Prognostic Importance of Coronary Anatomy and LVEF
Prognostic Importance of Coronary Anatomy and LVEF
Table summarizes the Cox regression analyses using treatment assignment to OMT + PCI, VD, and low LVEF variables. Death was predicted by both low LVEF (hazard ratio [HR] 1.86, CI 1.34–2.59, P < .001) and VD (HR 1.45, CI 1.20–1.75, P < 001). Myocardial infarction was predicted by VD (HR 1.53, CI 1.30–1.81, P < 001) as was NSTE-ACS (HR 1.24, CI 1.06–1.44, P = .007). The composite of death or MI was predicted by both low LVEF (HR 1.50, CI 1.18–1.91, P < .001) and VD (HR 1.43, CI 1.26–1.63, P < .001). The composite outcome of death, MI, or NSTE-ACS was also predicted by both low LVEF (HR 1.34, CI 1.10–1.64, P = .004) and VD (HR 1.36, CI 1.23–1.51, P < 001). No interactions with treatment randomization were significant; pLAD was not predictive of outcome. Reassessment of these relationships using LVEF as a continuous variable confirmed that LVEF was a significant and independent predictor of death (P < .001), death or MI (P < .001), and death or MI or NSTE-ACS (P < .001) but not of MI (P = .05) or NSTE-ACS (P = .14). Figure 1 shows a forest plot comparing OMT and OMT + PCI for all outcomes. There were no significant differences in outcomes based on randomization, even when adjusted as described above. The highest event rates were seen for the composite end point of death, MI, or NSTE-ACS in patients with 3 VD and low LVEF (48.8% vs 40.8% per 4.6 years for the OMT and OMT + PCI groups, respectively) indicating a potential 16% risk reduction in the OMT + PCI group.
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Figure 1.
Forest plots showing relative risk of events in angiographic subsets based on initial treatment arm. Rates are expressed as percentages per 4.6 years. Adjustments were made for age, female sex, current smoker, diabetes, prior MI, prior coronary artery bypass graft, heart failure, CCS class, baseline low-density lipoprotein and baseline high-density lipoprotein. #, number of patients; adj inter, adjusted test of interaction; UL, upper limit.
Figure 2 shows Kaplan-Meier curves of freedom from death, MI, or NSTE-ACS in angiographic subsets determined by VD and LVEF. Prognosis progressively worsened with more severe VD and low LVEF (P = .003). Figure 3 shows the Kaplan-Meier curves for freedom from death, MI, or NSTE-ACS in patients with 3 VD and low LVEF, stratified by initial randomization to OMT + PCI and OMT alone. The curves overlap for the first 2 to 3 years and subsequently separate, suggestive of a more favorable, long-term outcome in the OMT + PCI arm but not statistically significant (P = .59).
(Enlarge Image)
Figure 2.
Kaplan-Meier curves showing freedom from the composite end point of death, MI, or NSTE-ACS based on coronary VD and LVEF.
(Enlarge Image)
Figure 3.
Kaplan-Meier curves showing freedom from outcome of death, MI, or NSTE-ACS in patients with 3-vessel disease and low LVEF, stratified by initial randomization to PCI + OMT or OMT alone (P value is unadjusted. See "Methods" section).
More detailed analyses of the possible impact of pLAD were undertaken. Kaplan-Meier analyses of freedom from death, MI, or NSTE-ACS in angiographic subsets determined by presence or absence of pLAD disease, including presence or absence of low LVEF, showed no significant difference (P = .50). Figure 4 is a Kaplan-Meier plot showing that the extent of VD is a more consistent determinant of death, MI, or NSTE-ACS, irrespective of presence or absence of pLAD (P = .002). The group with the highest proportion free from death, MI, or NSTE-ACS was unexpectedly the group with single-vessel pLAD. There was no subgroup of patients based on percent DS severity of pLAD that showed a preferential outcome with either treatment strategies (Figure 5, P = .79). This figure shows, however, that the worst outcome occurred in the subgroup with pLAD ≥90% DS treated with OMT + PCI.
(Enlarge Image)
Figure 4.
Kaplan-Meier curves showing freedom from death/MI/NSTE-ACS according to presence or absence of pLAD and in the presence of significant disease in other vessels.
(Enlarge Image)
Figure 5.
Analysis of patients with increasing severity of proximal left anterior descending stenosis and with respect to randomization to OMT or OMT + PCI.
Results
Table summarizes the Cox regression analyses using treatment assignment to OMT + PCI, VD, and low LVEF variables. Death was predicted by both low LVEF (hazard ratio [HR] 1.86, CI 1.34–2.59, P < .001) and VD (HR 1.45, CI 1.20–1.75, P < 001). Myocardial infarction was predicted by VD (HR 1.53, CI 1.30–1.81, P < 001) as was NSTE-ACS (HR 1.24, CI 1.06–1.44, P = .007). The composite of death or MI was predicted by both low LVEF (HR 1.50, CI 1.18–1.91, P < .001) and VD (HR 1.43, CI 1.26–1.63, P < .001). The composite outcome of death, MI, or NSTE-ACS was also predicted by both low LVEF (HR 1.34, CI 1.10–1.64, P = .004) and VD (HR 1.36, CI 1.23–1.51, P < 001). No interactions with treatment randomization were significant; pLAD was not predictive of outcome. Reassessment of these relationships using LVEF as a continuous variable confirmed that LVEF was a significant and independent predictor of death (P < .001), death or MI (P < .001), and death or MI or NSTE-ACS (P < .001) but not of MI (P = .05) or NSTE-ACS (P = .14). Figure 1 shows a forest plot comparing OMT and OMT + PCI for all outcomes. There were no significant differences in outcomes based on randomization, even when adjusted as described above. The highest event rates were seen for the composite end point of death, MI, or NSTE-ACS in patients with 3 VD and low LVEF (48.8% vs 40.8% per 4.6 years for the OMT and OMT + PCI groups, respectively) indicating a potential 16% risk reduction in the OMT + PCI group.
(Enlarge Image)
Figure 1.
Forest plots showing relative risk of events in angiographic subsets based on initial treatment arm. Rates are expressed as percentages per 4.6 years. Adjustments were made for age, female sex, current smoker, diabetes, prior MI, prior coronary artery bypass graft, heart failure, CCS class, baseline low-density lipoprotein and baseline high-density lipoprotein. #, number of patients; adj inter, adjusted test of interaction; UL, upper limit.
Figure 2 shows Kaplan-Meier curves of freedom from death, MI, or NSTE-ACS in angiographic subsets determined by VD and LVEF. Prognosis progressively worsened with more severe VD and low LVEF (P = .003). Figure 3 shows the Kaplan-Meier curves for freedom from death, MI, or NSTE-ACS in patients with 3 VD and low LVEF, stratified by initial randomization to OMT + PCI and OMT alone. The curves overlap for the first 2 to 3 years and subsequently separate, suggestive of a more favorable, long-term outcome in the OMT + PCI arm but not statistically significant (P = .59).
(Enlarge Image)
Figure 2.
Kaplan-Meier curves showing freedom from the composite end point of death, MI, or NSTE-ACS based on coronary VD and LVEF.
(Enlarge Image)
Figure 3.
Kaplan-Meier curves showing freedom from outcome of death, MI, or NSTE-ACS in patients with 3-vessel disease and low LVEF, stratified by initial randomization to PCI + OMT or OMT alone (P value is unadjusted. See "Methods" section).
More detailed analyses of the possible impact of pLAD were undertaken. Kaplan-Meier analyses of freedom from death, MI, or NSTE-ACS in angiographic subsets determined by presence or absence of pLAD disease, including presence or absence of low LVEF, showed no significant difference (P = .50). Figure 4 is a Kaplan-Meier plot showing that the extent of VD is a more consistent determinant of death, MI, or NSTE-ACS, irrespective of presence or absence of pLAD (P = .002). The group with the highest proportion free from death, MI, or NSTE-ACS was unexpectedly the group with single-vessel pLAD. There was no subgroup of patients based on percent DS severity of pLAD that showed a preferential outcome with either treatment strategies (Figure 5, P = .79). This figure shows, however, that the worst outcome occurred in the subgroup with pLAD ≥90% DS treated with OMT + PCI.
(Enlarge Image)
Figure 4.
Kaplan-Meier curves showing freedom from death/MI/NSTE-ACS according to presence or absence of pLAD and in the presence of significant disease in other vessels.
(Enlarge Image)
Figure 5.
Analysis of patients with increasing severity of proximal left anterior descending stenosis and with respect to randomization to OMT or OMT + PCI.
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