Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study

被引：238

作者：

Escaned, Javier ^{[1
,2
,3
]}

Collet, Carlos ^{[4
,5
]}

Ryan, Nicola ^{[1
,2
,3
]}

De Maria, Giovanni Luigi ^{[6
,7
]}

Walsh, Simon ^{[8
,9
]}

Sabate, Manel ^{[10
,11
]}

Davies, Justin ^{[12
]}

Lesiak, Maciej ^{[13
,14
]}

Moreno, Raul ^{[15
,16
]}

Cruz-Gonzalez, Ignacio ^{[17
,18
]}

Hoole, Stephan P. ^{[19
]}

West, Nick Ej ^{[19
]}

Piek, J. J. ^{[4
,5
]}

Zaman, Azfar ^{[20
,21
]}

Fath-Ordoubadi, Farzin ^{[22
,23
]}

Stables, Rodney H. ^{[24
]}

Appleby, Clare ^{[24
]}

van Mieghem, Nicolas ^{[25
,26
]}

van Geuns, Robert Jm. ^{[25
,26
]}

Uren, Neal ^{[27
,28
]}

Zueco, Javier ^{[29
,30
]}

Buszman, Pawel ^{[31
,32
]}

Iniguez, Andres ^{[33
,34
]}

Goicolea, Javier ^{[33
,34
]}

Hildick-Smith, David ^{[35
,36
]}

Ochala, Andrzej ^{[37
]}

Dudek, Dariusz ^{[38
]}

Hanratty, Colm ^{[8
,9
]}

Cavalcante, Rafael ^{[25
,26
]}

Kappetein, Arie Pieter ^{[25
,26
]}

Taggart, David P. ^{[6
,7
]}

van Es, Gerrit-Anne ^{[39
,40
,41
]}

Morel, Marie-Angele ^{[39
,40
]}

de Vries, Ton ^{[39
,40
]}

Onuma, Yoshinobu ^{[25
,26
,39
]}

Farooq, Vasim ^{[22
,23
]}

Serruys, Patrick W. ^{[12
]}

Banning, Adrian P. ^{[6
,7
]}

机构：

[1] Hosp Clin San Carlos IDISSC, Madrid, Spain

[2] Univ Complutense Madrid, Madrid, Spain

[3] Calle Profesor Martin Lagos S-N, E-28040 Madrid, Spain

[4] Acad Med Ctr, Cardiol, Dept Cardiol, Amsterdam, Netherlands

[5] Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands

[6] John Radcliffe Hosp, Cardiol, Dept Cardiol, Oxford, England

[7] Headley Way, Oxford OX3 9DU, England

[8] Belfast Hlth & Social Care Trust, Dept Cardiol, Belfast, Antrim, North Ireland

[9] Knockbracken Healthcare Pk,Saintfield Rd, Belfast BT8 8BH, Antrim, North Ireland

[10] Hosp Clin Barcelona, Barcelona, Spain

[11] Carrer Villarroel 170, Barcelona 08036, Spain

[12] Imperial Coll London, Dept Cardiol, London, England

[13] Univ Med Sci, Dept Cardiol 1, Poznan, Poland

[14] Collegium Maius, Fredry 10, PL-61701 Poznan, Poland

[15] Hosp Univ La Paz, Dept Cardiol, Madrid, Spain

[16] Paseo Castellana 261, Madrid 28046, Spain

[17] Hosp Univ Salamanca, IBSAL, Dept Cardiol, Salamanca, Spain

[18] Paseo San Vicente 58, Salamanca 37007, Spain

[19] Papworth Hosp NHS Fdn Trust, Dept Cardiol, Cambridge, England

[20] Freeman Rd Hosp, Dept Cardiol, Newcastle Upon Tyne, Tyne & Wear, England

[21] Newcastle Univ, Newcastle Upon Tyne, Tyne & Wear, England

[22] Cent Manchester Univ Hosp, Manchester Royal Infirm, Manchester Heart Ctr, Manchester, Lancs, England

[23] Oxford Rd, Manchester M13 9WL, Lancs, England

[24] Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England

[25] Erasmus MC, Thoraxctr, Rotterdam, Netherlands

[26] S-Gravendijkwal 230, NL-3015 CE Rotterdam, Netherlands

[27] Royal Infirm Edinburgh NHS Trust, Edinburgh, Midlothian, Scotland

[28] 51 Little France Dr, Edinburgh EH16 4SA, Midlothian, Scotland

[29] Hosp Univ Valdecilla, Dept Cardiol, Cantabria, Spain

[30] Av Valdecilla 25, Santander 39008, Spain

[31] Amer Heart Poland PAK, Ustron, Poland

[32] Sanatoryjna 1, PL-43450 Ustron, Poland

[33] Hosp Meixoeiro, Dept Cardiol, Pontevedra, Spain

[34] Camino Meixoeiro S-N, Vigo 36214, Spain

[35] Brighton & Sussex Univ Hosp NHS Trust, Brighton, E Sussex, England

[36] Barry Bldg,Eastern Rd, Brighton BN2 5BE, E Sussex, England

[37] Gornoslaskie Ctr Med, Katowice, Poland

[38] Jagiellonian Univ, Dept Intervent Cardiol, Golebia 24, PL-31007 Krakow, Poland

[39] Cardialysis BV, Rotterdam, Netherlands

[40] Westblaak 98, NL-3012 KM Rotterdam, Netherlands

[41] European Cardiovasc Res Inst, Westblaak 98, NL-3012 KM Rotterdam, Netherlands

来源：

EUROPEAN HEART JOURNAL | 2017年 / 38卷 / 42期

关键词：

PCI; Drug-eluting stents; Multivessel disease; Coronary artery bypass graft; FRACTIONAL FLOW RESERVE; EVEROLIMUS-ELUTING STENTS; CHRONIC TOTAL OCCLUSIONS; BYPASS GRAFT-SURGERY; LEFT MAIN; 3-VESSEL DISEASE; INTERVENTION; MULTIVESSEL; ANGIOGRAPHY; RATIONALE;

D O I：

10.1093/eurheartj/ehx512

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable- polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted.

引用

页码：3124 / 3134

页数：11

共 29 条

[1] Clinical end points in coronary stent trials - A case for standardized definitions [J].

Cutlip, Donald E. ;

Windecker, Stephan ;

Mehran, Roxana ;

Boam, Ashley ;

Cohen, David J. ;

van Es, Gerrit-Anne ;

Steg, P. Gabriel ;

Morel, Marie-angele ;

Mauri, Laura ;

Vranckx, Pascal ;

McFadden, Eugene ;

Lansky, Alexandra ;

Hamon, Martial ;

Krucoff, Mitchell W. ;

Serruys, Patrick W. .

CIRCULATION, 2007, 115 (17) :2344-2351

[2] Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI [J].

Davies, J. E. ;

Sen, S. ;

Dehbi, H. -M. ;

Al-Lamee, R. ;

Petraco, R. ;

Nijjer, S. S. ;

Bhindi, R. ;

Lehman, S. J. ;

Walters, D. ;

Sapontis, J. ;

Janssens, L. ;

Vrints, C. J. ;

Khashaba, A. ;

Laine, M. ;

Van Belle, E. ;

Krackhardt, F. ;

Bojara, W. ;

Going, O. ;

Harle, T. ;

Indolfi, C. ;

Niccoli, G. ;

Ribichini, F. ;

Tanaka, N. ;

Yokoi, H. ;

Takashima, H. ;

Kikuta, Y. ;

Erglis, A. ;

Vinhas, H. ;

Silva, P. Canas ;

Baptista, S. B. ;

Alghamdi, A. ;

Hellig, F. ;

Koo, B. -K. ;

Nam, C. -W. ;

Shin, E. -S. ;

Doh, J. -H. ;

Brugaletta, S. ;

Alegria-Barrero, E. ;

Meuwissen, M. ;

Piek, J. J. ;

van Royen, N. ;

Sezer, M. ;

Di Mario, C. ;

Gerber, R. T. ;

Malik, I. S. ;

Sharp, A. S. P. ;

Talwar, S. ;

Tang, K. ;

Samady, H. ;

Altman, J. .

NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (19) :1824-1834

[3] Fractional Flow Reserve-Guided PCI for Stable Coronary Artery Disease [J].

De Bruyne, Bernard ;

Fearon, William F. ;

Pijls, Nico H. J. ;

Barbato, Emanuele ;

Tonino, Pim ;

Piroth, Zsolt ;

Jagic, Nikola ;

Mobius-Winckler, Sven ;

Rioufol, Gilles ;

Witt, Nils ;

Kala, Petr ;

MacCarthy, Philip ;

Engstroem, Thomas ;

Oldroyd, Keith ;

Mavromatis, Kreton ;

Manoharan, Ganesh ;

Verlee, Peter ;

Frobert, Ole ;

Curzen, Nick ;

Johnson, Jane B. ;

Limacher, Andreas ;

Nueesch, Eveline ;

Jueni, Peter .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (13) :1208-1217

[4] Intravascular ultrasound-guided optimized stent deployment - Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) [J].

de Jaegere, P ;

Mudra, H ;

Figulla, H ;

Almagor, Y ;

Doucet, S ;

Penn, I ;

Colombo, A ;

Hamm, C ;

Bartorelli, A ;

Rothman, M ;

Nobuyoshi, M ;

Yamaguchi, T ;

Voudris, V ;

DiMario, C ;

Makovski, S ;

Hausmann, D ;

Rowe, S ;

Rabinovich, S ;

Sunamura, M ;

van Es, GA .

EUROPEAN HEART JOURNAL, 1998, 19 (08) :1214-1223

[5] Rationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease [J].

Escaned, Javier ;

Banning, Adrian ;

Farooq, Vasim ;

Echavarria-Pinto, Mauro ;

Onuma, Yoshinobu ;

Ryan, Nicola ;

Cavalcante, Rafael ;

Campos, Carlos M. ;

Stanetic, Bojan M. ;

Ishibashi, Yuki ;

Suwannasom, Pannipa ;

Kappetein, Arie-Pieter ;

Taggart, David ;

Morel, Marie-Angele ;

van Es, Gerrit-Anne ;

Serruys, Patrick W. .

EUROINTERVENTION, 2016, 12 (02) :E224-E234

[6] Strategies for Multivessel Revascularization in Patients with Diabetes [J].

Farkouh, Michael E. ;

Domanski, Michael ;

Sleeper, Lynn A. ;

Siami, Flora S. ;

Dangas, George ;

Mack, Michael ;

Yang, May ;

Cohen, David J. ;

Rosenberg, Yves ;

Solomon, Scott D. ;

Desai, Akshay S. ;

Gersh, Bernard J. ;

Magnuson, Elizabeth A. ;

Lansky, Alexandra ;

Boineau, Robin ;

Weinberger, Jesse ;

Ramanathan, Krishnan ;

Sousa, J. Eduardo ;

Rankin, Jamie ;

Bhargava, Balram ;

Buse, John ;

Hueb, Whady ;

Smith, Craig R. ;

Muratov, Victoria ;

Bansilal, Sameer ;

King, Spencer, III ;

Bertrand, Michel ;

Fuster, Valentin .

NEW ENGLAND JOURNAL OF MEDICINE, 2012, 367 (25) :2375-2384

[7] Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II [J].

Farooq, Vasim ;

van Klaveren, David ;

Steyerberg, Ewout W. ;

Meliga, Emanuele ;

Vergouwe, Yvonne ;

Chieffo, Alaide ;

Kappetein, Arie Pieter ;

Colombo, Antonio ;

Holmes, David R., Jr. ;

Mack, Michael ;

Feldman, Ted ;

Morice, Marie-Claude ;

Stahle, Elisabeth ;

Onuma, Yoshinobu ;

Morel, Marie-angele ;

Garcia-Garcia, Hector M. ;

van Es, Gerrit Anne ;

Dawkins, Keith D. ;

Mohr, Friedrich W. ;

Serruys, Patrick W. .

LANCET, 2013, 381 (9867) :639-650

[8] Economic Evaluation of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Multivessel Disease [J].

Fearon, William F. ;

Bornschein, Bernhard ;

Tonino, Pim A. L. ;

Gothe, Raffaella M. ;

De Bruyne, Bernard ;

Pijls, Nico H. J. ;

Siebert, Uwe .

CIRCULATION, 2010, 122 (24) :2545-2550

[9] 2014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease [J].

Fihn, Stephan D. ;

Blankenship, James C. ;

Naidu, Srihari S. ;

Ohman, E. Magnus ;

Smith, Peter K. ;

Alexander, Karen P. ;

Bittl, John A. ;

Byrne, John G. ;

Fletcher, Barbara J. ;

Fonarow, Gregg C. ;

Lange, Richard A. ;

Levine, Glenn N. ;

Maddox, Thomas M. ;

Anderson, Jeffrey L. ;

Halperin, Jonathan L. ;

Albert, Nancy M. ;

Bozkurt, Biykem ;

Brindis, Ralph G. ;

Curtis, Lesley H. ;

DeMets, David ;

Guyton, Robert A. ;

Hochman, Judith S. ;

Kovacs, Richard J. ;

Pressler, Susan J. ;

Sellke, Frank W. ;

Shen, Win-Kuang .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2014, 64 (18) :1929-1949

[10] Lumen enlargement of the coronary segments located distal to chronic total occlusions successfully treated with drug-eluting stents at follow-up [J].

Gomez-Lara, Josep ;

Teruel, Luis ;

Homs, Silvia ;

Luis Ferreiro, Jose ;

Romaguera, Rafael ;

Roura, Gerard ;

Sanchez-Elvira, Guillermo ;

Jara, Francesc ;

Brugaletta, Salvatore ;

Gomez-Hospital, Joan-Antoni ;

Cequier, Angel .

EUROINTERVENTION, 2014, 9 (10) :1181-1188

← 1 2 3 →