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

Javier Escaned, Carlos Collet, Nicola Ryan, Giovanni Luigi De Maria, Simon Walsh, Manel Sabate, Justin Davies, Maciej Lesiak, Raul Moreno, Ignacio Cruz-Gonzalez, Stephan P Hoole, Nick Ej West, J J Piek, Azfar Zaman, Farzin Fath-Ordoubadi, Rodney H Stables, Clare Appleby, Nicolas van Mieghem, Robert Jm van Geuns, Neal Uren, Javier Zueco, Pawel Buszman, Andres Iñiguez, Javier Goicolea, David Hildick-Smith, Andrzej Ochala, Dariusz Dudek, Colm Hanratty, Rafael Cavalcante, Arie Pieter Kappetein, David P Taggart, Gerrit-Anne van Es, Marie-Angèle Morel, Ton de Vries, Yoshinobu Onuma, Vasim Farooq, Patrick W Serruys, Adrian P Banning, Javier Escaned, Carlos Collet, Nicola Ryan, Giovanni Luigi De Maria, Simon Walsh, Manel Sabate, Justin Davies, Maciej Lesiak, Raul Moreno, Ignacio Cruz-Gonzalez, Stephan P Hoole, Nick Ej West, J J Piek, Azfar Zaman, Farzin Fath-Ordoubadi, Rodney H Stables, Clare Appleby, Nicolas van Mieghem, Robert Jm van Geuns, Neal Uren, Javier Zueco, Pawel Buszman, Andres Iñiguez, Javier Goicolea, David Hildick-Smith, Andrzej Ochala, Dariusz Dudek, Colm Hanratty, Rafael Cavalcante, Arie Pieter Kappetein, David P Taggart, Gerrit-Anne van Es, Marie-Angèle Morel, Ton de Vries, Yoshinobu Onuma, Vasim Farooq, Patrick W Serruys, Adrian P Banning

Abstract

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.

Clinicaltrials.gov identifier: NCT02015832.

Keywords: Coronary artery bypass graft; Drug-eluting stents; Multivessel disease; PCI.

© The Author 2017. Published on behalf of the European Society of Cardiology

Figures

Figure 1
Figure 1
Flowchart of the study. Patients were screened on the basis of the SYNTAX score II and discussed within the heart team to assess the appropriateness of percutaneous based revascularization; 708 patients with three-vessel (3VD) demonstrated on angiography were screened using the SYNTAX score II by the local study coordinator and submitted to the assessment of the Heart Team who had to confirm the treatment recommendation based on the SYNTAX score II. Despite equipoise in the treatment recommendation, the Heart Team recommended CABG in 42 patients; the other reasons for non-compliance to the treatment recommendation of the SYNTAX score II were: patient preference or decline participation (n = 57) exclusion criteria (n = 11) and others (see flowchart).The 1-year clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) using the SYNTAX II strategy were compared with predefined cohorts of the PCI and CABG arm of the original SYNTAX trial. CABG, coronary-artery bypass grafting.
Figure 2
Figure 2
Flowchart depicting ischaemia-driven revascularization in the SYNTAX II study. Physiologic evaluation of target lesions was performed using an hybrid iFR/FFR strategy. An iFR 0.93 indicated deferral of PCI. iFR, instantaneous wave-free-ratio; FFR, fractional flow reserve.
Figure 3
Figure 3
One-year clinical outcomes among the study patients, compared with the equipoise-derived SYNTAX-I PCI cohort. Kaplan–Meier curves are shown for the SYNTAX-II group (blue) and the percutaneous coronary intervention (PCI) arm of the original SYNTAX-I trial (red) for the composite primary endpoint of major adverse cardiac or cerebrovascular events (MACCE, panel A), all-cause death/stroke/MI (panel B), all cause death (panel C); stroke (panel D); any myocardial infarction (panel E); any revascularization (panel F).

References

    1. Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A.. 2014 ESC/EACTS guidelines on myocardial revascularization. EuroIntervention 2015;10:1024–1094.
    1. Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr., Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW.. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629–638.
    1. Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V.. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012;367:2375–2384.
    1. Park SJ, Ahn JM, Kim YH, Park DW, Yun SC, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Choo SJ, Chung CH, Lee JW, Cohen DJ, Yeung AC, Hur SH, Seung KB, Ahn TH, Kwon HM, Lim DS, Rha SW, Jeong MH, Lee BK, Tresukosol D, Fu GS, Ong TK.. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med 2015;372:1204–1212.
    1. Serruys PW, Farooq V, Vranckx P, Girasis C, Brugaletta S, Garcia-Garcia HM, Holmes DR Jr., Kappetein AP, Mack MJ, Feldman T, Morice MC, Stahle E, James S, Colombo A, Pereda P, Huang J, Morel MA, Van Es GA, Dawkins KD, Mohr FW, Steyerberg EW.. A global risk approach to identify patients with left main or 3-vessel disease who could safely and efficaciously be treated with percutaneous coronary intervention: the SYNTAX Trial at 3 years. JACC Cardiovasc Interv 2012;5:606–617.
    1. Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, Feldman T, Morice MC, Stahle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys PW.. 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. Lancet 2013;381:639–650.
    1. Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, Freij A, Thorsen M.. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009;361:1045–1057.
    1. Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM.. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007;357:2001–2015.
    1. Palmerini T, Benedetto U, Biondi-Zoccai G, Della Riva D, Bacchi-Reggiani L, Smits PC, Vlachojannis GJ, Jensen LO, Christiansen EH, Berencsi K, Valgimigli M, Orlandi C, Petrou M, Rapezzi C, Stone GW.. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2015;65:2496–2507.
    1. Zhang YJ, Pang S, Chen XY, Bourantas CV, Pan DR, Dong SJ, Wu W, Ren XM, Zhu H, Shi SY, Iqbal J, Gogas BD, Xu B, Chen SL.. Comparison of intravascular ultrasound guided versus angiography guided drug eluting stent implantation: a systematic review and meta-analysis. BMC Cardiovasc Disord 2015;15:153..
    1. De Bruyne B, Fearon WF, Pijls NHJ, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nüesch E, Jüni P; for the FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med 2014;371:1208–1217.
    1. Escaned J, Banning A, Farooq V, Echavarria-Pinto M, Onuma Y, Ryan N, Cavalcante R, Campos CM, Stanetic BM, Ishibashi Y, Suwannasom P, Kappetein AP, Taggart D, Morel MA, van Es GA, Serruys PW.. 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. EuroIntervention 2016;12:e224–e234.
    1. Serruys PW, Onuma Y, Garg S, Sarno G, van den Brand M, Kappetein AP, Van Dyck N, Mack M, Holmes D, Feldman T, Morice MC, Colombo A, Bass E, Leadley K, Dawkins KD, van Es GA, Morel MA, Mohr FW.. Assessment of the SYNTAX score in the Syntax study. EuroIntervention 2009;5:50–56.
    1. Ong AT, Serruys PW, Mohr FW, Morice MC, Kappetein AP, Holmes DR Jr., Mack MJ, van den Brand M, Morel MA, van Es GA, Kleijne J, Koglin J, Russell ME.. The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase. Am Heart J 2006;151:1194–1204.
    1. 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.. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J 1998; 19: 1214–1223.
    1. Lassen JF, Holm NR, Banning A, Burzotta F, Lefevre T, Chieffo A, Hildick-Smith D, Louvard Y, Stankovic G.. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention 2016; 12: 38–46.
    1. Fihn SD, Blankenship JC, Alexander KP, Bittl JA, Byrne JG, Fletcher BJ, Fonarow GC, Lange RA, Levine GN, Maddox TM, Naidu SS, Ohman EM, Smith PK.. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation 2014;130:1749–1767.
    1. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW.. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–2351.
    1. Kappetein AP, Serruys PW, Sabik JF, Leon MB, Taggart DP, Morice MC, Gersh BJ, Pocock SJ, Cohen DJ, Wallentin L, Ben-Yehuda O, van Es GA, Simonton CA, Stone GW.. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial. EuroIntervention 2016;12:861–872.
    1. Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, Van' T Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF.. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213–224.
    1. Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, 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, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J.. Use of the instantaneous wave-free ratio or fractional flow reserve in PCI. N Engl J Med 2017;376:1824–1834.
    1. Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O.. Instantaneous wave-free ratio versus fractional flow reserve to guide PCI. N Engl J Med 2017;376:1813–1823.
    1. Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, Siebert U.. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation 2010;122:2545–2550.
    1. Otsuka F, Vorpahl M, Nakano M, Foerst J, Newell JB, Sakakura K, Kutys R, Ladich E, Finn AV, Kolodgie FD, Virmani R.. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans. Circulation 2014;129:211–223.
    1. Wang JC, Normand SL, Mauri L, Kuntz RE.. Coronary artery spatial distribution of acute myocardial infarction occlusions. Circulation 2004;110:278–284.
    1. Taggart DP, Thomas B.. Ferguson Lecture. Coronary artery bypass grafting is still the best treatment for multivessel and left main disease, but patients need to know. Ann Thorac Surg 2006;82:1966–1975.
    1. Maeremans J, Walsh S, Knaapen P, Spratt JC, Avran A, Hanratty CG, Faurie B, Agostoni P, Bressollette E, Kayaert P, Bagnall AJ, Egred M, Smith D, Chase A, McEntegart MB, Smith WH, Harcombe A, Kelly P, Irving J, Smith EJ, Strange JW, Dens J.. The hybrid algorithm for treating chronic total occlusions in Europe: the RECHARGE Registry. J Am Coll Cardiol 2016;68:1958–1970.
    1. Gomez-Lara J, Teruel L, Homs S, Ferreiro JL, Romaguera R, Roura G, Sanchez-Elvira G, Jara F, Brugaletta S, Gomez-Hospital JA, Cequier A.. Lumen enlargement of the coronary segments located distal to chronic total occlusions successfully treated with drug-eluting stents at follow-up. EuroIntervention 2014;9:1181–1188.
    1. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BR, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR.. Third universal definition of myocardial infarction. J Am Coll Cardiol 2012;60:1581–1598.

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