Early Aggressive Versus Initially Conservative Treatment in Elderly Patients With Non–ST-Segment Elevation Acute Coronary Syndrome A Randomized Controlled Trial

ObjectivesThis study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non–ST-segment elevation acute coronary syndromes (NSTEACS).BackgroundElderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS.MethodsA total of 313 patients ≥75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year.ResultsDuring admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03).ConclusionsThe present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185

Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet 2008;371:5

Summary Background Thrombolysis remains the treatment of choice in ST-segment elevation myocardial infarction (STEMI) when primary percutaneous coronary intervention (PCI) cannot be done within 90 min. However, the best subsequent management of patients after thrombolytic therapy remains unclear. To assess the best management, we randomised patients with STEMI treated by thrombolysis and abciximab at a non-interventional hospital to immediate transfer for PCI, or to standard medical therapy with transfer for rescue angioplasty

Unilateral renal sympathetic denervation may reduce blood pressure in patients with refractory hypertension

A 52-year-old Caucasian woman with essential resistant and refractory hypertension despite optimal medical therapy, including 6 different antihypertensive drugs was referred for the catheter-based renal denervation. Due to unfavourable anatomy because of non-critical fibromuscular dysplasia on the right renal artery, renal denervation of only the left renal artery was performed. Before and after the renal denervation, the patient’s blood pressure was monitored by office measurements and ambulatory blood pressure measurements (ABPM). Before the procedure, the mean office blood pressure was 157/98 mmHg; at ABPM, the mean blood pressure values were 145/94 mmHg. At 6 months of follow-up, the mean office blood pressure was 134/90 mmHg and 121/76 mmHg at ABPM. In latest 12 months of follow-up, office and ABPM blood pressure were 125/80 and 127/80 mmHg respectively. This unique case suggests that unilateral renal denervation may be effective in lowering blood pressure in patients with refractory hypertension and unfavorable renal arteries anatomy

Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis

<p>Abstract</p> <p>Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting.</p> <p>Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used.</p> <p>Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.</p

Endovascular radiofrequency renal denervation in resistant hypertension: a single center experience

Eight patients with office blood pressure &gt;140/90 mmHg, despite being treated with at least three antihypertensive drugs, underwent catheter-based renal denervation. Secondary hypertension was excluded in all patients. Every patient underwent follow-up at 30 days, and then every 3 months. At 6 and 12 months the median value of systolic clinic blood pressure decreased from 161 mmHg (25th-75th percentiles: 158-191 mmHg) at baseline to 144 mmHg (25th-75th percentiles: 136-153 mmHg) at follow up (P=0.012), and the median value of diastolic clinic blood pressure decreased from 102 mmHg (25th-75th percentiles: 94-122 mmHg) at baseline to 90 mmHg (25th-75th percentiles: 78-99 mmHg) at follow-up (P=0.012). The number of medications decreased from 5 (range, 2-8) at baseline to 3.3 (range, 0-6) at follow up. There was a significant decrease of left ventricular mass index from a median of 160 g/m2 (25th-75th percentiles: 147-151 g/m2) at baseline to 126 g/m2 (25th-75th percentiles 107-151 g/m2) at follow-up (P=0.043) was detected. The renal function, and metabolic and neurohumoral parameters, did not change significantly. No complications were observed

Endovascular radiofrequency renal denervation in resistant hypertension: a single center experience

Eight patients with office blood pressure &gt;140/90 mmHg, despite being treated with at least three antihypertensive drugs, underwent catheter-based renal denervation. Secondary hypertension was excluded in all patients. Every patient underwent follow-up at 30 days, and then every 3 months. At 6 and 12 months the median value of systolic clinic blood pressure decreased from 161 mmHg (25th-75th percentiles: 158-191 mmHg) at baseline to 144 mmHg (25th-75th percentiles: 136-153 mmHg) at follow up (P=0.012), and the median value of diastolic clinic blood pressure decreased from 102 mmHg (25th-75th percentiles: 94-122 mmHg) at baseline to 90 mmHg (25th-75th percentiles: 78-99 mmHg) at follow-up (P=0.012). The number of medications decreased from 5 (range, 2-8) at baseline to 3.3 (range, 0-6) at follow up. There was a significant decrease of left ventricular mass index from a median of 160 g/m2 (25th-75th percentiles: 147-151 g/m2) at baseline to 126 g/m2 (25th-75th percentiles 107-151 g/m2) at follow-up (P=0.043) was detected. The renal function, and metabolic and neurohumoral parameters, did not change significantly. No complications were observed

Acute kidney injury after primary angioplasty: Effect of different hydration treatments

AIMS: We evaluated the effect of different dose hydration protocols, with normal saline or bicarbonate, on the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI). METHODS: We considered 592 STEMI patients treated with PPCI in 5 Italian centers. Patients were randomized to receive standard or high-dose infusions of normal saline or sodium bicarbonate started immediately before contrast medium administration and continued for the following 12 h. RESULTS: The cumulative incidence of CI-AKI was 18.1% without any difference among treatment groups. Shock, age, ejection fraction 35% or less, and basal serum creatinine were significantly associated with an increased risk of CI-AKI. Follow-up at 12 months was complete in 573 patients. Overall, 25 out of 573 patients died (4.3%). We observed higher short-term mortality rates in patients receiving high-volume hydration. Otherwise, only age, shock and CI-AKI were significantly associated with 1-year mortality. CONCLUSION: In patients with STEMI undergoing PPCI, high-volume hydration with normal saline or sodium bicarbonate administrated at the time of contrast media administration was not associated with any significant advantage in terms of CI-AKI prevention

Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial.

BACKGROUND: This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial. METHODS AND RESULTS: This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%). CONCLUSIONS: Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years

Assessing MICRO-vascular resistances via IMR to predict outcome in STEMI patients with multivessel disease undergoing primary PCI (AMICRO): Rationale and design of a prospective multicenter clinical trial

BACKGROUND: In STEMI patients treated with primary percutaneous coronary angioplasty (PPCI) the evaluation of coronary microcirculatory resistance index (IMR) predict the extent of microvascular damage and left ventricular (LV) remodeling. However, the impact of IMR on the clinical outcome after PPCI in patients with multivessel disease (MVD) remains unsettled. AIM: We designed a prospective multicenter controlled clinical trial to evaluate the prognostic value of IMR in terms of clinical outcome and left ventricular remodeling in STEMI patients with MVD undergoing PPCI. METHODS AND DESIGN: The study will involve 242 patients with MVD defines as the presence of at least a non-culprit lesion of >50% stenosis at index coronary angiography. Both fractional flow reserve (FFR) and IMR will be measured in the infarct-related artery (IRA) after successful PPCI. Measurements of FFR and IMR will be repeated in the IRA and performed in the non-culprit vessels at staged angiography. The non-culprit vessel lesions will be treated only in the presence of a FFR<0.75. A 2D echocardiographic evaluation of the left ventricular (LV) volumes and ejection fraction will be performed before hospital discharge and at 1-year follow-up. The primary end-point of the study will be the composite of cardiovascular death, re-hospitalization for heart failure and resuscitation or appropriate ICD shock during 1-year of follow-up. Secondary end-points will be the impact of IMR in predicting LV remodeling during follow-up and correlations between IMR and ST-segment resolution. Other secondary endpoints will be need for new revascularization, stent thrombosis and re-infarction of the non-culprit vessels territory. IMPLICATIONS: If IMR significantly correlates with differences in outcome and LV remodeling, it will emerge as a potential prognostic index after PPCI in patients with MVD