Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study
Background. The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. Purpose. The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with...
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| Format: | Article |
| Language: | English |
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Wiley
2019-01-01
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| Series: | Journal of Interventional Cardiology |
| Online Access: | http://dx.doi.org/10.1155/2019/3146848 |
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| author | Shunji Yoshikawa Takashi Ashikaga Toru Miyazaki Ken Kurihara Kenzo Hirao |
| author_facet | Shunji Yoshikawa Takashi Ashikaga Toru Miyazaki Ken Kurihara Kenzo Hirao |
| author_sort | Shunji Yoshikawa |
| collection | DOAJ |
| description | Background. The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. Purpose. The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with ACS. Methods. The Tokyo-MD PCI study is a multicenter, observational cohort study enrolling consecutive patients who underwent everolimus-eluting stent (EES) implantation. The 5-year clinical events were compared between the ACS group (n = 644) and the stable coronary artery disease (SCAD) group (n = 1255). The primary efficacy endpoint was ischemia-driven target lesion revascularization (TLR), and the primary safety endpoint was the composite of all-cause death or myocardial infarction (MI). Results. The median follow-up duration was 5.4 years. The cumulative incidence of ischemia-driven TLR was similar between ACS and SCAD (1 year: 3.0% versus 2.7%; P=0.682, 1–5 years: 2.7% versus 2.9%; P=0.864). The cumulative incidence of all-cause death or MI within 1 year was significantly higher in ACS than in SCAD (7.4% versus 3.8%; P<0.001); however, ACS did not increase the risk of all-cause death or MI after adjusting confounders (adjusted hazard ratio, 1.260; 95% confidence interval, 0.774–2.053; P=0.352). From 1 to 5 years, the cumulative incidence of all-cause death or MI was not significantly different between ACS and SCAD (11.6% versus 11.4%; P=0.706). The cumulative incidence of very late stent thrombosis was low and similar between ACS and SCAD (0.2% versus 0.2%; P=0.942). Conclusion. This real-world registry suggested that EES has comparable long-term efficacy and safety in patients with ACS and SCAD. |
| format | Article |
| id | doaj-art-47ab8a6fb29f4e7a8d6aa81145a87bb2 |
| institution | OA Journals |
| issn | 0896-4327 1540-8183 |
| language | English |
| publishDate | 2019-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Interventional Cardiology |
| spelling | doaj-art-47ab8a6fb29f4e7a8d6aa81145a87bb22025-08-20T02:37:53ZengWileyJournal of Interventional Cardiology0896-43271540-81832019-01-01201910.1155/2019/31468483146848Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI StudyShunji Yoshikawa0Takashi Ashikaga1Toru Miyazaki2Ken Kurihara3Kenzo Hirao4Department of Cardiology, Tokyo Yamate Medical Center, Tokyo, JapanDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, JapanDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, JapanDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, JapanDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, JapanBackground. The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. Purpose. The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with ACS. Methods. The Tokyo-MD PCI study is a multicenter, observational cohort study enrolling consecutive patients who underwent everolimus-eluting stent (EES) implantation. The 5-year clinical events were compared between the ACS group (n = 644) and the stable coronary artery disease (SCAD) group (n = 1255). The primary efficacy endpoint was ischemia-driven target lesion revascularization (TLR), and the primary safety endpoint was the composite of all-cause death or myocardial infarction (MI). Results. The median follow-up duration was 5.4 years. The cumulative incidence of ischemia-driven TLR was similar between ACS and SCAD (1 year: 3.0% versus 2.7%; P=0.682, 1–5 years: 2.7% versus 2.9%; P=0.864). The cumulative incidence of all-cause death or MI within 1 year was significantly higher in ACS than in SCAD (7.4% versus 3.8%; P<0.001); however, ACS did not increase the risk of all-cause death or MI after adjusting confounders (adjusted hazard ratio, 1.260; 95% confidence interval, 0.774–2.053; P=0.352). From 1 to 5 years, the cumulative incidence of all-cause death or MI was not significantly different between ACS and SCAD (11.6% versus 11.4%; P=0.706). The cumulative incidence of very late stent thrombosis was low and similar between ACS and SCAD (0.2% versus 0.2%; P=0.942). Conclusion. This real-world registry suggested that EES has comparable long-term efficacy and safety in patients with ACS and SCAD.http://dx.doi.org/10.1155/2019/3146848 |
| spellingShingle | Shunji Yoshikawa Takashi Ashikaga Toru Miyazaki Ken Kurihara Kenzo Hirao Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study Journal of Interventional Cardiology |
| title | Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study |
| title_full | Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study |
| title_fullStr | Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study |
| title_full_unstemmed | Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study |
| title_short | Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study |
| title_sort | long term efficacy and safety of everolimus eluting stent implantation in japanese patients with acute coronary syndrome five year real world data from the tokyo md pci study |
| url | http://dx.doi.org/10.1155/2019/3146848 |
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