Sinergia tra PCI con TAXUS e cardiochirurgia: sopravvivenza estesa SYNTAX (SYNTAXES)
28 gennaio 2020 aggiornato da: Stuart Head, Erasmus Medical Center
Uno studio retrospettivo guidato dai ricercatori per confrontare i dati di sopravvivenza a lungo termine (follow-up a 10 anni) di pazienti con malattia coronarica (CAD), precedentemente arruolati nello studio SYNTAX, che sono stati randomizzati a intervento coronarico percutaneo (PCI) utilizzando uno stent a rilascio di farmaco (DES) di paclitaxel (TAXUS) o un bypass coronarico (CABG).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
2636
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 21 anni a 100 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Ai pazienti arruolati nello studio SYNTAX e nei registri doveva essere diagnosticata una malattia coronarica a tre vasi (3VD) o principale sinistra (LM).
I vasi (diametro ≥1,5 mm e stenosi significativa > 50%) ritenuti importanti da rivascolarizzare sono stati determinati dall'Heart Team prima della randomizzazione.
Il gruppo di 3VD è costituito da pazienti con stenosi significativa nei vasi che riforniscono tutti e tre i principali territori epicardici in assenza di malattia LM, come determinato dai ricercatori del sito.
Il gruppo di pazienti con malattia LM è costituito da pazienti con una stenosi significativa dell'arteria coronaria principale sinistra, indipendentemente dalla malattia vascolare aggiuntiva.
Descrizione
Pazienti che sono stati precedentemente arruolati nello studio SYNTAX (pazienti randomizzati e registrati)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Pazienti CABG randomizzati
Pazienti che sono stati randomizzati a sottoporsi a CABG.
|
Nessun intervento avrà luogo per questo studio retrospettivo e osservazionale.
|
|
Pazienti PCI randomizzati
Pazienti che sono stati randomizzati a sottoporsi a PCI.
|
Nessun intervento avrà luogo per questo studio retrospettivo e osservazionale.
|
|
Registro CABG
I pazienti per i quali era adatta una sola opzione terapeutica sono stati inclusi in un registro parallelo e nidificato: il registro CABG per i pazienti non idonei al PCI.
|
Nessun intervento avrà luogo per questo studio retrospettivo e osservazionale.
|
|
Registro PCI
I pazienti per i quali era adatta una sola opzione terapeutica sono stati inclusi in un registro parallelo e nidificato: il registro PCI per i pazienti non idonei al CABG.
|
Nessun intervento avrà luogo per questo studio retrospettivo e osservazionale.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stato di sopravvivenza a lungo termine
Lasso di tempo: 10 anni
|
Morte per tutte le cause
|
10 anni
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Causa di morte
Lasso di tempo: 10 anni
|
Morte per causa specifica, distinta in morte cardiovascolare e non cardiovascolare con cause specifiche per morte cardiovascolare.
|
10 anni
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: A. Pieter Kappetein, MD, PhD, Erasmus Medical Center
- Investigatore principale: Friedrick W. Mohr, MD, PhD, German Heart Center, Leipzig, Germany
- Investigatore principale: Patrick W.J.C. Serruys, MD, PhD, Imperial College London
- Investigatore principale: Michael J. Mack, MD, PhD, Baylor Scott & White Health, Plano, TX, United States
- Investigatore principale: David R. Holmes, MD, Mayo Clinic, Rochester, MN, United States
- Investigatore principale: Marie-Claude Morice, MD, ICPS Ramsay-Generale de Sante, Massy, France
- Investigatore principale: Piroze M. Davierwala, MD, German Heart Center, Leipzig, Germany
- Investigatore principale: Stuart J. Head, MD, PhD, Erasmus Medical Center
- Cattedra di studio: Daniel J.F.M. Thuijs, MD, Erasmus Medical Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Farooq V, Serruys PW, Garcia-Garcia HM, Zhang Y, Bourantas CV, Holmes DR, Mack M, Feldman T, Morice MC, Stahle E, James S, Colombo A, Diletti R, Papafaklis MI, de Vries T, Morel MA, van Es GA, Mohr FW, Dawkins KD, Kappetein AP, Sianos G, Boersma E. The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. J Am Coll Cardiol. 2013 Jan 22;61(3):282-94. doi: 10.1016/j.jacc.2012.10.017. Epub 2012 Dec 19.
- Farooq V, Girasis C, Magro M, Onuma Y, Morel MA, Heo JH, Garcia-Garcia H, Kappetein AP, van den Brand M, Holmes DR, Mack M, Feldman T, Colombo A, Stahle E, James S, Carrie D, Fournial G, van Es GA, Dawkins KD, Mohr FW, Morice MC, Serruys PW. The CABG SYNTAX Score - an angiographic tool to grade the complexity of coronary disease following coronary artery bypass graft surgery: from the SYNTAX Left Main Angiographic (SYNTAX-LE MANS) substudy. EuroIntervention. 2013 Mar;8(11):1277-85. doi: 10.4244/EIJV8I11A196.
- Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kappetein AP, Dawkins KD, Mohr FW, Morice MC, Mack MJ, Russell ME, Pomar J, Serruys PW. Current percutaneous coronary intervention and coronary artery bypass grafting practices for three-vessel and left main coronary artery disease. Insights from the SYNTAX run-in phase. Eur J Cardiothorac Surg. 2006 Apr;29(4):486-91. doi: 10.1016/j.ejcts.2006.01.047. Epub 2006 Feb 23.
- 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 Jun;151(6):1194-204. doi: 10.1016/j.ahj.2005.07.017.
- 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 May;5(1):50-6. doi: 10.4244/eijv5i1a9.
- 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.
- Girasis C, Serruys PW, Onuma Y, Colombo A, Holmes DR Jr, Feldman TE, Bass EJ, Leadley K, Dawkins KD, Morice MC. 3-Dimensional bifurcation angle analysis in patients with left main disease: a substudy of the SYNTAX trial (SYNergy Between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery). JACC Cardiovasc Interv. 2010 Jan;3(1):41-8. doi: 10.1016/j.jcin.2009.10.019.
- Garg S, Girasis C, Sarno G, Goedhart D, Morel MA, Garcia-Garcia HM, Bressers M, van Es GA, Serruys PW; SYNTAX trial investigators. The SYNTAX score revisited: a reassessment of the SYNTAX score reproducibility. Catheter Cardiovasc Interv. 2010 May 1;75(6):946-52. doi: 10.1002/ccd.22372.
- 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.
- 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.
- Cohen DJ, Lavelle TA, Van Hout B, Li H, Lei Y, Robertus K, Pinto D, Magnuson EA, Mcgarry TF, Lucas SK, Horwitz PA, Henry CA, Serruys PW, Mohr FW, Kappetein AP. Economic outcomes of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with left main or three-vessel coronary artery disease: one-year results from the SYNTAX trial. Catheter Cardiovasc Interv. 2012 Feb 1;79(2):198-209. doi: 10.1002/ccd.23147. Epub 2011 Sep 26.
- Kappetein AP, Feldman TE, Mack MJ, Morice MC, Holmes DR, Stahle E, Dawkins KD, Mohr FW, Serruys PW, Colombo A. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011 Sep;32(17):2125-34. doi: 10.1093/eurheartj/ehr213. Epub 2011 Jun 22.
- 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.
- Mack MJ, Banning AP, Serruys PW, Morice MC, Taeymans Y, Van Nooten G, Possati G, Crea F, Hood KL, Leadley K, Dawkins KD, Kappetein AP. Bypass versus drug-eluting stents at three years in SYNTAX patients with diabetes mellitus or metabolic syndrome. Ann Thorac Surg. 2011 Dec;92(6):2140-6. doi: 10.1016/j.athoracsur.2011.06.028. Epub 2011 Oct 2.
- Head SJ, Mack MJ, Holmes DR Jr, Mohr FW, Morice MC, Serruys PW, Kappetein AP. Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data. Eur J Cardiothorac Surg. 2012 Mar;41(3):535-41. doi: 10.1093/ejcts/ezr105. Epub 2011 Dec 21.
- 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.
- 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.
- 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.
- Farooq V, Vergouwe Y, Raber L, Vranckx P, Garcia-Garcia H, Diletti R, Kappetein AP, Morel MA, de Vries T, Swart M, Valgimigli M, Dawkins KD, Windecker S, Steyerberg EW, Serruys PW. Combined anatomical and clinical factors for the long-term risk stratification of patients undergoing percutaneous coronary intervention: the Logistic Clinical SYNTAX score. Eur Heart J. 2012 Dec;33(24):3098-104. doi: 10.1093/eurheartj/ehs295. Epub 2012 Oct 9.
- Farooq V, Serruys PW, Bourantas C, Vranckx P, Diletti R, Garcia Garcia HM, Holmes DR, Kappetein AP, Mack M, Feldman T, Morice MC, Colombo A, Morel MA, de Vries T, van Es GA, Steyerberg EW, Dawkins KD, Mohr FW, James S, Stahle E. Incidence and multivariable correlates of long-term mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial. Eur Heart J. 2012 Dec;33(24):3105-13. doi: 10.1093/eurheartj/ehs367. Epub 2012 Oct 26.
- Kappetein AP, Head SJ, Morice MC, Banning AP, Serruys PW, Mohr FW, Dawkins KD, Mack MJ; SYNTAX Investigators. Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the SYNTAX trial. Eur J Cardiothorac Surg. 2013 May;43(5):1006-13. doi: 10.1093/ejcts/ezt017. Epub 2013 Feb 14.
- 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, Girasis C, Magro M, Onuma Y, Morel MA, Heo JH, Garcia-Garcia HM, Kappetein AP, van den Brand M, Holmes DR, Mack M, Feldman T, Colombo A, Stahle E, James S, Carrie D, Fournial G, van Es GA, Dawkins KD, Mohr FW, Morice MC, Serruys PW. The coronary artery bypass graft SYNTAX Score: final five-year outcomes from the SYNTAX-LE MANS left main angiographic substudy. EuroIntervention. 2013 Dec;9(8):1009-10. doi: 10.4244/EIJV9I8A170. No abstract available.
- Farooq V, Serruys PW, Vranckx P, Bourantas CV, Girasis C, Holmes DR, Kappetein AP, Mack M, Feldman T, Morice MC, Colombo A, Morel MA, de Vries T, Dawkins KD, Mohr FW, James S, Stahle E. Incidence, correlates, and significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous based revascularisation: a substudy from the Synergy between Percutaneous Coronary Interventions with Taxus and Cardiac Surgery (SYNTAX) Trial. Int J Cardiol. 2013 Oct 15;168(6):5287-92. doi: 10.1016/j.ijcard.2013.08.013. Epub 2013 Aug 14.
- Farooq V, Serruys PW, Zhang Y, Mack M, Stahle E, Holmes DR, Feldman T, Morice MC, Colombo A, Bourantas CV, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW. Short-term and long-term clinical impact of stent thrombosis and graft occlusion in the SYNTAX trial at 5 years: Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery trial. J Am Coll Cardiol. 2013 Dec 24;62(25):2360-2369. doi: 10.1016/j.jacc.2013.07.106. Epub 2013 Oct 16.
- Girasis C, Farooq V, Diletti R, Muramatsu T, Bourantas CV, Onuma Y, Holmes DR, Feldman TE, Morel MA, van Es GA, Dawkins KD, Morice MC, Serruys PW. Impact of 3-dimensional bifurcation angle on 5-year outcome of patients after percutaneous coronary intervention for left main coronary artery disease: a substudy of the SYNTAX trial (synergy between percutaneous coronary intervention with taxus and cardiac surgery). JACC Cardiovasc Interv. 2013 Dec;6(12):1250-60. doi: 10.1016/j.jcin.2013.08.009.
- 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.
- 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.
- Thuijs DJFM, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Holmes DR Jr, Curzen N, Davierwala P, Noack T, Milojevic M, Dawkins KD, da Costa BR, Juni P, Head SJ; SYNTAX Extended Survival Investigators. 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. Lancet. 2019 Oct 12;394(10206):1325-1334. doi: 10.1016/S0140-6736(19)31997-X. Epub 2019 Sep 2. Erratum In: Lancet. 2020 Mar 14;395(10227):870.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 dicembre 2016
Completamento primario (Effettivo)
8 agosto 2019
Completamento dello studio (Effettivo)
8 agosto 2019
Date di iscrizione allo studio
Primo inviato
25 gennaio 2018
Primo inviato che soddisfa i criteri di controllo qualità
25 gennaio 2018
Primo Inserito (Effettivo)
31 gennaio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 gennaio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 gennaio 2020
Ultimo verificato
1 gennaio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MEC-2016-716
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Disfunsione dell'arteria coronaria
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I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioReclutamentoCoronary Artery DiseaseItalia
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