SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries (SYNTAX)

• ClinicalTrials.gov Identifier: NCT00114972
• Recruitment Status: Unknown
• First Posted: June 21, 2005
• Results First Posted: June 23, 2010
• Last Update Posted: June 23, 2010
• Sponsor: Boston Scientific Corporation
• Collaborator: Cardialysis BV
• Information provided by: Boston Scientific Corporation

Tracking Information

• First Submitted Date: June 20, 2005
• First Posted Date: June 21, 2005
• Results First Submitted Date: March 27, 2009
• Results First Posted Date: June 23, 2010
• Last Update Posted Date: June 23, 2010
• Study Start Date: March 2005
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2010)

• Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 12 months post enrollment ]
  Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).
• 12-month Composite Safety Endpoint. [ Time Frame: 12 months after enrollment ]
  Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
• Repeat Revascularization (PCI and/or CABG). [ Time Frame: 12 Months post enrollment ]
  Number of participants with repeat revascularization (PCI and/or CABG).

Original Primary Outcome Measures (submitted: June 23, 2005)

• 12-month MACCE rate. MACCE is defined as:
• *all cause death
• *cerebrovascular event (such as stroke)
• *documented myocardial infarction
• *repeat revascularization (PCI and/or CABG)

Current Secondary Outcome Measures (submitted: May 27, 2010)

• Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation. [ Time Frame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation ]
  Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.
• Individual Components of MACCE at 1 Month Post-procedure. [ Time Frame: 1 month after procedure ]
  Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
• Individual Components of MACCE at 6 Months Post-allocation. [ Time Frame: 6 months post allocation ]
  Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
• Individual Components of MACCE at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ]
  Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
• Freedom From MACCE and Its Components at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ]
  Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).
• Freedom From MACCE and Its Components at 3 Years Post-allocation [ Time Frame: 3 years post allocation ]
• Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ]
• Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation [ Time Frame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation ]
• Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ]
• The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible) [ Time Frame: 5 Years ]

Original Secondary Outcome Measures (submitted: June 23, 2005)

• Overall MACCE rate at 1 month post-procedure and at 6 months, 3 and 5 years post-allocation
• Rates of the individual components of MACCE at 1 month post-procedure and at 6 months, 1, 3 and 5 years post-allocation
• Freedom from MACCE and its components at 1, 3 and 5 years post-allocation
• Quality of life at 1 month post-procedure and at 6 months, 1, 3 and 5 years post-allocation
• Cost and cost-effectiveness at 1, 3 and 5 years post-allocation
• The characteristics (including co-morbidity and coronary vascular lesion complexity scoring referred to as the SYNTAX score) of the following: PCI versus CABG randomized cohort, PCI registry cohort (CABG ineligible), CABG registry cohort (PCI ineligible)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
• Official Title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
• Brief Summary: The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).

Detailed Description

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Artery Disease

Intervention

• Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
  Drug Eluting Stent
  Other Names:

  • Percutaneous coronary intervention
  • Paclitaxel eluting stent
  • 3 vessel disease
  • Left main stem
• Procedure: Coronary Artery Bypass Surgery
  Coronary Artery Bypass Surgery
  Other Names:

  • Coronary artery disease
  • Coronary artery bypass graft
  • Left Main coronary artery

Study Arms

• Experimental: PCI with DES
  Intervention: Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
• Active Comparator: CABG (coronary artery bypass graft)
  Coronary Artery Bypass Graft
  Intervention: Procedure: Coronary Artery Bypass Surgery

Publications *

• Ono M, Serruys PW, Garg S, Kawashima H, Gao C, Hara H, Lunardi M, Wang R, O'Leary N, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Noack T, Mohr FW, Davierwala PM, Spertus JA, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. Effect of Patient-Reported Preprocedural Physical and Mental Health on 10-Year Mortality After Percutaneous or Surgical Coronary Revascularization. Circulation. 2022 Oct 25;146(17):1268-1280. doi: 10.1161/CIRCULATIONAHA.121.057021. Epub 2022 Jul 18.
• Ono M, Hara H, Gao C, Kawashima H, Wang R, O'Leary N, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes D, Morice MC, Head S, Kappetein AP, Noack T, Davierwala PM, Mohr FW, Garg S, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Mortality after multivessel revascularisation involving the proximal left anterior descending artery. Heart. 2022 Oct 28;108(22):1784-1791. doi: 10.1136/heartjnl-2022-320934.
• Ninomiya K, Serruys PW, Garg S, Gao C, Masuda S, Lunardi M, Lassen JF, Banning AP, Colombo A, Burzotta F, Morice MC, Mack MJ, Holmes DR, Davierwala PM, Thuijs DJFM, van Klaveren D, Onuma Y; SYNTAX Extended Survival Investigators. Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1231-1242. doi: 10.1016/j.jcin.2022.04.025. Epub 2022 May 17.
• Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.
• Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification. JACC Cardiovasc Interv. 2022 Jan 24;15(2):193-204. doi: 10.1016/j.jcin.2021.10.026. Epub 2021 Dec 29.
• Hara H, Kawashima H, Ono M, Takahashi K, Mack MJ, Holmes DR Jr, Morice MC, Davierwala PM, Mohr FW, Thuijs DJFM, Kappetein AP, O'Leary N, van Klaveren D, Onuma Y, Serruys PW. Impact of preprocedural biological markers on 10-year mortality in the SYNTAXES trial. EuroIntervention. 2022 Apr 22;17(18):1477-1487. doi: 10.4244/EIJ-D-21-00415.
• Thuijs DJFM, Davierwala P, Milojevic M, Deo SV, Noack T, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle LEGE, Verberkmoes NJ, Holmes DR, Head SJ; SYNTAX Extended Survival Investigators. Long-term survival after coronary bypass surgery with multiple versus single arterial grafts. Eur J Cardiothorac Surg. 2022 Mar 24;61(4):925-933. doi: 10.1093/ejcts/ezab392.
• Wang R, Garg S, Gao C, Kawashima H, Ono M, Hara H, van Geuns RJ, Morice MC, Davierwala PM, Kappetein AP, Holmes DR, Wijns W, Tao L, Onuma Y, Serruys PW. Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease. Clin Res Cardiol. 2021 Oct;110(10):1680-1691. doi: 10.1007/s00392-021-01922-y. Epub 2021 Aug 25.
• Davierwala PM, Gao C, Thuijs DJFM, Wang R, Hara H, Ono M, Noack T, Garg S, O'leary N, Milojevic M, Kappetein AP, Morice MC, Mack MJ, van Geuns RJ, Holmes DR, Gaudino M, Taggart DP, Onuma Y, Mohr FW, Serruys PW; SYNTAX Extended Survival Investigators. Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease. Eur Heart J. 2022 Mar 31;43(13):1334-1344. doi: 10.1093/eurheartj/ehab537.
• Wang R, Serruys PW, Gao C, Hara H, Takahashi K, Ono M, Kawashima H, O'leary N, Holmes DR, Witkowski A, Curzen N, Burzotta F, James S, van Geuns RJ, Kappetein AP, Morel MA, Head SJ, Thuijs DJFM, Davierwala PM, O'Brien T, Fuster V, Garg S, Onuma Y. Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease. Eur Heart J. 2021 Dec 28;43(1):56-67. doi: 10.1093/eurheartj/ehab441.
• Ono M, Kawashima H, Hara H, Mancone M, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Noack T, Mohr FW, Davierwala PM, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Impact of major infections on 10-year mortality after revascularization in patients with complex coronary artery disease. Int J Cardiol. 2021 Oct 15;341:9-12. doi: 10.1016/j.ijcard.2021.08.013. Epub 2021 Aug 8.
• Kawashima H, Serruys PW, Ono M, Hara H, O'Leary N, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Sharif F, McEvoy JW, Onuma Y; SYNTAX Extended Survival Investigators. Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization. J Am Coll Cardiol. 2021 Jul 6;78(1):27-38. doi: 10.1016/j.jacc.2021.04.087.
• Ono M, Serruys PW, Hara H, Kawashima H, Gao C, Wang R, Takahashi K, O'Leary N, Wykrzykowska JJ, Sharif F, Piek JJ, Garg S, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Davierwala PM, Mohr FW, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease. J Am Coll Cardiol. 2021 Jun 8;77(22):2761-2773. doi: 10.1016/j.jacc.2021.04.016.
• Ono M, Kawashima H, Hara H, O'Leary N, Gao C, Wang R, Takahashi K, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Friedrich MW, Davierwala PM, McEvoy JW, Onuma Y, Serruys PW. Impact of Body Composition Indices on Ten-year Mortality After Revascularization of Complex Coronary Artery Disease (From the Syntax Extended Survival Trial). Am J Cardiol. 2021 Jul 15;151:30-38. doi: 10.1016/j.amjcard.2021.04.008. Epub 2021 May 26.
• Takahashi K, Serruys PW, Gao C, Ono M, Wang R, Thuijs DJFM, Mack MJ, Curzen N, Mohr FW, Davierwala P, Milojevic M, Wykrzykowska JJ, de Winter RJ, Sharif F, Onuma Y, Head SJ, Kappetein AP, Morice MC, Holmes DR Jr; SYNTAX Extended Survival Study Investigators. Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study. Circulation. 2021 Jul 13;144(2):96-109. doi: 10.1161/CIRCULATIONAHA.120.046289. Epub 2021 May 20.
• Wang R, Tomaniak M, Takahashi K, Gao C, Kawashima H, Hara H, Ono M, van Klaveren D, van Geuns RJ, Morice MC, Davierwala PM, Mack MJ, Witkowski A, Curzen N, Berti S, Burzotta F, James S, Kappetein AP, Head SJ, Thuijs DJFM, Mohr FW, Holmes DR, Tao L, Onuma Y, Serruys PW. Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study. Clin Res Cardiol. 2021 Jul;110(7):1083-1095. doi: 10.1007/s00392-021-01833-y. Epub 2021 Mar 12.
• Takahashi K, Thuijs DJFM, Gao C, Ono M, Holmes DR, Mack MJ, Morice MC, Mohr FW, Curzen N, Davierwala PM, Milojevic M, Dawkins KD, Wykrzykowska JJ, de Winter RJ, McEvoy JW, Onuma Y, Head SJ, Kappetein AP, Serruys PW; SYNTAX Extended Survival Study Investigators. Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization. Eur J Prev Cardiol. 2022 Mar 11;29(2):312-320. doi: 10.1093/eurjpc/zwaa089.
• Kawashima H, Takahashi K, Ono M, Hara H, Wang R, Gao C, Sharif F, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Serruys PW, Onuma Y; SYNTAX Extended Survival Investigators. Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions. J Am Coll Cardiol. 2021 Feb 9;77(5):529-540. doi: 10.1016/j.jacc.2020.11.055.
• Wang R, Takahashi K, Garg S, Thuijs DJFM, Kappetein AP, Mack MJ, Morice MC, Mohr FW, Curzen N, Davierwala P, Milojevic M, van Geuns RJ, Head SJ, Onuma Y, Holmes DR Jr, Serruys PW. Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study. Clin Res Cardiol. 2021 Oct;110(10):1543-1553. doi: 10.1007/s00392-020-01802-x. Epub 2021 Jan 30.
• Hara H, Serruys PW, Takahashi K, Kawashima H, Ono M, Gao C, Wang R, Mohr FW, Holmes DR, Davierwala PM, Head SJ, Thuijs DJFM, Milojevic M, Kappetein AP, Garg S, Onuma Y, Mack MJ; SYNTAX Extended Survival Investigators. Impact of Peri-Procedural Myocardial Infarction on Outcomes After Revascularization. J Am Coll Cardiol. 2020 Oct 6;76(14):1622-1639. doi: 10.1016/j.jacc.2020.08.009.
• Hara H, Takahashi K, van Klaveren D, Wang R, Garg S, Ono M, Kawashima H, Gao C, Mack M, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Onuma Y, Noack T, Mohr FW, Davierwala PM, Serruys PW; SYNTAX Extended Survival Investigators. Sex Differences in All-Cause Mortality in the Decade Following Complex Coronary Revascularization. J Am Coll Cardiol. 2020 Aug 25;76(8):889-899. doi: 10.1016/j.jacc.2020.06.066.
• Modolo R, Chichareon P, Kogame N, Dressler O, Crowley A, Ben-Yehuda O, Puskas J, Banning A, Taggart DP, Kappetein AP, Sabik JA, Onuma Y, Stone GW, Serruys PW. Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease. J Am Coll Cardiol. 2019 Apr 23;73(15):1877-1886. doi: 10.1016/j.jacc.2018.12.090.
• Milojevic M, Head SJ, Mack MJ, Mohr FW, Morice MC, Dawkins KD, Holmes DR Jr, Serruys PW, Kappetein AP. Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):445-453. doi: 10.1093/ejcts/ezx104.
• Sotomi Y, Onuma Y, Cavalcante R, Ahn JM, Lee CW, van Klaveren D, de Winter RJ, Wykrzykowska JJ, Farooq V, Morice MC, Steyerberg EW, Park SJ, Serruys PW. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017 May;10(5):e005027. doi: 10.1161/CIRCINTERVENTIONS.117.005027.
• Abdallah MS, Wang K, Magnuson EA, Osnabrugge RL, Kappetein AP, Morice MC, Mohr FA, Serruys PW, Cohen DJ; SYNTAX Trial Investigators. Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease. J Am Coll Cardiol. 2017 Apr 25;69(16):2039-2050. doi: 10.1016/j.jacc.2017.02.031.
• Cavalcante R, Sotomi Y, Zeng Y, Lee CW, Ahn JM, Collet C, Tenekecioglu E, Suwannasom P, Onuma Y, Park SJ, Serruys PW. Coronary bypass surgery versus stenting in multivessel disease involving the proximal left anterior descending coronary artery. Heart. 2017 Mar;103(6):428-433. doi: 10.1136/heartjnl-2016-309720. Epub 2016 Sep 20.
• Migliorini A, Valenti R, Parodi G, Vergara R, Buonamici P, Cerisano G, Carrabba N, Antoniucci D. Angiographic and Clinical Outcomes After Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity. JACC Cardiovasc Interv. 2016 May 23;9(10):1001-7. doi: 10.1016/j.jcin.2016.02.016.
• Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of Death Following PCI Versus CABG in Complex CAD: 5-Year Follow-Up of SYNTAX. J Am Coll Cardiol. 2016 Jan 5;67(1):42-55. doi: 10.1016/j.jacc.2015.10.043.
• Osnabrugge RL, Magnuson EA, Serruys PW, Campos CM, Wang K, van Klaveren D, Farooq V, Abdallah MS, Li H, Vilain KA, Steyerberg EW, Morice MC, Dawkins KD, Mohr FW, Kappetein AP, Cohen DJ; SYNTAX trial investigators. Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective. Heart. 2015 Dec;101(24):1980-8. doi: 10.1136/heartjnl-2015-307578. Epub 2015 Nov 9.
• Parasca CA, Head SJ, Mohr FW, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Colombo A, Dawkins KD, Serruys PW, Kappetein AP; SYNTAX Investigators. The impact of a second arterial graft on 5-year outcomes after coronary artery bypass grafting in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Trial and Registry. J Thorac Cardiovasc Surg. 2015 Sep;150(3):597-606.e2. doi: 10.1016/j.jtcvs.2015.05.010. Epub 2015 May 8.
• Iqbal J, Zhang YJ, Holmes DR, Morice MC, Mack MJ, Kappetein AP, Feldman T, Stahle E, Escaned J, Banning AP, Gunn JP, Colombo A, Steyerberg EW, Mohr FW, Serruys PW. Optimal medical therapy improves clinical outcomes in patients undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting: insights from the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial at the 5-year follow-up. Circulation. 2015 Apr 7;131(14):1269-77. doi: 10.1161/CIRCULATIONAHA.114.013042. Epub 2015 Feb 24.
• Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.
• Zhang YJ, Iqbal J, van Klaveren D, Campos CM, Holmes DR, Kappetein AP, Morice MC, Banning AP, Grech ED, Bourantas CV, Onuma Y, Garcia-Garcia HM, Mack MJ, Colombo A, Mohr FW, Steyerberg EW, Serruys PW. Smoking is associated with adverse clinical outcomes in patients undergoing revascularization with PCI or CABG: the SYNTAX trial at 5-year follow-up. J Am Coll Cardiol. 2015 Mar 24;65(11):1107-15. doi: 10.1016/j.jacc.2015.01.014.
• Cohen DJ, Osnabrugge RL, Magnuson EA, Wang K, Li H, Chinnakondepalli K, Pinto D, Abdallah MS, Vilain KA, Morice MC, Dawkins KD, Kappetein AP, Mohr FW, Serruys PW; SYNTAX Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2014 Sep 30;130(14):1146-57. doi: 10.1161/CIRCULATIONAHA.114.009985. Epub 2014 Aug 1.
• Zhang YJ, Iqbal J, Campos CM, Klaveren DV, Bourantas CV, Dawkins KD, Banning AP, Escaned J, de Vries T, Morel MA, Farooq V, Onuma Y, Garcia-Garcia HM, Stone GW, Steyerberg EW, Mohr FW, Serruys PW. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. J Am Coll Cardiol. 2014 Aug 5;64(5):423-32. doi: 10.1016/j.jacc.2014.05.022.
• Head SJ, Davierwala PM, Serruys PW, Redwood SR, Colombo A, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Stahle E, Underwood P, Dawkins KD, Kappetein AP, Mohr FW. Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. Eur Heart J. 2014 Oct 21;35(40):2821-30. doi: 10.1093/eurheartj/ehu213. Epub 2014 May 21.
• Morice MC, Serruys PW, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR, Choi JW, Ruzyllo W, Religa G, Huang J, Roy K, Dawkins KD, Mohr F. Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial. Circulation. 2014 Jun 10;129(23):2388-94. doi: 10.1161/CIRCULATIONAHA.113.006689. Epub 2014 Apr 3.
• Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Juni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.
• Farooq V, Serruys PW, Bourantas CV, Zhang Y, Muramatsu T, Feldman T, Holmes DR, Mack M, Morice MC, Stahle E, Colombo A, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW. Quantification of incomplete revascularization and its association with five-year mortality in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial validation of the residual SYNTAX score. Circulation. 2013 Jul 9;128(2):141-51. doi: 10.1161/CIRCULATIONAHA.113.001803. Epub 2013 Jun 13.
• Mack MJ, Head SJ, Holmes DR Jr, Stahle E, Feldman TE, Colombo A, Morice MC, Unger F, Erglis A, Stoler R, Dawkins KD, Serruys PW, Mohr FW, Kappetein AP. Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease. JACC Cardiovasc Interv. 2013 Apr;6(4):344-54. doi: 10.1016/j.jcin.2012.11.010. Epub 2013 Mar 20.
• 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 Feb 23;381(9867):639-50. doi: 10.1016/S0140-6736(13)60108-7.
• 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 Feb 23;381(9867):629-38. doi: 10.1016/S0140-6736(13)60141-5.
• Head SJ, Holmes DR Jr, Mack MJ, Serruys PW, Mohr FW, Morice MC, Colombo A, Kappetein AP; SYNTAX Investigators. Risk profile and 3-year outcomes from the SYNTAX percutaneous coronary intervention and coronary artery bypass grafting nested registries. JACC Cardiovasc Interv. 2012 Jun;5(6):618-25. doi: 10.1016/j.jcin.2012.02.013.
• 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 Jun;5(6):606-17. doi: 10.1016/j.jcin.2012.03.016.
• Arnold SV, Magnuson EA, Wang K, Serruys PW, Kappetein AP, Mohr FW, Cohen DJ; SYNTAX Investigators. Do differences in repeat revascularization explain the antianginal benefits of bypass surgery versus percutaneous coronary intervention?: implications for future treatment comparisons. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):267-75. doi: 10.1161/CIRCOUTCOMES.111.964585. Epub 2012 Apr 10.
• Morice MC, Feldman TE, Mack MJ, Stahle E, Holmes DR, Colombo A, Morel MA, van den Brand M, Serruys PW, Mohr F, Carrie D, Fournial G, James S, Leadley K, Dawkins KD, Kappetein AP. Angiographic outcomes following stenting or coronary artery bypass surgery of the left main coronary artery: fifteen-month outcomes from the synergy between PCI with TAXUS express and cardiac surgery left main angiographic substudy (SYNTAX-LE MANS). EuroIntervention. 2011 Oct 30;7(6):670-9. doi: 10.4244/EIJV7I6A109.
• Cohen DJ, Van Hout B, Serruys PW, Mohr FW, Macaya C, den Heijer P, Vrakking MM, Wang K, Mahoney EM, Audi S, Leadley K, Dawkins KD, Kappetein AP; Synergy between PCI with Taxus and Cardiac Surgery Investigators. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011 Mar 17;364(11):1016-26. doi: 10.1056/NEJMoa1001508.
• Mohr FW, Rastan AJ, Serruys PW, Kappetein AP, Holmes DR, Pomar JL, Westaby S, Leadley K, Dawkins KD, Mack MJ. Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years. J Thorac Cardiovasc Surg. 2011 Jan;141(1):130-40. doi: 10.1016/j.jtcvs.2010.07.094.
• Morice MC, Serruys PW, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR, Torracca L, van Es GA, Leadley K, Dawkins KD, Mohr F. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2010 Jun 22;121(24):2645-53. doi: 10.1161/CIRCULATIONAHA.109.899211. Epub 2010 Jun 7.
• Banning AP, Westaby S, Morice MC, Kappetein AP, Mohr FW, Berti S, Glauber M, Kellett MA, Kramer RS, Leadley K, Dawkins KD, Serruys PW. Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents. J Am Coll Cardiol. 2010 Mar 16;55(11):1067-75. doi: 10.1016/j.jacc.2009.09.057. Epub 2010 Jan 14.
• Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: February 22, 2006): 1800
• Original Enrollment (submitted: June 23, 2005): 1500
• Estimated Study Completion Date: May 2012
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
• De novo lesions with at least 50% stenosis
• Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria:

• Prior PCI or CABG
• Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)
• Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
• Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
• Inability to give informed consent due to mental condition, mental retardation, or language barrier

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT00114972
• Other Study ID Numbers: S2024; 90169394
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nic Van Dyck, Boston Scientific
• Original Responsible Party: Not Provided
• Current Study Sponsor: Boston Scientific Corporation
• Original Study Sponsor: Same as current
• Collaborators: Cardialysis BV

Investigators

• Principal Investigator: Patrick W. Serruys, MD, PhD; Erasmus Medical Center
• Principal Investigator: Friedrich W Mohr, MD; Heart Center Leipzig - University Hospital
• Study Director: Monika Hanisch, PhD; Boston Scientific Corporation

• PRS Account: Boston Scientific Corporation
• Verification Date: May 2010