Baseline angina did not modify the effect of PCI versus optimal medical therapy on MACE in patients undergoing TAVI (HR 0.71 with angina vs 0.69 without angina; P=0.97 for interaction).
RCT (n=454)
randomized
Does PCI reduce MACE compared to OMT in patients with severe aortic stenosis and coronary artery disease undergoing TAVI, and does baseline angina modify this effect?
Baseline angina does not appear to modify the relative effect of PCI on clinical outcomes in patients with severe aortic stenosis and coronary artery disease undergoing TAVI.
Hazard Ratio: 0.71 (95% CI 0.45–1.13)
Absolute Event Rate: 27% vs 37%
p-value: p=0.97 for interaction
Abstract Background Angina is common in patients with coronary artery disease and severe aortic stenosis. Whether angina should guide coronary revascularization in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Aims To assess whether angina modifies the effect of percutaneous coronary intervention (PCI) on clinical outcomes and whether percutaneous coronary intervention influences angina burden after TAVI. Methods and results This prespecified secondary analysis of the NOTION-3 trial included patients with severe aortic stenosis and significant coronary artery disease randomized to TAVI with percutaneous coronary intervention or optimal medical therapy (OMT). Baseline angina was assessed by Seattle Angina Questionnaire-7 Angina Frequency score, supplemented by Canadian Cardiovascular Society class when questionnaire data were missing. Of 454 patients, 229 (50%) had angina and 225 (50%) had no angina. In the baseline angina subgroup, the primary outcome MACE, a composite of death from any cause, myocardial infarction, or urgent revascularization, occurred in 27% randomized to PCI versus 37% randomized to OMT. Without angina, rates were 26% versus 35%. Hazard ratios for PCI versus OMT were 0.71 (95%-CI 0.45–1.13) in patients with angina and 0.69 (95%-CI 0.43–1.12) in those without, with no interaction by baseline angina (P=0.97). SAQ-7 summary scores improved at 1 year in angina groups, with no between-group difference in change (16 vs. 17; P=0.78). Conclusion We found no evidence that baseline angina modified the relative effect of PCI on clinical outcomes, although the study was not powered to exclude clinically meaningful heterogeneity.
Zimmer et al. (Tue,) conducted a rct in Severe aortic stenosis and coronary artery disease (n=454). Percutaneous coronary intervention (PCI) vs. Optimal medical therapy (OMT) was evaluated on MACE (composite of death from any cause, myocardial infarction, or urgent revascularization) in patients with baseline angina (HR 0.71, 95% CI 0.45-1.13, p=0.97 for interaction). Baseline angina did not modify the effect of PCI versus optimal medical therapy on MACE in patients undergoing TAVI (HR 0.71 with angina vs 0.69 without angina; P=0.97 for interaction).
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