Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.

OBJECTIVES: The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). BACKGROUND: The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. METHODS: XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. RESULTS: At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. CONCLUSIONS: At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.

Effects of a fixed-dose ACE inhibitor-diuretic combination on ambulatory blood pressure and arterial properties in isolated systolic hypertension.

The ideal therapy for patients with isolated systolic hypertension remains unclear; diuretics, calcium channel blockers, and angiotensin-converting enzyme (ACE) inhibitors are all used in clinical practice. The aim of this study was to determine whether a fixed-dose ACE inhibitor/diuretic combination would reduce ambulatory blood pressures (BP) and arterial stiffness in isolated systolic hypertension more than antihypertensive monotherapy. In this randomized, double-blind study, 8 weeks of fosinopril/hydrochlorothiazide combination (10/12.5 mg titrated up to 20/12.5 mg) was compared with the calcium channel blocker (amlodipine, 5 mg titrated up to 10 mg) and diuretic (indapamide, 2.5 mg) monotherapy in 28 patients with isolated systolic hypertension. Each patient received all 3 therapies. Assessments included 24-hour ambulatory BP, clinic BP, and applanation tonometry-derived augmentation index. At 8 weeks, the fall in average 24-hour systolic BP and night time systolic BP were significantly greater in the fosinopril-hydrochlorothiazide group, compared to amlodipine and indapamide. The decrease in augmentation index and central aortic systolic BP was also greater in the fosinopril-hydrochlorothiazide group, compared to either amlodipine or indapamide. There was no difference between therapies in decrease in clinic systolic or diastolic BP, or diastolic ABP (average 24-h, diurnal, or nocturnal). Compared with either calcium channel blocker or diuretic therapy, a fixed-dose ACE inhibitor-diuretic combination induces greater reductions in systolic ABP, particularly at night, favorable effects that may be related to a decrease in the intensity of or delay in arterial wave reflections. ACE inhibitor-diuretic combination therapy is a useful approach to cardiovascular risk reduction in isolated systolic hypertension.

Risk factors for coronary drug-eluting stent thrombosis: influence of procedural, patient, lesion, and stent related factors and dual antiplatelet therapy.

The complication of stent thrombosis (ST) emerged at a rate of 0.5% annually for first-generation drug-eluting stents (DES), often presenting as death or myocardial infarction. Procedural factors such as stent underexpansion and malapposition are risk factors for ST in patients. The type of lesion being treated and lesion morphology also influence healing after treatment with DES and can contribute to ST. Second-generation DES such as the XIENCE V everolimus-eluting stent differ from the first-generation stents with respect to antiproliferative agents, coating technologies, and stent frame. Improvements in stent structure have resulted in a more complete endothelialization, thereby decreasing the incidence of ST. Bioresorbable scaffolds show promise for restoring vasomotor function and minimizing rates of very late ST. Post-PCI treatment with aspirin and clopidogrel for a year is currently the standard of care for DES, but high-risk patients may benefit from more potent antiplatelet agents. The optimal duration of DAPT for DES is currently unclear and will be addressed in large-scale randomized clinical trials.

Impact of age on clinical outcomes after everolimus-eluting and paclitaxel-eluting stent implantation: pooled analysis from the SPIRIT III and SPIRIT IV clinical trials.

AIMS: The impact of age on outcomes following everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) implantation was evaluated in a patient-level pooled analysis of the SPIRIT III (n=1,002) and SPIRIT IV (n=3,687) trials. METHODS AND RESULTS: Clinical outcomes with EES compared to PES in elderly (≥ 65 years, n=2,071) and younger (<65 years, n=2,617) patients were evaluated at one year. At one year, elderly patients treated with EES rather than PES showed a significant reduction in target lesion failure (TLF) (3.9% EES vs. 6.8% PES, p=0.006), major adverse cardiac events (MACE) (4.0% EES vs. 7.1% PES, p=0.005), and ischaemia-driven target lesion revascularisation (ID-TLR) (2.0% EES vs. 4.0% PES, p=0.01). Younger patients treated with EES rather than PES also had significantly reduced one-year rates of TLF (4.9% EES vs. 7.9% PES, p=0.003), MACE (5.0% EES vs. 8.0% PES, p=0.004), target vessel myocardial infarction (MI) (2.0% EES vs. 3.4% PES, p=0.04), ID-TLR (3.3% EES vs. 5.5% PES, p=0.01) and stent thrombosis (0.5% EES vs. 1.6% PES, p=0.01). CONCLUSIONS: In a pooled analysis from the SPIRIT III and IV trials, EES was safer and more effective than PES in both younger and older cohorts as evidenced by lower rates of TLR, TLF and MACE.