVR were defined as any percutaneous or surgical revascularization procedure on a target lesion and a target vessel [10,11]. ST was defined as definite ST according to the Academic Research Consortium definition [12]. Hypertension was defined as systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg, or medical treatment for hypertension. Diabetes mellitus was defined as a hemoglobin A1c level >6.5% or treatment for diabetes mellitus. Hyperlipidemia was defined as a total cholesterol level >220 mg/ dl, a low-density lipoprotein cholesterol level >140 mg/dl, or treatment for hyperlipidemia. Chronic kidney disease was defined as creatinine clearance level <60 ml/min. Acute coronary syndrome was defined as ST-segment elevation myocardial infarction,
Descriptive results were expressed as frequency and percentage for categorical variables and were compared using the chi square test (or Fisher exact test for small samples). For continuous variables, statistics were expressed as mean SD and were analyzed using Student’s t-test. Event-free survival curves for MACE were constructed using the Kaplan–Meier method, and statistical differences between curves were assessed by the log-lank test. To identify predictors of MACE, a multivariate logistic regression model was performed using stepwise method by the backward selection procedure with likelihood ratios. Marginally significant variables (p < 0.10 in univariate analysis) [14] were included. Statistical significance was defined as a two-sided value of p < 0.05. Statistical analyses were performed using SPSS (Chicago, IL, USA). Results A total of 121 patients received PCI for the diffuse long lesion of RCA using multiple DES between July 2007 and October 2015. Among them, 53 patients were classified as c-FMJ, while 68 patients were classified as i-FMJ. Thirty patients received angiographical follow-up in the c-FMJ group, whereas 34 patients received angiographical follow-up in the i-FMJ group (Fig. 2).
Fig. 1. The scheme of complete and incomplete full metal jacket.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
3
Fig. 2. The flowchart of this study. PCI, percutaneous coronary intervention; RCA, right coronary artery; CT, computed tomography.
Median angiographical follow-up duration was 247 days in the c-FMJ group and 246 days in the i-FMJ group (p = 0.91). The patient characteristics are shown in Table 1. Mean age was similar between the c-FMJ (67 9 years) and i-FMJ (65 9 years) groups (p = 0.68). The frequency of acute coronary syndrome (ACS) was comparable in both groups (26.7% in the c-FMJ and 26.4% in the iFMJ groups, p = 0.99). The prevalence of chronic kidney disease was significantly higher in the i-FMJ group (35.5%) compared to the c-FMJ group (3.3%) (p = 0.002). The lesion and procedure characteristics are shown in Table 2. The frequency of chronic total occlusion was comparable in both groups (50% in the c-FMJ group and 35.3% in the i-FMJ group) (p = 0.24). The lesion requiring rotational atherectomy was
less in the c-FMJ group (6.7%) than the i-FMJ group (20.6%) without reaching statistical significance (p = 0.11). The stent diameter, stent length, and stent number were not significantly different between the two groups. All cases except one in the i-FMJ group underwent a planned strategy. Only one case involved unplanned stenting. In this case, coronary dissection occurred because of a guiding catheter. We performed stent deployment at proximal site to bailout ostium dissection. The incidence of MACE was significantly lower in the c-FMJ group (13.3%) than in the i-FMJ group (41.2%) (p = 0.013). There was no cardiac death in either group. The incidence of ST was similar between the c-FMJ (3.3%) and i-FMJ (2.9%) groups (p = 1.00), while the incidence of TVR was significantly less in
Table 1 Clinical characteristics between c-FMJ and i-FMJ groups. Variables Patient characteristics Age (years) Men – no. (%) Hypertension – no. (%) Diabetes mellitus – no. (%) Hyperlipidemia – no. (%) Chronic kidney disease (creatinine clearance level <60 ml/min) – no. (%) Family history of cardiac disease – no. (%) Current smoking – no. (%) Acute coronary syndrome – no. (%) Previous myocardial infarction – no. (%) Previous percutaneous coronary intervention – no. (%) Previous coronary artery bypass grafting – no. (%) Medication Aspirin – no. (%) Thienopyridine – no. (%) Statin – no. (%) ACE-inhibitor/ARB – no. (%) Beta-blocker – no. (%) Calcium channel blocker – no. (%) Insulin – no. (%) Left ventricular ejection fraction (%) Follow-up duration (days)
All (n = 64)
c-FMJ (n = 30)
i-FMJ (n = 34)
p-Value
66 9 47 (73.4) 57 (89.1) 38 (59.4) 51 (79.7) 13 (20.3) 13 (20.3) 23 (35.9) 17 (26.6) 2 (3.1) 34 (53.1) 5 (7.8)
67 9 19 (63.3) 27 (90) 16 (53.3) 22 (73.3) 1 (3.3) 7 (23.3) 12 (40) 8 (26.7) 1 (3.3) 16 (53.3) 1 (3.3)
65 9 28 (82.3) 30 (88.2) 22 (64.7) 29 (85.3) 12 (35.5) 6 (17.6) 11 (32.3) 9 (26.4) 1 (2.9) 18 (52.9) 4 (11.8)
0.68 0.09 0.82 0.36 0.24 0.002 0.57 0.53 0.99 0.12 0.98 0.21
64 (100) 64 (100) 62 (96.9) 48 (75) 51 (79.7) 20 (31.3) 6 (9.4) 58.7 10.1 247 71
30 (100) 30 (100) 29 (96.7) 23 (76.3) 24 (80) 7 (23.3) 3 (10) 59.3 10.5 247 77
34 (100) 34 (100) 33 (97.1) 25 (73.5) 27 (79.4) 13 (38.2) 3 (8.8) 58.2 09.9 246 67
1.00 1.00 0.93 0.77 0.95 0.20 0.87 0.77 0.91
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 4
K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
Table 2 Lesion and procedural characteristics: comparison of the c-FMJ and i-FMJ groups. Variables Calcified lesion None/mild – no. (%) Moderate – no. (%) Severe – no. (%) Chronic total occlusion – no. (%) Rotational atherectomy – no. (%) IVUS use Mean stent diameter (mm) Stent length (mm) Stent number Stent BP-SES – no. (%) EES – no. (%) BES – no. (%) ZES – no. (%) PES – no. (%) SES – no. (%) EES and ZES – no. (%) BES and ZES – no. (%) EES and PES – no. (%) PES and SES – no. (%) Incomplete site Ostium (proximal) – no. (%) Gap – no. (%) – no. (%) Distal – no. (%)
All (n = 64)
c-FMJ (n = 30)
i-FMJ (n = 34)
p-Value
41 (64.1) 15 (23.4) 8 (12.5) 27 (42.2) 9 (14.1) 64 (100) 3.05 0.28 75.5 19.3 2.80 0.62
20 (66.7) 6 (20.0) 4 (13.3) 15 (50) 2 (6.7) 30 (100) 3.04 0.25 79.8 22.1 2.90 0.66
21 (61.8) 9 (26.5) 4 (11.8) 12 (35.3) 7 (20.6) 34 (100) 3.05 0.31 71.7 15.8 2.71 0.58
0.68 0.54 0.85 0.24 0.11 1.00 0.08 0.50 0.22 0.72
23 (35.9) 17 (26.6) 2 (3.1) 34 (53.1) 5 (7.8)
12 (40) 8 (26.7) 1 (3.3) 16 (53.3) 1 (3.3)
11 (32.3) 9 (26.4) 1 (2.9) 18 (52.9) 4 (11.8)
64 64 62 48
30 30 29 23
34 34 33 25
(100) (100) (96.9) (75)
(100) (100) (96.7) (76.3)
(100) (100) (97.1) (73.5)
20 (58.8) 12 (35.5) 2 (5.9)
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket; IVUS, intravascular ultrasound; BP-SES, biodegradable-polymer sirolimus-eluting stent; EES, everolimuseluting stent; ZES, zotarolimus-eluting stent; BES, biolimus-eluting stent; PES, paclitaxel-eluting stent; SES, sirolimus-eluting stent.
Table 3 Clinical outcomes: comparison of the c-FMJ and i-FMJ groups. Variables MACE Cardiac death – no. (%) Stent thrombosis – no. (%) Target lesion revascularization – no. (%) Target vessel revascularization – no. (%)
All (n = 64) 18 (28.1) 0 2 (1) 13 (20.3) 18 (28.1)
c-FMJ (n = 30) 4 0 1 2 4
(13.3) (3.3) (6.7) (13.3)
i-FMJ (n = 34)
p-Value
14 (41.2) 0 1 (2.9) 11 (32.4) 14 (41.2)
0.013 1.0 0.011 0.013
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket; MACE, major adverse cardiac events.
the c-FMJ group (13.3%) as compared to the i-FMJ group (41.2%) (p = 0.013) (Table 3). In the QCA analysis, the pre-procedure and post-procedure parameters were comparable between the 2 groups, whereas the percent diameter stenosis was significantly less in the c-FMJ group (p = 0.011) (Table 4). In the univariate logistic regression, i-FMJ was the only predictor of MACE (OR 0.22; 95% CI 0.063–0.771, p = 0.018). We performed a multivariate logistic regression analysis using variables with p < 0.10 in univariate logistic regression analysis. i-FMJ (p = 0.018), mean stent diameter (p = 0.095), and follow-up duration (p = 0.093) were included in the model. Multivariate logistic regression analysis revealed that i-FMJ (OR 0.15; 95% CI 0.036–0.630, p = 0.01) and mean stent diameter (OR 0.275; 95% CI 0.083–0909, p = 0.034) were significantly associated with MACE after controlling covariates (Table 5). Kaplan–Meier analysis showed that MACE was less frequently observed in the c-FMJ group; however, the differences were not significant (Fig. 3). Discussion The present study compared the mid-term MACE of diffuse RCA lesions in the i-FMJ group with that in the c-FMJ group, and showed that the MACE was significantly less in the c-FMJ group than in the
i-FMJ group. To date, there was no clinical study comparing the outcomes of diffuse RCA lesions between c-FMJ and i-FMJ. Our findings suggest the importance of complete stent coverage for revascularization for the diffuse RCA lesion. Since there are fewer major branches in RCA as compared to left coronary artery (LCA), FMJ strategy may be more frequently considered in RCA than in LCA. Furthermore, PCI for the ostium of RCA is different from that for the ostium of LCA, because PCI for the ostium of RCA does not consider bifurcation stenting, which is closely associated with PCI for the ostium of LCA [15]. Therefore, the present study was limited to the RCA lesion for the purpose of simplifying the question. The short- and long-term outcomes of PCI for RCA ostium have been unsatisfactory since the bare metal stent (BMS) era [16,17]. Although the clinical outcomes in PCI have significantly improved in the DES era compared to the BMS era [18], stenting to RCA ostium is still a predictor of TLR even using the second-generation DES [19]. This may be partly explained by the rigid nature of the vessel wall in the coronary ostium [20]. Previous reports revealed that incomplete lesion revascularization is a risk factor for MACE [8,21]. In addition, stent gap and residual uncovered atherosclerotic plaque were risk factors for TLR [7,22]. Residual plaques between 2 stents or stent edge might have damage due to balloon dilation, which should increase the
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
5
Table 4 Quantitative coronary angiography: comparison of the c-FMJ and i-FMJ groups. Variables Pre-procedure Reference diameter (mm) Minimum lumen diameter (mm) Percent diameter stenosis (%) Lesion length (mm) Post-procedure Reference diameter (mm) Minimum lumen diameter (mm) Percent diameter stenosis (%) Acute gain (mm) Stent/artery ratio Follow-up Reference diameter (mm) Minimum lumen diameter (mm) Percent diameter stenosis (%) Late loss (mm) Incomplete site post-procedure Reference diameter (mm) Minimum lumen diameter (mm) Diameter stenosis (%) Incomplete site follow-up Reference diameter (mm) Minimum lumen diameter (mm) Diameter stenosis (%) Late loss (mm)
All (n = 64)
c-FMJ (n = 30)
i-FMJ (n = 34)
p-Value
2.87 0.58 0.42 0.50 84.9 18.4 54.1 11.1
2.75 0.61 0.45 0.54 83.4 19.8 53.3 10.5
2.97 0.55 0.39 0.47 86.2 17.3 54.7 11.8
0.13 0.63 0.54 0.62
3.17 0.38 2.50 0.41 10.6 12.7 2.09 0.62 1.10 0.21
3.12 0.33 2.46 0.40 20.6 13.9 2.01 0.68 1.15 0.22
3.22 0.41 2.54 0.43 20.7 11.7 2.15 0.57 1.05 0.18
0.37 0.44 0.59 0.37 0.13
3.13 0.49 1.99 0.69 36.0 21.5 0.51 0.70
3.08 0.49 2.12 0.59 31.0 17.4 0.33 0.63
3.18 0.49 1.86 0.76 40.4 23.9 0.66 0.73
0.86 0.15 0.011 0.059
3.04 0.69 2.47 0.83 20.1 16.4
3.04 0.69 2.47 0.83 20.1 16.4
3.11 0.68 2.39 0.79 23.1 20.9 0.07 0.52
3.11 0.68 2.39 0.79 23.1 20.9 0.07 0.52
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket.
incidence of TLR. In our study, while the QCA outcomes of incomplete site were not significantly different between the 2 groups, the percent diameter of follow-up was significantly less in the c-FMJ group. The presence of residual plaques may be the reason why the present study showed MACE was greater in i-FMJ than in c-FMJ.
Lee et al. showed the long-term clinical outcomes in 352 native coronary lesions, which were treated by FMJ strategy. They reported that the risk of MACE was stent length >80 mm and left ventricular dysfunction [23], which were not risk factors for MACE in our study. Because our study only included RCA lesions, mean left ventricular ejection fraction in our study was within normal
Table 5 Determinants of MACE: univariate and multivariate logistic regression analysis. Dependent variable: MACE Univariate logistic regression analysis
Independent variables Age Male (vs. female) Previous myocardial infarction Previous coronary artery bypass grafting Acute coronary syndrome Family history Smoking Hypertension Hyperlipidemia Diabetes mellitus Chronic kidney disease ACE-inhibitor/ARB treatment Beta blocker treatment Statin treatment Calcium channel blocker treatment Diuretics Insulin treatment Left ventricular ejection fraction (10% increase) Follow up duration (30 days increase) Incomplete full metal jacket Chronic total occlusion Rotational atherectomy Mean stent diameter (0.5 mm increase) Stent length (10 mm increase)
OR
95% CI
1.02 1.38 0.64 0.558 0.437 0.720 2.463 0.976 0.851 1.11 2.79 0.556 1.175 2.647 2.27 1.684 0.482 1.134 0.804 0.22 2.383 2.34 0.42 0.81
0.96–1.09 0.38–4.98 0.16–2.61 0.085–3.654 0.134–1.413 0.173–2.99 0.701–8.654 0.171–5.551 0.225–3.215 0.36–3.37 078–9.90 0.167–1.853 0.311–4.435 0.157–44.74 0.73–7.08 0.322–8.822 0.052–4.442 0.669–1.924 0.623–1.037 0.06–0.77 0.73–7.776 0.55–9.97 0.156–1.159 0.592–1.108
p-Value 0.53 0.62 0.53 0.543 0.168 0.651 0.160 0.978 0.812 0.86 0.113 0.339 0.813 0.500 0.16 0.53 0.52 0.64 0.093 0.018 0.15 0.25 0.095 0.187
Multivariate logistic regression analysis OR
95% CI
p-Value
0.753 0.15
0.563–1.007 0.036–0.630
0.056 0.01
0.275
0.083–0.909
0.034
Univariate logistic regression analysis was performed to identify variables that had marginal association with MACE (p < 0.10). OR, odds ratio; CI, confidence interval; MACE, major adverse cardiac event; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
6
Acknowledgment The authors are grateful to the staff of the catheter laboratory in Saitama Medical Center, Jichi Medical University. References
Fig. 3. Kaplan–Meier curves describing survival free from major adverse cardiac events (MACE). c-FMJ, complete full-metal jacket stenting strategy; i-FMJ, incomplete full-metal jacket stenting strategy.
range (58.7 10.1%), which partly explains the difference in risk factors between their study and our study. One serious concern in using DES is the ongoing hazard of ST. In the present study, the incidence of ST was not significantly different between the two groups. Previous reports showed that the rate of definite and probable ST in FMJ was 3.6%, which is similar to the present study [5]. Considering the diffuse long lesions that require multiple DES, the incidence of ST in FMJ strategy may be acceptable. Study limitations Our study has several limitations, which are mainly inherent to a retrospective study. First, as we did not randomly assign patients to either c-FMJ or i-FMJ, there could be a patient selection bias. Second, the PCI strategy including selection of stent type was determined by each interventional cardiologist, which also yielded selection bias. Third, we could not match the lesion characteristics between the 2 groups, because of the small study sample size. Fourth, we could not fully evaluate remaining myocardial ischemia after the PCI in most cases, which may have influenced the outcomes. Since we did not perform a statistical power analysis, there is a possibility of beta error. Further study is warranted to evaluate appropriate strategy in patients who received FMJ-PCI. Conclusions The mid-term MACE was significantly less in the c-FMJ group than in the i-FMJ group, indicating that c-FMJ stenting was a favorable strategy for the diffuse long RCA lesions. Our findings will help interventional cardiologists to determine the appropriate therapeutic strategy for patients with diffuse RCA lesions. Funding None. Conflict of interest Dr Sakakura received speaking honorarium from Abbott Vascular, Boston Scientific, Medtronic Cardiovascular, and Terumo.
[1] Aoki J, Kirtane AJ, Dangas GD, Dangas G, Lansky D, Morales AJ, Kimura AM, Kim YH, Moussa I, Weisz G, Kreps EM, Collins M, Frankin-Bond T, Stone GW, Moses JW, et al. Clinical outcomes after heterogeneous overlap stenting with drugeluting stents and bare-metal stents for de novo coronary artery narrowings. Am J Cardiol 2008;101:58–62. [2] Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, Thuesen L, Hauptman K, Marco J, Wijns W, Popma JJ, Koglin J, Russell ME. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation 2005;112:3306–13. [3] Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773–80. [4] Mizuguchi Y, Hashimoto S, Yamada T, Taniguchi N, Nakajima S, Hata T, Takahashi A. Percutaneous coronary intervention for nonagenarian patients with ST-segment elevation myocardial infarction: experience of a single Japanese center. J Cardiol 2016;67:331–4. [5] Basavarajaiah S, Naganuma T, Latib A, Hasegawa T, Sharp A, Rezq A, Sticchi A, Figini F, Amato A, Colombo A. Extended follow-up following full-metal jacket percutaneous coronary interventions with drug-eluting stents. Catheter Cardiovasc Interv 2014;84:1042–50. [6] Londono JC, Singh V, O’Neill WW. Total aorto-ostial chronic occlusion of the right coronary artery successfully recanalized via retrograde approach. Catheter Cardiovasc Interv 2011;78:400–4. [7] Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010;56:1897–907. [8] Head SJ, Mack MJ, Holmes Jr DR, Mohr FW, Morice MC, Serruys PW, Kappetein AP. Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data. Eur J Cardiothorac Surg 2012;41: 535–41. [9] Austen WG, Edwards JE, Frye RL, Gensini GG, Gott VL, Griffith LS, McGoon DC, Murphy ML, Roe BB. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc Committee for Grading of Coronary Artery Disease, Council on Cardiovascular Surgery, American Heart Association. Circulation 1975;51:5–40. [10] Abe D, Sato A, Hoshi T, Maruta S, Misaki M, Kakefuda Y, Watabe H, Hiraya D, Sakai S, Kawabe M, Takeyasu N, Aonuma K. Drug-eluting versus bare-metal stents in large coronary arteries of patients with ST-segment elevation myocardial infarction: findings from the ICAS registry. J Cardiol 2014;64:377–83. [11] Liu HL, Jin ZG, Yang SL, Han W, Jing QM, Zhang L, Luo JP, Ma DX, Liu Y, Yang LX, Jiang TM, Qu P, Li WM, Li SM, Xu B, et al. Five-year outcomes of ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome treated with biodegradable polymer-coated sirolimus-eluting stents: insights from the CREATE trial. J Cardiol 2016. [12] Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. [13] Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation 1995;91:1959–65. [14] Jinnouchi H, Sakakura K, Wada H, Arao K, Kubo N, Sugawara Y, Funayama H, Momomura S, Ako J. Transient no reflow following primary percutaneous coronary intervention. Heart Vessels 2014;29:429–36. [15] Lee MS, Stone GW, Park SJ, Teirstein P, Moses J, Colombo A, Kandzari DE. Percutaneous coronary intervention of unprotected left main coronary artery disease: procedural strategies and technical considerations. Catheter Cardiovasc Interv 2012;79:812–22. [16] Mavromatis K, Ghazzal Z, Veledar E, Diamandopoulos L, Weintraub WS, Douglas JS, Kalynych AM. Comparison of outcomes of percutaneous coronary intervention of ostial versus nonostial narrowing of the major epicardial coronary arteries. Am J Cardiol 2004;94:583–7. [17] Mathias DW, Mooney JF, Lange HW, Goldenberg IF, Gobel FL, Mooney MR. Frequency of success and complications of coronary angioplasty of a stenosis at the ostium of a branch vessel. Am J Cardiol 1991;67:491–5. [18] Sakamoto H, Ishikawa T, Mutoh M, Imai K, Mochizuki S. Angiographic and clinical outcomes after sirolimus-eluting stent implantation to de novo ostial lesion of the right coronary artery: a retrospective study. Circ J 2008;72:880–5. [19] Lam MK, Sen H, Tandjung K, Lowik MM, Basalus MW, Mewes JC, Stoel MG, van Houwelingen KG, Linssen GC, Ijzerman MJ, Doggen CJ, von Birgelen C. Clinical outcome of patients with implantation of second-generation drug-eluting stents in the right coronary ostium: insights from 2-year follow-up of the TWENTE trial. Catheter Cardiovasc Interv 2015;85:524–31.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx [20] Rensing BJ, Hermans WR, Strauss BH, Serruys PW. Regional differences in elastic recoil after percutaneous transluminal coronary angioplasty: a quantitative angiographic study. J Am Coll Cardiol 1991;17:34B–8B. [21] Sarno G, Garg S, Onuma Y, Gutierrez-Chico JL, van den Brand MJ, Rensing BJ, Morel MA, Serruys PW. Impact of completeness of revascularization on the five-year outcome in percutaneous coronary intervention and coronary artery bypass graft patients (from the ARTS-II study). Am J Cardiol 2010;106:1369–75.
7
[22] Kereiakes DJ, Wang H, Popma JJ, Kuntz RE, Donohoe DJ, Schofer J, Schampaert E, Meier B, Leon MB, Moses JW. Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials. J Am Coll Cardiol 2006;48:21–31. [23] Lee CW, Ahn JM, Lee JY, Kim WJ, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Park SJ. Long-term (8 year) outcomes and predictors of major adverse cardiac events after full metal jacket drug-eluting stent implantation. Catheter Cardiovasc Interv 2014;84:361–5.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
JJCC-1400; No. of Pages 7 Journal of Cardiology xxx (2016) xxx–xxx
Contents lists available at ScienceDirect
Journal of Cardiology journal homepage: www.elsevier.com/locate/jjcc
Original article
Comparison of mid-term clinical outcomes between ‘‘complete fullmetal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents Kei Yamamoto (MD)*, Kenichi Sakakura (MD), Yusuke Adachi (MD), Yousuke Taniguchi (MD), Hiroshi Wada (MD, FJCC), Shin-ichi Momomura (MD, FJCC), Hideo Fujita (MD, FJCC) Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan
A R T I C L E I N F O
A B S T R A C T
Article history: Received 26 April 2016 Received in revised form 18 August 2016 Accepted 28 September 2016 Available online xxx
Background: The optimal strategy for diffuse right coronary artery (RCA) stenosis remains unclear. Objective: The objective of this study was to compare the mid-term outcomes of ‘‘complete full-metal jacket (c-FMJ) stenting strategy’’ with ‘‘incomplete full-metal jacket (i-FMJ) stenting strategy’’ for the diffuse long RCA lesion using drug-eluting stents (DES). Methods: Between July 2007 and October 2015, 121 patients underwent percutaneous coronary intervention (PCI) for diffuse RCA lesions using DES. Fifty-three patients underwent c-FMJ PCI, whereas 68 patients underwent i-FMJ. Thirty patients received angiographical follow-up in the c-FMJ group, while 34 patients received angiographical follow-up in the i-FMJ group. The primary endpoint was major adverse cardiac events (MACE): cardiac death, stent thrombosis (ST), target lesion revascularization (TLR), and target vessel revascularization (TVR). Results: The incidence of MACE was significantly lower in the c-FMJ group (13.3%) as compared to the iFMJ group (41.2%) (p = 0.013). There was no cardiac death in either group. The incidence of ST was comparable between the i-FMJ group (2.9%) and c-FMJ group (3.3%) (p = 1.00), while TLR was significantly less in the c-FMJ group (6.7%) compared to the i-FMJ group (32.4%) (p = 0.011). Conclusions: The mid-term MACE was significantly less in the c-FMJ group than in the i-FMJ group, indicating that c-FMJ stenting was a favorable strategy for the diffuse long RCA lesion. ß 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Keywords: Full metal jacket Right coronary artery Percutaneous coronary intervention Drug-eluting stent
Introduction The development of drug-eluting stents (DES) has expanded indications for percutaneous coronary intervention (PCI) [1–4]. However, PCI strategy for the diffuse long lesion remains controversial. Stenting for the diffuse long lesion often resulted in full lesion coverage with multiple stents, which is called fullmetal jacket (FMJ). FMJ was defined as total stent length > 60 mm without gap [5]. As compared to the diffuse long lesion of left anterior descending artery or left circumflex artery, the diffuse long lesion
* Corresponding author at: Division of Cardiology, Department of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-city, Saitama 330-8503, Japan. Fax: +81 48 648 5188/252 0375. E-mail address: [email protected] (K. Yamamoto).
of right coronary artery (RCA) more frequently requires complete coverage by multiple stents from the aorto-ostium [6]. However, the current definition of FMJ does not refer to the complete whole vessel coverage by multiple stents, but only to stent length > 60 mm without gap. Therefore, incomplete vessel coverage with multiple stents such as from the proximal segment of RCA (not ostium) to the distal segment of RCA is also called FMJ, which we consider as incomplete FMJ (i-FMJ). Since previous studies revealed that stent gap or incomplete lesion coverage was the risk factor for future cardiovascular events [7,8], we hypothesized that the clinical outcomes would be worse in the lesion treated by i-FMJ strategy as compared to complete FMJ (c-FMJ) strategy, which we defined as complete coverage with multiple stents (>60 mm without gap) from the ostium to around the distal bifurcation of RCA. The purpose of this study was to compare the mid-term clinical outcomes between c-FMJ and i-FMJ strategies for the diffuse long lesion of RCA.
http://dx.doi.org/10.1016/j.jjcc.2016.09.014 0914-5087/ß 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
2
non-ST-segment elevation myocardial infarction, or unstable angina. Left ventricular ejection fraction was calculated by Mmode in echocardiography. The calcified lesions were classified as none/mild, moderate, and severe [13].
Methods Study design The present study was a retrospective and single center study. The inclusion criteria were the patients who received PCI to the RCA diffuse lesion and needed multiple DES. The stent site was located from segment 1 to segment 3 or more distal according to American College of Cardiology/American Heart Association (ACC/ AHA) classification [9]. The type of DES included both firstgeneration sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) and second-generation zotarolimus-eluting stent (ZES), everolimus-eluting stent (EES), biolimus-eluting stent (BES), and biodegradable-polymer SES (BP-SES). The exclusion criteria were the patients who underwent PCI with bare metal stent (BMS). We also excluded the patients who received multiple stents in several sessions.
Quantitative coronary angiography Quantitative coronary angiography (QCA) parameters were measured using a cardiovascular angiography analysis system (QAngio XA 7.3, GOODMAN, Aichi, Japan). The values of minimum lumen diameter, percent diameter stenosis, and reference diameter were obtained at 3 time points: pre-procedural, postprocedural, and follow-up. In addition, we calculated the acute gain, late loss, and stent/artery ratio. We also analyzed incomplete site by QCA; the parameters were reference diameter, minimum lumen diameter, and diameter stenosis at the post-procedural and follow-up times.
Definitions
Statistics
In the present study, a diffuse RCA lesion was defined as a continuous lesion from the proximal segment to the distal bifurcation of the RCA. C-FMJ was defined as full stent coverage from the ostium to around the distal bifurcation of RCA (beyond acute marginal branch), whereas i-FMJ was defined as incomplete stent coverage. Uncovered site was classified as proximal (ostium), middle, and distal of RCA (Fig. 1). Major adverse cardiac events (MACE) were defined as the occurrence of cardiac death, stent thrombosis (ST), target lesion revascularization (TLR), and target vessel revascularization (TVR). TLR and TVR were defined as any percutaneous or surgical revascularization procedure on a target lesion and a target vessel [10,11]. ST was defined as definite ST according to the Academic Research Consortium definition [12]. Hypertension was defined as systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg, or medical treatment for hypertension. Diabetes mellitus was defined as a hemoglobin A1c level >6.5% or treatment for diabetes mellitus. Hyperlipidemia was defined as a total cholesterol level >220 mg/ dl, a low-density lipoprotein cholesterol level >140 mg/dl, or treatment for hyperlipidemia. Chronic kidney disease was defined as creatinine clearance level <60 ml/min. Acute coronary syndrome was defined as ST-segment elevation myocardial infarction,
Descriptive results were expressed as frequency and percentage for categorical variables and were compared using the chi square test (or Fisher exact test for small samples). For continuous variables, statistics were expressed as mean SD and were analyzed using Student’s t-test. Event-free survival curves for MACE were constructed using the Kaplan–Meier method, and statistical differences between curves were assessed by the log-lank test. To identify predictors of MACE, a multivariate logistic regression model was performed using stepwise method by the backward selection procedure with likelihood ratios. Marginally significant variables (p < 0.10 in univariate analysis) [14] were included. Statistical significance was defined as a two-sided value of p < 0.05. Statistical analyses were performed using SPSS (Chicago, IL, USA). Results A total of 121 patients received PCI for the diffuse long lesion of RCA using multiple DES between July 2007 and October 2015. Among them, 53 patients were classified as c-FMJ, while 68 patients were classified as i-FMJ. Thirty patients received angiographical follow-up in the c-FMJ group, whereas 34 patients received angiographical follow-up in the i-FMJ group (Fig. 2).
Fig. 1. The scheme of complete and incomplete full metal jacket.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
3
Fig. 2. The flowchart of this study. PCI, percutaneous coronary intervention; RCA, right coronary artery; CT, computed tomography.
Median angiographical follow-up duration was 247 days in the c-FMJ group and 246 days in the i-FMJ group (p = 0.91). The patient characteristics are shown in Table 1. Mean age was similar between the c-FMJ (67 9 years) and i-FMJ (65 9 years) groups (p = 0.68). The frequency of acute coronary syndrome (ACS) was comparable in both groups (26.7% in the c-FMJ and 26.4% in the iFMJ groups, p = 0.99). The prevalence of chronic kidney disease was significantly higher in the i-FMJ group (35.5%) compared to the c-FMJ group (3.3%) (p = 0.002). The lesion and procedure characteristics are shown in Table 2. The frequency of chronic total occlusion was comparable in both groups (50% in the c-FMJ group and 35.3% in the i-FMJ group) (p = 0.24). The lesion requiring rotational atherectomy was
less in the c-FMJ group (6.7%) than the i-FMJ group (20.6%) without reaching statistical significance (p = 0.11). The stent diameter, stent length, and stent number were not significantly different between the two groups. All cases except one in the i-FMJ group underwent a planned strategy. Only one case involved unplanned stenting. In this case, coronary dissection occurred because of a guiding catheter. We performed stent deployment at proximal site to bailout ostium dissection. The incidence of MACE was significantly lower in the c-FMJ group (13.3%) than in the i-FMJ group (41.2%) (p = 0.013). There was no cardiac death in either group. The incidence of ST was similar between the c-FMJ (3.3%) and i-FMJ (2.9%) groups (p = 1.00), while the incidence of TVR was significantly less in
Table 1 Clinical characteristics between c-FMJ and i-FMJ groups. Variables Patient characteristics Age (years) Men – no. (%) Hypertension – no. (%) Diabetes mellitus – no. (%) Hyperlipidemia – no. (%) Chronic kidney disease (creatinine clearance level <60 ml/min) – no. (%) Family history of cardiac disease – no. (%) Current smoking – no. (%) Acute coronary syndrome – no. (%) Previous myocardial infarction – no. (%) Previous percutaneous coronary intervention – no. (%) Previous coronary artery bypass grafting – no. (%) Medication Aspirin – no. (%) Thienopyridine – no. (%) Statin – no. (%) ACE-inhibitor/ARB – no. (%) Beta-blocker – no. (%) Calcium channel blocker – no. (%) Insulin – no. (%) Left ventricular ejection fraction (%) Follow-up duration (days)
All (n = 64)
c-FMJ (n = 30)
i-FMJ (n = 34)
p-Value
66 9 47 (73.4) 57 (89.1) 38 (59.4) 51 (79.7) 13 (20.3) 13 (20.3) 23 (35.9) 17 (26.6) 2 (3.1) 34 (53.1) 5 (7.8)
67 9 19 (63.3) 27 (90) 16 (53.3) 22 (73.3) 1 (3.3) 7 (23.3) 12 (40) 8 (26.7) 1 (3.3) 16 (53.3) 1 (3.3)
65 9 28 (82.3) 30 (88.2) 22 (64.7) 29 (85.3) 12 (35.5) 6 (17.6) 11 (32.3) 9 (26.4) 1 (2.9) 18 (52.9) 4 (11.8)
0.68 0.09 0.82 0.36 0.24 0.002 0.57 0.53 0.99 0.12 0.98 0.21
64 (100) 64 (100) 62 (96.9) 48 (75) 51 (79.7) 20 (31.3) 6 (9.4) 58.7 10.1 247 71
30 (100) 30 (100) 29 (96.7) 23 (76.3) 24 (80) 7 (23.3) 3 (10) 59.3 10.5 247 77
34 (100) 34 (100) 33 (97.1) 25 (73.5) 27 (79.4) 13 (38.2) 3 (8.8) 58.2 09.9 246 67
1.00 1.00 0.93 0.77 0.95 0.20 0.87 0.77 0.91
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 4
K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
Table 2 Lesion and procedural characteristics: comparison of the c-FMJ and i-FMJ groups. Variables Calcified lesion None/mild – no. (%) Moderate – no. (%) Severe – no. (%) Chronic total occlusion – no. (%) Rotational atherectomy – no. (%) IVUS use Mean stent diameter (mm) Stent length (mm) Stent number Stent BP-SES – no. (%) EES – no. (%) BES – no. (%) ZES – no. (%) PES – no. (%) SES – no. (%) EES and ZES – no. (%) BES and ZES – no. (%) EES and PES – no. (%) PES and SES – no. (%) Incomplete site Ostium (proximal) – no. (%) Gap – no. (%) – no. (%) Distal – no. (%)
All (n = 64)
c-FMJ (n = 30)
i-FMJ (n = 34)
p-Value
41 (64.1) 15 (23.4) 8 (12.5) 27 (42.2) 9 (14.1) 64 (100) 3.05 0.28 75.5 19.3 2.80 0.62
20 (66.7) 6 (20.0) 4 (13.3) 15 (50) 2 (6.7) 30 (100) 3.04 0.25 79.8 22.1 2.90 0.66
21 (61.8) 9 (26.5) 4 (11.8) 12 (35.3) 7 (20.6) 34 (100) 3.05 0.31 71.7 15.8 2.71 0.58
0.68 0.54 0.85 0.24 0.11 1.00 0.08 0.50 0.22 0.72
23 (35.9) 17 (26.6) 2 (3.1) 34 (53.1) 5 (7.8)
12 (40) 8 (26.7) 1 (3.3) 16 (53.3) 1 (3.3)
11 (32.3) 9 (26.4) 1 (2.9) 18 (52.9) 4 (11.8)
64 64 62 48
30 30 29 23
34 34 33 25
(100) (100) (96.9) (75)
(100) (100) (96.7) (76.3)
(100) (100) (97.1) (73.5)
20 (58.8) 12 (35.5) 2 (5.9)
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket; IVUS, intravascular ultrasound; BP-SES, biodegradable-polymer sirolimus-eluting stent; EES, everolimuseluting stent; ZES, zotarolimus-eluting stent; BES, biolimus-eluting stent; PES, paclitaxel-eluting stent; SES, sirolimus-eluting stent.
Table 3 Clinical outcomes: comparison of the c-FMJ and i-FMJ groups. Variables MACE Cardiac death – no. (%) Stent thrombosis – no. (%) Target lesion revascularization – no. (%) Target vessel revascularization – no. (%)
All (n = 64) 18 (28.1) 0 2 (1) 13 (20.3) 18 (28.1)
c-FMJ (n = 30) 4 0 1 2 4
(13.3) (3.3) (6.7) (13.3)
i-FMJ (n = 34)
p-Value
14 (41.2) 0 1 (2.9) 11 (32.4) 14 (41.2)
0.013 1.0 0.011 0.013
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket; MACE, major adverse cardiac events.
the c-FMJ group (13.3%) as compared to the i-FMJ group (41.2%) (p = 0.013) (Table 3). In the QCA analysis, the pre-procedure and post-procedure parameters were comparable between the 2 groups, whereas the percent diameter stenosis was significantly less in the c-FMJ group (p = 0.011) (Table 4). In the univariate logistic regression, i-FMJ was the only predictor of MACE (OR 0.22; 95% CI 0.063–0.771, p = 0.018). We performed a multivariate logistic regression analysis using variables with p < 0.10 in univariate logistic regression analysis. i-FMJ (p = 0.018), mean stent diameter (p = 0.095), and follow-up duration (p = 0.093) were included in the model. Multivariate logistic regression analysis revealed that i-FMJ (OR 0.15; 95% CI 0.036–0.630, p = 0.01) and mean stent diameter (OR 0.275; 95% CI 0.083–0909, p = 0.034) were significantly associated with MACE after controlling covariates (Table 5). Kaplan–Meier analysis showed that MACE was less frequently observed in the c-FMJ group; however, the differences were not significant (Fig. 3). Discussion The present study compared the mid-term MACE of diffuse RCA lesions in the i-FMJ group with that in the c-FMJ group, and showed that the MACE was significantly less in the c-FMJ group than in the
i-FMJ group. To date, there was no clinical study comparing the outcomes of diffuse RCA lesions between c-FMJ and i-FMJ. Our findings suggest the importance of complete stent coverage for revascularization for the diffuse RCA lesion. Since there are fewer major branches in RCA as compared to left coronary artery (LCA), FMJ strategy may be more frequently considered in RCA than in LCA. Furthermore, PCI for the ostium of RCA is different from that for the ostium of LCA, because PCI for the ostium of RCA does not consider bifurcation stenting, which is closely associated with PCI for the ostium of LCA [15]. Therefore, the present study was limited to the RCA lesion for the purpose of simplifying the question. The short- and long-term outcomes of PCI for RCA ostium have been unsatisfactory since the bare metal stent (BMS) era [16,17]. Although the clinical outcomes in PCI have significantly improved in the DES era compared to the BMS era [18], stenting to RCA ostium is still a predictor of TLR even using the second-generation DES [19]. This may be partly explained by the rigid nature of the vessel wall in the coronary ostium [20]. Previous reports revealed that incomplete lesion revascularization is a risk factor for MACE [8,21]. In addition, stent gap and residual uncovered atherosclerotic plaque were risk factors for TLR [7,22]. Residual plaques between 2 stents or stent edge might have damage due to balloon dilation, which should increase the
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
5
Table 4 Quantitative coronary angiography: comparison of the c-FMJ and i-FMJ groups. Variables Pre-procedure Reference diameter (mm) Minimum lumen diameter (mm) Percent diameter stenosis (%) Lesion length (mm) Post-procedure Reference diameter (mm) Minimum lumen diameter (mm) Percent diameter stenosis (%) Acute gain (mm) Stent/artery ratio Follow-up Reference diameter (mm) Minimum lumen diameter (mm) Percent diameter stenosis (%) Late loss (mm) Incomplete site post-procedure Reference diameter (mm) Minimum lumen diameter (mm) Diameter stenosis (%) Incomplete site follow-up Reference diameter (mm) Minimum lumen diameter (mm) Diameter stenosis (%) Late loss (mm)
All (n = 64)
c-FMJ (n = 30)
i-FMJ (n = 34)
p-Value
2.87 0.58 0.42 0.50 84.9 18.4 54.1 11.1
2.75 0.61 0.45 0.54 83.4 19.8 53.3 10.5
2.97 0.55 0.39 0.47 86.2 17.3 54.7 11.8
0.13 0.63 0.54 0.62
3.17 0.38 2.50 0.41 10.6 12.7 2.09 0.62 1.10 0.21
3.12 0.33 2.46 0.40 20.6 13.9 2.01 0.68 1.15 0.22
3.22 0.41 2.54 0.43 20.7 11.7 2.15 0.57 1.05 0.18
0.37 0.44 0.59 0.37 0.13
3.13 0.49 1.99 0.69 36.0 21.5 0.51 0.70
3.08 0.49 2.12 0.59 31.0 17.4 0.33 0.63
3.18 0.49 1.86 0.76 40.4 23.9 0.66 0.73
0.86 0.15 0.011 0.059
3.04 0.69 2.47 0.83 20.1 16.4
3.04 0.69 2.47 0.83 20.1 16.4
3.11 0.68 2.39 0.79 23.1 20.9 0.07 0.52
3.11 0.68 2.39 0.79 23.1 20.9 0.07 0.52
Data are expressed as the mean SD or number (percentage). A Student’s t test was used for normally distributed continuous variables, a Mann–Whitney U test was used for abnormally distributed continuous variables, and a chi-square test was used for categorical variables. c-FMJ, complete full metal jacket; i-FMJ, incomplete full metal jacket.
incidence of TLR. In our study, while the QCA outcomes of incomplete site were not significantly different between the 2 groups, the percent diameter of follow-up was significantly less in the c-FMJ group. The presence of residual plaques may be the reason why the present study showed MACE was greater in i-FMJ than in c-FMJ.
Lee et al. showed the long-term clinical outcomes in 352 native coronary lesions, which were treated by FMJ strategy. They reported that the risk of MACE was stent length >80 mm and left ventricular dysfunction [23], which were not risk factors for MACE in our study. Because our study only included RCA lesions, mean left ventricular ejection fraction in our study was within normal
Table 5 Determinants of MACE: univariate and multivariate logistic regression analysis. Dependent variable: MACE Univariate logistic regression analysis
Independent variables Age Male (vs. female) Previous myocardial infarction Previous coronary artery bypass grafting Acute coronary syndrome Family history Smoking Hypertension Hyperlipidemia Diabetes mellitus Chronic kidney disease ACE-inhibitor/ARB treatment Beta blocker treatment Statin treatment Calcium channel blocker treatment Diuretics Insulin treatment Left ventricular ejection fraction (10% increase) Follow up duration (30 days increase) Incomplete full metal jacket Chronic total occlusion Rotational atherectomy Mean stent diameter (0.5 mm increase) Stent length (10 mm increase)
OR
95% CI
1.02 1.38 0.64 0.558 0.437 0.720 2.463 0.976 0.851 1.11 2.79 0.556 1.175 2.647 2.27 1.684 0.482 1.134 0.804 0.22 2.383 2.34 0.42 0.81
0.96–1.09 0.38–4.98 0.16–2.61 0.085–3.654 0.134–1.413 0.173–2.99 0.701–8.654 0.171–5.551 0.225–3.215 0.36–3.37 078–9.90 0.167–1.853 0.311–4.435 0.157–44.74 0.73–7.08 0.322–8.822 0.052–4.442 0.669–1.924 0.623–1.037 0.06–0.77 0.73–7.776 0.55–9.97 0.156–1.159 0.592–1.108
p-Value 0.53 0.62 0.53 0.543 0.168 0.651 0.160 0.978 0.812 0.86 0.113 0.339 0.813 0.500 0.16 0.53 0.52 0.64 0.093 0.018 0.15 0.25 0.095 0.187
Multivariate logistic regression analysis OR
95% CI
p-Value
0.753 0.15
0.563–1.007 0.036–0.630
0.056 0.01
0.275
0.083–0.909
0.034
Univariate logistic regression analysis was performed to identify variables that had marginal association with MACE (p < 0.10). OR, odds ratio; CI, confidence interval; MACE, major adverse cardiac event; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx
6
Acknowledgment The authors are grateful to the staff of the catheter laboratory in Saitama Medical Center, Jichi Medical University. References
Fig. 3. Kaplan–Meier curves describing survival free from major adverse cardiac events (MACE). c-FMJ, complete full-metal jacket stenting strategy; i-FMJ, incomplete full-metal jacket stenting strategy.
range (58.7 10.1%), which partly explains the difference in risk factors between their study and our study. One serious concern in using DES is the ongoing hazard of ST. In the present study, the incidence of ST was not significantly different between the two groups. Previous reports showed that the rate of definite and probable ST in FMJ was 3.6%, which is similar to the present study [5]. Considering the diffuse long lesions that require multiple DES, the incidence of ST in FMJ strategy may be acceptable. Study limitations Our study has several limitations, which are mainly inherent to a retrospective study. First, as we did not randomly assign patients to either c-FMJ or i-FMJ, there could be a patient selection bias. Second, the PCI strategy including selection of stent type was determined by each interventional cardiologist, which also yielded selection bias. Third, we could not match the lesion characteristics between the 2 groups, because of the small study sample size. Fourth, we could not fully evaluate remaining myocardial ischemia after the PCI in most cases, which may have influenced the outcomes. Since we did not perform a statistical power analysis, there is a possibility of beta error. Further study is warranted to evaluate appropriate strategy in patients who received FMJ-PCI. Conclusions The mid-term MACE was significantly less in the c-FMJ group than in the i-FMJ group, indicating that c-FMJ stenting was a favorable strategy for the diffuse long RCA lesions. Our findings will help interventional cardiologists to determine the appropriate therapeutic strategy for patients with diffuse RCA lesions. Funding None. Conflict of interest Dr Sakakura received speaking honorarium from Abbott Vascular, Boston Scientific, Medtronic Cardiovascular, and Terumo.
[1] Aoki J, Kirtane AJ, Dangas GD, Dangas G, Lansky D, Morales AJ, Kimura AM, Kim YH, Moussa I, Weisz G, Kreps EM, Collins M, Frankin-Bond T, Stone GW, Moses JW, et al. Clinical outcomes after heterogeneous overlap stenting with drugeluting stents and bare-metal stents for de novo coronary artery narrowings. Am J Cardiol 2008;101:58–62. [2] Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, Thuesen L, Hauptman K, Marco J, Wijns W, Popma JJ, Koglin J, Russell ME. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation 2005;112:3306–13. [3] Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773–80. [4] Mizuguchi Y, Hashimoto S, Yamada T, Taniguchi N, Nakajima S, Hata T, Takahashi A. Percutaneous coronary intervention for nonagenarian patients with ST-segment elevation myocardial infarction: experience of a single Japanese center. J Cardiol 2016;67:331–4. [5] Basavarajaiah S, Naganuma T, Latib A, Hasegawa T, Sharp A, Rezq A, Sticchi A, Figini F, Amato A, Colombo A. Extended follow-up following full-metal jacket percutaneous coronary interventions with drug-eluting stents. Catheter Cardiovasc Interv 2014;84:1042–50. [6] Londono JC, Singh V, O’Neill WW. Total aorto-ostial chronic occlusion of the right coronary artery successfully recanalized via retrograde approach. Catheter Cardiovasc Interv 2011;78:400–4. [7] Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010;56:1897–907. [8] Head SJ, Mack MJ, Holmes Jr DR, Mohr FW, Morice MC, Serruys PW, Kappetein AP. Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data. Eur J Cardiothorac Surg 2012;41: 535–41. [9] Austen WG, Edwards JE, Frye RL, Gensini GG, Gott VL, Griffith LS, McGoon DC, Murphy ML, Roe BB. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc Committee for Grading of Coronary Artery Disease, Council on Cardiovascular Surgery, American Heart Association. Circulation 1975;51:5–40. [10] Abe D, Sato A, Hoshi T, Maruta S, Misaki M, Kakefuda Y, Watabe H, Hiraya D, Sakai S, Kawabe M, Takeyasu N, Aonuma K. Drug-eluting versus bare-metal stents in large coronary arteries of patients with ST-segment elevation myocardial infarction: findings from the ICAS registry. J Cardiol 2014;64:377–83. [11] Liu HL, Jin ZG, Yang SL, Han W, Jing QM, Zhang L, Luo JP, Ma DX, Liu Y, Yang LX, Jiang TM, Qu P, Li WM, Li SM, Xu B, et al. Five-year outcomes of ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome treated with biodegradable polymer-coated sirolimus-eluting stents: insights from the CREATE trial. J Cardiol 2016. [12] Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. [13] Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation 1995;91:1959–65. [14] Jinnouchi H, Sakakura K, Wada H, Arao K, Kubo N, Sugawara Y, Funayama H, Momomura S, Ako J. Transient no reflow following primary percutaneous coronary intervention. Heart Vessels 2014;29:429–36. [15] Lee MS, Stone GW, Park SJ, Teirstein P, Moses J, Colombo A, Kandzari DE. Percutaneous coronary intervention of unprotected left main coronary artery disease: procedural strategies and technical considerations. Catheter Cardiovasc Interv 2012;79:812–22. [16] Mavromatis K, Ghazzal Z, Veledar E, Diamandopoulos L, Weintraub WS, Douglas JS, Kalynych AM. Comparison of outcomes of percutaneous coronary intervention of ostial versus nonostial narrowing of the major epicardial coronary arteries. Am J Cardiol 2004;94:583–7. [17] Mathias DW, Mooney JF, Lange HW, Goldenberg IF, Gobel FL, Mooney MR. Frequency of success and complications of coronary angioplasty of a stenosis at the ostium of a branch vessel. Am J Cardiol 1991;67:491–5. [18] Sakamoto H, Ishikawa T, Mutoh M, Imai K, Mochizuki S. Angiographic and clinical outcomes after sirolimus-eluting stent implantation to de novo ostial lesion of the right coronary artery: a retrospective study. Circ J 2008;72:880–5. [19] Lam MK, Sen H, Tandjung K, Lowik MM, Basalus MW, Mewes JC, Stoel MG, van Houwelingen KG, Linssen GC, Ijzerman MJ, Doggen CJ, von Birgelen C. Clinical outcome of patients with implantation of second-generation drug-eluting stents in the right coronary ostium: insights from 2-year follow-up of the TWENTE trial. Catheter Cardiovasc Interv 2015;85:524–31.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014
G Model
JJCC-1400; No. of Pages 7 K. Yamamoto et al. / Journal of Cardiology xxx (2016) xxx–xxx [20] Rensing BJ, Hermans WR, Strauss BH, Serruys PW. Regional differences in elastic recoil after percutaneous transluminal coronary angioplasty: a quantitative angiographic study. J Am Coll Cardiol 1991;17:34B–8B. [21] Sarno G, Garg S, Onuma Y, Gutierrez-Chico JL, van den Brand MJ, Rensing BJ, Morel MA, Serruys PW. Impact of completeness of revascularization on the five-year outcome in percutaneous coronary intervention and coronary artery bypass graft patients (from the ARTS-II study). Am J Cardiol 2010;106:1369–75.
7
[22] Kereiakes DJ, Wang H, Popma JJ, Kuntz RE, Donohoe DJ, Schofer J, Schampaert E, Meier B, Leon MB, Moses JW. Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials. J Am Coll Cardiol 2006;48:21–31. [23] Lee CW, Ahn JM, Lee JY, Kim WJ, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Park SJ. Long-term (8 year) outcomes and predictors of major adverse cardiac events after full metal jacket drug-eluting stent implantation. Catheter Cardiovasc Interv 2014;84:361–5.
Please cite this article in press as: Yamamoto K, et al. Comparison of mid-term clinical outcomes between ‘‘complete full-metal jacket strategy’’ versus ‘‘incomplete full-metal jacket strategy’’ for diffuse right coronary artery stenosis with drug-eluting stents. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.09.014