Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial

被引:482
作者
Thuijs, Daniel J. F. M. [1 ]
Kappetein, A. Pieter [1 ,2 ]
Serruys, Patrick W. [3 ]
Mohr, Friedrich-Wilhelm [4 ]
Morice, Marie-Claude [5 ]
Mack, Michael J. [6 ]
Holmes, David R., Jr. [7 ]
Curzen, Nick [8 ,9 ]
Davierwala, Piroze [4 ]
Noack, Thilo [4 ]
Milojevic, Milan [1 ]
Dawkins, Keith D. [10 ]
da Costa, Bruno R. [11 ,13 ]
Juni, Peter [11 ,12 ]
Head, Stuart J. [1 ,14 ]
机构
[1] Erasmus Univ, Dept Cardiothorac Surg, Med Ctr, NL-3015 GD Rotterdam, Netherlands
[2] Medtronic, Maastricht, Netherlands
[3] Imperial Coll London, Dept Cardiol, London, England
[4] Heart Ctr Leipzig, Univ Dept Cardiac Surg, Leipzig, Germany
[5] Ramsay Gen Sante, Hop Prive Jacques Cartier, Cardiovasc Inst Paris Sud, Dept Cardiol, Massy, France
[6] Baylor Univ, Med Ctr, Dept Cardiothorac Surg, Dallas, TX USA
[7] Mayo Clin, Dept Cardiovasc Dis & Internal Med, Rochester, MN USA
[8] Univ Southampton, Univ Hosp Southampton NHS Fdn Trust, Southampton, Hants, England
[9] Univ Southampton, Sch Med, Southampton, Hants, England
[10] Shockwave Med Inc, Santa Clara, CA USA
[11] St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada
[12] Univ Toronto, Inst Hlth Policy Management & Evaluat, Dept Med, Toronto, ON, Canada
[13] Univ Bern, Inst Primary Hlth Care, Bern, Switzerland
[14] Medtronic, Minneapolis, MN USA
关键词
EVEROLIMUS-ELUTING STENTS; CARDIAC-SURGERY SYNTAX; INCOMPLETE REVASCULARIZATION; POOLED ANALYSIS; OUTCOMES; SYNERGY; TAXUS; ANGIOGRAPHY; MORTALITY; CABG;
D O I
10.1016/S0140-6736(19)31997-X
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. Methods The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. Findings From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], P-interaction=0.019). There was no treatment-by-subgroup interaction with diabetes (P-interaction=0.66) and no linear trend across SYNTAX score tertiles (P-trend=0.30). Interpretation At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. Copyright (C) 2019 Elsevier Ltd. All rights reserved.
引用
收藏
页码:1325 / 1334
页数:10
相关论文
共 50 条
[31]   Long-Term Outcomes of Unprotected Left Main Coronary Artery Disease: Comparison of Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention [J].
Song, Kai ;
Kim, Moo Hyun ;
Li, Jia Xin ;
Kim, Soo Jin ;
Lee, Kwang Min ;
Cho, Young-Rak ;
Park, Jong Sung ;
Park, Tae Ho ;
Kim, Young Dae ;
Lee, Michael S. .
JOURNAL OF INVASIVE CARDIOLOGY, 2020, 32 (03) :111-116
[32]   Revascularization in left main coronary artery disease: comparison of off-pump coronary artery bypass grafting vs percutaneous coronary intervention [J].
Jeong, Dong Seop ;
Lee, Young Tak ;
Chung, Su Ryeun ;
Jeong, Jae Han ;
Kim, Wook Sung ;
Sung, Kiick ;
Park, Pyo Won .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2013, 44 (04) :718-724
[33]   Percutaneous coronary intervention versus bypass surgery for left main coronary artery disease: a meta-analysis of randomised trials [J].
Ferrante, Giuseppe ;
Presbitero, Patrizia ;
Valgimigli, Marco ;
Morice, Marie-Claude ;
Pagnotta, Paolo ;
Belli, Guido ;
Corrada, Elena ;
Onuma, Yoshinobu ;
Barlis, Peter ;
Locca, Didier ;
Eeckhout, Eric ;
Di Mario, Carlo ;
Serruys, Patrick W. .
EUROINTERVENTION, 2011, 7 (06) :738-746
[34]   Left Main Coronary Artery Revascularization in Patients with Impaired Renal Function; Percutaneous Coronary Intervention vs. Coronary Artery Bypass Grafting [J].
Daoulah, Amin ;
Baqais, Rasha Taha ;
Aljohar, Alwaleed ;
Alhassoun, Abdulkarim ;
Hersi, Ahmad S. ;
Almahmeed, Wael ;
Yousif, Nooraldaem ;
Alasmari, Abdulaziz ;
Alshehri, Mohammed ;
Eltaieb, Fakhreldein ;
Alzahrani, Badr ;
Elmahrouk, Ahmed ;
Arafat, Amr A. ;
Jamjoom, Ahmed ;
Alshali, Khalid Z. ;
Abuelatta, Reda ;
Ahmed, Waleed A. ;
Alqahtani, Abdulrahman H. ;
Al Garni, Turki ;
Hashmani, Shahrukh ;
Dahdouh, Ziad ;
Refaat, Wael ;
Kazim, Hameedullah M. ;
Ghani, Mohamed Ajaz ;
Amin, Haitham ;
Hiremath, Niranjan ;
Elmahrouk, Youssef ;
Selim, Ehab ;
Aithal, Jairam ;
Qutub, Mohammed A. ;
Alama, Mohamed N. ;
Ibrahim, Ahmed M. ;
Elganady, Abdelmaksoud ;
Abohasan, Abdulwali ;
Asrar, Farhan M. ;
Farghali, Tarek ;
Jameel Naser, Maryam ;
Hassan, Taher ;
Balghith, Mohammed ;
Hussien, Adnan Fathey ;
Abdulhabeeb, Ibrahim A. M. ;
Ahmad, Osama ;
Ramadan, Mohamed ;
Ghonim, Ahmed A. ;
Shawky, Abeer M. ;
Noor, Husam A. ;
Haq, Ejazul ;
Alqahtani, Abdulrahman M. ;
Al Samadi, Faisal ;
Abualnaja, Seraj .
KIDNEY & BLOOD PRESSURE RESEARCH, 2023, 48 (01) :545-555
[35]   Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Myocardial Infarction and Left Main or Multivessel Coronary Disease [J].
Freitas, Pedro ;
Madeira, Marcio ;
Raposo, Luis ;
Madeira, Sergio ;
Brito, Joao ;
Brizido, Catarina ;
Gama, Francisco ;
Vale, Nelson ;
Ranchordas, Sara ;
Magro, Pedro ;
Braga, Ana ;
Goncalves, Pedro de Araujo ;
Gabriel, Henrique Mesquita ;
Nolasco, Tiago ;
Boshoff, Sergio ;
Marques, Marta ;
Bruges, Luis ;
Calquinha, Jose ;
Sousa-Uva, Miguel ;
Abecasis, Miguel ;
Almeida, Manuel ;
Neves, Jose Pedro ;
Mendes, Miguel .
AMERICAN JOURNAL OF CARDIOLOGY, 2019, 123 (05) :717-724
[36]   A Comparison Between Coronary Artery Bypass Grafting Surgery and Percutaneous Coronary Intervention for the Treatment of Unprotected Left Main Coronary Artery Disease [J].
Qin, Qing ;
Qian, Juying ;
Wu, Xuefeng ;
Fan, Bing ;
Ge, Lei ;
Ge, Junbo .
CLINICAL CARDIOLOGY, 2013, 36 (01) :54-60
[37]   Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial [J].
Fearon, William F. ;
Zimmermann, Frederik M. ;
Ding, Victoria Y. ;
Takahashi, Kuniaki ;
Piroth, Zsolt ;
Straten, Albert H. M. van ;
Szekely, Laszlo ;
Davidavicius, Giedrius ;
Kalinauskas, Gintaras ;
Mansour, Samer ;
Kharbanda, Rajesh ;
Ostlund-Papadogeorgos, Nikolaos ;
Aminian, Adel ;
Oldroyd, Keith G. ;
Al-Attar, Nawwar ;
Jagic, Nikola ;
Dambrink, Jan-Henk E. ;
Kala, Petr ;
Angeras, Oskar ;
Maccarthy, Philip ;
Wendler, Olaf ;
Casselman, Filip ;
Witt, Nils ;
Mavromatis, Kreton ;
Miner, Steven E. S. ;
Sarma, Jaydeep ;
Engstrom, Thomas ;
Christiansen, Evald H. ;
Tonino, Pim A. L. ;
Reardon, Michael J. ;
Otsuki, Hisao ;
Kobayashi, Yuhei ;
Hlatky, Mark A. ;
Mahaffey, Kenneth W. ;
Desai, Manisha ;
Woo, Y. Joseph ;
Yeung, Alan C. ;
Pijls, Nico H. J. ;
De Bruyne, Bernard .
LANCET, 2025, 405 (10488) :1481-1490
[38]   Clinical implications of residual SYNTAX score after percutaneous coronary intervention in patients with chronic total occlusion and multivessel coronary artery disease: a comparison with coronary artery bypass grafting [J].
Jang, Woo Jin ;
Yang, Jeong Hoon ;
Bin Song, Young ;
Hahn, Joo-Yong ;
Choi, Jin-Ho ;
Chun, Woo Jung ;
Oh, Ju Hyeon ;
Park, Yong Hwan ;
Kim, Wook Sung ;
Lee, Young Tak ;
Gwon, Hyeon-Cheol ;
Choi, Seung-Hyuk .
EUROINTERVENTION, 2017, 13 (01) :97-105
[39]   Percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass grafting in left main coronary artery disease: an individual patient data meta-analysis [J].
Sabatine, Marc S. ;
Bergmark, Brian A. ;
Murphy, Sabina A. ;
O'Gara, Patrick T. ;
Smith, Peter K. ;
Serruys, Patrick W. ;
Kappetein, A. Pieter ;
Park, Seung-Jung ;
Park, Duk-Woo ;
Christiansen, Evald H. ;
Holm, Niels R. ;
Nielsen, Per H. ;
Stone, Gregg W. ;
Sabik, Joseph F. ;
Braunwald, Eugene .
LANCET, 2021, 398 (10318) :2247-2257
[40]   Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Versus Without Chronic Kidney Disease [J].
Yamamoto, Ko ;
Natsuaki, Masahiro ;
Morimoto, Takeshi ;
Shiomi, Hiroki ;
Takeji, Yasuaki ;
Kadota, Kazushige ;
Imada, Kazuaki ;
Toyofuku, Mamoru ;
Kanemitsu, Naoki ;
Shinoda, Eiji ;
Suwa, Satoru ;
Iwakura, Atsushi ;
Tamura, Toshihiro ;
Soga, Yoshiharu ;
Inada, Tsukasa ;
Matsuda, Mitsuo ;
Koyama, Tadaaki ;
Aoyama, Takeshi ;
Kato, Eri ;
Sato, Yukihito ;
Furukawa, Yutaka ;
Ando, Kenji ;
Yamazaki, Fumio ;
Komiya, Tatsuhiko ;
Minatoya, Kenji ;
Nakagawa, Yoshihisa ;
Kimura, Takeshi .
AMERICAN JOURNAL OF CARDIOLOGY, 2021, 145 :37-46