Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome: a Double-Blind, Randomized, Sham-Controlled Trial.

Bigler, Marius Reto; Kieninger-Gräfitsch, Andrea; Tschannen, Christine; Grossenbacher, Raphael; Seiler, Christian (2024). Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome: a Double-Blind, Randomized, Sham-Controlled Trial. (In Press). The American journal of cardiology, 225, pp. 160-170. Elsevier 10.1016/j.amjcard.2024.06.030

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The CLIMACCS trial, a randomized, sham-controlled trial tested the CLinical efficacy of permanent internal mammary artery (IMA) device occlusion on symptoms in patients with chronic coronary syndrome (CCS), on coronary artery occlusive blood supply, and on myocardial ischemia. This was a prospective trial in 101 patients with CCS randomly allocated (1:1) to IMA device occlusion (verum group) or to IMA sham intervention (placebo group). The primary study endpoint was the change in treadmill exercise time (ΔET in seconds, s) at 6 weeks after trial intervention. Secondary study endpoints were the changes in collateral flow index (CFI), and angina pectoris during a simultaneous 1-minute proximal balloon occlusion of a coronary artery. CFI is the ratio between simultaneous mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure. In the verum and placebo group, exercise time changed from 398±176s to 421±198s in the verum group (p=0.1745), and from 426±162s to 430±166s in the placebo group (p=0.55); DET amounted to +23±116s and +4±120s, respectively (p=0.44). CFI change during follow-up equalled +0.022±0.061 in the verum and-0.039±0.072 in the placebo group (p<0.0001). Angina pectoris at follow-up during the coronary balloon occlusion for CFI measurement had decreased or disappeared in 20/48 patients of the verum, and in 9/47 patients of the placebo group (p=0.0242). In conclusion, permanent IMA device occlusion tends to augment treadmill exercise time in response to heightened coronary artery occlusive blood supply, the fact of which is reflected by mitigated symptoms and signs of myocardial ischemia.

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