European Heart Journal Advance Access originally published online on June 9, 2009
European Heart Journal 2009 30(17):2087-2094; doi:10.1093/eurheartj/ehp223
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Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology
1 Istituto di Cardiologia, Policlinico S. Orsola, Università di Bologna, Policlinico S. Orsola, Via Massarenti 9, 40 138 Bologna, Italy
2 Dipartimento di Cardiologia, Ospedale Ferrarotto, Università di Catania, Catania, Italy
3 Divisione di Cardiologia, Università di Torino, Torino, Italy
4 Dipartimento Cardiovascolare, Ospedale Careggi, Università di Firenze, Firenze, Italy
5 Dipartimento di Cardiologia, Ospedale S. Maria delle Croci, Ravenna, Italy
6 Centro Emocolumbus, Milano, Italy
7 Dipartimento di Cardiologia, Ospedale degli Infermi, Rimini, Italy
8 Centro Cardiologico Monzino, Università di Milano, Milano, Italy
9 Dipartimento di Cardiologia, Clinica Mediterranea, Napoli, Italy
10 Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria, Parma, Italy
11 Dipartimento di Cardiologia, Azienda Ospedaliera, Mestre, Italy
12 Dipartimento di Scienze Cardiovascolari, Università di Padova, Padova, Italy
13 Cardiovascular Interventional Radiology Department, IRCCS Policlinico S. Donato, S, Donato Milanese, Italy
14 Dipartimento Cardio-Toracico, Ospedale Cisanello, Pisa, Italy
15 Dipartimento Cardiovascolare, Ospedale S. Donato, Arezzo, Italy
16 Dipartimento di Cardiologia, Hesperia Hospital, Modena, Italy
17 Istituto Fisiologia Clinica, CNR, Massa, Italy
18 Dipartimento Cardiovascolare, Ospedale Cervello, Palermo, Italy
19 Dipartimento di Malattie Cardiovascolari, Ospedale Civile, Legnano, Italy
Received 4 November 2008; revised 10 April 2009; accepted 6 May 2009; online publish-ahead-of-print 9 June 2009.
* Corresponding author. Tel: +39 051 349858, Fax: +39 051 344859, Email: tulliopalmerini{at}hotmail.com
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Abstract |
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Aims: In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES).
Methods and results: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38).
Conclusion: Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.
Key Words: Stents • Bifurcations • Left main
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Introduction |
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Although the introduction of drug-eluting stent (DES) has significantly improved the outcome of patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI),1–6 bifurcation lesions still represent a technical challenge.7 There is a general perception that the introduction of DES has not resolved major drawbacks associated with bifurcation lesions in the setting of ULMCA stenosis. This perception originated from the demonstration that patients with ostial or midshaft left main lesions have a very good mid-term clinical outcome8 and from the results of a single study in which bifurcation lesions turned out to be an independent predictor of major adverse cardiac events (MACE) during a 2 year follow-up after the implantation of DES.9 However, that study enrolled a limited number of patients and although the authors reported clinical outcomes at 2 year follow-up, few patients were available for the analysis at that time point. Bifurcation lesions present a wide spectrum of anatomical complexity which varies from simple lesions, which may be treated with a single stent, to complex lesions that require more complex techniques. To the best of our knowledge, there is no study with an adequate number of patients that has ever addressed how the technique used to treat bifurcation lesions impacts on clinical outcomes of patients with distal ULMCA stenosis compared with patients with ostial and midshaft lesions. As a consequence, it is not known whether the worse prognosis carried by bifurcation lesions depends on the anatomical location itself at the distal part of the left main or on the technical approach used, which may reflect the anatomical complexity. For these reasons, we compared 2 year clinical outcomes of patients with ostial and midshaft left main lesions with those of patients with bifurcation lesions in a large observational study promoted by the Gruppo Italiano Studi Emodinamici (GISE-SICI). To investigate whether the technique used to treat bifurcation lesions had a prognostic impact during a 2 year follow-up, we compared the clinical outcome of patients with ostial and midshaft lesions with that of both patients with bifurcation lesions treated with one stent and patients treated with two stents.
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Methods |
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The characteristics of the ‘GISE-SICI Survey on ULMCA stenosis’ have already been reported in detail.10 In the present study, we included only patients treated with DES and compared the 2 year clinical outcome of patients with ostial or midshaft lesions with that of patients with distal lesions. Clinical follow-up was performed through office visits, telephone interviews, or, when patients could not be contacted either way, by consulting civil registries of mortality. The study complies with the declaration of Helsinki and was approved by local Ethic Committees.
Definitions
The primary objective of the study was the incidence of MACE at 2 year follow-up. Major adverse cardiac events were defined as the occurrence of death, myocardial infarction (MI), or target lesion revascularization (TLR). In the computation of the composite clinical endpoint, events were counted once, whichever occurred first. Secondary objectives of the study were the occurrence of mortality, cardiac mortality, MI, or TLR defined as single endpoint. Distal ULMCA stenosis was defined as a >50% lesion involving both distal left main and the origin of at least one of the arteries stemming from the left main. In case of disease involving more than one segment, the lesion was classified according to the following hierarchical order: distal, ostial, and shaft. Other definitions of the study have already been published in detail.10
Statistical analysis
Data are presented as mean ± SD or median and range as appropriate. Continuous data were compared using the unpaired Student's t-test or Mann–Whitney rank-sum test, as appropriate. Categorical variables were compared by chi-square statistics or Fisher exact test as appropriate. Survival, survival free from cardiac death, MI-free survival, TLR-free survival, and MACE-free survival were analysed by the Kaplan–Meier method and differences between groups were analysed with the log-rank test. In the analysis of MI-free and TLR-free survival, death was regarded as a censoring event.
Independent predictors of 2 year MACE were analysed using Cox proportional hazards regression models. Two criteria were considered necessary for a variable to be entered in the model: a plausible association with the risk of MACE according to data provided by the literature1–5 and availability in the database 
85%. The proportional hazards assumptions of the model were assessed by plotting the scaled Schoenfeld residuals against time and the linearity assumption was assessed by plotting the Martingale residuals against continuous covariates. All patients were censored at 2 years. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored. Given the non-randomized nature of the study, to minimize any selection bias, a second multivariable analysis was performed using the propensity score as a covariate. All variables present in the database with an availability 85% were considered to calculate the propensity score. It was determined by use of a logistic regression model from which the probability of having an ostial or midshaft lesion rather than a bifurcation lesion was calculated for each patient. Model discrimination was assessed with the c-statistic and model calibration with the Hosmer–Lemeshow statistic. Each patient's propensity score was calculated from the sum of the values for all variables in the model multiplied by their respective logistic coefficient. A Cox regression analysis was then performed on the risk of 2 year MACE using the location of stenosis as covariates (ostial and midshaft lesions vs. bifurcation lesions) and the propensity score as a simple linear term.
To investigate whether the strategy of revascularization used to treat bifurcation lesions had an impact on the risk of MACE, we stratified patients according to the treatment used and performed Kaplan–Meier analyses of survival considering three groups of patients: patients with ostial or midshaft lesions, patients with bifurcation lesions treated with one stent, and patients with bifurcation lesions treated with two stents. Differences between groups were evaluated with the log-rank test. Then, to adjust for possible confounding factors, we performed a Cox proportional hazards regression model using the same variables as specified for the preceding test. In this analysis, patients with ostial or midshaft lesions were considered as the reference group. Statistical analyses were performed using SPSS 12.0 for Windows (SPSS Inc., Chicago, IL, USA) and STATA/SE 9.2 for Windows (Statacorp, LP, TX, USA). P-values < 0.05 were considered statistically significant.
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Results |
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From January 2002 to December 2006, 1111 patients with ULMCA stenosis were treated with DES in 19 high-volume interventional centres affiliated to GISE-SICI. Of these patients, 334 had an ostial or midshaft lesion (group 1) and 777 a bifurcation lesion (group 2). Enrolment and follow up data are shown in Figure 1. Clinical and procedural characteristics of patients are shown in Tables 1 and 2. We observed no significant differences with respect to main clinical variables between groups 1 and 2. In group 1, 222 patients had an ostial lesion and 112 a midshaft lesion. In group 2, 456 were treated with one stent (group 2A) and 317 with two stents (group 2B). In four patients, we did not have data on the technique used to treat bifurcations and in seven patients we did not have data on the type of DES implanted. Compared with patients in group 2B, patients in group 2A were older (median age 72 years vs. 70; P = 0.02), had more frequently diabetes (33 vs. 24%; P = 0.01), acute coronary syndromes (57 vs. 47%; P = 0.005), and higher Euroscore (5 vs. 4; P = 0.007). Patients with ostial and midshaft lesions received more frequently a paclitaxel-eluting stent (Taxus, Boston Scientific) than patients with bifurcation lesions. Not surprisingly, mean diameters of stent used in patients in group 1 were significantly greater than patients in group 2. Median follow-up was 545 days with interquartiles range of 300 and 974 days. The cumulative risk of MACE in the whole population was 20% at 1 year and 26% at 2 years.
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Two year clinical outcomes
The incidence of MACE during 2 year follow-up is shown in Figure 2A. Survival (95% confidence interval) free from MACE was 80% (75–85%) in group 1 vs. 72% (68–76%) in group 2 (P = 0.03). Event-free survivals in relation to single clinical outcomes are shown in Figure 3. Survival, survival free from cardiac death, survival free from MI, and survival free from TLR were 88% (83–92%), 92% (88–95%), 95% (93–98%), and 92% (88–95%) in group 1, respectively, and 91% (89–93%), 94% (92–95%), 95% (94–98%), and 81% (78–84%) in group 2 (for TLR-free survival P = 0.0003, for other comparisons P= ns). Two year MACE-free survival in patients with ostial and midshaft lesions and in those with bifurcation lesions stratified by the procedural technique is shown in Figure 2B. Patients with bifurcation lesions treated with two stents had the worst outcome, whereas patients with bifurcation lesions treated with one stent had a clinical outcome similar to patients with ostial and midshaft lesions. In particular, the incidence of 2 year MACE was 75% (70–80%) in patients in group 2A and 67% (61–73%) in those in group 2B (for group 1 vs. group 2A: P = 0.38; for group 1 vs. group 2B: P = 0.001; for group 2A vs. group 2B: P = 0.02). The difference in MACE was mainly driven by the difference in TLR (Figure 4). In fact survival, survival free from cardiac death, survival free from MI, and survival free from TLR were 90% (87–93%), 94% (90–96%), 96% (94–98%), and 87% (83–90%) in group 2A and 92% (88–95%), 96% (93–97%), 96% (93–98%), and 73% (67–78%) for group 2B, respectively (for TLR-free survival between group 2A and group 2B: P = 0.00001; for other comparisons: P = ns).
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Five patients had a definite stent thrombosis proven by angiography (one in group 1 and four in group 2). Of these five patients, four died and one had a MI. Four episodes of stent thrombosis occurred within 30 days and one between 30 days and 1 year. We did not observe cases of very late stent thrombosis (>1 year).
Independent predictors of major adverse cardiac events
The following variables were included in the Cox proportional hazards regression model: lesion location (ostial or midshaft lesions vs. bifurcation lesions), age, gender, diabetes, acute coronary syndrome, renal dysfunction, multivessel disease, left ventricular ejection fraction (LVEF), type of DES used [sirolimus-eluting stent (Cypher, Cordis) vs. Taxus], and the participating centre. To adjust for possible confounders associated with this last variable, we divided all participating centres into quartiles according to the number of cases provided by each centre. We considered the first one as the reference quartile, which included those centres which provided the lowest number of cases. We could not include chronic pulmonary disease and peripheral vascular disease in the multivariable model because their availability was <85%. After adjusting for possible confounders, bifurcation lesions remained an independent predictor of MACE. The adjusted hazards ratio of 2 year MACE in patients with bifurcation lesions vs. patients with ostial and midshaft lesions was 1.50 (95% confidence interval 1.05–2.12; P = 0.024). Other variables significantly associated with the risk of MACE were age, female gender, diabetes, renal dysfunction, and LVEF (Table 3).
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To minimize possible selection bias, a second multivariable analysis was performed adjusting for the propensity score (Table 3). The following variables were included in the model: age, gender, hypertension, diabetes, hypercholesterolaemia, smoking, acute coronary syndrome, renal dysfunction, Euroscore, LVEF, multivessel disease, use of glycoprotein IIb–IIIa inhibitors, type of DES used, and participating centre as specified earlier. The c-statistic of the regression model was 0.64 and the calibration 0.44. Bifurcation lesions remained a significant predictor of 2 year MACE also after adjusting for the propensity score. The propensity-adjusted hazards ratio of 2 year MACE in patients with bifurcation lesions vs. those with ostial and midshaft lesions was 1.45 (95% confidence interval 1.02–2.06; P = 0.038). We then performed a multivariable analysis considering three groups: patients with ostial and midshaft lesions, patients with bifurcation lesions treated with one stent, and patients with bifurcation lesions treated with two stents. We observed that there was a significant difference in the adjusted risk of MACE between patients with bifurcations treated with two stents and those with ostial and midshaft lesions, but not between patients with bifurcation lesions treated with one stent and those with ostial and midshaft lesions (Table 3). The adjusted hazards ratio of the risk of 2 year MACE in patients in group 2B vs. those in group 1 was 1.92 (95% confidence interval 1.30–2.84; P = 0.001). On the other hand, the adjusted hazards ratio of the risk of MACE in patients in group 2A vs. patients in group 1 was 1.19 (95% confidence interval 0.81–1.75; P = 0.38).
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Discussion |
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The main findings of our study are: (i) patents with bifurcations have a significantly higher incidence of MACE than patients with ostial and midshaft lesions; (ii) patients with bifurcations treated with two stents have a worse outcome than both patients with ostial and midshaft lesions and those with bifurcations treated with one stent; (iii) patients with bifurcations treated with one stent have similar outcomes to patients with ostial and midshaft lesions.
This study represents the current standard of PCI of ULMCA stenosis in a real world setting of high volume tertiary care interventional centres. Put in the perspective of the SYNTAX trial,11 we enrolled patients with a higher clinical risk profile. In fact patients enrolled in our study were older, had more frequently acute coronary syndromes and higher Euroscore. Nevertheless, the 20% cumulative risk of 1 year MACE observed in our study well compares with the 16% cumulative risk observed in the subgroup of patents with left main enrolled in the SYNTAX trial.11
The main focus of our study was to compare clinical outcomes of patients with distal left main with that of patients with ostial and midshaft lesions. Although it is generally believed that bifurcation lesions carry a worse prognosis than ostial and midshaft lesions in patients with ULMCA stenosis treated with PCI, this notion is based on few studies that enrolled a limited number of patients.12,13 In particular, there is only one study that has specifically addressed this issue in patients with left main stenosis treated with DES.9 In that study, patients were followed for a median follow-up of around 600 days, but at that time point only 22 patients with ostial and midshaft lesions and 31 with bifurcation lesions were available for evaluation of outcomes. In that study, the technique used to treat bifurcation lesions failed to impact on clinical outcomes, which were similar for 1-stent and 2-stent treatment. However, less than 50 patients per group were available at the beginning of the observational period.
Our study shows that the 2 year incidence of MACE was significantly higher in patients with bifurcation lesions compared with patients with ostial and midshaft lesions, thus confirming previous reports.9,12 However, when we stratified patients with bifurcation lesions according to the technique used, we observed that while patients treated with two stents had a significantly higher incidence of MACE compared with patients with ostial and midshaft lesions, patients with bifurcation lesions treated with one stent had a clinical outcome similar to that of patients with ostial and midshaft lesions.
These findings challenge the current notion that attributes to bifurcation lesions an adverse and independent prognostic value. In fact, although the 5% difference in the incidence of 2 year MACE between patients with ostial and midshaft lesions and those with bifurcation lesions treated with one stent may have not been statistically significant because of inadequate sample size to detect statistically significant differences, nevertheless the concept that attributes to patients with distal ULMCA stenosis a poor prognosis needs to be re-evaluated. It has been suggested that the presence of distal ULMCA stenosis should be regarded as a stratification variable to select the optimal strategy of revascularization between PCI and surgery.9 Our study suggests that not all bifurcations should be considered in the same way and that those patients with ULMCA stenosis who can be treated with one stent, irrespective of lesion location, have a favourable outcome that may challenge the results of surgery. On the other hand, patients with a more complex anatomy requiring two or more stents have an increased risk of MACE and therefore they may be at higher risk of adverse events if treated with PCI instead of surgery. These considerations should be taken into account when interpreting the results of the SYNTAX trial11 or of other studies comparing PCI with surgery.6,14–16 Unfortunately, we do not have data on the anatomical characteristics of bifurcation lesions and therefore we cannot infer about the reasons that drove towards the selection of a particular technique. Nevertheless, the main message of our study is that there is a considerable proportion of patients with distal left main disease who can be treated with one stent and whose outcome is not significantly different from that of patients with ostial and midshaft lesions.
In our study, the cumulative risk of 2 year MACE in patients with ostial and midshaft lesions was 20%. This rate of events is higher than that reported in the work by Chieffo et al.8 In that study, the incidence of 2 year MACE was around 6%. However, we must emphasize that patients enrolled in our study presented a higher clinical risk profile than patients enrolled in the aforementioned study. In fact, patients enrolled in our study were significantly older (mean age 70 vs. 62 years), had a lower LVEF (mean LVEF 51 vs. 55%), had a higher Euroscore (median Euroscore 5 with a range of 0–15 vs. 4 with a range 1–7), and had more frequently acute coronary syndromes (59 vs. 43%) and diabetes mellitus (31 vs. 19%). Therefore, the worse outcome observed in our study may depend on the different baseline clinical characteristics of the two populations. Whether other procedural variables such as the use of intravascular ultrasound, which was performed in almost 50% of patients in the study by Chieffo et al., played a role in determining the different clinical outcome deserves further investigations.8
Limitations
This is an observational study. Although several statistical adjustments were performed, we cannot exclude the presence of unmeasured selection bias. We do not have data on the angiographic characteristics of bifurcation lesions. Therefore, we could not evaluate the relation between the anatomy of bifurcations and the choice of the technique used to treat the bifurcation. An angiographic analysis with quantitative coronary angiography or using the Medina classification would have helped to clarify the reasons of choosing one bifurcation technique rather than another.
The classification of events was made at participating sites without a central adjudication committee. Thus, there may be some other bias entering the study which is not possible to control. We do not have data on stent thrombosis according to the Academic Research Consortium definition.
Conflict of interest: none declared.
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