Sex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic Shock: A Substudy of the CULPRIT-SHOCK Trial.

BACKGROUND: Women are more likely to suffer and die from cardiogenic shock (CS) as the most severe complication of acute myocardial infarction. Data concerning optimal management for women with CS are scarce. Aim of this study was to better define characteristics of women experiencing CS and to the influence of sex on different treatment strategies. METHODS: In the CULPRIT-SHOCK trial (The Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock), patients with CS complicating acute myocardial infarction and multivessel coronary artery disease were randomly assigned to one of the following revascularization strategies: either percutaneous coronary intervention of the culprit-lesion-only or immediate multivessel percutaneous coronary intervention. Primary end point was composite of death from any cause or severe renal failure leading to renal replacement therapy within 30 days. We investigated sex-specific differences in general and according to the revascularization strategies. RESULTS: Among all 686 randomized patients included in the analysis, 24% were women. Women were older and had more often diabetes mellitus and renal insufficiency, whereas they had less often history of previous acute myocardial infarction and smoking. After 30 days, the primary clinical end point was not significantly different between groups (56% women versus 49% men; odds ratio, 1.29 [95% CI, 0.91-1.84]; P=0.15). There was no interaction between sex and coronary revascularization strategy regarding mortality and renal failure (Pinteraction=0.11). The primary end point occurred in 56% of women treated by the culprit-lesion-only strategy versus 42% men, whereas 55% of women and 55% of men in the multivessel percutaneous coronary intervention group. CONCLUSIONS: Although women presented with a different risk profile, mortality and renal replacement were similar to men. Sex did not influence mortality and renal failure according to the different coronary revascularization strategies. Based on these data, women and men presenting with CS complicating acute myocardial infarction and multivessel coronary artery disease should not be treated differently. However, further randomized trials powered to address potential sex-specific differences in CS are still necessary. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01927549.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Economic implications of intra-aortic balloon support for myocardial infarction with cardiogenic shock: an analysis from the IABP-SHOCK II-trial.

BACKGROUND: The Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial has demonstrated the safety of intra-aortic balloon (IABP) support in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock, but no beneficial effect on mortality. Currently, intra-aortic balloon pumping is still the most widely used support device. However, little is known about the economic implications associated with this device. METHODS: Data of 600 patients included in the IABP-SHOCK II trial (registered at ClinicalTrials.gov, NCT00491036) with follow-up at 30 days, 6 and 12 months were subjected to an economic analysis. Patients with cardiogenic shock complicating AMI were randomly assigned to IABP additionally to optimal medical therapy (OMT; n = 301) or OMT alone (n = 299) before early revascularization. Costs were calculated from the perspective of a German healthcare payer. Cost-effectiveness and cost-utility analyses were performed using quality-adjusted life years (QALY) and reduction in New York Heart Association (NYHA) and Canadian Cardiac Society (CCS) class as effectiveness measures. RESULTS: There was a statistically significant difference in overall costs between the IABP (33,155 ± 14,593 ) and the control group (32,538 ± 14,031 , p < 0.00001). This was predominantly attributed to the IABP costs in the IABP (760 ± 174 ) versus control group (64 ± 218 , p < 0.0001) whilst the intensive care unit costs did not differ between the groups (29,177 ± 12,013 and 29,401 ± 12,063 , p = 0.82). There was no significant difference in QALY or NYHA and CCS reduction, respectively (p = n.s.). CONCLUSION: IABP support is associated with higher healthcare costs as compared to conservative treatment regimens. Clinically, IABP support cannot generally be recommended in AMI complicated by cardiogenic shock in the absence of a mortality benefit. However, economically considering the relatively little contribution to overall costs generated by IABP therapy it may still be considered if clinical scenarios with an IABP-induced benefit may be identified in the future.