Key result
Radial artery grafts were associated with a lower 10-year death rate compared to saphenous vein grafts in a pooled analysis (24.0% vs 26.7%, P=0.01), though the author questions the statistical power.
Why the study?
Does the use of a radial artery graft compared to a saphenous vein graft improve long-term outcomes and graft patency in patients undergoing CABG?
Does the use of a radial artery graft compared to a saphenous vein graft improve long-term outcomes and graft patency in patients undergoing CABG?
Effect estimate: 10% relative reduction
Absolute Event Rate: 24% vs 26.7%
p-value: p=0.01
This editorial questions the statistical power of previous pooled analyses favoring radial artery over saphenous vein grafts for CABG, highlighting discrepancies with the sample size calculations of the ongoing ROMA trial.
I read with great interest the article by Gaudino et al. [1] comparing differences in long-term outcomes when radial artery (RA), right internal thoracic artery (ITA) or saphenous vein graft (SVG) were used to complement the left ITA-to-left anterior descending graft. The authors [1] emphasized that randomized trials failed to confirm an association between the use of multiple arterial grafting for coronary artery bypass grafting (CABG) and improved long-term outcomes compared to the use of a single arterial grafting. However, the authors [1] underlined that in a pooled analysis of individual patients data from 5 randomized trials, the use of RA as the second conduit was associated with a significant reduction in the risk of cardiac events and a survival benefit at 10 years compared to the use of SVG [2]. Those data are presented in Table 4 (Post Hoc Outcomes in a Study of the Association of RA vs SVG With Cardiovascular Outcomes Among Patients Undergoing CABG) of that pooled analysis [2]: RA group—outcome death: 128/534 patients (24.0%); SVG group—outcome death: 134/502 patients (26.7%), P = 0.01 (altogether, 262 events/deaths and 1036 patients). This means that there is only a 10% relative reduction (24% vs 26.7%) in death rate in favor of the patients with RA graft versus patients with SVG. Gaudino et al. [3] are currently conducting ROMA study. The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent CABG, the use of 2 or more arterial grafts compared with a single arterial graft will be associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The authors [3] also wrote: ‘Because of the known increase in graft attrition rate after the 5th postoperative year, we expect to see a linearized rate of death of 2% between 5 and 10 years postoperatively and estimate that the overall 10-year mortality will be 18–20%. We consider a 20% relative risk reduction in mortality to be clinically meaningful and sufficient to change practice. To detect a 20% relative reduction (from 18% to 14.4%) in 10-year mortality, with 80% power at 5% alpha, the sample size must include 3650 patients or 631 events’. How so, that for detection of 20% relative reduction of mortality we need a sample size of 3605 patients and 631 events and, on the other hand, for 10% relative reduction of mortality, a smaller sample of 262 events/deaths and 1036 patients [2] was large enough? Testing RA artery patency up to 20 years following surgery, Gaudino et al. [4] showed that for targeted coronary artery stenosis <90%, RA and SVG have around 45% of probability of graft failure at 10 years, and at 20 years, probability of graft failure was 72.5% for SVG and 80.4% for RA (P = 0.95). For targeted coronary artery stenosis >90%, RA graft patency was superior—87.3% [ITA (81.5%), SVG (51%)]. If we assume that long-term outcome is connected with better graft patency [1], than, would not it be irrelevant which second graft we use to graft targeted coronary artery with stenosis <90%?
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Dusko G. Nezic (2022) conducted a letter in Coronary artery bypass grafting (CABG) (n=1,036). Radial artery graft vs. Saphenous vein graft was evaluated on Death (10% relative reduction, p=0.01). Radial artery grafts were associated with a lower 10-year death rate compared to saphenous vein grafts in a pooled analysis (24.0% vs 26.7%, P=0.01), though the author questions the statistical power.
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