July 21, 2020
 
 
Dear Professors Licht and Pagano,
 
We are writing to share our concerns with regards to the latest events surrounding the EXCEL trial analysis and its implication for clinical practice guidelines and for the treatment of patients with left main coronary artery disease.
 
On July 16th 2020, the NEJM published a letter in which the EXCEL trial leadership present the incidence of myocardial infarction defined by the 3rd Universal Definition at 5-year follow-up. The new data show a significantly higher risk for this complication in the PCI group. This is in clear contrast with the original EXCEL publication that used the protocol definition of myocardial infarction and reported a similar incidence in the two arms.
 
This finding raises several questions:

1. In the EXCEL protocol the analysis of myocardial infarction using the 3rd Universal Definition was a pre-specified secondary end point. Why was this not analyzed and described at the time of the original manuscript?
2. Why did the authors repeatedly claim that re-adjudication of the myocardial infarction data using the Universal Definition was impossible?
3. Were the ESC-EACTS Myocardial Revascularization Guidelines adversely influenced by this important data omission?
4. Have there been any adverse consequences to patient care as a result?

We request that the ESC-EACTS Myocardial Revascularization Guidelines be reviewed as a matter of real urgency. In addition, we would ask that you work with the major surgical and cardiological organizations collaboratively to provide accountability for clinical trials conduct and interpretation.  This is extremely important to safeguard our patients.

Finally, with regards to the EXCEL trial, it is essential that the data be made publicly available for truly independent scrutiny and the results of the original reports should be amended with the addition of the Universal Definition data.

We trust that EACTS leadership will be sympathetic to this “Call for Action”.
With regards

1. Almeida Rui MS – Universidade Estadual do Oeste do Paraná, Cascavel, PR, Brazil
2. Angiolillo Dominick – University of Florida College of Medicine, Jacksonville, FL, USA
3. Arai Hirokuni - Tokyo Medical and Dental University, Tokyo, Japan
4. Asai Tohru - Shiga University of Medical Science, Otsu, Shiga, Japan
5. Bakaeen Faisal - Cleveland Clinic, Cleveland OH, USA
6. Balkhy Husam - The University of Chicago Medicine & Biological Sciences, Chicago, IL, USA
7. Benedetto Umberto – Bristol Heart Institute, Bristol, United Kingdom
8. Biondi-Zoccai Giuseppe - Sapienza University of Rome, Rome, Italy
9. Boening Andreas - Justus-Liebig University Gießen, Gießen, Germany
10. Brophy James - McGill University, Montréal, Quebec, Canada
11. Calafiore Antonio Maria - John Paul II Foundation, Campobasso, Italy
12. Chikwe Joanna - Cedars-Sinai Medical Center, Los Angeles, CA, USA
13. Davierwala Piroze - Leipzig Heart Center, Leipzig, Germany
14. Dayan Victor - Instituto Nacional de Cirugía Cardíaca, Montevideo, Uruguay
15. Doenst Torsten - Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany
16. Flather Marcus - Norfolk and Norwich University Hospitals, Norwich, UK
17. Fremes Stephen - University of Toronto, Toronto, Canada
18. Gaudino Mario - Weill Cornell Medicine, New York, NY, USA
19. Girardi Leonard N - Weill Cornell Medicine, New York, NY, USA
20. Glineur David - Ottawa Heart Institute, Ottawa, Canada
21. Gomes Walter - Universidade Federal de São Paulo, São Paulo, SP, Brazil
22. Grau Juan - Ottawa Heart Institute, Ottawa, Canada
23. Kim Ki-Bong - Seoul National University Hospital, Seoul, South Korea
24. Kofidis Theodoros – National University Heart Centre, Singapore, Singapore, Singapore
25. Kurlansky Paul A - Columbia University Medical Center, New York, NY, USA
26. Lall Kulvinder - St Bartholomew's Hospital, London, UK
27. Lamy Andre - McMaster University, Hamilton, Ontario, Canada
28. Lawton Jennifer- Johns Hopkins University School of Medicine, Baltimore, MD, USA
29. Lemma Massimo – Jilin Heart Hospital, Changchun, China
30. Lorusso Roberto - Maastricht University Medical Center, Maastricht, The Netherlands
31. Mandrola John - Baptist Health Louisville, Louisville, KY, USA
32. Menicanti Lorenzo - IRCCS Policlinico San Donato, San Donato Milanese, Italy
33. Myers Patrick - CHUV Lausanne University Hospital, Lausanne, Switzerland
34. Patel Nirav - Lenox Hill Hospital/Northwell Health, New York, NY, USA
35. Raja Shahzad Gull – Harefield Hospital, Harefield, Middlesex, United Kingdom
36. Royse Alistair - University of Melbourne, Melbourne, Australia
37. Ruel Marc - University of Ottawa Heart Institute, Ottawa, Ontario, Canada
38. Salerno Tomas – University of Miami/Jackson Memorial Hospital, Miami, FL, USA
39. Sandner Sigrid - Medical University Vienna, Wien, Austria
40. Schwann Thomas - University of Massachusetts-Baystate, Springfield, MA, USA
41. Sellke Frank - Rhode Island Hospital, Providence, RI, USA
42. Sergeant Paul - Katholieke Universiteit Leuven, Leuven, Belgium
43. Taggart David – University of Oxford, Oxford, United Kingdom
44. Tatoulis James – Royal Melbourne Hospital, Melbourne, Australia
45. Tranbaugh Robert F – Weill Cornell Medicine, New York, NY, USA
46. Vallely Michael - The Wexner Medical Center, The Ohio State University, Columbus, OH, USA
47. Voisine Pierre - Quebec Heart-Lung Institute, Quebec, Canada
48. Williams Matthew - University of Pennsylvania, Philadelphia, PA, USA
49. Zamvar Vipin - Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
50. Zhao Yuan - The Second Xiangya Hospital of CSU, Hunan, China
51. Zheng Zhe - Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
52. Zhu Yunpeng - Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China