Abstract
Background:
The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.
Hypothesis:
We hypothesized that the type of drug‐eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.
Methods:
One hundred fifteen patients who underwent stent implantation using a provisional T‐stenting technique with sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.
Results:
Ninety‐four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow‐up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow‐up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug‐eluting stent used (SES vs PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29–11.67, P = 0.016).
Conclusions:
According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials. © 2011 Wiley Periodicals, Inc.
The authors have no funding, financial relationships, or conflicts of interest to disclose.
Introduction
Up to 6% of patients with coronary artery disease present with significant unprotected left main coronary artery (uLMCA) lesions.1 Although coronary artery bypass graft (CABG) surgery has been the standard treatment approach for uLMCA, percutaneous coronary intervention (PCI) using drug‐eluting stent (DES) implantation has recently been shown to have clinical outcomes comparable to CABG.2 However, bifurcation lesions have been associated with an increased risk of major adverse cardiac events (MACE) after DES implantation in uLMCA.3 In a recent study, patients with bifurcation lesions treated with sirolimus‐eluting stents (SES; Cypher, Cordis, Johnson & Johnson, New Brunswick, NJ) showed significantly lower rates of late loss and target lesion revascularization (TLR) than patients treated with paclitaxel‐eluting stents (PES; Taxus, Boston Scientific, Natick, MA).4 However, no comparisons have yet been performed to evaluate the efficacies of different types of DES in this coronary lesion subset.
The purpose of this study was to assess the safety and efficacy of SES and PES in patients with uLMCA bifurcation lesions.
Methods
Study Design and Patient Population
This study was a single‐center prospective registry, including 115 consecutive patients with de novo uLMCA bifurcation lesions who underwent DES implantation from March 2005 to November 2008 in Samsung Medical Center, Seoul, Korea. The LMCA was considered unprotected if there were no patent CABG to the LAD or LCX. The uLMCA bifurcation lesion was defined as a significant lumen obstruction (≥50%) at visual estimation occupying the distal third of the LMCA with part of or the entire lesion either directly involving the ostium of the left anterior descending coronary artery (LAD) and/or the left circumflex coronary artery (LCX) or in close contact with ≥1 of the ostia. Inclusion criteria were symptomatic uLMCA bifurcation lesion or documented myocardial ischemia and angiographic evidence of ≥50%‐ diameter stenosis at the uLMCA bifurcation that was treated with PCI with either SES or PES. Patients were excluded if they had hemodynamic instability, life expectancy <1 year due to comorbid conditions, implantations with both SES and PES, or primary PCI for acute myocardial infarction (MI). This study was approved by the institutional review board. Written informed consent was obtained from all patients.
Stenting Procedures and Post‐Intervention Medications
All interventions were performed according to current standard guidelines. The only approach was a provisional T‐stenting and the small protrusion technique (TAP‐stenting), which have been described previously.5
A glycoprotein IIb/IIIa receptor inhibitor was used at the operator's discretion. All patients were advised to maintain lifelong aspirin therapy. Clopidogrel was loaded with 300 mg before the procedure if patients were not pretreated, and followed with 75 mg/day for ≥12 months. Baseline, post‐procedural, and follow‐up coronary angiograms were recorded and assessed with an automated edge‐detection system (DCAS GP2004 quantitative coronary angiography [QCA] program; GP&P, Seoul, Korea).
All patients were evaluated by office visits or telephone interviews. Repeat coronary angiography was performed at approximately 9 months after stenting or sooner if clinically indicated.
Definitions and Clinical Follow‐Up
Baseline bifurcation anatomy was assessed according to the Medina classification.6 A MACE was defined as cardiac death, MI, or TLR. All deaths were considered to be of cardiac origin unless a noncardiac cause was clearly established. The diagnosis of MI required the presence of new significant Q waves on the electrocardiogram and/or elevation of creatine kinase‐myocardial band level ≥2× the upper limit of the normal range in no fewer than 2 blood samples. Stent thrombosis (ST) was defined according to Academic Research Consortium criteria.7 Angiographic restenosis was defined as diameter stenosis ≥50% measured by quantitative coronary angiography (QCA). Late loss was defined as the difference between minimum lumen diameters (MLDs) after the procedure and at follow‐up. Target lesion revascularization (TLR) was defined as repeat intervention (percutaneous or surgical) to treat luminal stenosis within the stent or in the 5‐mm distal or proximal segments adjacent to the stent. Repeated PCI was performed in patients with angiographic restenosis who had symptoms or objective evidence of myocardial ischemia.
Statistical Analysis
Continuous variables were shown as median and interquartile range (IQR) or mean ± SD and were compared using 2‐independent‐sample tests. Categorical variables were presented as counts and percentages and were compared using the Fisher exact test. Survival curves were generated using the Kaplan‐Meier method. Differences in survival parameters were assessed for significance and relative risks were calculated by means of the log‐rank test. Multivariable analysis with a Cox proportional hazards model were performed to adjust confounders and to identify independent predictors of clinical events. Probability was significant at a level of <0.05. All statistical tests were 2‐tailed. Statistical analysis was performed using SPSS 15.0 software (SPSS Inc., Chicago, IL).
Results
Baseline and Procedural Characteristics
A total of 115 patients were enrolled. Ninety‐four patients were treated with SES and 21 patients with PES. There were no significant differences between the 2 treatment groups in terms of age, sex, cardiac risk factors, or other clinical conditions (Table 1). Also, the 2 groups did not differ significantly with respect to the type of bifurcation lesions according to the Medina classification.
Table 1.
Baseline Clinical, Angiographic, and Procedural Characteristics in the 2 Patient Groups
| All Patients (n = 115) | SES (n = 94) | PES (n = 21) | P Value | |
|---|---|---|---|---|
| Age, mean ± SD (y) | 62 ± 10 | 62 ± 10 | 63 ± 9 | 0.70 |
| Male sex | 92 (80) | 76 (81) | 16 (76) | 0.63 |
| Hypertension | 61 (53) | 47 (50) | 14 (67) | 0.17 |
| DM | 34 (30) | 28 (30) | 6 (29) | 0.91 |
| Hypercholesterolemia | 14 (12) | 13 (14) | 1 (5) | 0.25 |
| Current smoker | 23 (20) | 21 (22) | 2 (10) | 0.18 |
| CVA | 12 (10) | 12 (13) | 0 (0) | 0.08 |
| Chronic renal failure | 5 (4) | 5 (5) | 0 (0) | 0.28 |
| Family history of CAD | 7 (6) | 7 (7) | 0 (0) | 0.20 |
| Previous PCI | 12 (10) | 10 (11) | 2 (10) | >0.99 |
| Previous MI | 5 (4) | 5 (5) | 0 (0) | 0.28 |
| ACS | 41 (36) | 32 (34) | 9 (43) | 0.45 |
| LVEF, mean ± SD (%) | 62 ± 9 | 61 ± 10 | 65 ± 5 | 0.15 |
| Vessel involved | 0.89 | |||
| LMCA only | 27 (24) | 23 (24) | 4 (19) | |
| LMCA + single‐vessel disease | 26 (23) | 20 (21) | 6 (29) | |
| LMCA + double‐vessel disease | 45 (39) | 37 (39) | 8 (38) | |
| LMCA + triple‐vessel disease | 17 (15) | 14 (15) | 3 (14) | |
| Medina classification of bifurcation lesions | 0.56 | |||
| 1, 1, 1 | 41 (36) | 36 (38) | 5 (24) | |
| 1, 0, 1 | 8 (7) | 7 (7) | 1 (5) | |
| 0, 1, 1 | 9 (8) | 7 (7) | 2 (10) | |
| Others | 57(49) | 44 (48) | 13 (61) | |
| Angle between bifurcation, mean ± SD (°) | 74 ± 18 | 74 ± 17 | 71 ± 20 | 0.84 |
| LMCA to LAD | ||||
| Stent diameter, mean ± SD (mm) | 3.41 ± 0.30 | 3.38 ± 0.27 | 3.52 ± 0.40 | 0.13 |
| Stent length, mean ± SD (mm) | 24.9 ± 5.7 | 25.1 ± 5.7 | 24.0 ± 6.1 | 0.45 |
| Stent max. inflation pressure, mean ± SD (atm) | 17.0 ± 2.8 | 17.1 ± 2.9 | 16.8 ± 2.1 | 0.35 |
| LCX | ||||
| Stent diameter, mean ± SD (mm) | 3.26 ± 0.33 | 3.26 ± 0.32 | 3.23 ± 0.37 | 0.85 |
| Stent length, mean ± SD (mm) | 19.1 ± 5.9 | 18.7 ± 5.9 | 21.2 ± 6.0 | 0.14 |
| Stent max. inflation pressure, mean ± SD (atm) | 16.4 ± 2.6 | 16.6 ± 2.6 | 15.4 ± 2.7 | 0.19 |
| LCX balloon inflation after stenting of the LMCA to LAD | 89 (77) | 70 (74) | 19 (90) | 0.15 |
| 2‐stent strategy (stenting of the LCX) | 56 (49) | 49 (52) | 7 (33) | 0.12 |
Data are presented as n (%) unless otherwise noted.
Abbreviations: ACS, acute coronary syndrome; atm, atmosphere; CAD, coronary artery disease; CVA, cerebrovascular accident; DM, diabetes mellitus; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; LMCA, left main coronary artery; LVEF, left ventricular ejection fraction; max., maximum; MI, myocardial infarction; PES, paclitaxel‐eluting stent; PCI, percutaneous coronary intervention; SD, standard deviation; SES, sirolimus‐eluting stent.
Implantation of the stent was successful in all patients. The groups were well‐matched with regard to procedural characteristics (Table 1). There were no significant differences between the 2 groups with respect to the use of LCX balloon inflation after stenting of the LMCA to LAD, or the stenting rate of the LCX. Stent lengths and stent diameters were similar for the 2 groups in both the LMCA to LAD and the LCX.
Clinical Outcomes
Clinical information was collected for all patients (Table 2). The follow‐up duration was a median of 712 (IQR, 1–1520) days for all patients. There was 1 case of acute ST 9 hours after the procedure in the SES group.
Table 2.
Clinical and Angiographic Outcomes in the 2 Patient Groups
| All Patients (n = 115) | SES (n = 94) | PES (n = 21) | P Value | |
|---|---|---|---|---|
| Cardiac death | 3 (3) | 2 (2) | 1 (5) | 0.50 |
| MI | 2 (2) | 1 (1) | 1 (5) | 0.20 |
| Cardiac death/MI | 5 (4) | 3 (3) | 2 (10) | 0.20 |
| TLR, total | 11 (10) | 7 (7) | 4 (19) | 0.11 |
| TLR in the LMCA to LAD | 2 (2) | 1 (1) | 1 (5) | 0.33 |
| TLR in the LCX | 9 (8) | 6 (6) | 3 (14) | 0.36 |
| MACE | 16 (14) | 10 (11) | 6 (29) | 0.032 |
| ST | 1 (1) | 1 (1) | 0 (0) | >0.99 |
| Angiographic reevaluation | ||||
| Follow‐up rate | 99 (86) | 81 (86) | 18 (86) | >0.99 |
| Time (d), median (IQR) | 273 (126–392) | 273 (126–392) | 270 (224–301) | 0.61 |
| ISR, total | 17 (17) | 12 (15) | 5 (28) | 0.17 |
| ISR in the LMCA to LAD | 4 (4) | 2 (2) | 2 (11) | 0.15 |
| ISR in the LCX | 14 (14) | 11 (13) | 3 (17) | 0.71 |
Data are presented as n (%) unless otherwise noted.
Abbreviations: IQR, interquartile range; ISR, in‐stent restenosis; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; LMCA, left main coronary artery; MACE, major adverse cardiac events; MI, myocardial infarction; PES, paclitaxel‐eluting stent; SES, sirolimus‐eluting stent; ST, stent thrombosis; TLR, target lesion revascularization.
During the follow‐up period, the composite cardiac death/MI was 3% in the SES group and 10% in the PES group. All‐cause deaths were 5. Two deaths were classified as noncardiac: 1 from hematologic disease (myelodysplastic syndrome) and 1 from septic shock. Three deaths were classified as cardiac. As cardiac deaths, 1 patient died from ventricular fibrillation 521 days after the procedure in the PES group. Two patients from the SES group died: 1 from acute ST as described above, and 1 from sudden cardiac death 67 days after PCI.
The target lesion was revascularized in 7 patients in the SES group and in 4 patients in the PES group. Nine of 11 TLRs occurred in the LCX, with 7 TLRs at the ostium of the LCX (Figure 1). The MACE rate was significantly lower in the SES group compared with the PES group. Survival analysis also showed that the MACE‐free survival rate was higher in the SES group than in the PES group with the log‐rank test (Figure 2). In multivariate analysis using a Cox proportional hazards model adjusting for age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy (single stent vs 2 stents) and DES type (SES vs PES), PES emerged as a single independent predictor of MACE (hazard ratio: 3.88, 95% confidence interval: 1.29–11.67, P = 0.016).
Figure 1.
Locations of target lesion revascularization. Abbreviations: d LMCA, distal left main coronary artery; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; LMCA, left main coronary artery; os LAD, ostium of LAD; os LCX, ostium of LCX; PES, paclitaxel‐eluting stent; p LAD, proximal LAD; p LCX, proximal LCX; SES, sirolimus‐eluting stent.
Figure 2.
Kaplan‐Meier curve for survival without MACE showed a significantly better result in the SES group compared with the PES group. Abbreviations: MACE, major adverse cardiac event; PES, paclitaxel‐eluting stent; RR, relative risk; SES, sirolimus‐eluting stent.
Angiographic Outcomes
All procedures were successfully performed without any occurrences of death, MI, or emergency bypass surgery during hospitalization, except for 1 case of acute ST as described above. Angiographic re‐evaluation was obtained in 99 (86%) patients at a median of 273 days after the procedure. There were no significant differences between SES and PES groups in terms of angiographic follow‐up rate and time to re‐evaluation. The incidence of angiographic restenosis was lower in the SES group than in the PES group, but that difference did not reach statistical significance (Table 2). Results of QCA analyses are described in Table 3. In the analysis of the LMCA to LAD, MLD tended to be larger in the PES group than in the SES group immediately after the procedure. However, late loss was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). Likewise, late loss at the LCX tended to be lower in the SES group than in the PES group.
Table 3.
QCA Data in the 2 Patient Groups
| SES (n = 94) | PES (n = 21) | P Value | |
|---|---|---|---|
| Pre‐PCI | |||
| LMCA to LAD | |||
| Lesion length, mean ± SD (mm) | 10.87 ± 6.51 | 12.28 ± 6.04 | 0.21 |
| Proximal RD, mean ± SD (mm) | 3.55 ± 0.84 | 3.50 ± 1.04 | 0.82 |
| Distal RD, mean ± SD (mm) | 2.68 ± 0.62 | 2.59 ± 0.61 | 0.18 |
| MLD, mean ± SD (mm) | 1.03 ± 0.52 | 1.06 ± 0.47 | 0.71 |
| LCX | |||
| Lesion length, mean ± SD (mm) | 3.35 ± 4.00 | 4.50 ± 4.31 | 0.20 |
| Distal RD, mean ± SD (mm) | 2.00 ± 1.41 | 2.44 ± 1.10 | 0.48 |
| MLD, mean ± SD (mm) | 1.61 ± 0.73 | 1.81 ± 0.96 | 0.50 |
| Post‐PCI | |||
| LMCA to LAD | |||
| MLD, mean ± SD (mm) | 2.91 ± 0.52 | 3.12 ± 0.64 | 0.24 |
| LCX | |||
| MLD, mean ± SD (mm) | 2.31 ± 0.65 | 2.36 ± 0.83 | 0.71 |
| Follow‐up | |||
| LMCA to LAD | |||
| MLD, mean ± SD (mm) | 2.61 ± 0.58 | 2.28 ± 0.50 | 0.06 |
| Late loss, mean ± SD (mm) | 0.28 ± 0.54 | 1.03 ± 0.45 | <0.001 |
| LCX | |||
| MLD, mean ± SD (mm) | 1.97 ± 0.74 | 1.70 ± 0.64 | 0.21 |
| Late loss, mean ± SD (mm) | 0.46 ± 0.68 | 0.81 ± 0.99 | 0.18 |
Abbreviations: LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; LMCA, left main coronary artery; MLD, minimal lumen diameter; PCI, percutaneous coronary intervention; PES, paclitaxel‐eluting stent; QCA, quantitative coronary angiography; RD, reference diameter; SD, standard deviation; SES, sirolimus‐eluting stent.
Discussion
Our primary finding was that implantation of SES was associated with a significantly lower rate of MACE during the follow‐up median duration of 712 days in uLMCA bifurcation lesions. The occurrence of cardiac death, MI, and TLR was also numerically lower in the SES group, but the differences did not reach statistical significance.
Comparison Between SES and PES in uLMCA Bifurcation Lesions
Although most clinical studies comparing SES and PES for non‐LMCA lesions have reported better angiographic results for SES than PES, the 2 largest randomized stent trials8, 9 and multiple smaller randomized controlled and registry studies have reported that PES and SES resulted in equivalent clinical outcomes.10, 11, 12, 13
There has been only 1 randomized controlled study comparing SES and PES in bifurcation lesions, which showed a lower rate of late loss, restenosis, and TLR in SES group.4 For the LMCA, the Intracoronary Stenting and Angiographic Results: Drug‐Eluting Stents for Unprotected Coronary Left Main Lesions (ISAR‐LEFT‐MAIN) trial14 and subanalysis of the Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization (MAIN‐COMPARE) registry15 showed that SES and PES were equally effective and safe in patients undergoing unprotected LMCA stenting. There have been no studies comparing the effectiveness of the 2 stent types in LMCA bifurcation lesions. We compared angiographic and clinical outcomes of 2 stents in the LMCA bifurcation lesion and found that SES had a significantly lower rate of late loss and MACE than PES.
It is well known that the late loss of SES is lower than that of PES.16, 17 The QCA analysis from the Treatment of De Novo Coronary Disease Using a Single Paclitaxel‐Eluting Stent (TAXUS IV) trial showed a good relation between TLR and late lumen loss, but only if late lumen loss was >0.65 mm.18 The impact of late lumen loss on revascularization rate may be less pronounced in LMCA as compared with other coronary lesions, possibly due to short lesion length and large artery diameter.15 The difference of clinical outcome of the 2 stents reached statistical significance mostly in the complex lesions with high late loss, such as bifurcation,4 in‐stent restenosis,10 and long lesions.19 Stents could be underexpanded and deformed during the ballooning or stenting of the LCX in the uLMCA bifurcation lesion. As a result, late losses were somewhat higher in this study compared with other reports, which may explain the different clinical outcomes between the 2 stents in present study.
The lower rate of cardiac death or MI in the SES group also contributed to the lower MACE rate in this stent group, although it was not statistically significant. Meta‐analysis of randomized controlled trials showed the lower rate of ST in SES groups, which was consistent with the result of this study.20
The Safety of DES Implantation for the Treatment of uLMCA Bifurcation Lesions
Because procedural complications or ST in the LMCA lesion are most likely to result in fatality, CABG remains the standard treatment modality. Recently, however, the stenting of LMCA was recommended as a class IIb recommendation by the American Heart Association and American College of Cardiology21 and as a class IIa recommendation by the European Society of Cardiology.22 Stenting should possibly be reserved for patients with isolated LMCA lesions with ostial or midshaft LMCA lesions, or patients with high surgical risk.21 The safety of stenting for uLMCA bifurcation remains highly controversial.
This study demonstrated a TLR rate of 10% and ST rate of 1% for 2 years, suggesting that DES implantation might be safe and effective treatment for uLMCA bifurcation lesions. The overall adverse event rates observed in our study are comparable with results observed in patients treated with SES or PES implantation in nonbifurcation LMCA lesions23 and results reported in an observational study, in which 2 strategies (stents vs CABG) were compared in patients with LMCA disease.24
Study Limitations
Our study had several limitations. Most important, this study is a registry of a single‐center experience and is limited by the small number of patients, despite the positive results. The findings of this study should be confirmed in a larger study. The unblinded evaluation of coronary angiography may affect the operator's decision of revascularization. The selection of stenting strategy (single stent vs 2 stents) and stent type (SES vs PES) was at the discretion of the operators. Although there were no significant differences in baseline clinical and angiographic characteristics between the 2 stent groups and multivariate analysis was performed to adjust confounding factors, we were unable to correct for unmeasured variables. Because only T‐stenting and small protrusion techniques (TAP‐stenting) were used for the 2‐stent techniques, the result cannot be generalized to other 2‐stent techniques.
Conclusion
Patients with uLMCA bifurcation lesions treated with SES using a provisional T‐stenting technique showed significantly lower rate of late loss and MACE than patients treated with PES. Further studies with multicenter randomized design and a larger patient group are needed to confirm this finding and also to verify the safety and efficacy of stenting in uLMCA bifurcation lesions.
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