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Time to Intervention During Cardiac Interventions. Are We Forgetting a Confounder?

Chicago, USA
¹ Plymouth Meeting, USA

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Time to intervention is a potentially important factor in clinical trials comparing medical procedures or devices (but not in drug trials as there is usually little delay in treatment). This is because average waiting times may differ substantially between 2 treatments being compared. An example is randomized controlled trials (RCTs) comparing percutaneous coronary interventions (PCI) with coronary artery bypass grafting (CABG), which have shown that average waiting time for CABG is usually 2–3-fold longer than for PCI. If there is a difference in waiting times, a longer wait in one group could increase the number of adverse events during the delay. Such events must be included in analyses of event rates for accurate comparison of the risks of different treatment strategies.

Patients waiting for cardiac surgery remain at risk of a fatal or non-fatal event. In a study by Ray and colleagues¹ of 1,854 patients undergoing CABG, aortic valve replacement, or combined procedures, median waiting times were: urgent group, 8 days; semi-urgent A group, 37 days; semi-urgent B group, 64 days; and elective group, 113 days. There were 13 (0.7%) deaths (12 cardiac) during the waiting period. Rexius and colleagues² found an increased mortality risk of 11% per month after acceptance for CABG, and concluded that long waiting lists are associated with considerable mortality. Studies have also documented major cardiac events (death and myocardial infarction) in patients waiting for PCI.^3,4 Alterations in lesion characteristics during waiting have resulted in unsuccessful procedures.⁵ There was a significant decrease . . . [Full Text of this Article]