Objectives
The aim of this study was to test the hypothesis that invasive coronary function testing at time of angiography could help stratify management of angina patients without obstructive coronary artery disease.
Background
Medical therapy for angina guided by invasive coronary vascular function testing holds promise, but the longer-term effects on quality of life and clinical events are unknown among patients without obstructive disease.
Methods
A total of 151 patients with angina with symptoms and/or signs of ischemia and no obstructive coronary artery disease were randomized to stratified medical therapy guided by an interventional diagnostic procedure versus standard care (control group with blinded interventional diagnostic procedure results). The interventional diagnostic procedure–facilitated diagnosis (microvascular angina, vasospastic angina, both, or neither) was linked to guideline-based management. Pre-specified endpoints included 1-year patient-reported outcome measures (Seattle Angina Questionnaire, quality of life [EQ-5D]) and major adverse cardiac events (all-cause mortality, myocardial infarction, unstable angina hospitalization or revascularization, heart failure hospitalization, and cerebrovascular event) at subsequent follow-up.
Results
Between November 2016 and December 2017, 151 patients with ischemia and no obstructive coronary artery disease were randomized (n = 75 to the intervention group, n = 76 to the control group). At 1 year, overall angina (Seattle Angina Questionnaire summary score) improved in the intervention group by 27% (difference 13.6 units; 95% confidence interval: 7.3 to 19.9; p < 0.001). Quality of life (EQ-5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 95% confidence interval: 0.03 to 0.19; p = 0.010). After a median follow-up duration of 19 months (interquartile range: 16 to 22 months), major adverse cardiac events were similar between the groups, occurring in 9 subjects (12%) in the intervention group and 8 (11%) in the control group (p = 0.803).
Conclusions
Stratified medical therapy in patients with ischemia and no obstructive coronary artery disease leads to marked and sustained angina improvement and better quality of life at 1 year following invasive coronary angiography. (Coronary Microvascular Angina [CorMicA];
NCT03193294
)
(4.6%), VT=1 (0.3%). ANS referrals resulted in greater trend towards change of management (38.2%) of patients compared with GC (32.7%) and EP (31.4%) (p=0.593 nurse vs. consultant). For those needing pacing, 24 were from ANS referrals compared to 25 for clinicians (23.5% vs 18.3% respectively, p=0.012). Median time to developing a pacing indication was 2.6 months for ANS and 4.1 months for clinicians; 25 had pacing indication within 3 months of ILR insertion. Overall, an ILR had a diagnostic yield of 34.1% (n= 104) (table 1). Conclusion The diagnostic yield of ILR insertion was 34%. ANS referrals trended towards greater diagnostic yield compared with clinicians and significantly more pacemaker indications. Our data suggest ANS patient selection for ILRs are at least comparable to clinicians.
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