Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.

BACKGROUND: Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. OBJECTIVES: The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. METHODS: EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. RESULTS: Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints. CONCLUSIONS: At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

Predictors of death after coronary stenting with sirolimus-eluting stent in high-risk patients.

BACKGROUND: Long-term safety of drug eluting stents (DES) is under evaluation. Whether late mortality with DES may be higher than with bare metal stents is controversial and factors influencing death after DES implantation are not well known. The present observational registry analyses predictors of death during follow up after coronary stenting with sirolimus-eluting stents (SES). METHODS: We performed an analysis of the causes of death on 233 patients included in a prospective registry that evaluated angiographic and clinical outcomes after SES implantation in complex scenarios. We analysed the relation of death with: 1) clinical, angiographic and procedural variables, and 2) clinical events, after a median follow up of 3.7 [3.4-3.9] years. We performed Cox regression analysis to assess predictors of mortality. RESULTS: Nineteen patients (8.1%) died. Survival free of death was 91.85%. Two deaths (0.8%) were due to ictus, 2 (0.8%) were due to cancer, 2 (0.8%) were of unknown causes--not cardiac--and 13 (5.6%) were cardiac. After multivariate analysis independent predictors of death were depressed left ventricular function (HR 10.8 [3.31-35.14], p=0.0001), age (HR 1.1 [1.04-1.19], p=0.001), AMI during follow up (HR 7.03 [2.04-24.29], p=0.002), proximal LAD lesions (HR 0.15 [0.04-0.59], p=0.006), female gender (HR 3.54 [1.18-10.57], p=0.023), renal insufficiency (HR 5.82 [1.25-27.11], p=0.025) and IIb-IIIa inhibitors (HR 0.31 [0.09-1.03], p=0.054). CONCLUSIONS: Mortality after SES implantation seems to be related to basal conditions of the patient, use of IIb-IIIa inhibitors, left ventricular dysfunction and progression of disease.

One-year results of unprotected left main disease treatment with paclitaxel-eluting stents: results of a multicenter registry.

BACKGROUND: Preliminary data suggest that drug-eluting stents might have a role in selected cases of unprotected left main stenosis (ULMS). The purpose of this study was to determine the rates of death, myocardial infarction, and repeated revascularization in a multicenter, prospective series of patients with ULMS treated with paclitaxel-eluting stents. METHODS: A prospective registry was initiated in March 2003 through December 2004 in five tertiary centers including all patients with a significant (>50%) stenosis in ULMS treated with at least one paclitaxel-eluting stent. There were no clinical or angiographic exclusion criteria. Clinical follow-up was obtained at 6 and 12 months. RESULTS: A total of 100 patients were included. Mean age was 67.6 +/- 11.4 years and 36% were diabetics. Distal left main was affected in 53% of patients. Implantation of two stents was required in only 15%. Angiographic success was achieved in all cases. Significant periprocedural CK-MB elevation occurred in 5 patients and there was 1 intraprocedural death. At a median 9 months follow-up, cardiac death occurred in 7%, the majority of which (4%) in patients with ST-elevation myocardial infarction and cardiogenic shock before stent implantation. Only 3 patients (3%) required repeated target-vessel revascularization, all repeated angioplasty procedures. CONCLUSION: Percutaneous treatment of unprotected left main lesions with paclitaxel-eluting stents is associated with acceptable mid-term results in selected patients, with very low rates of repeated revascularization.

[Long-term follow-up of patients with proximal left anterior descending coronary artery stenosis treated with stent]. / Seguimiento a largo plazo de pacientes con estenosis de la arteria coronaria descendente anterior proximal tratadas con stent.

INTRODUCTION AND OBJECTIVE: Patients with lesions of the proximal left anterior descending coronary artery are a special high-risk group. In the present study we analyzed the efficacy and safety of coronary stenting in such lesions and the factors related to a less favorable prognosis in long-term follow-up. METHODS: Ninety-eight consecutive patients with severe left anterior descending artery stenosis were enrolled, all with coronary angioplasty and elective stenting. Clinical follow-up was carried out annually in all patients by personal interview or telephone contact. The incidence of death, new infarction, anginal status, and new revascularization procedures was registered. Clinical, angiographic, and procedural variables were analyzed to identify predictors of long term prognosis. RESULTS: Mean follow-up was 38 11 months. There was only one major periprocedural complication, which required urgent surgery. Five deaths were registered, 3 of non-cardiac and 2 of cardiac origin. Twenty-five patients developed angina and 11 underwent a new revascularization of the proximal left anterior descending coronary artery (6 surgical and 5 angioplasty). Two patients had new anterior myocardial infarction. At 60 months the major cardiac event-free rate was 83.7% and the cardiac death-free rate was 98%. The use of two stents and the association of diabetes-hypertension-hypercholesterolemia were associated with a less favorable prognosis in our population. CONCLUSIONS: Stenting of left anterior descending coronary stenosis was safe and effective in a long-term analysis. The survival rate was high and the incidence of new revascularization was low.