- Email: [email protected]
Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention
Michael S. Lee a,b,c,d,⇑, Ehtisham Mahmud a,b,c,d, Lawrence Ang a,b,c,d, Gentian Lluri a,b,c,d, Richard K. Cheng a,b,c,d, Joseph Aragon a,b,c,d, Imad Sheiban a,b,c,d a
UCLA Medical Center, Los Angeles, CA ; b UCSD Medical Center, La Jolla, CA; c Santa Barbara Cottage Hospital, Santa Barbara, CA; d University of Turin – San Giovanni Battista ‘‘Molinette’’ Hospital, Turin
a–d
United States, Italy
Objectives: This retrospective study evaluated the outcomes of patients who underwent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with different types of drug-eluting stents (DES). Background: The standard of care for patients with ULMCA is coronary artery bypass surgery. However, current guidelines recommend PCI in clinical conditions where there is an increased risk of adverse surgical outcomes. Clinical outcomes of patients undergoing ULMCA PCI with different types of drug-eluting stents (DES) are unknown. Methods: Data from a multicenter international registry, which included 239 consecutive patients from four institutions who ULMCA PCI with DES, were collected. Results: There were 42 patients receiving paclitaxel-eluting stent (PES), 158 patients receiving sirolimus-eluting stent (SES), and 39 patients receiving everolimus-eluting stent (EES). There was no statistical difference in major adverse cardiovascular events, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis among PES, SES, and EES at 30 days and 1 year. Conclusions: There are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease. Ó 2012 King Saud University. Production and hosting by Elsevier B.V. All rights reserved. Keywords: Percutaneous coronary intervention, Drug-eluting stent, Left main disease
Introduction
T
he standard of care for patients with unprotected left main coronary artery (ULMCA) disease is coronary artery bypass grafting (CABG).
However, the 2011 American College of Cardiology Foundation/American Heart Association/ Society for Cardiovascular Angiography and Interventions percutaneous coronary intervention (PCI) guidelines state that ULMCA stenting can
Received 27 December 2012; revised 1 March 2013; accepted 2 March 2013. Available online 14 March 2013
⇑ Corresponding author. Address: UCLA Medical Center, Adult Cardiac Catheterization Laboratory, 10833 Le Conte Avenue, Rm A2-237 CHS, Los Angeles, CA 90095-1679, United States. E-mail address: [email protected] (M.S. Lee).
P.O. Box 2925 Riyadh – 11461KSA Tel: +966 1 2520088 ext 40151 Fax: +966 1 2520718 Email: [email protected] URL: www.sha.org.sa
1016–7315 Ó 2012 King Saud University. Production and hosting by Elsevier B.V. All rights reserved. Peer review under responsibility of King Saud University. URL: www.ksu.edu.sa http://dx.doi.org/10.1016/j.jsha.2013.03.001
Production and hosting by Elsevier
FULL LENGTH ARTICLE
Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention
76 FULL LENGTH ARTICLE
LEE ET AL PES VS. SES VS. EES IN LEFT MAIN PCI
J Saudi Heart Assoc 2013;25:75–78
Table 1. Baseline Characteristics. Age LVEF Male gender (%) Prior MI (%) Prior PCI (%) Hypertension (%) Dyslipidemia (%) Diabetes mellitus (%) IABP (%) GP IIb/IIIa (%) Bifurcation (%) Stent number Stent diameter (mm) Stent length (mm)
Total (N = 239)
PES (N = 42)
SES (N = 158)
EES (N = 39)
p value
68.4 ± 11.3 55.1 ± 9.1 72.4 34.2 34.9 88.0 79.4 29.7 13.4 15.5 72.8 1.6 ± 0.7 3.5 ± 0.4 17.7 ± 9.2
68.9 ± 12.3 56.1 ± 6.1 78.6 39.5 24.3 87.5 85.0 31.6 7.1 14.6 81.0 1.5 ± 0.6 3.6 ± 0.5 17.6 ± 9.9
67.8 ± 11.0 55.3 ± 8.0 73.4 37.1 36.7 93.5 78.6 27.0 13.3 16.4 73.4 1.7 ± 0.6 3.3 ± 0.3 16.7 ± 8.7
69.9 ± 11.4 52.8 ± 14.2 61.5 17.9 38.5 66.7 76.9 38.5 20.5 12.8 61.5 0.9 ± 0.2 3.9 ± 0.5 21.7 ± 9.8
0.55 0.21 0.20 0.06 0.33 <0.001 0.61 0.36 0.21 0.84 0.14 0.28 <0.001 0.009
Values are shown as mean ± SD or percentages where appropriate. EES = everolimus-eluting stent; IABP = intra-aortic balloon pump; GP = Glycoprotein; LVEF = left ventricular ejection fraction; MI = myocardial infarction; PCI = percutaneous coronary intervention; PES = paclitaxel-eluting stent; SES = sirolimus-eluting stent.
Table 2. 30-Days Outcomes. (%)
Total (N = 239)
PES (N = 42)
SES (N = 158)
EES (N = 39)
p value
MACE Death MI TLR Stent thrombosis
0.4 0.4 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0
0.6 0.6 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0
0.77 0.77 >0.9 >0.9 >0.9
EES = Everolimus-eluting stent; MACE = Major adverse cardiovascular events; MI = Myocardial infarction; PES = Paclitaxel-eluting stent; SES = Sirolimus-eluting stent; TLR = Target lesion revascularization.
be considered in certain patient populations [1,2]. Bare metal stents (BMS) are associated with high rates of restenosis and frequent rates of reintervention [3]. Drug-eluting stents (DES) decrease the rate of restenosis compared to BMS [4,5]. Data on ULMCA PCI with DES are based on studies with first-generation DES. There are only limited data with regard to second-generation DES for ULMCA disease. We report on the outcomes of ULMCA PCI with paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), and everolimus-eluting stents (EES).
Methods This was a multicenter, non-randomized retrospective study of 239 consecutive patients with ULMCA disease who received PES (Taxus, Boston Scientific Corporation, Natick, Massachusetts), SES (Cypher, Cordis, Johnson & Johnson Corporation, Miami, Florida), or EES (Xience, Abbot Vascular, Santa Clara, CA, also distributed as Promus; Boston Scientific), during the 2003–2011 period. Baseline demographic, procedural, angiographic, and clinical outcomes were collected and analyzed from UCLA Medical Center, UCSD Medical Center, University of Turin, and Santa
Barbara Cottage Hospital. The Institutional Review Board for each institution approved the use of the database review for the study. PCI was performed with standard techniques and all patients received at least 300 mg of aspirin and loading dose of clopidogrel 300– 600 mg. The choice of anticoagulation was at the discretion of the operator. All patients continued to take at least 80 mg of aspirin and 75 mg of clopidogrel for a minimum of 1 year after PCI. The type of stent was period dependent and operator dependent. The clinical data includes patients who underwent PCI of the LM with or without PCI of other vessels. The type of stenting technique for bifurcation lesions was left to the discretion of the operator. The primary endpoint was major adverse cardiovascular events (MACE), as defined by death, myocardial infarction (MI), and target lesion revascularization (TLR). Death was considered cardiac unless an unequivocal non-cardiac cause was identified. MI was diagnosed by the presence of ischemic signs or symptoms plus significant new Q waves on electrocardiogram or elevation of cardiac markers. TLR was defined as repeat revascularization with either CABG or PCI because of restenosis within the stent or in the
LEE ET AL PES VS. SES VS. EES IN LEFT MAIN PCI
77
Table 3. 1-Year outcomes. (%)
Total (N = 239)
PES (N = 42)
SES (N = 158)
EES (N = 39)
p value
MACE Death MI TLR (%) Stent thrombosis
13.0 2.9 3.8 7.5 1.3
14.3 7.1 4.8 2.4 4.8
13.9 1.9 3.2 9.5 0.6
7.7 2.6 5.1 5.1 0.0
0.56 0.20 0.79 0.25 0.08
EES = everolimus-eluting stent; MACE = major adverse cardiovascular events; MI = myocardial infarction; PES = paclitaxel-eluting stent; SES = sirolimus-eluting stent; TLR = target lesion revascularization.
5 mm proximal or distal segments. The Academic Research Consortium definition for definite or probable stent thrombosis was used [6]. Continuous variables are presented as mean ± SD. Categorical variables are presented as percentages and compared by ANOVA test. Statistical analysis was performed with SPSS version 20.0 (SPSS, INC., Chicago, Illinois). A value of p < 0.05 was considered statistically significant.
Results Of the 239 patients who underwent ULMCA PCI with DES, 42 patients received PES, 158 patients received SES, and 39 patients received EES. All three groups were well matched for baseline characteristics including age, sex, hyperlipidemia, and diabetes except hypertension, as patients receiving EES were less likely to have hypertension (Table 1). Patients receiving EES also had larger stent diameter and length. The clinical event rates were very low in the three groups at 30 days with only one death in the SES group (Table 2). At 1 year, there was no significant difference in MACE (PES 14.3% vs SES 13.9% vs EES 7.7%, p = 0.56), death (PES 7.1% vs SES 1.9% vs EES 2.6%, p = 0.20), myocardial infarction (PES 4.8% vs SES 3.2% vs EES 5.1%, p = 0.79), and target lesion revascularization (PES 2.4% vs SES 9.5% vs EES 5.1%, p = 0.25) (Table 3). There was a trend towards increased stent thrombosis with PES (4.8% vs SES 0.6% vs EES 0%, p = 0.08).
Discussion The main finding of this multicenter, international registry is that in patients treated with PCI for ULMCA disease, there were no significant differences in the primary outcomes among PES, SES, and EES. In addition, our study suggests that DES appear to be safe, associated with low rates of death, MI, and stent thrombosis. Initial studies comparing DES and BMS for ULMCA PCI showed less MACE with DES, mainly due to a reduction in TLR [7]. However, some stud-
ies suggest that the second-generation DES to be approved has demonstrated superiority over first-generation DES by reducing death or MI [8]. Several studies have evaluated the clinical outcomes of ULMCA PCI. In the SYNTAX trial, the rate of MACE or cerebrovascular events at 12 months in the ULMCA subset was similar in the CABG and PCI groups, 13.7% and 15.8%, respectively. Furthermore, the higher rate of repeat revascularization among patients with ULMCA disease in the PCI groups (11.8% vs 6.5%) was offset by a higher rate of stroke in the CABG group (2.7% vs 0.3%) [9]. In addition, a meta-analysis study comparing CABG with PCI with DES for ULMCA disease did not demonstrate a significant difference between the CABG and DES in the risk for death, MI, or stroke [10]. There is a paucity of data with second generation DES for ULMCA disease. It may be difficult to demonstrate a difference in clinical events because the large caliber of the ULMCA requires more neointimal hyperplasia to result in restenosis [11]. In the ISAR-LEFT-MAIN trial, the 1-year TLR rate was 7.8% and 6.5% with SES and PES, respectively [12]. In our study, the small number of patients with no required angiography could explain the 0% TLR rate. PES had similar results with EES in ULMCA PCI at 3 years [13]. In our study, the rates of death and stent thrombosis were numerically high with PES. One potential reason for this observation may be due to more distal bifurcation lesions (81% vs. SES 73% vs. EES 62%) that were treated with more stents (1.5% vs. SES 0.6% vs. EES 0.9%). However, the differences in these baseline characteristics were not statistically significant. Another reason may be the improved biocompatibility of the fluoropolymer in the EES, resulting in less hypersensitivity, inflammation of the endothelial layer, and stent thrombosis. The small number of patients receiving PES and EES is a limitation to draw firm conclusions on any differences among these stent types. This can explain the difference of stent thrombosis, which appears to be higher in patients receiving PES.
FULL LENGTH ARTICLE
J Saudi Heart Assoc 2013;25:75–78
78 FULL LENGTH ARTICLE
LEE ET AL PES VS. SES VS. EES IN LEFT MAIN PCI
Furthermore, the study was not powered to find any differences in the individual components of the composite outcome. Another limitation of this study is the nonrandomized design and the short duration of follow-up.
Conclusions There are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease. Large prospective randomized trials are needed to compare the long-term safety and efficacy of different types of DES.
References [1] Smith Jr SC, Feldman TE, Hirshfeld Jr JW, Jacobs AK, Kern MJ, King 3rd SB, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention-summary article: a report of the American college of Cardiology/ American heart Association task force on practice guidelines (ACC/AHA/SCAI writing committee to update the 2001 guidelines for percutaneous coronary intervention). J Am Coll Cardiol 2006;47:216–35. [2] Kushner FG, Hand M, Smith Jr SC, King 3rd SB, Anderson JL, Antman EM, et al. 2009 focused updates: ACC/AHA guidelines for the management of patients with STelevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update) a report of the American college of cardiology Foundation/ American heart association task force on practice guidelines. J Am Coll Cardiol 2009;54:2205–41. [3] Bravata DM, Gienger AL, McDonald KM, Sundaram V, Perez MV, Varghese R, et al. Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. Ann Intern Med 2007;147:703–16.
J Saudi Heart Assoc 2013;25:75–78
[4] Dibra A, Kastrati A, Alfonso F, Seyfarth M, Perez-Vizcayno MJ, Mehilli J, et al. Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol 2007;49:616–23. [5] Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network metaanalysis. Lancet 2007;370:937–48. [6] Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, Van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. [7] Malenka DJ, Kaplan AV, Lucas FL, Sharp SM, Skinner JS. Outcomes following coronary stenting in the era of baremetal vs the era of drug-eluting stents. Jama 2008;299:2868–76. [8] Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. Jama 2008;299:1903–13. [9] Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009;360:961–72. [10] Lee MS, Yang T, Dhoot J, Liao H. Meta-analysis of clinical studies comparing coronary artery bypass grafting with percutaneous coronary intervention and drug-eluting stents in patients with unprotected left main coronary artery narrowings. Am J Cardiol 2010;105:1070–5. [11] Mauri L, Orav EJ, O’Malley AJ, Moses JW, Leon MB, Holmes Jr DR, et al. Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents. Circulation 2005;111:321–7. [12] Mehilli J, Kastrati A, Byrne RA, Bruskina O, Iijima R, Schulz S, et al. Paclitaxel- vs sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol 2009;53:1760–8. [13] Hernandez J, Recalde AS, Garcia del Blanco B, Salvatella N, Camarero TG, Hernandez F, et al. TCT-45: The ESTROFA-LM Registry: Comparison of Taxus and Xience Stents in Left Main Coronary Artery Disease. Preliminary Results at 3 Years Follow-up. Transcatheter Cardiovascular Therapeutics. San Francisco (CA); 2011.
UCLA Medical Center, Los Angeles, CA ; b UCSD Medical Center, La Jolla, CA; c Santa Barbara Cottage Hospital, Santa Barbara, CA; d University of Turin – San Giovanni Battista ‘‘Molinette’’ Hospital, Turin
a–d
United States, Italy
Objectives: This retrospective study evaluated the outcomes of patients who underwent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with different types of drug-eluting stents (DES). Background: The standard of care for patients with ULMCA is coronary artery bypass surgery. However, current guidelines recommend PCI in clinical conditions where there is an increased risk of adverse surgical outcomes. Clinical outcomes of patients undergoing ULMCA PCI with different types of drug-eluting stents (DES) are unknown. Methods: Data from a multicenter international registry, which included 239 consecutive patients from four institutions who ULMCA PCI with DES, were collected. Results: There were 42 patients receiving paclitaxel-eluting stent (PES), 158 patients receiving sirolimus-eluting stent (SES), and 39 patients receiving everolimus-eluting stent (EES). There was no statistical difference in major adverse cardiovascular events, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis among PES, SES, and EES at 30 days and 1 year. Conclusions: There are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease. Ó 2012 King Saud University. Production and hosting by Elsevier B.V. All rights reserved. Keywords: Percutaneous coronary intervention, Drug-eluting stent, Left main disease
Introduction
T
he standard of care for patients with unprotected left main coronary artery (ULMCA) disease is coronary artery bypass grafting (CABG).
However, the 2011 American College of Cardiology Foundation/American Heart Association/ Society for Cardiovascular Angiography and Interventions percutaneous coronary intervention (PCI) guidelines state that ULMCA stenting can
Received 27 December 2012; revised 1 March 2013; accepted 2 March 2013. Available online 14 March 2013
⇑ Corresponding author. Address: UCLA Medical Center, Adult Cardiac Catheterization Laboratory, 10833 Le Conte Avenue, Rm A2-237 CHS, Los Angeles, CA 90095-1679, United States. E-mail address: [email protected] (M.S. Lee).
P.O. Box 2925 Riyadh – 11461KSA Tel: +966 1 2520088 ext 40151 Fax: +966 1 2520718 Email: [email protected] URL: www.sha.org.sa
1016–7315 Ó 2012 King Saud University. Production and hosting by Elsevier B.V. All rights reserved. Peer review under responsibility of King Saud University. URL: www.ksu.edu.sa http://dx.doi.org/10.1016/j.jsha.2013.03.001
Production and hosting by Elsevier
FULL LENGTH ARTICLE
Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention
76 FULL LENGTH ARTICLE
LEE ET AL PES VS. SES VS. EES IN LEFT MAIN PCI
J Saudi Heart Assoc 2013;25:75–78
Table 1. Baseline Characteristics. Age LVEF Male gender (%) Prior MI (%) Prior PCI (%) Hypertension (%) Dyslipidemia (%) Diabetes mellitus (%) IABP (%) GP IIb/IIIa (%) Bifurcation (%) Stent number Stent diameter (mm) Stent length (mm)
Total (N = 239)
PES (N = 42)
SES (N = 158)
EES (N = 39)
p value
68.4 ± 11.3 55.1 ± 9.1 72.4 34.2 34.9 88.0 79.4 29.7 13.4 15.5 72.8 1.6 ± 0.7 3.5 ± 0.4 17.7 ± 9.2
68.9 ± 12.3 56.1 ± 6.1 78.6 39.5 24.3 87.5 85.0 31.6 7.1 14.6 81.0 1.5 ± 0.6 3.6 ± 0.5 17.6 ± 9.9
67.8 ± 11.0 55.3 ± 8.0 73.4 37.1 36.7 93.5 78.6 27.0 13.3 16.4 73.4 1.7 ± 0.6 3.3 ± 0.3 16.7 ± 8.7
69.9 ± 11.4 52.8 ± 14.2 61.5 17.9 38.5 66.7 76.9 38.5 20.5 12.8 61.5 0.9 ± 0.2 3.9 ± 0.5 21.7 ± 9.8
0.55 0.21 0.20 0.06 0.33 <0.001 0.61 0.36 0.21 0.84 0.14 0.28 <0.001 0.009
Values are shown as mean ± SD or percentages where appropriate. EES = everolimus-eluting stent; IABP = intra-aortic balloon pump; GP = Glycoprotein; LVEF = left ventricular ejection fraction; MI = myocardial infarction; PCI = percutaneous coronary intervention; PES = paclitaxel-eluting stent; SES = sirolimus-eluting stent.
Table 2. 30-Days Outcomes. (%)
Total (N = 239)
PES (N = 42)
SES (N = 158)
EES (N = 39)
p value
MACE Death MI TLR Stent thrombosis
0.4 0.4 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0
0.6 0.6 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0
0.77 0.77 >0.9 >0.9 >0.9
EES = Everolimus-eluting stent; MACE = Major adverse cardiovascular events; MI = Myocardial infarction; PES = Paclitaxel-eluting stent; SES = Sirolimus-eluting stent; TLR = Target lesion revascularization.
be considered in certain patient populations [1,2]. Bare metal stents (BMS) are associated with high rates of restenosis and frequent rates of reintervention [3]. Drug-eluting stents (DES) decrease the rate of restenosis compared to BMS [4,5]. Data on ULMCA PCI with DES are based on studies with first-generation DES. There are only limited data with regard to second-generation DES for ULMCA disease. We report on the outcomes of ULMCA PCI with paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), and everolimus-eluting stents (EES).
Methods This was a multicenter, non-randomized retrospective study of 239 consecutive patients with ULMCA disease who received PES (Taxus, Boston Scientific Corporation, Natick, Massachusetts), SES (Cypher, Cordis, Johnson & Johnson Corporation, Miami, Florida), or EES (Xience, Abbot Vascular, Santa Clara, CA, also distributed as Promus; Boston Scientific), during the 2003–2011 period. Baseline demographic, procedural, angiographic, and clinical outcomes were collected and analyzed from UCLA Medical Center, UCSD Medical Center, University of Turin, and Santa
Barbara Cottage Hospital. The Institutional Review Board for each institution approved the use of the database review for the study. PCI was performed with standard techniques and all patients received at least 300 mg of aspirin and loading dose of clopidogrel 300– 600 mg. The choice of anticoagulation was at the discretion of the operator. All patients continued to take at least 80 mg of aspirin and 75 mg of clopidogrel for a minimum of 1 year after PCI. The type of stent was period dependent and operator dependent. The clinical data includes patients who underwent PCI of the LM with or without PCI of other vessels. The type of stenting technique for bifurcation lesions was left to the discretion of the operator. The primary endpoint was major adverse cardiovascular events (MACE), as defined by death, myocardial infarction (MI), and target lesion revascularization (TLR). Death was considered cardiac unless an unequivocal non-cardiac cause was identified. MI was diagnosed by the presence of ischemic signs or symptoms plus significant new Q waves on electrocardiogram or elevation of cardiac markers. TLR was defined as repeat revascularization with either CABG or PCI because of restenosis within the stent or in the
LEE ET AL PES VS. SES VS. EES IN LEFT MAIN PCI
77
Table 3. 1-Year outcomes. (%)
Total (N = 239)
PES (N = 42)
SES (N = 158)
EES (N = 39)
p value
MACE Death MI TLR (%) Stent thrombosis
13.0 2.9 3.8 7.5 1.3
14.3 7.1 4.8 2.4 4.8
13.9 1.9 3.2 9.5 0.6
7.7 2.6 5.1 5.1 0.0
0.56 0.20 0.79 0.25 0.08
EES = everolimus-eluting stent; MACE = major adverse cardiovascular events; MI = myocardial infarction; PES = paclitaxel-eluting stent; SES = sirolimus-eluting stent; TLR = target lesion revascularization.
5 mm proximal or distal segments. The Academic Research Consortium definition for definite or probable stent thrombosis was used [6]. Continuous variables are presented as mean ± SD. Categorical variables are presented as percentages and compared by ANOVA test. Statistical analysis was performed with SPSS version 20.0 (SPSS, INC., Chicago, Illinois). A value of p < 0.05 was considered statistically significant.
Results Of the 239 patients who underwent ULMCA PCI with DES, 42 patients received PES, 158 patients received SES, and 39 patients received EES. All three groups were well matched for baseline characteristics including age, sex, hyperlipidemia, and diabetes except hypertension, as patients receiving EES were less likely to have hypertension (Table 1). Patients receiving EES also had larger stent diameter and length. The clinical event rates were very low in the three groups at 30 days with only one death in the SES group (Table 2). At 1 year, there was no significant difference in MACE (PES 14.3% vs SES 13.9% vs EES 7.7%, p = 0.56), death (PES 7.1% vs SES 1.9% vs EES 2.6%, p = 0.20), myocardial infarction (PES 4.8% vs SES 3.2% vs EES 5.1%, p = 0.79), and target lesion revascularization (PES 2.4% vs SES 9.5% vs EES 5.1%, p = 0.25) (Table 3). There was a trend towards increased stent thrombosis with PES (4.8% vs SES 0.6% vs EES 0%, p = 0.08).
Discussion The main finding of this multicenter, international registry is that in patients treated with PCI for ULMCA disease, there were no significant differences in the primary outcomes among PES, SES, and EES. In addition, our study suggests that DES appear to be safe, associated with low rates of death, MI, and stent thrombosis. Initial studies comparing DES and BMS for ULMCA PCI showed less MACE with DES, mainly due to a reduction in TLR [7]. However, some stud-
ies suggest that the second-generation DES to be approved has demonstrated superiority over first-generation DES by reducing death or MI [8]. Several studies have evaluated the clinical outcomes of ULMCA PCI. In the SYNTAX trial, the rate of MACE or cerebrovascular events at 12 months in the ULMCA subset was similar in the CABG and PCI groups, 13.7% and 15.8%, respectively. Furthermore, the higher rate of repeat revascularization among patients with ULMCA disease in the PCI groups (11.8% vs 6.5%) was offset by a higher rate of stroke in the CABG group (2.7% vs 0.3%) [9]. In addition, a meta-analysis study comparing CABG with PCI with DES for ULMCA disease did not demonstrate a significant difference between the CABG and DES in the risk for death, MI, or stroke [10]. There is a paucity of data with second generation DES for ULMCA disease. It may be difficult to demonstrate a difference in clinical events because the large caliber of the ULMCA requires more neointimal hyperplasia to result in restenosis [11]. In the ISAR-LEFT-MAIN trial, the 1-year TLR rate was 7.8% and 6.5% with SES and PES, respectively [12]. In our study, the small number of patients with no required angiography could explain the 0% TLR rate. PES had similar results with EES in ULMCA PCI at 3 years [13]. In our study, the rates of death and stent thrombosis were numerically high with PES. One potential reason for this observation may be due to more distal bifurcation lesions (81% vs. SES 73% vs. EES 62%) that were treated with more stents (1.5% vs. SES 0.6% vs. EES 0.9%). However, the differences in these baseline characteristics were not statistically significant. Another reason may be the improved biocompatibility of the fluoropolymer in the EES, resulting in less hypersensitivity, inflammation of the endothelial layer, and stent thrombosis. The small number of patients receiving PES and EES is a limitation to draw firm conclusions on any differences among these stent types. This can explain the difference of stent thrombosis, which appears to be higher in patients receiving PES.
FULL LENGTH ARTICLE
J Saudi Heart Assoc 2013;25:75–78
78 FULL LENGTH ARTICLE
LEE ET AL PES VS. SES VS. EES IN LEFT MAIN PCI
Furthermore, the study was not powered to find any differences in the individual components of the composite outcome. Another limitation of this study is the nonrandomized design and the short duration of follow-up.
Conclusions There are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease. Large prospective randomized trials are needed to compare the long-term safety and efficacy of different types of DES.
References [1] Smith Jr SC, Feldman TE, Hirshfeld Jr JW, Jacobs AK, Kern MJ, King 3rd SB, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention-summary article: a report of the American college of Cardiology/ American heart Association task force on practice guidelines (ACC/AHA/SCAI writing committee to update the 2001 guidelines for percutaneous coronary intervention). J Am Coll Cardiol 2006;47:216–35. [2] Kushner FG, Hand M, Smith Jr SC, King 3rd SB, Anderson JL, Antman EM, et al. 2009 focused updates: ACC/AHA guidelines for the management of patients with STelevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update) a report of the American college of cardiology Foundation/ American heart association task force on practice guidelines. J Am Coll Cardiol 2009;54:2205–41. [3] Bravata DM, Gienger AL, McDonald KM, Sundaram V, Perez MV, Varghese R, et al. Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. Ann Intern Med 2007;147:703–16.
J Saudi Heart Assoc 2013;25:75–78
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