Ann Thorac Surg 2005;79:2200-2201
© 2005 The Society of Thoracic Surgeons
a Indiana Heart Institute, 8333 Naab Rd, Suite 300, Indianapolis, IN 46290
b Jewish Heart and Lung Institute, 201 Abraham Flexner Way, Suite 1200, Louisville, KY 40202
c University of Iowa Hospital, 200 Hawkins Dr, Iowa City, IA 52242
To the Editor:
Doctor Furnary, a proponent and user of CO2 TMR, has requested clarification of our recently published 5-year follow-up of "no option" class IV angina patients prospectively randomly assigned to holmium:YAG TMR or continued medical management. As a longitudinal follow-up of a prospectively conducted 1-year trial , our goal was to obtain long-term assessments that could be made in a high proportion of patients and with a high degree of confidence: masked angina assessment independent of study investigators and survival. Centers that participated in the original trial and who were capable of providing this long-term assessment obtained follow-up in 77% of originally randomized patients (212 of 275) at a mean of 5.7 years.
The statistical analyses in our original trial and the CO2 randomized trial reported by Frazier and colleagues  are complicated by the subset of patients who were randomly assigned to medical therapy but met the a priori treatment failure criteria and crossed over to receive TMR while unstable. As requested by the Food and Drug Administration and the New England Journal of Medicine, two primary statistical analyses have been consistently applied in all of our publicationsthe intention-to-treat analysis and a three-group analysis that separates out crossover patients. Regardless of the analysis used, the significant angina relief observed 1 year after holmium:YAG TMR was sustained long term and continued to be superior to that observed for patients maintained on medical management. As we reported, intention-to-treat long-term improvement was significantly increased in TMR patients (88% versus 44%, p < 0.0001) and "after excluding all patients who had a reintervention since randomization, long-term improvement remained significantly superior in TMR versus medically managed patients (91% versus 30%, p < 0.0001)." As we further reported, a bivariate model that considered the effect of a reintervention on long-term angina improvement reinforced the continued superiority of TMR over medical management, in terms of both two-class improvement and long-term freedom from angina. Doctor Furnarys request to deviate from standard, accepted statistical methods is perplexing and can be criticized because it excludes patients who fail their randomized therapy and it is strongly biased in favor of TMR.
As noted by Dr Furnary, not all patients were assessed by the masked evaluator in this longitudinal long-term follow-upbecause many were dead. As evidenced by the 49% 5-year survival after CO2 TMR,  diffuse, distal coronary artery disease not amenable to bypass surgery or percutaneous intervention is a serious, morbid disease. We were pleased to observe that, compared with medically managed patients, patients randomly assigned to holmium:YAG TMR enjoyed a significant long-term survival benefit (65% versus 52%, p = 0.05) with a decreased risk of late death beyond 1 year (annualized mortality 8% versus 13%, p = 0.03).
Our robust, balanced analyses support our conclusions that holmium:YAG TMR for class IV "no option" patients yields significant and sustained clinical and survival benefits. Long-term follow-up reported in this and other TMR randomized trials [4, 5] lend further support to currently published practice guidelines by The Society of Thoracic Surgeons  and American College of Cardiology/American Heart Association  recommending TMR as an option for patients suffering from intractable angina.
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