Catheterization and Cardiovascular Interventions 00:00–00 (2015)
Original Studies Comparison Between One-Stent Versus Two-Stent Technique for Treatment of Left Main Bifurcation Lesions: A Large Single-Center Data Zhan Gao,1 MD, Bo Xu,1 MBBS, Yuejin Yang,1 MD, FACC, Shubin Qiao,1 MD, Yongjian Wu,1 MD, Tao Chen,2 PhD, Liang Xu,1 MSC, Jinqing Yuan,1 MD, Jue Chen,1 MD, and Run-lin Gao,1* MD Background: Comparisons between one- and two-stent strategies for unprotected left main (UPLM) coronary bifurcation disease have yielded inconsistent results. This large-sample, long-term follow-up study comparatively assessed stenting strategy impact in patients with distal left main disease. Methods: Totally, 1,528 consecutive patients underwent left main percutaneous coronary intervention in a single center from January 2004 to December 2010 were enrolled; among them, 1033 patients with distal UPLM lesions treated by one (n 5 661) or two (n 5 372) drug-eluting stent (DES) technique were comparatively analyzed. Primary outcome was rate of major adverse cardiovascular events (MACE), defined as a composite of death, myocardial infarction (MI), and target vessel revascularization (TVR). Results: Overall, baseline SYNTAX score was low-intermediate (one stent: 25 6 6 vs. two stents: 26 6 5, P 5 0.02), and mean clinical SYNTAX score was similar between groups (one stent: 30 6 22 vs. two stents: 31 6 22, P 5 0.47). Final kissing balloon was successfully achieved in most of the patients treated with two-stent technique (one stent: 30.9% vs. two stents: 96.0%, P < 0.01), and use of intravascular ultrasound was also more common in them (one stent: 32.2% vs. two stents: 53.8%, P < 0.01). At mean 4 years follow-up, rates of MACE (one stent: 9.2% vs. two stents: 11.6%, P 5 0.23), death, MI, and TVR were similar between groups. In multivariate propensity-matched regression analysis, two-stent technique was not predictive of MACE. Conclusions: For patients with distal UPLM disease and low-intermediate SYNTAX score treated with DES, clinical outcomes appear similar between optimal twostent implantation and one-stent strategy. VC 2015 Wiley Periodicals, Inc. Key words: percutaneous coronary angioplasty; drug-eluting stents; unprotected left main; bifurcation
1
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China 2 Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China
*Correspondence to: Runlin Gao, MD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167 Beilishi Road, Xicheng District, Beijing 100037, China. E-mail: [email protected] Received 30 June 2014; Revision accepted 18 January 2015
Conflict of interest: Nothing to report. Z.G. and B.X. contributed equally to this work.
C 2015 Wiley Periodicals, Inc. V
DOI: 10.1002/ccd.25849 Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com)
2
Gao et al.
main PCI from January 2004 to December 2010 were prospectively collected (Fig. 1). Among them, 1033 patients with distal UPLM lesions treated with drugeluting stent (DES) by one-stent (n ¼ 661) or two-stent (n ¼ 372) technique were analyzed. UPLM disease was defined as documented myocardial ischemia with 50% UPLM stenosis and no patent bypass graft to the left anterior descending (LAD) or left circumflex (LCX) arteries. Distal UPLM lesions were defined as Medina classifications of 0,1,1; 1,0,1; 1,1,0; and 1,1,1. Patients with acute myocardial infarction (MI) within 24 hr and cardiac shock were excluded. The decision for UPLM PCI was based on consultation with both patients and surgeons in instances of patient refusal for surgery or comorbidity that posed excessive surgical risk. Procedural Details Fig. 1. Study profile. PCI, percutaneous coronary intervention; AMI, acute myocardial infarction; BMS, bare metal stent; PTCA, percutaneous transluminal coronary angioplasty.
INTRODUCTION
Although coronary artery bypass grafting is standard treatment for distal unprotected left main (UPLM) coronary artery disease [1,2], percutaneous coronary intervention (PCI) remains an alternative in patients with low-intermediate SYNTAX scores (i.e., 360 days) and to the level of certainty as definite, probable, and possible [20]. Statistical Analysis
Continuous variables are described as mean (standard deviation) or median (Q1–Q3), and Student’s t tests or Wilcoxon test were performed for between-group comparisons, as appropriate. Categorical variables are displayed as percentages and compared by v2 test. Propensity score matching analysis was performed to minimize potential bias secondary to between-group imbalance. Propensity scores were calculated using a logistic model (C-statistics: 0.881) with the inclusion of the following variables: sex, age, body mass index, prior MI, prior PCI, previous coronary artery bypass grafting, diabetes mellitus, hypertension, unstable angina, hyperlipidemia, family history of coronary artery disease, prior stroke, left ventricular ejection fraction, transradial approach, stent diameter, stent length, use of intravascular ultrasound, and baseline SYNTAX score. Patients were matched 1:1 using the greedy 8to-1 digit matching algorithm without replacement. Kaplan–Meier product limit methods were used to calculate survival curves for outcomes in the different groups and log-rank tests were used to examine differences among groups. Hazard ratios (HRs) were estimated by the Cox proportional hazard regression model after controlling for the abovementioned confounders. All tests were two sided and conducted at the 0.05 level. RESULTS Baseline Patient Characteristics
The two groups were matched for all clinical characteristics except for prior PCI and unstable angina, which were more prevalent in the two-stent group (Table I). Lesion and procedural characteristics are presented in Table II. The patients enrolled in this study were at
3
TABLE I. Baseline Clinical Characteristics
Age (years) Male BMI (kg/m2) Diabetes mellitusa Hypertensiona Hyperlipidemiaa Prior MI Prior PCI Prior CABG Current smoker Family history of CAD Prior stroke Peripheral vascular disease Chronic lung disease Unstable angina LVEF (%) Creatinine clearance rate (mL/min)
One stent (n ¼ 661)
Two stents (n ¼ 372)
P
60 11 536 (81.1) 26 3 150 (22.7) 366 (55.4) 327 (49.5) 160 (24.2) 138 (20.9) 16 (2.4) 185 (28.0) 83 (12.6) 43 (6.5) 32 (4.8) 7 (1.1) 412 (62.9) 63 7 81 19
60 11 304 (81.7) 26 3 98 (26.3) 211 (56.7) 184 (49.5) 96 (25.8) 105 (28.2) 6 (1.6) 103 (27.7) 39 (10.5) 24 (6.5) 23 (6.2) 2 (0.5) 267 (71.8) 63 7 82 17
0.70 0.80 0.13 0.19 0.67 1.00 0.57
Original Studies Comparison Between One-Stent Versus Two-Stent Technique for Treatment of Left Main Bifurcation Lesions: A Large Single-Center Data Zhan Gao,1 MD, Bo Xu,1 MBBS, Yuejin Yang,1 MD, FACC, Shubin Qiao,1 MD, Yongjian Wu,1 MD, Tao Chen,2 PhD, Liang Xu,1 MSC, Jinqing Yuan,1 MD, Jue Chen,1 MD, and Run-lin Gao,1* MD Background: Comparisons between one- and two-stent strategies for unprotected left main (UPLM) coronary bifurcation disease have yielded inconsistent results. This large-sample, long-term follow-up study comparatively assessed stenting strategy impact in patients with distal left main disease. Methods: Totally, 1,528 consecutive patients underwent left main percutaneous coronary intervention in a single center from January 2004 to December 2010 were enrolled; among them, 1033 patients with distal UPLM lesions treated by one (n 5 661) or two (n 5 372) drug-eluting stent (DES) technique were comparatively analyzed. Primary outcome was rate of major adverse cardiovascular events (MACE), defined as a composite of death, myocardial infarction (MI), and target vessel revascularization (TVR). Results: Overall, baseline SYNTAX score was low-intermediate (one stent: 25 6 6 vs. two stents: 26 6 5, P 5 0.02), and mean clinical SYNTAX score was similar between groups (one stent: 30 6 22 vs. two stents: 31 6 22, P 5 0.47). Final kissing balloon was successfully achieved in most of the patients treated with two-stent technique (one stent: 30.9% vs. two stents: 96.0%, P < 0.01), and use of intravascular ultrasound was also more common in them (one stent: 32.2% vs. two stents: 53.8%, P < 0.01). At mean 4 years follow-up, rates of MACE (one stent: 9.2% vs. two stents: 11.6%, P 5 0.23), death, MI, and TVR were similar between groups. In multivariate propensity-matched regression analysis, two-stent technique was not predictive of MACE. Conclusions: For patients with distal UPLM disease and low-intermediate SYNTAX score treated with DES, clinical outcomes appear similar between optimal twostent implantation and one-stent strategy. VC 2015 Wiley Periodicals, Inc. Key words: percutaneous coronary angioplasty; drug-eluting stents; unprotected left main; bifurcation
1
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China 2 Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China
*Correspondence to: Runlin Gao, MD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167 Beilishi Road, Xicheng District, Beijing 100037, China. E-mail: [email protected] Received 30 June 2014; Revision accepted 18 January 2015
Conflict of interest: Nothing to report. Z.G. and B.X. contributed equally to this work.
C 2015 Wiley Periodicals, Inc. V
DOI: 10.1002/ccd.25849 Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com)
2
Gao et al.
main PCI from January 2004 to December 2010 were prospectively collected (Fig. 1). Among them, 1033 patients with distal UPLM lesions treated with drugeluting stent (DES) by one-stent (n ¼ 661) or two-stent (n ¼ 372) technique were analyzed. UPLM disease was defined as documented myocardial ischemia with 50% UPLM stenosis and no patent bypass graft to the left anterior descending (LAD) or left circumflex (LCX) arteries. Distal UPLM lesions were defined as Medina classifications of 0,1,1; 1,0,1; 1,1,0; and 1,1,1. Patients with acute myocardial infarction (MI) within 24 hr and cardiac shock were excluded. The decision for UPLM PCI was based on consultation with both patients and surgeons in instances of patient refusal for surgery or comorbidity that posed excessive surgical risk. Procedural Details Fig. 1. Study profile. PCI, percutaneous coronary intervention; AMI, acute myocardial infarction; BMS, bare metal stent; PTCA, percutaneous transluminal coronary angioplasty.
INTRODUCTION
Although coronary artery bypass grafting is standard treatment for distal unprotected left main (UPLM) coronary artery disease [1,2], percutaneous coronary intervention (PCI) remains an alternative in patients with low-intermediate SYNTAX scores (i.e., 360 days) and to the level of certainty as definite, probable, and possible [20]. Statistical Analysis
Continuous variables are described as mean (standard deviation) or median (Q1–Q3), and Student’s t tests or Wilcoxon test were performed for between-group comparisons, as appropriate. Categorical variables are displayed as percentages and compared by v2 test. Propensity score matching analysis was performed to minimize potential bias secondary to between-group imbalance. Propensity scores were calculated using a logistic model (C-statistics: 0.881) with the inclusion of the following variables: sex, age, body mass index, prior MI, prior PCI, previous coronary artery bypass grafting, diabetes mellitus, hypertension, unstable angina, hyperlipidemia, family history of coronary artery disease, prior stroke, left ventricular ejection fraction, transradial approach, stent diameter, stent length, use of intravascular ultrasound, and baseline SYNTAX score. Patients were matched 1:1 using the greedy 8to-1 digit matching algorithm without replacement. Kaplan–Meier product limit methods were used to calculate survival curves for outcomes in the different groups and log-rank tests were used to examine differences among groups. Hazard ratios (HRs) were estimated by the Cox proportional hazard regression model after controlling for the abovementioned confounders. All tests were two sided and conducted at the 0.05 level. RESULTS Baseline Patient Characteristics
The two groups were matched for all clinical characteristics except for prior PCI and unstable angina, which were more prevalent in the two-stent group (Table I). Lesion and procedural characteristics are presented in Table II. The patients enrolled in this study were at
3
TABLE I. Baseline Clinical Characteristics
Age (years) Male BMI (kg/m2) Diabetes mellitusa Hypertensiona Hyperlipidemiaa Prior MI Prior PCI Prior CABG Current smoker Family history of CAD Prior stroke Peripheral vascular disease Chronic lung disease Unstable angina LVEF (%) Creatinine clearance rate (mL/min)
One stent (n ¼ 661)
Two stents (n ¼ 372)
P
60 11 536 (81.1) 26 3 150 (22.7) 366 (55.4) 327 (49.5) 160 (24.2) 138 (20.9) 16 (2.4) 185 (28.0) 83 (12.6) 43 (6.5) 32 (4.8) 7 (1.1) 412 (62.9) 63 7 81 19
60 11 304 (81.7) 26 3 98 (26.3) 211 (56.7) 184 (49.5) 96 (25.8) 105 (28.2) 6 (1.6) 103 (27.7) 39 (10.5) 24 (6.5) 23 (6.2) 2 (0.5) 267 (71.8) 63 7 82 17
0.70 0.80 0.13 0.19 0.67 1.00 0.57
