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J Thorac Cardiovasc Surg 2004;127:300-301
© 2004 The American Association for Thoracic Surgery
Letter to the editor |
Bristol Heart Institute, Bristol Royal Infirmary, Bristol, United Kingdom
To the Editor:
We congratulate Puskas and colleagues1 on their prospective, randomized study assessing the efficacy of off-pump coronary artery bypass grafting (CABG) relative to conventional CABG techniques. We are pleased to see that their early in-hospital findings are similar to the results of the Beating Heart Against Cardioplegic Arrest Study (BHACAS) 1 and 2 trials conducted by our group.2 Indeed, since our first randomized study3 several others have been published, some with respectable sample sizes,4-5 and the Surgical Management of Arterial Revascularization Therapies (SMART) trial is the latest in this series. We appreciate that the available presence of all these trials somehow reduces the "visibility" of each of them, particularly if they are not the first or the largest.
Puskas and colleagues1 (a total of 17 authors of the SMART trial) in the introduction of their article state, "Moreover, most previous studies have failed to adequately address legitimate concerns about the completeness of revascularization provided or to document the quality of anastomoses." Furthermore, they state, "There have been no published reports comparing OPCAB versus CABG with CPB among randomly assigned patients unselected for coronary anatomy, ventricular function, or comorbidities." This is simply not the case.
The BHACAS 1 trial was the first ever randomized study, carried out between March 1997 and August 1998. The randomization rate was 32%, and all patients underwent complete coronary revascularization. The limited number of grafts per patient was the result of stringent selection criteria that excluded those who needed grafting of the distal branches of the circumflex artery, because this was regarded as too difficult at the beginning of our experience with off-pump CABG surgery.
After establishing the safety of the technique, we then moved to BHACAS 2 (September 1998 through November 1999), in which coronary anatomy was not an exclusion criterion. We excluded from the study emergency and salvage operations and patients with such potentially confounding variables as previous stroke, renal failure, and reoperative CABG, which might have affected the interpretation of clinical outcome. Nevertheless, the off-pump and conventional CABG groups of BHACAS 2 included 48% and 43% of urgent in-hospital unstable angina referrals, 17% and 13% of those with previous myocardial infarction less than 14 days before surgery, 24% and 23% of patients with ejection fraction less than 50%, and 32% and 30% of patients with diabetes, respectively. The overall randomization rate was 63%, a much higher percentage than the 43% reported by Puskas and colleagues.1 More importantly, we achieved a homogenous distribution of risk factors between groups. This unfortunately did not happen in Puskas and colleagues' SMART trial,1 where for example the values for previous stroke history were 9% and 1% (P = .018) in the on-and off-pump groups, respectively.
The BHACAS trials also provided midterm clinical outcomes, with particular attention to mortality and cardiac-related events, both as single trial or pooled analysis of the 401 randomized patients, and concluded that off-pump CABG significantly reduces early in-hospital morbidity without compromising outcome in the first 1 to 3 years after surgery relative to conventional on-pump technique. We believe that when bringing to light new evidence it is important to present in a complete and objective fashion what is already available in the literature: "Give to Caesar what is Caesars."
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