In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease.

Objectives: The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background: The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and "all-comers" observational studies. Methods: For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results: 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions: The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.

Arterial stiffness evaluated by measurement of the QKD interval is an independent predictor of cardiovascular events.

BACKGROUND: The QKD interval is the time between the QRS wave on the electrocardiogram (ECG) and the detection of the last Korotkoff sound during BP measurement. Measurement of the QKD interval during ambulatory blood pressure (BP) monitoring provides an automatic evaluation of arterial stiffness. The objective of this longitudinal study was to examine the relationship between arterial stiffness assessed by this method and the occurrence of cardiovascular complications in a cohort of initially untreated hypertensive patients. METHODS: The initially untreated hypertensive patients were included in the cohort of hypertensives recruited to our center between January 1992 and December 1999. All benefited from ambulatory measurement of the QKD interval and BP over 24 h. Most of these patients were given antihypertensive treatment and were followed up by their family physicians, who were unaware of the QKD results. Their outcome was evaluated in 2003 by inquiring of the patients themselves or of their family physicians. RESULTS: The initial population comprised 412 patients. At the end point, 33 had been lost to follow-up. We recorded 49 cardiovascular events in this population with an average follow up of 65 +/- 36 months. In a Cox model, the arterial stiffness assessed by the QKD(100-60) as a percentage of the height-predicted normal value was significantly associated with the occurrence of cardiovascular complications, independent of age and mean 24-h BP. CONCLUSIONS: This study using ambulatory measurement of the QKD interval showed that an increase in arterial stiffness was a marker of cardiovascular risk. We show for the first time that its value persists after taking account of the mean systolic pressure over 24 h.

Blood pressure surge on rising.

OBJECTIVES: Since cardiovascular complications tend to occur more often in the morning, it is tempting to link this to the surge in blood pressure (BP) on rising. Our objective was to measure BP and heart rate (HR) on rising and compare values with those recorded immediately beforehand and seek variables related to marked changes in the two parameters in a cohort of initially untreated hypertensives. METHODS: The 24-h ambulatory BP measurement along with an accurate measurement of the BP on rising (either manually or automatically from the device coupled with a position sensor) was obtained in untreated hypertensives. Left ventricular mass was measured with echocardiography at baseline. Patients were then treated and followed by their general physician and news was obtained at regular intervals. RESULTS: A total of 507 patients with adequate recordings were included. Rising led to a mean increase of 14 mmHg in systolic blood pressure (SBP) and a 13 beats per minute (bpm) increase in HR. This elevation in BP on rising in the morning differed from the alteration in BP on normal changes in position. It was associated with left ventricular hypertrophy at baseline and an increased risk of future cardiovascular complications. CONCLUSIONS: Our study confirms the surge in BP on rising in the morning. This elevation in BP is accompanied by an acceleration in cardiac rhythm with no significant correlation between the two parameters. The increase in BP on rising was linked with the overall variability in BP, but was independent of the mean BP over 24 h. It was associated with an increased risk of cardiovascular complications independently of age and average 24-h SBP.

Acoustic videodensitometric parameters correlate with abnormalities of left ventricular filling in hypertensive patients assessed via Doppler Tissue Imaging.

PURPOSE: Using a videodensitometric technique developed in our center we investigated whether the amplitude of variation of gray levels in the interventricular septum was related to functional parameters, especially ventricular filling as studied by doppler tissue imaging (DTI) in hypertensive patients. METHODS AND RESULTS: We included 35 hypertensive patients from whom we recorded a two dimensional sequence of the left ventricle from the short axis parasternal view and a doppler tissue scan of the mitral ring. Two-dimensional sections were then analyzed with Iodp software to measure variations in levels of gray in the septum. We observed significant correlations between these variations and the velocity of the Ea wave on DTI of the lateral wall (r = 0.49, p < 0.002). On dividing this population into three sub-groups according to the Appleton classification of ventricular filling, we noted a tendency to a reduction in amplitude of variations of gray of the septum in cases with abnormalities of relaxation. This was even more marked in cases with a restrictive or pseudo-normal profile. CONCLUSION: These observations point to the interest of sonographic videodensitometry in the evaluation of hypertensive cardiopathy. Further studies will be required to determine whether it can define the extent of the abnormalities of myocardial structure and the degree of fibrosis.

Importance of anterograde visualization of the coronary venous network by selective left coronary angiography prior to resynchronization.

BACKGROUND: Understanding of coronary anatomy is essential to the advancement of cardiac resynchronization therapy (CRT) techniques. We determined whether the difficulties associated with catheterization of the coronary sinus (CS) and its lateral branches could be overcome by a preliminary angiographical study of the coronary venous system carried out during a pre-operative coronary angiography with examination of venous return. METHODS AND RESULTS: All patients were scheduled for an exploratory angiography procedure and indicated for CRT. Group A patients were implanted with a CRT device after a right arterial angiographical procedure while group B patients had a selective left angiogram including examination of venous return. Data analyzed in group B were: position of CS ostium, number and distribution of lateral branches, and ability to preselect a marginal vein suitable for catheterization. Subsequent device implantation was guided by these parameters. A total of 96 and 89 patients were included in groups A and B, respectively. Implantation success rates were not different (98% and 100%, respectively), but CS catheterization time was reduced in group B (6 minutes vs 4 minutes; P < 10(-6)) as well as total time required to position the left ventricular lead (25 minutes vs 15 minutes; P < 10(-6)), fluoroscopy exposure (7 minutes vs 5 minutes; P < 10(-6)), and volume of contrast medium required (45 mL vs 15 mL; P < 10(-6)). CONCLUSION: A coronary angiographical study, including examination of the coronary venous return prior to implantation of a CRT device, can simplify the device implant and allows patient-specific preselection of appropriate tools for the procedure.