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The efficacy and safety of drug-eluting stents in patients with acute myocardial infarction: Results from Korea Acute Myocardial Infarction (KAMIR)
International Journal of Cardiology 163 (2013) 1–4
Contents lists available at SciVerse ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Editorial
The efficacy and safety of drug-eluting stents in patients with acute myocardial infarction: Results from Korea Acute Myocardial Infarction (KAMIR) Young Joon Hong, Myung Ho Jeong ⁎, Youngkeun Ahn, Jung Chaee Kang Korea Cardiovascular Stent Research Institute, Heart Center of Chonnam National University Hospital, Gwangju, Republic of Korea
a r t i c l e
i n f o
Article history: Received 26 December 2011 Received in revised form 29 January 2012 Accepted 5 February 2012 Available online 25 February 2012 Keywords: Acute myocardial infarction Drug-eluting stent
a b s t r a c t There are controversies about the use of drug-eluting stent (DES) in patients with acute myocardial infarction (AMI). Recent trials of DES in patients with AMI have shown the relative safety of DES. However, some physicians hesitate to use DES in AMI patients because of increased risk of stent thrombosis and death. We summarized in this article about the efficacy and safety of DES in AMI patients who were enrolled in Korea Acute Myocardial Infarction Registry (KAMIR). © 2012 Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. KAMIR
Drug-eluting stent (DES) can cause delayed arterial healing characterized by incomplete endothelialization and persistent fibrin deposition compared with bare-metal stent (BMS) [1,2]. Delayed arterial healing and late acquired stent malapposition are the important risk factors to cause stent thrombosis especially after DES implantation. Thrombus, along with an underlying necrotic core, is a frequent finding in culprit lesions in patients with acute myocardial infarction (AMI) [3]. Nakajawa et al. [4] reported the different pathological vascular responses after DES implantation between patients with AMI and those with stable angina. They concluded that vessel healing at the culprit site in AMI patients treated with DES is substantially delayed compared with the culprit site in patients receiving DES for stable angina, emphasizing the importance of underlying plaque morphology in the arterial response to DES. Even though there is a more increased risk of thrombus formation after DES implantation than BMS implantation in AMI patients, recent several studies have shown the relative safety of DES in AMI patients [5–7]. However, long-term data about the efficacy and safety of DES in AMI patients are still limited. Therefore, we summarized about the efficacy and safety of DES in AMI patients who were enrolled in Korea Acute Myocardial Infarction Registry (KAMIR).
The KAMIR is a Korean prospective multicenter online registry designed to reflect the “real-world” practice in Asian patients presenting with AMI [including both ST segment elevation MI (STEMI) and non-ST segment elevation MI (NSTEMI)] with support from the Korean Circulation Society since November 2005 [8,9]. Online registry of AMI (at www.kamir.or.kr) has been performed at 52 university or community hospitals that are high-volume centers with facilities for primary percutaneous coronary intervention (PCI) and onsite cardiac surgery. From November 2005 to January 2008, the registry enrolled 14,870 consecutive patients. PCI was performed in 11,441 patients (10,457 with stent implantation and 984 with balloon angioplasty or thrombectomy). Among 10,457 patients who underwent stent implantation, DES was used in 9553 patients and BMS was used in 903 patients (Fig. 1). The success of the KAMIR led to the establishment of the Korea Working Group on Myocardial Infarction (KorMI), a subsequent study of the KAMIR, which is an ongoing open-ended registry that captures data on the complete spectrum of patients with AMI including long-term clinical follow-up. The study protocol was approved by the ethics committee at each participating institution. Data were registered and submitted from individual institutions via password-protected Internet-based electronic case report forms. 3. Comparison of the efficacy and safety of DES vs. BMS in AMI patients: experience from KAMIR
⁎ Corresponding author at: Professor, principal investigator of Korea Acute Myocardial Infarction Registry (KAMIR), director of Heart Research Center nominated by Korea Ministry of Health and Welfare, director of Korea Cardiovascular Stent Research Institute, Chonnam National University Hospital, 671 Jaebongro, Dong-gu, Gwangju 501757, Republic of Korea. Tel.: + 82 62 220 6243; fax: 82 62 228 7174. E-mail address: [email protected] (M.H. Jeong). 0167-5273/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2012.02.003
Recent studies indicate that early invasive strategy for high-risk patients with NSTEMI yields improved outcomes compared with early conservative strategy [10,11]. The 2009 focused update of the American College of Cardiology/American Heart Association guidelines for the management of patients with STEMI states that it is
2
Editorial
Fig. 1. Study population diagram. AMI: acute myocardial infarction, KAMIR: Korea Acute Myocardial Infarction Registry, PCI: percutaneous coronary intervention, DES: drug-eluting stent, BMS: bare-metal stent.
reasonable to use DES as an alternative to a BMS for primary PCI in STEMI [12]. According to the KAMIR data, early invasive strategy was applied in 48.5% of NSTEMI patients, and primary PCI was done in 75% of STEMI patients, and the DES penetration rate was 91% in both patients with STEMI and NSTEMI. Several studies have reported the efficacy and safety of DESs over BMSs in patients with AMI [13–15]. Pasceri et al. [13] performed a meta-analysis of 7 randomized trials comparing the effects of DES and BMS in AMI and they reported that DESs significantly reduced need for revascularization in patients with AMI, without changes in incidence of death or MI and the use of DES was not associated with an increased risk of stent thrombosis at 1-year follow-up. Kastrati et al. [14] performed a meta-analysis of eight randomized trials comparing DESs [sirolimus-eluting stent (SES, Cypher® stent) or paclitaxeleluting stent (PES, Taxus® stent)] with BMSs in 2786 patients with STEMI and they reported that DESs significantly reduced the risk of reintervention, and the overall risk of stent thrombosis, death, and recurrent MI was not significantly different for patients receiving DESs vs. BMSs. Recently, Stone et al. [15] reported that patients who received PES had significantly lower 12-month rates of ischemiadriven target-lesion revascularization (TLR) and target-vessel revascularization (TVR) and had similar 12-month rates of death and stent thrombosis as compared with those who received BMS in patients with STEMI who are undergoing primary PCI in HORIZONSAMI Trial. Several studies regarding the efficacy and safety of DES vs. BMS in patients with AMI using KAMIR data have been performed. Sim et al. [16] compared clinical outcomes of DES vs. BMS in large coronary arteries (≥3.5 mm) in 985 AMI patients using KAMIR data. In-hospital outcome was similar between DES group (n = 841) and BMS group
(n = 144). At 6 months, death/MI rate was not different between both groups, however, DES group had a significantly lower rate of TLR (1.7% vs. 5.6%, p = 0.021), TVR (2.2% vs. 5.6%, p = 0.032), and total major adverse cardiac events (MACE) (3.4% vs. 11.9%, p = 0.025) compared with BMS group. At 12 months, the rates of TLR and TVR remained lower in the DES group compared with the BMS group (2.5% vs. 5.9%, p = 0.032 and 5.9% vs. 3.1%, p = 0.041), but the rates of death/MI and total MACE were not statistically different between both groups. So, they concluded that the use of DES in large vessels in the setting of AMI is associated with a lower need for repeat revascularization compared to BMS without compromising the overall safety over the course of one-year follow-up. Bae et al. [17] evaluated whether DES is preferable for the treatment of AMI with renal insufficiency and elucidated the impact of diabetes mellitus on outcomes of each stent using KAMIR data in 2175 AMI patients with renal insufficiency (glomerular filtration rate b60 ml/min) comprising 208 patients with BMS and 1967 DES implantation. In the overall population, the MACE rate at 1 year was significantly higher in the BMS group than in that of the DES (44% vs. 26%, p b 0.05), which was mainly due to the higher number of cardiac death rather than repeat intervention. In the diabetic group with DES implantation, the MACE rate was higher compared with the DES group without diabetes mellitus, mainly due to repeat intervention (5% vs. 8%, p b 0.05). So, they concluded that DES implantation exhibits a favorable 1year clinical outcome than BMS implantation, and subgroup analysis for diabetic subjects showed worse outcomes in the diabetic group with implanted DES in AMI patients with renal insufficiency. The above KAMIR studies comparing DES and BMS have shown the similar results compared with previous clinical trials [13–15] in patients with AMI. The inclusion criteria, used stents, and endpoint in above KAMIR studies are summarized in Table 1. 4. Comparison of the efficacy and safety of each DES in AMI patients: experience from KAMIR Recently, several studies have shown the efficacy and safety of each DES in patients with AMI [18–20]. Choi et al. [18] reported that there was a trend toward a higher incidence of binary restenosis at 6-months in the PES group compared with the SES or ZES groups, however, clinical outcomes, including mortality, MI, repeat PCI and overall MACEs, were not different among the 3 groups in patients with AMI. Lee et al. [19] reported that restenosis rate at 8-months was lowest in the SES group compared to the ZES and PES groups, however incidence of death, recurrent MI, or ischemia-driven TVR did not differ among the 3 groups in patients with STEMI. Kang et al. [20] reported that the use of ZES in patients with STEMI undergoing primary PCI, showed similar rates of MACE, cardiac death and recurrent MI at 12 and 18 months compared with SES and PES, and
Table 1 Inclusion criteria and used stents, and endpoint in cited KAMIR studies. Study
Inclusion criteria
Sim et al. [16]
Lee et al. [21]
985 AMI patients (744 STEMI and 241 NSTEMI) with DES (n = 841) vs. BMS (n = 144) large coronary arteries (≥3.5 mm) 2175 AMI patients (1570 STEMI and 605 NSTEMI) with DES (n = 1967) vs. BMS (n = 208) renal insufficiency (glomerular filtration rate b 60 ml/min) 1541 AMI patients (1034 STEMI and 507 NSTEMI) SES (n = 834) vs. PES (n = 707)
Cho et al. [22]
4416 STEMI patients
Bae et al. [17]
Kim et al. [23] 873 STEMI patients Lee et al. [24]
1768 STEMI patients with metabolic syndrome
Used stents
Endpoint
Composite of death, MI, and TLR or TVR at 12-month Composite of mortality, nonfatal MI, and TLR at 12-month Composite of death, MI, TLR, and CABG at 1- and 6-month PES (n = 1882) vs. SES (n = 2534) Composite of mortality, nonfatal MI, and TLR at 12-month ZES (n = 306) vs. SES (n = 567) Composite of all causes of death, MI, and TLR at 12-month PES (n = 634) vs. SES (n = 906) vs. ZES (n = 228) Composite of all causes of death, MI, and TLR at 12-month
KAMIR: Korea Acute Myocardial Infarction Registry, AMI: acute myocardial infarction, STEMI: ST segment elevation myocardial infarction, NSEMI: non-ST segment elevation myocardial infarction, DES: drug-eluting stent, BMS: bare-metal stent, SES: sirolimus-eluting stent, PES: paclitaxel-eluting stent, ZES: zotarolimus-eluting stent, TLR: target-lesion revascularization, TVR: target-vessel revascularization, CABG: coronary artery bypass graft.
Editorial
there was a trend towards a higher rate of TLR with ZES or PES compared to SES. Several studies regarding the comparison of efficacy and safety of each DES in patients with AMI using KAMIR data have been performed. Lee et al. [21] investigated the incidence of MACE and stent thrombosis in 1541 AMI patients who had been implanted with either SES (n = 834) or PES (n = 707) during a 6-month clinical follow-up using KAMIR data. MACE rate was not significantly different between the SES and PES groups at both 1 month (0.8% vs. 1.0%, p = 0.793) and 6 months (3.8% vs. 5.2%, p = 0.177). There were 17 cases of stent thrombosis, but the incidence of stent thrombosis was not significantly different between the 2 groups (1.1% vs. 1.1%, p = 1.000). So, they concluded that MACE and stent thrombosis rates did not differ between the 2 types of DES identified in KAMIR. Cho et al. [22] evaluated which DES is preferable for the treatment of STEMI and elucidated the impact of diabetes mellitus on the outcome of each DES in 4416 STEMI patients (26% with diabetes) treated with PES or SES. In the overall population, the MACE rate at 1 year was significantly higher in the PES than the SES group (11.6% vs. 8.6%, p = 0.014), which was mainly due to increased TLR (3.7% vs. 1.8%, p b 0.001). In the diabetic subgroup, however, the MACE rate was not significantly different between PES and SES groups (14.5% vs. 12.3%, p = 0.217), in contrast to the non-diabetic subgroup, where PES was inferior to SES as in the overall population. So, they concluded that the PES was inferior to the SES in the overall population, with regard to the occurrence of MACE and TLR, however, subgroup analysis for diabetic subjects showed no differences in clinical outcomes between PES and SES. Kim et al. [23] compared the clinical outcomes of zotarolimuseluting stent (ZES, Endeavor® stent) and SES in 873 patients with STEMI (306 patients in the ZES group and 567 patients in the SES group) who were enrolled in a KAMIR. During 1 year of follow-up, MACE including death, MI, and TLR occurred in 140 patients (16.0%). The SES group had a significantly lower incidence of MACE (hazard ratio [HR] 1.52, 95% confidence interval [CI] 1.07 to 2.16, p = 0.02), TLR (HR 2.16, 95% CI 1.01 to 4.59, p = 0.046), and TVR (HR 2.24, 95% CI 1.18 to 4.24, p = 0.013) compared with the ZES group, however, no significant differences were found in death or MI between both groups (HR 1.37, 95% CI 0.91 to 2.05, p = 0.129). So, they concluded that ZES implantation was associated with an increased incidence of MACE, mainly driven by increase of TLR and TVR, but was not associated with increase of safety endpoint including death or MI compared with SES implantation. Lee et al. [24] compared the efficacy and safety of PES, SES, and ZES in 1768 metabolic syndrome (MS) patients with STEMI who underwent primary PCI using DES [PES group (n = 634) vs. SES group (n = 906) vs. ZES group (n = 228)]. At 12 months, the cumulative incidence of primary endpoint (all cause death, re-MI, TLR) was not different significantly in the PES, SES, and ZES groups (10.9%, 9.1%, and 11.0%, respectively, p = 0.086). Incidences of death, recurrent MI, TLR, and stent thrombosis did not differ among the 3 groups. So, they concluded that implantation of SES, PES, and ZES in MS patients with STEMI undergoing primary PCI provided comparable clinical outcomes in patients enrolled in KAMIR. The above KAMIR studies comparing each DES have shown similar results compared with previous clinical trials [18–20] in patients with AMI. The inclusion criteria, used stents, and endpoint in the above KAMIR studies are summarized in Table 1. 5. Conclusions According to the KAMIR data, DES penetration rate is more than 90%. As compared with BMS, the event rates are lower after DES implantation in patients with AMI. There were no significant differences in the incidences of overall MACE according to the DES types except for the lower need for repeat revascularization in SES compared with PES or ZES. According to KAMIR data, DES can be used safely and effectively to treat AMI patients by reducing the need for repeat
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revascularizations and by not increasing the risks of mortality, MI, and stent thrombosis. Disclosures There are no potential conflicts to declare. Acknowledgment KAMIR was carried out with the support of the Korean Circulation Society in the memorandum of the 50th anniversary of the Korean Circulation Society. This study was supported by a grant of the Korea Healthcare technology R&D Project, Ministry for Health, Welfare and Family Affairs (A084869), Republic of Korea. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. References [1] Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193–202. [2] Finn AV, Nakazawa G, Joner M, et al. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol 2007;27:1500–10. [3] Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol 2000;20:1262–75. [4] Nakazawa G, Finn AV, Joner M, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation 2008;118:1138–45. [5] Menichelli M, Parma A, Pucci E, et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol 2007;49:1924–30. [6] Spaulding C, Henry P, Teiger E, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 2006;355:1093–104. [7] Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 2006;355: 1105–13. [8] Sim DS, Jeong MH, Kang JC. Current management of acute myocardial infarction: experience from the Korea Acute Myocardial Infarction Registry. J Cardiol 2010;56:1–7. [9] Chen KY, Rha SW, Li YJ, et al. Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Circulation 2009;119:3207–14. [10] Ohman EM, Roe MT, Smith Jr SC, et al. Care of non-ST-segment elevation patients: insights from the CRUSADE national quality improvement initiative. Am Heart J 2004;148:34–9. [11] Gulati M, Patel S, Jaffe AS, Joseph AJ, Calvin Jr JE. Impact of contemporary guideline compliance on risk stratification models for acute coronary syndromes in The Registry of Acute Coronary Syndromes. Am J Cardiol 2004;94:873–8. [12] Kushner FG, Hand M, Smith Jr SC, et al. 2009 focused updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation 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. Circulation 2009;120:2271–306. [13] Pasceri V, Patti G, Speciale G, Pristipino C, Richichi G, Di Sciascio G. Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. Am Heart J 2007;153:749–54. [14] Kastrati A, Dibra A, Spaulding C, et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J 2007;28:2706–13. [15] Stone GW, Lansky AJ, Pocock SJ, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med 2009;360:1946–59. [16] Sim DS, Jeong MH, Ahn Y, et al. Effectiveness of drug-eluting stents versus bare-metal stents in large coronary arteries in patients with acute myocardial infarction. J Korean Med Sci 2011;26:521–7. [17] Bae EH, Lim SY, Choi YH, et al. Drug-eluting vs. bare-metal stents for treatment of acute myocardial infarction with renal insufficiency. Circ J 2011;75:2798–804. [18] Choi CU, Rha SW, Chen KY, et al. Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimuseluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention. Circ J 2009;73:2229–35. [19] Lee CW, Park DW, Lee SH, et al. Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with STelevation myocardial infarction. Am J Cardiol 2009;104:1370–6. [20] Kang WC, Ahn T, Lee K, et al. Comparison of zotarolimus-eluting stents versus sirolimus-eluting stents versus paclitaxel-eluting stents for primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: results from the Korean Multicentre Endeavor (KOMER) acute myocardial infarction (AMI) trial. EuroIntervention 2011;7:936–43.
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[21] Lee SR, Jeong MH, Ahn YK, et al. Clinical safety of drug-eluting stents in the Korea acute myocardial infarction registry. Circ J 2008;72:392–8. [22] Cho Y, Yang HM, Park KW, et al. Paclitaxel- versus sirolimus-eluting stents for treatment of ST-segment elevation myocardial infarction: with analyses for diabetic and nondiabetic subpopulation. JACC Cardiovasc Interv 2010;3: 498–506.
[23] Kim HK, Jeong MH, Ahn YK, et al. Comparison of outcomes between zotarolimusand sirolimus-eluting stents in patients with ST-segment elevation acute myocardial infarction. Am J Cardiol 2010;105:813–8. [24] Lee MG, Jeong MH, Ahn Y, et al. Comparison of paclitaxel-, sirolimus-, and zotarolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction and metabolic syndrome. Circ J 2011;75:2120–7.
Contents lists available at SciVerse ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Editorial
The efficacy and safety of drug-eluting stents in patients with acute myocardial infarction: Results from Korea Acute Myocardial Infarction (KAMIR) Young Joon Hong, Myung Ho Jeong ⁎, Youngkeun Ahn, Jung Chaee Kang Korea Cardiovascular Stent Research Institute, Heart Center of Chonnam National University Hospital, Gwangju, Republic of Korea
a r t i c l e
i n f o
Article history: Received 26 December 2011 Received in revised form 29 January 2012 Accepted 5 February 2012 Available online 25 February 2012 Keywords: Acute myocardial infarction Drug-eluting stent
a b s t r a c t There are controversies about the use of drug-eluting stent (DES) in patients with acute myocardial infarction (AMI). Recent trials of DES in patients with AMI have shown the relative safety of DES. However, some physicians hesitate to use DES in AMI patients because of increased risk of stent thrombosis and death. We summarized in this article about the efficacy and safety of DES in AMI patients who were enrolled in Korea Acute Myocardial Infarction Registry (KAMIR). © 2012 Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. KAMIR
Drug-eluting stent (DES) can cause delayed arterial healing characterized by incomplete endothelialization and persistent fibrin deposition compared with bare-metal stent (BMS) [1,2]. Delayed arterial healing and late acquired stent malapposition are the important risk factors to cause stent thrombosis especially after DES implantation. Thrombus, along with an underlying necrotic core, is a frequent finding in culprit lesions in patients with acute myocardial infarction (AMI) [3]. Nakajawa et al. [4] reported the different pathological vascular responses after DES implantation between patients with AMI and those with stable angina. They concluded that vessel healing at the culprit site in AMI patients treated with DES is substantially delayed compared with the culprit site in patients receiving DES for stable angina, emphasizing the importance of underlying plaque morphology in the arterial response to DES. Even though there is a more increased risk of thrombus formation after DES implantation than BMS implantation in AMI patients, recent several studies have shown the relative safety of DES in AMI patients [5–7]. However, long-term data about the efficacy and safety of DES in AMI patients are still limited. Therefore, we summarized about the efficacy and safety of DES in AMI patients who were enrolled in Korea Acute Myocardial Infarction Registry (KAMIR).
The KAMIR is a Korean prospective multicenter online registry designed to reflect the “real-world” practice in Asian patients presenting with AMI [including both ST segment elevation MI (STEMI) and non-ST segment elevation MI (NSTEMI)] with support from the Korean Circulation Society since November 2005 [8,9]. Online registry of AMI (at www.kamir.or.kr) has been performed at 52 university or community hospitals that are high-volume centers with facilities for primary percutaneous coronary intervention (PCI) and onsite cardiac surgery. From November 2005 to January 2008, the registry enrolled 14,870 consecutive patients. PCI was performed in 11,441 patients (10,457 with stent implantation and 984 with balloon angioplasty or thrombectomy). Among 10,457 patients who underwent stent implantation, DES was used in 9553 patients and BMS was used in 903 patients (Fig. 1). The success of the KAMIR led to the establishment of the Korea Working Group on Myocardial Infarction (KorMI), a subsequent study of the KAMIR, which is an ongoing open-ended registry that captures data on the complete spectrum of patients with AMI including long-term clinical follow-up. The study protocol was approved by the ethics committee at each participating institution. Data were registered and submitted from individual institutions via password-protected Internet-based electronic case report forms. 3. Comparison of the efficacy and safety of DES vs. BMS in AMI patients: experience from KAMIR
⁎ Corresponding author at: Professor, principal investigator of Korea Acute Myocardial Infarction Registry (KAMIR), director of Heart Research Center nominated by Korea Ministry of Health and Welfare, director of Korea Cardiovascular Stent Research Institute, Chonnam National University Hospital, 671 Jaebongro, Dong-gu, Gwangju 501757, Republic of Korea. Tel.: + 82 62 220 6243; fax: 82 62 228 7174. E-mail address: [email protected] (M.H. Jeong). 0167-5273/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2012.02.003
Recent studies indicate that early invasive strategy for high-risk patients with NSTEMI yields improved outcomes compared with early conservative strategy [10,11]. The 2009 focused update of the American College of Cardiology/American Heart Association guidelines for the management of patients with STEMI states that it is
2
Editorial
Fig. 1. Study population diagram. AMI: acute myocardial infarction, KAMIR: Korea Acute Myocardial Infarction Registry, PCI: percutaneous coronary intervention, DES: drug-eluting stent, BMS: bare-metal stent.
reasonable to use DES as an alternative to a BMS for primary PCI in STEMI [12]. According to the KAMIR data, early invasive strategy was applied in 48.5% of NSTEMI patients, and primary PCI was done in 75% of STEMI patients, and the DES penetration rate was 91% in both patients with STEMI and NSTEMI. Several studies have reported the efficacy and safety of DESs over BMSs in patients with AMI [13–15]. Pasceri et al. [13] performed a meta-analysis of 7 randomized trials comparing the effects of DES and BMS in AMI and they reported that DESs significantly reduced need for revascularization in patients with AMI, without changes in incidence of death or MI and the use of DES was not associated with an increased risk of stent thrombosis at 1-year follow-up. Kastrati et al. [14] performed a meta-analysis of eight randomized trials comparing DESs [sirolimus-eluting stent (SES, Cypher® stent) or paclitaxeleluting stent (PES, Taxus® stent)] with BMSs in 2786 patients with STEMI and they reported that DESs significantly reduced the risk of reintervention, and the overall risk of stent thrombosis, death, and recurrent MI was not significantly different for patients receiving DESs vs. BMSs. Recently, Stone et al. [15] reported that patients who received PES had significantly lower 12-month rates of ischemiadriven target-lesion revascularization (TLR) and target-vessel revascularization (TVR) and had similar 12-month rates of death and stent thrombosis as compared with those who received BMS in patients with STEMI who are undergoing primary PCI in HORIZONSAMI Trial. Several studies regarding the efficacy and safety of DES vs. BMS in patients with AMI using KAMIR data have been performed. Sim et al. [16] compared clinical outcomes of DES vs. BMS in large coronary arteries (≥3.5 mm) in 985 AMI patients using KAMIR data. In-hospital outcome was similar between DES group (n = 841) and BMS group
(n = 144). At 6 months, death/MI rate was not different between both groups, however, DES group had a significantly lower rate of TLR (1.7% vs. 5.6%, p = 0.021), TVR (2.2% vs. 5.6%, p = 0.032), and total major adverse cardiac events (MACE) (3.4% vs. 11.9%, p = 0.025) compared with BMS group. At 12 months, the rates of TLR and TVR remained lower in the DES group compared with the BMS group (2.5% vs. 5.9%, p = 0.032 and 5.9% vs. 3.1%, p = 0.041), but the rates of death/MI and total MACE were not statistically different between both groups. So, they concluded that the use of DES in large vessels in the setting of AMI is associated with a lower need for repeat revascularization compared to BMS without compromising the overall safety over the course of one-year follow-up. Bae et al. [17] evaluated whether DES is preferable for the treatment of AMI with renal insufficiency and elucidated the impact of diabetes mellitus on outcomes of each stent using KAMIR data in 2175 AMI patients with renal insufficiency (glomerular filtration rate b60 ml/min) comprising 208 patients with BMS and 1967 DES implantation. In the overall population, the MACE rate at 1 year was significantly higher in the BMS group than in that of the DES (44% vs. 26%, p b 0.05), which was mainly due to the higher number of cardiac death rather than repeat intervention. In the diabetic group with DES implantation, the MACE rate was higher compared with the DES group without diabetes mellitus, mainly due to repeat intervention (5% vs. 8%, p b 0.05). So, they concluded that DES implantation exhibits a favorable 1year clinical outcome than BMS implantation, and subgroup analysis for diabetic subjects showed worse outcomes in the diabetic group with implanted DES in AMI patients with renal insufficiency. The above KAMIR studies comparing DES and BMS have shown the similar results compared with previous clinical trials [13–15] in patients with AMI. The inclusion criteria, used stents, and endpoint in above KAMIR studies are summarized in Table 1. 4. Comparison of the efficacy and safety of each DES in AMI patients: experience from KAMIR Recently, several studies have shown the efficacy and safety of each DES in patients with AMI [18–20]. Choi et al. [18] reported that there was a trend toward a higher incidence of binary restenosis at 6-months in the PES group compared with the SES or ZES groups, however, clinical outcomes, including mortality, MI, repeat PCI and overall MACEs, were not different among the 3 groups in patients with AMI. Lee et al. [19] reported that restenosis rate at 8-months was lowest in the SES group compared to the ZES and PES groups, however incidence of death, recurrent MI, or ischemia-driven TVR did not differ among the 3 groups in patients with STEMI. Kang et al. [20] reported that the use of ZES in patients with STEMI undergoing primary PCI, showed similar rates of MACE, cardiac death and recurrent MI at 12 and 18 months compared with SES and PES, and
Table 1 Inclusion criteria and used stents, and endpoint in cited KAMIR studies. Study
Inclusion criteria
Sim et al. [16]
Lee et al. [21]
985 AMI patients (744 STEMI and 241 NSTEMI) with DES (n = 841) vs. BMS (n = 144) large coronary arteries (≥3.5 mm) 2175 AMI patients (1570 STEMI and 605 NSTEMI) with DES (n = 1967) vs. BMS (n = 208) renal insufficiency (glomerular filtration rate b 60 ml/min) 1541 AMI patients (1034 STEMI and 507 NSTEMI) SES (n = 834) vs. PES (n = 707)
Cho et al. [22]
4416 STEMI patients
Bae et al. [17]
Kim et al. [23] 873 STEMI patients Lee et al. [24]
1768 STEMI patients with metabolic syndrome
Used stents
Endpoint
Composite of death, MI, and TLR or TVR at 12-month Composite of mortality, nonfatal MI, and TLR at 12-month Composite of death, MI, TLR, and CABG at 1- and 6-month PES (n = 1882) vs. SES (n = 2534) Composite of mortality, nonfatal MI, and TLR at 12-month ZES (n = 306) vs. SES (n = 567) Composite of all causes of death, MI, and TLR at 12-month PES (n = 634) vs. SES (n = 906) vs. ZES (n = 228) Composite of all causes of death, MI, and TLR at 12-month
KAMIR: Korea Acute Myocardial Infarction Registry, AMI: acute myocardial infarction, STEMI: ST segment elevation myocardial infarction, NSEMI: non-ST segment elevation myocardial infarction, DES: drug-eluting stent, BMS: bare-metal stent, SES: sirolimus-eluting stent, PES: paclitaxel-eluting stent, ZES: zotarolimus-eluting stent, TLR: target-lesion revascularization, TVR: target-vessel revascularization, CABG: coronary artery bypass graft.
Editorial
there was a trend towards a higher rate of TLR with ZES or PES compared to SES. Several studies regarding the comparison of efficacy and safety of each DES in patients with AMI using KAMIR data have been performed. Lee et al. [21] investigated the incidence of MACE and stent thrombosis in 1541 AMI patients who had been implanted with either SES (n = 834) or PES (n = 707) during a 6-month clinical follow-up using KAMIR data. MACE rate was not significantly different between the SES and PES groups at both 1 month (0.8% vs. 1.0%, p = 0.793) and 6 months (3.8% vs. 5.2%, p = 0.177). There were 17 cases of stent thrombosis, but the incidence of stent thrombosis was not significantly different between the 2 groups (1.1% vs. 1.1%, p = 1.000). So, they concluded that MACE and stent thrombosis rates did not differ between the 2 types of DES identified in KAMIR. Cho et al. [22] evaluated which DES is preferable for the treatment of STEMI and elucidated the impact of diabetes mellitus on the outcome of each DES in 4416 STEMI patients (26% with diabetes) treated with PES or SES. In the overall population, the MACE rate at 1 year was significantly higher in the PES than the SES group (11.6% vs. 8.6%, p = 0.014), which was mainly due to increased TLR (3.7% vs. 1.8%, p b 0.001). In the diabetic subgroup, however, the MACE rate was not significantly different between PES and SES groups (14.5% vs. 12.3%, p = 0.217), in contrast to the non-diabetic subgroup, where PES was inferior to SES as in the overall population. So, they concluded that the PES was inferior to the SES in the overall population, with regard to the occurrence of MACE and TLR, however, subgroup analysis for diabetic subjects showed no differences in clinical outcomes between PES and SES. Kim et al. [23] compared the clinical outcomes of zotarolimuseluting stent (ZES, Endeavor® stent) and SES in 873 patients with STEMI (306 patients in the ZES group and 567 patients in the SES group) who were enrolled in a KAMIR. During 1 year of follow-up, MACE including death, MI, and TLR occurred in 140 patients (16.0%). The SES group had a significantly lower incidence of MACE (hazard ratio [HR] 1.52, 95% confidence interval [CI] 1.07 to 2.16, p = 0.02), TLR (HR 2.16, 95% CI 1.01 to 4.59, p = 0.046), and TVR (HR 2.24, 95% CI 1.18 to 4.24, p = 0.013) compared with the ZES group, however, no significant differences were found in death or MI between both groups (HR 1.37, 95% CI 0.91 to 2.05, p = 0.129). So, they concluded that ZES implantation was associated with an increased incidence of MACE, mainly driven by increase of TLR and TVR, but was not associated with increase of safety endpoint including death or MI compared with SES implantation. Lee et al. [24] compared the efficacy and safety of PES, SES, and ZES in 1768 metabolic syndrome (MS) patients with STEMI who underwent primary PCI using DES [PES group (n = 634) vs. SES group (n = 906) vs. ZES group (n = 228)]. At 12 months, the cumulative incidence of primary endpoint (all cause death, re-MI, TLR) was not different significantly in the PES, SES, and ZES groups (10.9%, 9.1%, and 11.0%, respectively, p = 0.086). Incidences of death, recurrent MI, TLR, and stent thrombosis did not differ among the 3 groups. So, they concluded that implantation of SES, PES, and ZES in MS patients with STEMI undergoing primary PCI provided comparable clinical outcomes in patients enrolled in KAMIR. The above KAMIR studies comparing each DES have shown similar results compared with previous clinical trials [18–20] in patients with AMI. The inclusion criteria, used stents, and endpoint in the above KAMIR studies are summarized in Table 1. 5. Conclusions According to the KAMIR data, DES penetration rate is more than 90%. As compared with BMS, the event rates are lower after DES implantation in patients with AMI. There were no significant differences in the incidences of overall MACE according to the DES types except for the lower need for repeat revascularization in SES compared with PES or ZES. According to KAMIR data, DES can be used safely and effectively to treat AMI patients by reducing the need for repeat
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revascularizations and by not increasing the risks of mortality, MI, and stent thrombosis. Disclosures There are no potential conflicts to declare. Acknowledgment KAMIR was carried out with the support of the Korean Circulation Society in the memorandum of the 50th anniversary of the Korean Circulation Society. This study was supported by a grant of the Korea Healthcare technology R&D Project, Ministry for Health, Welfare and Family Affairs (A084869), Republic of Korea. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. References [1] Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193–202. [2] Finn AV, Nakazawa G, Joner M, et al. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol 2007;27:1500–10. [3] Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol 2000;20:1262–75. [4] Nakazawa G, Finn AV, Joner M, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation 2008;118:1138–45. [5] Menichelli M, Parma A, Pucci E, et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol 2007;49:1924–30. [6] Spaulding C, Henry P, Teiger E, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 2006;355:1093–104. [7] Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 2006;355: 1105–13. [8] Sim DS, Jeong MH, Kang JC. Current management of acute myocardial infarction: experience from the Korea Acute Myocardial Infarction Registry. J Cardiol 2010;56:1–7. [9] Chen KY, Rha SW, Li YJ, et al. Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Circulation 2009;119:3207–14. [10] Ohman EM, Roe MT, Smith Jr SC, et al. Care of non-ST-segment elevation patients: insights from the CRUSADE national quality improvement initiative. Am Heart J 2004;148:34–9. [11] Gulati M, Patel S, Jaffe AS, Joseph AJ, Calvin Jr JE. Impact of contemporary guideline compliance on risk stratification models for acute coronary syndromes in The Registry of Acute Coronary Syndromes. Am J Cardiol 2004;94:873–8. [12] Kushner FG, Hand M, Smith Jr SC, et al. 2009 focused updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation 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. Circulation 2009;120:2271–306. [13] Pasceri V, Patti G, Speciale G, Pristipino C, Richichi G, Di Sciascio G. Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. Am Heart J 2007;153:749–54. [14] Kastrati A, Dibra A, Spaulding C, et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J 2007;28:2706–13. [15] Stone GW, Lansky AJ, Pocock SJ, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med 2009;360:1946–59. [16] Sim DS, Jeong MH, Ahn Y, et al. Effectiveness of drug-eluting stents versus bare-metal stents in large coronary arteries in patients with acute myocardial infarction. J Korean Med Sci 2011;26:521–7. [17] Bae EH, Lim SY, Choi YH, et al. Drug-eluting vs. bare-metal stents for treatment of acute myocardial infarction with renal insufficiency. Circ J 2011;75:2798–804. [18] Choi CU, Rha SW, Chen KY, et al. Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimuseluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention. Circ J 2009;73:2229–35. [19] Lee CW, Park DW, Lee SH, et al. Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with STelevation myocardial infarction. Am J Cardiol 2009;104:1370–6. [20] Kang WC, Ahn T, Lee K, et al. Comparison of zotarolimus-eluting stents versus sirolimus-eluting stents versus paclitaxel-eluting stents for primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: results from the Korean Multicentre Endeavor (KOMER) acute myocardial infarction (AMI) trial. EuroIntervention 2011;7:936–43.
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[21] Lee SR, Jeong MH, Ahn YK, et al. Clinical safety of drug-eluting stents in the Korea acute myocardial infarction registry. Circ J 2008;72:392–8. [22] Cho Y, Yang HM, Park KW, et al. Paclitaxel- versus sirolimus-eluting stents for treatment of ST-segment elevation myocardial infarction: with analyses for diabetic and nondiabetic subpopulation. JACC Cardiovasc Interv 2010;3: 498–506.
[23] Kim HK, Jeong MH, Ahn YK, et al. Comparison of outcomes between zotarolimusand sirolimus-eluting stents in patients with ST-segment elevation acute myocardial infarction. Am J Cardiol 2010;105:813–8. [24] Lee MG, Jeong MH, Ahn Y, et al. Comparison of paclitaxel-, sirolimus-, and zotarolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction and metabolic syndrome. Circ J 2011;75:2120–7.