2.1

Study patients

Between January 2007 and December 2013, 622 consecutive patients with de novo three-vessel coronary artery disease underwent PCI at our center (New Tokyo Hospital, Chiba, Japan). All patients were treated to achieve complete revascularization of all vessels with at least 2.5 mm in diameter with at least 70% stenosis.

Of these patients, those who underwent PCI with incomplete revascularization and were treated with BMS or both first- and new-generation DES were excluded. Therefore, 200 patients who received complete revascularization of three-vessel disease with either first-generation DES ( n = 85) or new-generation DES ( n = 115) were included in this retrospective study.

2.2

Definitions

First-generation DES included sirolimus-eluting stents [SES, Cypher family (Cordis Corp., Johnson & Johnson, Warren, NJ)] and paclitaxel-eluting stents [PES, Taxus family (Boston Scientific, Natick, MA)], whereas new-generation DES included everolimus-eluting stents [EES, XIENCE V®, and XIENCE PRIME™ (Abbott Vascular, Santa Clara, CA) and PROMUS® and PROMUS Element™ (Boston Scientific Corp., Natick, MA)], biolimus-eluting stents [BES, Nobori® (Terumo, Tokyo, Japan)], and zotarolimus-eluting stents [ZES, Resolute Integrity (Medtronic, Santa Rosa, CA)]. First-generation DES were used between 2007 and 2010, and new-generation DES were used between 2010 and 2013.

The decision to perform PCI for three-vessel disease depended on the physician’s assessment of high surgical risk as defined by the European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥ 6 and/or patient refusal of surgery.

Clinical data were collected during hospital visits or by telephone. In both cohorts, angiographic follow-up examinations were scheduled between 6 and 12 months after PCI or when clinical presentation suggested the presence of ischemia. Data on medication regimens were collected at the time of initial PCI.

The primary study endpoint was the incidence of MACE defined as the composite endpoints of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 3 years. Cardiac death was defined as death without an identifiable non-cardiac cause. MI was defined as the presence of pathological and new Q waves on electrocardiography or an increase in creatine kinase-myocardial band level to more than three times the normal limit. TLR was defined as any repeat intervention of the target lesion.

The secondary study endpoints were the individual components of MACE, all-cause death, target vessel revascularization (TVR), and definite or probable stent thrombosis (ST) based on the Academic Research Consortium definitions . TVR was defined as any repeat intervention of any treated vessel segment.

SYNTAX score was calculated from diagnostic angiograms according to the previously defined algorithm . Renal dysfunction was defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m ² , as patients with an eGFR in that range were more likely to have physical symptoms associated with kidney disease . eGFR measured immediately before the index PCI was included in the final analyses in this study.

2.3

Statistical analysis

Data were expressed as either frequencies (%) or means ± standard deviation. Continuous variables were compared using Student’s unpaired t test, and categorical variables were compared using the chi-square analysis or Fisher’s exact test. Event-free survival rates were estimated using the Kaplan–Meier method and compared using the log-rank test.

The multivariate Cox proportional hazards regression model was used to identify independent predictors of MACE. Variables that were associated with outcomes during univariate analysis, those variables with previously shown clinical significance, and baseline characteristics that differed between the first- and new-generation DES patients groups were selected as covariates for multivariate analysis. To avoid overfitting the data, the number of covariates was limited to a maximum of 1 for every 8 to 10 events. The results were reported as adjusted hazard ratios (HRs) with associated 95% confidence intervals (CIs). Statistical significance was defined as a p value of less than 0.05. Analyses were confirmed using SPSS version 18.0 (IBM SPSS, Chicago, IL).

2.1

Study patients

Between January 2007 and December 2013, 622 consecutive patients with de novo three-vessel coronary artery disease underwent PCI at our center (New Tokyo Hospital, Chiba, Japan). All patients were treated to achieve complete revascularization of all vessels with at least 2.5 mm in diameter with at least 70% stenosis.

Of these patients, those who underwent PCI with incomplete revascularization and were treated with BMS or both first- and new-generation DES were excluded. Therefore, 200 patients who received complete revascularization of three-vessel disease with either first-generation DES ( n = 85) or new-generation DES ( n = 115) were included in this retrospective study.

2.2

Definitions

First-generation DES included sirolimus-eluting stents [SES, Cypher family (Cordis Corp., Johnson & Johnson, Warren, NJ)] and paclitaxel-eluting stents [PES, Taxus family (Boston Scientific, Natick, MA)], whereas new-generation DES included everolimus-eluting stents [EES, XIENCE V®, and XIENCE PRIME™ (Abbott Vascular, Santa Clara, CA) and PROMUS® and PROMUS Element™ (Boston Scientific Corp., Natick, MA)], biolimus-eluting stents [BES, Nobori® (Terumo, Tokyo, Japan)], and zotarolimus-eluting stents [ZES, Resolute Integrity (Medtronic, Santa Rosa, CA)]. First-generation DES were used between 2007 and 2010, and new-generation DES were used between 2010 and 2013.

The decision to perform PCI for three-vessel disease depended on the physician’s assessment of high surgical risk as defined by the European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥ 6 and/or patient refusal of surgery.

Clinical data were collected during hospital visits or by telephone. In both cohorts, angiographic follow-up examinations were scheduled between 6 and 12 months after PCI or when clinical presentation suggested the presence of ischemia. Data on medication regimens were collected at the time of initial PCI.

The primary study endpoint was the incidence of MACE defined as the composite endpoints of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 3 years. Cardiac death was defined as death without an identifiable non-cardiac cause. MI was defined as the presence of pathological and new Q waves on electrocardiography or an increase in creatine kinase-myocardial band level to more than three times the normal limit. TLR was defined as any repeat intervention of the target lesion.

The secondary study endpoints were the individual components of MACE, all-cause death, target vessel revascularization (TVR), and definite or probable stent thrombosis (ST) based on the Academic Research Consortium definitions . TVR was defined as any repeat intervention of any treated vessel segment.

SYNTAX score was calculated from diagnostic angiograms according to the previously defined algorithm . Renal dysfunction was defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m ² , as patients with an eGFR in that range were more likely to have physical symptoms associated with kidney disease . eGFR measured immediately before the index PCI was included in the final analyses in this study.

2.3

Statistical analysis

Data were expressed as either frequencies (%) or means ± standard deviation. Continuous variables were compared using Student’s unpaired t test, and categorical variables were compared using the chi-square analysis or Fisher’s exact test. Event-free survival rates were estimated using the Kaplan–Meier method and compared using the log-rank test.

The multivariate Cox proportional hazards regression model was used to identify independent predictors of MACE. Variables that were associated with outcomes during univariate analysis, those variables with previously shown clinical significance, and baseline characteristics that differed between the first- and new-generation DES patients groups were selected as covariates for multivariate analysis. To avoid overfitting the data, the number of covariates was limited to a maximum of 1 for every 8 to 10 events. The results were reported as adjusted hazard ratios (HRs) with associated 95% confidence intervals (CIs). Statistical significance was defined as a p value of less than 0.05. Analyses were confirmed using SPSS version 18.0 (IBM SPSS, Chicago, IL).

3.1

Comparisons of baseline clinical, angiographic, and procedural characteristics and medications after the procedure

The clinical characteristics of patients that underwent PCI with first- and new-generation DES are shown in Table 1 . There were no significant differences in the clinical characteristics except for the higher insulin use rate and EuroSCORE (4.7% vs. 15%, p = 0.04, 3.6 ± 2.4 vs. 4.6 ± 2.7, p < 0.01, respectively) as well as the lower current smoking rate (33% vs. 18%, p = 0.03) in the new-generation DES group compared with the first-generation DES group.

Table 1

Baseline Characteristics.

	First-Generation DES	New-Generation DES
Variables	n = 85	n = 115	p value
Patient demographics
Age, years	66 ± 10	69 ± 11	0.07
Male	67 (79)	89 (77)	0.86
BMI	25 ± 2.6	24 ± 3.4	0.57
Risk factors
Diabetes mellitus	42 (49)	64 (56)	0.46
Use of insulin	4 (4.7)	17 (15)	0.04
Hypertension	61 (72)	83 (73)	0.99
Dyslipidemia	57 (67)	71 (62)	0.58
Current smoker	28 (33)	21 (18)	0.03
Comorbidities
PAD	10 (12)	23 (20)	0.17
CKD on HD	4 (5.0)	11 (10)	0.31
EuroSCORE	3.6 ± 2.4	4.6 ± 2.7	< 0.01
Clinical Presentation
AMI	2 (2.3)	8 (7.0)	0.25
Unstable angina	15 (18)	14 (12)	0.38
Stable angina	68 (80)	93 (81)	0.99
Clinical data
eGFR, ml/min/1.73 m 2	70 ± 27	63 ± 29	0.08
Renal dysfuntion	7 (8.2)	14 (12)	0.37
LVEF, %	57 ± 11	54 ± 13	0.06

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