A multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: cortisone plus BMS or DES versus BMS alone to eliminate restenosis (CEREA-DES) - study design and rationale.

BACKGROUND: Several randomized trials and registries have shown a reduction of restenosis after coronary angioplasty with drug-eluting stents (DESs) compared with bare metal stents (BMSs). However, cost-efficacy analysis and long-term outcome of DESs compared to BMSs deserve further assessment. Moreover, concern has been raised regarding adverse clinical events occurring late after DES implantation, in particular, late stent thrombosis related to the suspension of dual antiplatelet therapy. The use of a short-cycle oral treatment with prednisone at immunosuppressive dose after BMS implantation has shown remarkable efficacy in reducing restenosis in nondiabetic patients, with very low additional cost and without the need for long-term dual antiplatelet therapy. Such results are however limited by small sample size. STUDY DESIGN: Cortisone plus BMS or DES versus BMS alone to Eliminate Restenosis is an independent, prospective, multicenter, randomized study. It will randomize 375 nondiabetic patients with coronary artery disease in three different arms to BMS (control group), DES (DES group) or BMS followed by a 40-day prednisone treatment (prednisone group). The DES and the prednisone groups will be compared to the control group to investigate the expected clinical advantage. The primary endpoint of the study is the event-free survival of cardiovascular death, myocardial infarction and recurrence of ischemia-needing repeated target vessel revascularization at 1 year. Secondary endpoints are the event-free survival analysis at 2 and 3 years, the restenosis rate at 9 months, and cost-effectiveness at 1, 2 and 3 years. SAMPLE SIZE: The expected primary endpoint rates are 90% for DESs and for prednisone-treated patients and 77% for BMSs. The study was designed as a superiority trial, to compare DES, and BMS and prednisone, with BMS alone. A sample size of 118 patients per group provides an 80% power, assuming a complete 12-month follow-up information available for each patient. To obviate for cases of drop out, the sample size was increased to 375 patients to be enrolled in five Italian hospitals. CONCLUSION: This study will provide a magnitude of the net clinical and economic benefits of DES and of the safety and efficacy of BMS and cortisone compared to the standard use of BMS alone in nondiabetic patients with coronary artery disease.

Activity monitoring in heart failure patients with cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves functional capacity in heart failure patients. This study aimed to prospectively analyze long-term device-based monitoring of physical activity in patients undergoing CRT. METHODS AND RESULTS: The Activity Log Index (ALI), calculated by CRT devices, represents the percentage of time when acceleration exceeds a threshold and monitors the physical activity. Data from 178 CRT patients (New York Heart Association III 91%, left ventricular ejection fraction 21+/-6%, left ventricular end-diastolic diameter 69+/-9 mm, QRS 159+/-27 ms, sinus rhythm 81%) were retrieved. The ALI increased from a baseline value of 3.6+/-2.0 to 11.2+/-4.6 (p<0.005) 104 weeks after initiation of CRT. A plateau was reached at approximately 12 weeks and thereafter ALI remained stable for up to 2 years. The magnitude of the changes in ALI was similar in patients with different etiologies and underlying rhythms. Despite similar values at baseline, elderly patients (>or=65 years) exhibited significantly lower ALI values than younger patients during the follow-up and at the plateau (9.5+/-4.2 vs 13.3+/-4.8, p<0.001). CONCLUSIONS: Device-based monitoring of physical activity in CRT patients is feasible. CRT resulted in a large and long-term increase in physical activity.

Should sports activity be encouraged or contraindicated in hypertensive subjects?

Hypertension is considered one of the major risk factors for cardiovascular disease. There are a number of different approaches to the prevention, control and treatment of hypertension. One of these provides lifestyle modification as a means to facilitate drug step-down or drug withdrawal in hypertensive patients subjected to a pharmacological treatment, but also as a means to control blood pressure and reduce the risk of developing hypertension in subjects that have abnormal blood pressure but are not candidates for drug therapy. Lifestyle modification includes physical activity, and there is an ever-increasing amount of evidence that physical activity can modify the history of hypertension, acting as a reducer either of blood pressure or of the other cardiovascular risk factors. The aim of this article was to analyse the effects of exercise on blood pressure (neuro-hormonal, hormonal and vessel effects), illustrate which are the influences of age and gender on exercise-induced reduction of blood pressure, indicate how much exercise (in terms of intensity, frequency and duration) is required to induce positive modification of blood pressure and evaluate current Italian criteria for sports ability in athletes with hypertension.

Cardiac resynchronization therapy improves heart rate profile and heart rate variability of patients with moderate to severe heart failure.

OBJECTIVES: This study sought to report long-term changes of cardiac autonomic control by continuous, device-based monitoring of the standard deviation of the averages of intrinsic intervals in the 288 five-min segments of a day (SDANN) and of heart rate (HR) profile in heart failure (HF) patients treated with cardiac resynchronization therapy (CRT). BACKGROUND: Data on long-term changes of time-domain parameters of heart rate variability (HRV) and of HR in highly symptomatic HF patients treated with CRT are lacking. METHODS: Stored data were retrieved for 113 HF patients (New York Heart Association functional class III to IV, left ventricular ejection fraction < or =35%, QRS >120 ms) receiving a CRT device capable of continuous assessment of HRV and HR profile. RESULTS: The CRT induced a reduction of minimum HR (from 63 +/- 9 beats/min to 58 +/- 7 beats/min, p < 0.001) and mean HR (from 76 +/- 10 beats/min to 72 +/- 8 beats/min, p < 0.01) and an increase of SDANN (from 69 +/- 23 ms to 93 +/- 27 ms, p < 0.001) at three-month follow-up, which were consistent with improvement of functional capacity and structural changes. Different kinetics were observed among these parameters. The SDANN reached the plateau before minimum HR, and mean HR was the slowest parameter to change. Suboptimal left ventricular lead position was associated with no significant functional and structural improvement as well as no change or even worsening of HRV. The two-year event-free survival rate was significantly lower (62% vs. 94%, p < 0.005) in patients without any SDANN change (Delta change < or =0%) compared with patients who showed an increase in SDANN (Delta change >0%) four weeks after CRT initiation. CONCLUSIONS: Cardiac resynchronization therapy is able to significantly modify the sympathetic-parasympathetic interaction to the heart, as defined by HR profile and HRV. Lack of HRV improvement four weeks after CRT identifies patients at higher risk for major cardiovascular events.