Author + information
- Douglass A Morrison, MDa
- Gulshah Sethi, MD,
- Jerome Sacks, PhD,
- William Henderson, PhD and
- Richard Esposito, MD
We would like to thank Karamanoukian, Donias and Bergsland for their remarks regarding our randomized trial of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) in patients with medically refractory myocardial ischemia and risk factors for early mortality with CABG. They raise two specific issues about our surgeons’ CABG methods: 1) variability in myocardial protection, and 2) use of “beating heart” or “off-pump” techniques.
Our trial was an attempt to answer a real-world clinical question that often seems to arise on nights and weekends: “What is the best means of revascularizing this high-risk patient who desperately needs more myocardial blood flow?” To make the trial clinically relevant in an era when techniques are evolving and strong differences of opinion exist, we settled on a “strategy” study. That is, both our surgeons and interventionists could use whatever tools and methods they believed would yield the best long-term outcome for their individual patients. Accordingly, the means of myocardial protection varied from center to center and even operator to operator. We obtained prospective data regarding such issues as antegrade versus retrograde, cold versus warm and crystalloid versus blood, specifically so that we could look at both temporal and spatial variations in technique and attempt to determine what, if any, influence those variations had on outcome. From the overall perspective, an in-hospital mortality of 4% for the oldest (mean age 67 years; >5 years older than any other revascularization trial), and sickest (mean left ventricular ejection fraction = 0.45; >0.12 lower than any other revascularization trial and ∼1/3 patients within seven days of a myocardial infarction and ∼1/3 patients with prior CABG: both high-risk exclusions from previous trials), suggests that we had excellent myocardial protection.
Regarding the issue of “off-pump,” although Karamanoukian and colleagues state that 1995 is when the method was popularized, their citation is dated 1997, and most of their references are electronic abstracts, dated 2000 and 2001, after AWESOME completed enrollment. This timing explains why we did not even collect data on the use of this method. Several of our study surgeons are among the planners of a proposed Veterans Affairs cooperative study, which we are told would randomly allocate patients between conventional and off-pump surgery. We look forward to that type of data. In the meantime, we must continue to make the difficult and often nocturnal decisions, in part, influenced by the awareness of which techniques each of us is most comfortable using.
- American College of Cardiology