Five-Year Comparative Efficacy of Everolimus-Eluting vs. Resolute Zotarolimus-Eluting Stents in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Among drug-eluting stents (DESs), the durable polymer everolimus-eluting stent (EES) and resolute zotarolimus-eluting stent (R-ZES) are widely used in clinical practice and have contributed to improve the outcomes of patients undergoing percutaneous coronary intervention (PCI). Few studies addressed their long-term comparative performance in patients with acute coronary syndrome (ACS). We aimed to investigate the 5 year comparative efficacy of EES and R-ZES in ACS. We queried ACTION-ACS, a large-scale database of ACS patients undergoing PCI. The treatment groups were analyzed using propensity score matching. The primary endpoint was a composite of mortality, myocardial infarction (MI), stroke, repeat PCI, and definite or probable stent thrombosis, which was addressed at the five-year follow-up. A total of 3497 matched patients were analyzed. Compared with R-ZES, a significant reduction in the primary endpoint at 5 years was observed in patients treated with EES (hazard ratio (HR) [95%CI] = 0.62 [0.54-0.71], p < 0.001). By landmark analysis, differences between the two devices emerged after the first year and were maintained thereafter. The individual endpoints of mortality (HR [95%CI] = 0.70 [0.58-0.84], p < 0.01), MI (HR [95%CI] = 0.55 [0.42-0.74], p < 0.001), and repeat PCI (HR [95%CI] = 0.65 [0.53-0.73], p < 0.001) were all significantly lower in the EES-treated patients. Stroke risk did not differ between EES and R-ZES. In ACS, a greater long-term clinical efficacy with EES vs. R-ZES was observed. This difference became significant after the first year of the ACS episode and persisted thereafter.

Recurrence of angina after ST-segment elevation myocardial infarction: the role of coronary microvascular obstruction.

BACKGROUND: The recurrence of angina after percutaneous coronary intervention affects 20-35% of patients with stable coronary artery disease; however, few data are available in the setting of ST-segment elevation myocardial infarction. We evaluated the relation between coronary microvascular obstruction and the recurrence of angina at follow-up. METHODS: We prospectively enrolled patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Microvascular obstruction was defined as thrombolysis in myocardial infarction flow less than 3 or 3 with myocardial blush grade less than 2. The primary endpoint was the recurrence of angina at follow-up. Moreover, angina status was evaluated by the Seattle angina questionnaire summary score (SAQSS). Therapy at follow-up and the occurrence of major adverse cardiovascular events were also collected. RESULTS: We enrolled 200 patients. Microvascular obstruction occurred in 52 (26%) of them. Follow-up (mean time 25.17±9.28 months) was performed in all patients. Recurrent angina occurred in 31 (15.5%) patients, with a higher prevalence in patients with microvascular obstruction compared with patients without microvascular obstruction (13 (25.0%) vs. 18 (12.2%), P=0.008). Accordingly, SAQSS was lower and the need for two or more anti-anginal drugs was higher in patients with microvascular obstruction compared with patients without microvascular obstruction. At multiple linear regression analysis a history of previous acute coronary syndrome and the occurrence of microvascular obstruction were the only independent predictors of a worse SAQSS. Finally, the occurrence of major adverse cardiovascular events was higher in patients with microvascular obstruction compared with patients without microvascular obstruction. CONCLUSIONS: The recurrence of angina in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention is an important clinical issue. The occurrence of microvascular obstruction portends a worse angina status and is associated with the use of more anti-anginal drugs.

Age-Related 2-Year Mortality After Transcatheter Aortic Valve Replacement: the YOUNG TAVR Registry.

OBJECTIVE: To comparatively assess the natural history of patients of different ages undergoing transcatheter aortic valve replacement (TAVR). PATIENTS AND METHODS: For this study, we used the YOUNG TAVR, an international, multicenter registry investigating mortality trends up to 2 years in patients with aortic valve stenosis treated by TAVR, classified according to 3 prespecified age groups: 75 years or younger (n=179), 76 to 86 years (n=602), and older than 86 years (n=221). A total of 1002 patients undergoing TAVR were included. Demographic, clinical, and outcome data in the youngest group were compared with those of patients 76 to 86 years and older than 86 years. Patients were followed up for up to 2 years. RESULTS: Compared with patients 75 years or younger (reference group), patients aged 76 to 86 years and older than 86 years had nonsignificantly different 30-day mortality (odds ratio, 0.76; 95% CI, 0.41-1.38; P=.37 and odds ratio, 1.27; 95% CI, 0.62-2.60; P=.51, respectively) and 1-year mortality (hazard ratio (HR), 0.72; 95% CI, 0.48-1.09; P=.12 and HR, 1.11; 95% CI, 0.88-1.40; P=.34, respectively). Mortality at 2 years was significantly lower among patients aged 76 to 86 years (HR, 0.62; 95% CI, 0.42-0.90; P=.01) but not among the older group (HR, 1.06; 95% CI, 0.68-1.67; P=.79). The Society of Thoracic Surgeons 30-day mortality score was lower in younger patients who, however, had a significantly higher prevalence of chronic obstructive pulmonary disease (P=.005 vs the intermediate group and P=.02 vs the older group) and bicuspid aortic valves (P=.02 vs both older groups), larger left ventricles, and lower ejection fractions. CONCLUSION: In the present registry, mortality at 2 years after TAVR among patients 75 years or younger was higher compared with that of patients aged 75 to 86 years and was not markedly different from that of patients older than 86 years. The findings are attributable at least in part to a greater burden of comorbidities in the younger age group that are not entirely captured by current risk assessment tools.

Recurrence of angina after ST-segment elevation myocardial infarction: the role of coronary microvascular obstruction.

BACKGROUND: The recurrence of angina after percutaneous coronary intervention affects 20-35% of patients with stable coronary artery disease; however, few data are available in the setting of ST-segment elevation myocardial infarction. We evaluated the relation between coronary microvascular obstruction and the recurrence of angina at follow-up. METHODS: We prospectively enrolled patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Microvascular obstruction was defined as thrombolysis in myocardial infarction flow less than 3 or 3 with myocardial blush grade less than 2. The primary endpoint was the recurrence of angina at follow-up. Moreover, angina status was evaluated by the Seattle angina questionnaire summary score (SAQSS). Therapy at follow-up and the occurrence of major adverse cardiovascular events were also collected. RESULTS: We enrolled 200 patients. Microvascular obstruction occurred in 52 (26%) of them. Follow-up (mean time 25.17±9.28 months) was performed in all patients. Recurrent angina occurred in 31 (15.5%) patients, with a higher prevalence in patients with microvascular obstruction compared with patients without microvascular obstruction (13 (25.0%) vs. 18 (12.2%), P=0.008). Accordingly, SAQSS was lower and the need for two or more anti-anginal drugs was higher in patients with microvascular obstruction compared with patients without microvascular obstruction. At multiple linear regression analysis a history of previous acute coronary syndrome and the occurrence of microvascular obstruction were the only independent predictors of a worse SAQSS. Finally, the occurrence of major adverse cardiovascular events was higher in patients with microvascular obstruction compared with patients without microvascular obstruction. CONCLUSIONS: The recurrence of angina in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention is an important clinical issue. The occurrence of microvascular obstruction portends a worse angina status and is associated with the use of more anti-anginal drugs.

Drug-eluting stents vs. bare metal stents in saphenous vein graft disease. Insights from a meta-analysis of 7,090 patients.

BACKGROUND: Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease. METHODS AND RESULTS: Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P<0.0001) and overall mortality (OR, 0.63; CI, 0.40-0.99; P=0.05), but similar rates of MI (OR, 0.92; CI, 0.64-1.33; P=0.7). Subgroup analysis highlighted differences between non-randomized studies, in which DES improved mortality rates, and randomized trials, in which benefit from DES was not evident. Meta-regression analysis showed that DES were more effective in the presence of older grafts and type 2 diabetes. CONCLUSIONS: The present meta-analysis showed that, in SVG disease, DES significantly reduced TVR, but did not provide clear benefits on mortality and MI, with an opposite direction of results in mortality observed from randomized and observational data.

Instability mechanisms in unstable angina according to baseline serum levels of C-reactive protein: the role of thrombosis, fibrinolysis and atherosclerotic burden.

BACKGROUND: Mechanisms of instability in patients affected by unstable angina and who exhibit low levels of C-reactive protein (CRP) on admission are unclear. We compared levels of markers of thrombin generation [thrombin-antithrombin complexes (TAT), of fibrinolysis [plasmin-antiplasmin complexes (PAP)], and angiographic severity and extent of coronary atherosclerosis in patients with severe unstable angina and high or low systemic levels of CRP. METHODS: Forty consecutive patients (age 59.7+/-8.7, 76% males) admitted to our coronary care unit with severe unstable angina (Braunwald class IIIB) were included in the present study. We assayed TAT and PAP using commercially available ELISA assays and CRP with high sensitivity nephelometry. The evaluation of atherosclerotic disease severity and extent was performed. Patients were divided in two groups according to CRP levels: G1=CRP>3 mg/L and G2=CRP<3 mg/L. RESULTS: Number of diseased vessels and number of stenoses plus occlusion were similar between the two groups (1.8+/-0.9 in G1 vs 2.2+/-0.9 in G2, p=NS and 2.6+/-1.9 in G1 vs 2.7+/-1.3 in G2, p=NS, respectively), as well as extent score and index (8.4+/-4.5 in G1 vs 9.2+/-3.1 in G2, p=NS and 0.6+/-0.3 in G1 vs 0.6+/-0.27 in G2, p=NS, respectively). Episodic activation of thrombin generation, as assessed by TAT was more frequent in G1 than in G2 (85% vs 47%, p=0.03). Episodic activation of the fibrinolysis was more frequent in G1 than in G2 (80% vs 40%, p=0.01). CONCLUSION: Patients with coronary instability and systemic evidence of inflammation exhibit more frequent activation of the thrombin/fibrinolysis system than patients with a similar clinical presentation but no evidence of systemic inflammation, whereas the coronary atherosclerotic burden is similar. The mechanisms of coronary instability in the absence of systemic evidence of inflammation need to be elucidated by future studies.

Association of laryngeal cancer with previous gastric resection.

OBJECTIVE: To investigate the association between gastric surgery and cancer of the larynx. SUMMARY BACKGROUND DATA: Biliary reflux is frequent after gastric surgery and may reach the proximal segment of the esophagus and the larynx. It is possible that duodenal content (consisting in bile acids, trypsin), together with pepsin and acid residues when gastric resection is partial, may cause harmful action on the multistratified epithelium of the larynx. METHODS: A retrospective case-control study on subjects admitted between January 1987 and May 2002 in the same hospital in Rome was carried out. The study included 828 consecutive patients with laryngeal cancer (cases) and 825 controls with acute myocardial infarction. Controls were randomly sampled out of a total of 10,000 and matched with cases for age, sex, and year of admission. Logistic regression models were used to assess the role of gastric resection in determining laryngeal cancer risk while controlling for potential confounding factors. RESULTS: Previous gastrectomy was reported by 8.1% of cases and 1.8% of the controls (P < 0.0001). A 4-fold association emerged between gastric surgery and laryngeal cancer risk (adjusted OR = 4.3, 95% CI: 2.4-7.9). The risk appeared strongly increased 20 years after surgery (OR = 14.8, 95% CI: 3.4-64.6). Heavy alcohol drinking (OR = 2.5, 95% CI: 1.8-3.5), smoking (OR = 4.7, 95% CI: 3.3-6.7), and blue-collar occupation (OR = 4.6, 95% CI: 3.2-6.7) were all independently associated with the risk of laryngeal cancer. CONCLUSIONS: Previous gastric surgery is associated with an increased risk of laryngeal cancer. A periodic laryngeal examination should be considered in long-term follow-up of patients with gastric resection.