Optical coherence tomography for characterization of cardiac allograft vasculopathy in late survivors of pediatric heart transplantation.

BACKGROUND: Optical coherence tomography (OCT) has been shown to reliably detect cardiac allograft vasculopathy (CAV). In recent studies performed in adult heart transplant (HTx) recipients, OCT revealed the presence of vulnerable plaques and complicated coronary artery lesions, thus challenging the current concept that CAV disease is a diffuse concentric and fibrosing vasculopathy. The aim of our study was to characterize CAV by OCT in a young population of HTx recipients. METHODS: We prospectively enrolled 21 young HTx recipients (mean age 27 years, range 22 to 38 years) to undergo OCT of the left anterior descending coronary artery (LAD) in addition to annual CAV screening by coronary angiography and virtual histology intravascular ultrasound (VH-IVUS). Quantitative OCT analysis was performed at the site of maximal intimal thickness (MIT) for each LAD segment. RESULTS: Patients were 27 years old with a mean time from cardiac transplantation of 14.7 ± 6.8 years. All patients exhibited intimal hyperplasia with an abnormal (>1) intima-to-media ratio. The median (interquartile range) MIT values by OCT were 0.37 (0.22 to 0.54) mm, 0.46 (0.29 to 0.54) mm and 0.34 (0.25 to 0.49) mm in the distal, middle and proximal LAD segments, respectively. Qualitative OCT analysis rarely showed features of vulnerable plaque or complicated lesions. Consistently, at VH-IVUS, the prevalent component at the site of MIT per vessel assessed by OCT was fibrous tissue. CONCLUSIONS: Unlike recent evidence in adult HTx recipients, OCT findings of vulnerable plaque and complicated coronary lesions were found to be rare among late survivors of pediatric HTx.

One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer.

OBJECTIVES: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario. BACKGROUND: Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI. METHODS: We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up. RESULTS: Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 1.0%. CONCLUSIONS: In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials.

Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis.

BACKGROUND: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV. METHODS: Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm(2) and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV. RESULTS: Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4-2.8, p < 0.001), echocardiographic score > 8 (HR: 2.19; 95% CI: 1.6-2.9, p < 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2-2.1, p = 0.003) and valve area ≤ 1.75 cm(2) after PMV (HR: 3.1; 95% CI: 2.3-4.2, p < 0.001) were identified as independent predictors of the primary endpoint. CONCLUSIONS: Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result.

A prospective registry on carotid artery revascularisation selected by consensus of a cardiovascular team.

AIMS: This prospective registry was designed to evaluate the early and long-term incidence of clinical events in patients with carotid obstructive disease (COD), after carotid artery revascularisation selected by consensus of a cardiovascular team. METHODS AND RESULTS: 403 consecutive patients with COD scheduled for carotid revascularisation were included: 130 were treated with carotid endarterectomy (CEA) and 273 with carotid artery stenting (CAS). Propensity score matching was performed to assemble a cohort of patients in whom all baseline covariates would be well balanced. The occurrence of major adverse cardiac and cerebrovascular events (MACCE), including any death, non-fatal myocardial infarction or stroke, was assessed at 30 days and at long-term follow-up. The incidence of MACCE at 30 days was 4.0% (95% confidence interval: 2.1 to 6.0), without any significant difference between the CAS and CEA groups in unmatched and matched populations. The cumulative freedom from MACCE at two-year follow-up was 80.5%±0.94%, with no statistically significant differences between the CAS and CEA groups, both in the total population and in the matched cohort. CONCLUSIONS: In this registry of patients undergoing carotid artery revascularisation selected by consensus of a cardiovascular team, the early and long-term incidence of clinical events is up to standard.

Coronary plaque composition assessed by intravascular ultrasound virtual histology: association with long-term clinical outcomes after heart transplantation in young adult recipients.

OBJECTIVES: To assess coronary plaque composition by virtual histology intravascular ultrasound (VH-IVUS) analysis in young adult recipients and to correlate these findings with time from heart transplant (HTx) and long-term outcomes. BACKGROUND: Rapid progression of coronary allograft vasculopathy after heart transplantation is a powerful predictor of mortality and clinical events at long-term. METHODS: Forty consecutive young adult recipients transplanted during childhood undergoing VH-IVUS during coronary surveillance have been prospectively included in this study. According to the time interval from HTx to VH-IVUS assessment, our cohort was divided into two groups (group A: ≤5 years, n = 13; group B: >5 years, n = 27). RESULTS: Group B showed an higher percentage of necrotic core and dense calcium (12 ± 2 vs. 5 ± 1%, P = 0.04; 8.2 vs. 2.1%, P = 0.03; respectively). An "inflammatory plaque" (necrotic core and dense calcium ≥30%) was detected in 34.8% of patients in group B and in none among group A patients (P = 0.03). Patients in group B had a number of adverse clinical events significantly higher than group A patients (53.8 vs. 14.3%; HR 4.45; 95% CI 1.62-12.16; P = 0.029) at long-term follow-up (4.2 years). The multivariate regression analysis showed that age (HR 1.5; 95% CI 1.1-2.0; P = 0.007), time from HTx (HR 1.8; 95% CI 1.6-4.8; P = 0.02), and inflammatory plaque (HR 2.4; 95% CI 1.1-5.3; P = 0.03) were independent predictors of adverse clinical events. CONCLUSIONS: This study supports the hypothesis that time-dependent differences in plaque composition, as assessed by VH-IVUS, occur after HTx in young adult recipients, probably determining an increased risk of long-term clinical events.

Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study.

BACKGROUND: Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess. METHODS AND RESULTS: Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006). CONCLUSIONS: This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease. CLINICAL TRIAL REGISTRATION URL: http://clinicaltrials.gov. Unique identifier: NCT00818792.

Long-term clinical follow-up of the multicentre, 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).

AIMS: To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment. METHODS AND RESULTS: Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%). CONCLUSIONS: The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.

Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial.

BACKGROUND: Prednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups--bare metal stent plus oral prednisone or drug eluting stents--assuming similar optimal adjunctive medical treatment. METHODS: Five tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee. RESULTS: One-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively (P=.04 and .006). CONCLUSION: Compared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.

Long-term outcome of provisional side-branch T-stenting for the treatment of unprotected distal left main coronary artery disease.

Percutaneous coronary intervention (PCI) on distal left main (LM) remains an independent predictor of poor outcome. The strategy of implanting one stent on the main branch (MB), with provisional stenting on the side-branch (SB) only when required (provisional T-stenting), has become the default approach to most bifurcation lesions. This prospective registry sought to investigate the long-term safety and efficacy of provisional SB T-stenting for the treatment of unprotected distal LM disease in patients undergoing PCI. From January 2006 to May 2009, 107 consecutive patients affected by unprotected distal LM disease underwent PCI at our center with the intent to use a provisional SB-stenting technique. We evaluated the rate of major adverse cardiac events (MACE) at long-term follow-up (up to 12-41 months). Procedural success was obtained in 98% of patients. A final kissing balloon inflation was performed in 95% and intravascular ultrasound in 83% of patients. Additional stenting on the SB after provisional stenting on MB was required in 29% of lesions. Long-term follow-up (3.5 years; 25-75th percentile and 1.1-4.5 years) was completed in 97% of patients. The cumulative incidence of MACE was 32.7%: all-cause death was 15.8%, nonfatal myocardial infarction 8.4%, and target vessel revascularization 21.5%. At multivariable analysis, age (hazard ratio, 2.08; 95% confidence interval: 2.01-3.32, P = 0.03), European System for Cardiac Operative Risk Evaluation (HR 1.20, 95% CI: 1.04-1.33, P = 0.02), and diabetes mellitus (HR 3.48, 95% CI: 1.12-6.87, P = 0.01) were identified as independent predictors of MACE. In patients with unprotected distal LM disease undergoing PCI, a provisional strategy of stenting the MB only is associated with good long-term clinical outcomes.

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.

Long-term results of immunosuppressive oral prednisone after coronary angioplasty in non-diabetic patients with elevated C-reactive protein levels.

AIMS: To present the long-term results of prednisone-treated patients enrolled in the IMPRESS studies. Such studies demonstrated the efficacy of a short course of immunosuppression with oral prednisone after percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation compared to BMS alone at one year. METHODS AND RESULTS: Eighty-four non-diabetic patients with elevated C-reactive protein after PCI treated with BMS and prednisone, were followed clinically for a minimum of five years. Event-free survival was defined as freedom from death, myocardial infarction, and need for target vessel revascularisation. Event-free survival rate at a mean of 6.5 +/- 1.4 years was significantly better in prednisone-treated patients of the IMPRESS and IMPRESS-2/MVD respectively compared to their original control arms: 87.8 versus 47.6%, relative risk: 7.9; 95%CI: 2.6-24.1, p<0.0001, log-rank=13.06, p=0.0003; and 93 versus 60.5%, relative risk: 8.7; 95%CI: 2.3-32.7, p=0.0004, log-rank=13,18, p=0.0003, respectively. The event-free survival was 54.1% in controls and 90.5% in the prednisone group; relative risk: 8.1; 95%CI: 3.5-18.7, p<0.0001, log-rank= 26.33, p<0.0001. CONCLUSIONS: The clinical benefits of oral treatment with prednisone after conventional PCI in non-diabetic patients with evidence of systemic inflammation after stenting are maintained at long-term follow-up, either in patients with single or multivessel coronary artery disease.

Head-to-head comparison of sirolimus- and paclitaxel-eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study.

OBJECTIVE: It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES). RESEARCH DESIGN AND METHODS: We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up. RESULTS: A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n = 60; PES, n = 60). In-stent LLL was lower in the SES than in the PES group (0.26 +/- 0.4 vs. 0.50 +/- 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1-5.0]; P = 0.03). CONCLUSIONS: SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.

Elevated C-reactive protein levels and coronary microvascular dysfunction in patients with coronary artery disease.

AIMS: It is still unknown whether elevated C-reactive protein levels are responsible for coronary microcirculatory dysfunction in patients with coronary artery disease (CAD). This study was aimed at evaluating the association between C-reactive protein levels and endothelium-dependent and endothelium-independent coronary blood flow (CBF) responses in non-culprit arteries of patients with CAD. METHODS AND RESULTS: We studied 28 patients (14 with normal and 14 with elevated C-reactive protein levels, >5 mg/L) with single-vessel disease and otherwise angiographically normal coronary arteries undergoing percutaneous transluminal coronary angioplasty (PTCA). CBF was measured in the non-PTCA vessel using an intracoronary Doppler guide wire and quantitative coronary angiography at baseline, after intracoronary infusion of substance P and of adenosine, and expressed as per cent change from baseline. The increases in CBF during infusion of substance P and of adenosine were lesser in patients with elevated than in those with normal C-reactive protein levels (34+/-22 vs. 61+/-34%, P=0.04 and 131+/-53 vs. 189+/-89%, P=0.03, respectively). Multivariable analysis identified elevated C-reactive protein level as the only independent predictor of reduced response to substance P (P=0.01) and adenosine (P=0.02). CONCLUSION: In patients with CAD, evidence of systemic inflammation is independently associated with endothelium-dependent and endothelium-independent coronary microvascular dysfunction, which, in turn, may be critical to precipitate myocardial ischaemia, in particular, in unstable patients.

Mechanisms and predictors of transient left ventricular dysfunction early after successful percutaneous balloon mitral valvuloplasty.

BACKGROUND: The immediate effects of balloon mitral valvuloplasty (BMV) on left ventricular (LV) function in patients with mitral stenosis are still controversial. The aim of this study was to investigate the mechanisms and potential clinical, echocardiographic and hemodynamic predictors of transient LV dysfunction occurring in patients with mitral stenosis early after successful percutaneous BMV. METHODS: Sixty patients without residual mitral regurgitation were divided into two groups according to the changes in the left atrial (LA) pressure 15 min after successful BMV: 18 patients (group A) did not present with any reduction in LA pressure, and underwent nitroglycerin administration (0.4 mg, sublingually). The remaining 42 patients (group B) presented with a decrease in LA pressure. RESULTS: At baseline, both the mitral valve gradient and area assessed at echocardiography and during cardiac catheterization were similar in groups A and B. Group A patients presented with, however, higher LV early- and end-diastolic pressures and peak V waves during cardiac catheterization both prior to and 15 min after BMV than group B patients (all p values < 0.05). In group A, nitroglycerin administration was associated with a decrease in LV end-diastolic pressure (p = 0.049), LA pressure (p < 0.001), and peak V wave (p < 0.001) that was still persistent 30 min after its administration, reaching values similar to those observed in group B early after BMV. At multivariate analysis, the only independent predictors of LV dysfunction early after BMV were found to be LV early- (p = 0.015) and end-diastolic (p = 0.023) pressures at baseline and the Wilkins' score (p = 0.004). CONCLUSIONS: After successful BMV a transient lack of LV adaptation to the increased LV preload resulting in a persistently elevated LA pressure is predicted by higher baseline LV diastolic filling pressures and higher Wilkins' scores. It is promptly and steadily reversed by nitroglycerin administration through a transient LV unloading, thus allowing a correct hemodynamic evaluation of the immediate results of the procedure.

Coronary flow characteristics after a Bentall procedure with or without sinuses of Valsalva.

OBJECTIVES: The sinuses of Valsalva are known to contribute to the normal function of the aortic valve. Little is known about their role in promoting coronary artery blood flow. The aim of this study was to compare coronary artery flow characteristics among patients undergoing a Bentall operation by means of a conventional cylindrical Dacron conduit or with a new conduit with pseudosinuses of Valsalva or in patients retaining their natural sinuses of Valsalva after aortic valve and supracoronary ascending aorta replacement. METHODS: One year after a Bentall procedure with a standard cylindrical Dacron conduit (7 patients, group A) or with the new conduit (7 patients, group B), or after aortic valve and ascending aortic replacement (control group, 7 patients, group C) coronary flow velocity reserve and diastolic to systolic time integral ratio at baseline and after maximal hyperemia (with 40 microg of adenosine) were assessed by using a 0.014-in. Doppler guidewire positioned in the middle portion of the left anterior descending coronary artery. All patients were in NYHA class I, sinus rhythm and free of coronary disease. RESULTS: Arterial blood pressures and heart rate were comparable among groups. Intracoronary Doppler measurements did not show any significant difference in coronary vascular reserve between the three groups (3.6+/-0.4 vs 3.1+/-0.7 vs 3.7+/-0.5, P = 0.2). A greater diastolic component at baseline was present in group B patients (5.5+/-1.9 vs 3.5+/-0.9 in group A and 3.7+/-0.9 in group C, P = 0.024). After maximal hyperemia the diastolic component increased slightly in group A patients (8%) while both in groups B and C significantly decreased (-15 and -20%, respectively) (P = 0.017). CONCLUSIONS: The presence of pseudosinuses of Valsalva does not influence coronary flow reserve. After maximal coronary vasodilation the increase in the systolic component of coronary flow is more evident in the presence of sinuses or pseudosinuses of Valsalva, thus suggesting that coronary flow pattern may be affected by the presence of sinuses.

Effects of carbon-coated coronary stents on the markers of inflammation, thrombin generation and platelet and endothelial activation.

BACKGROUND: The effects of stent carbon coating on the activation of inflammatory and endothelial cells and of coagulation were assessed in patients undergoing coronary artery stent implantation. METHODS: Forty-four consecutive patients with stable angina and an isolated significant stenosis in a native coronary vessel undergoing stent implantation were randomized to a carbon-coated stent (Carbostent, n = 23) or an uncoated stent with a similar design (Multilink, n = 21). The markers of inflammation, of hemostasis and of platelet and endothelial activation were determined before and 6, 24, 48 and 72 hours after the procedure. RESULTS: Procedural success was achieved in all cases and no patient presented with major in-hospital adverse events. In both the Carbostent and Multilink groups, the median (interquartile range) plasma levels of C-reactive protein significantly increased after the procedure (p < 0.001 and p = 0.002 vs baseline levels, respectively), reaching a peak at 48 hours, without any difference between groups (p = 0.76). Similarly, in both groups the plasma levels of fibrinogen, thrombin-antithrombin III complexes, prothrombin fragments F1 + 2, plasminogen activator inhibitor-1, soluble E-selectin, soluble P-selectin and von Willebrand factor significantly increased after the procedure (all p < 0.05 vs baseline values), without any difference between groups (all p = NS). CONCLUSIONS: This study confirms that the markers of inflammation, of endothelial and platelet activation and of thrombin generation significantly increase after successful coronary artery stent implantation. More importantly, it demonstrates that carbon coating does not modify the biologic response of the vessel wall to stent implantation.

Combination of sotalol and magnesium prevents atrial fibrillation after coronary artery bypass grafting.

BACKGROUND: Atrial fibrillation (AF) is a common complication reported in 20% to 40% of patients after coronary operations. Sotalol alone and magnesium alone have been shown to partially decrease the incidence of AF. The goal of this study was to evaluate the efficacy of these two pharmacological agents, used alone or in combination, to reduce postoperative AF. METHODS: Two hundred seven consecutive coronary artery bypass patients (mean age 62 +/- 11 years) were randomized to receive sotalol alone (80 mg twice daily for 5 days starting from the morning of the first postoperative day) (group S), magnesium alone (1.5 g daily for 6 days starting in the operating room just before cardiopulmonary bypass) (group M), both pharmacologic agents at the same dosages (group S+M), or no antiarrhythmic agents (group CTR). All patients with an ejection fraction less than 0.40 were excluded. RESULTS: The incidence of postoperative AF was 11.8% (6/51) in the S group, 14.8% (8/54) in the M group, 1.9% (1/52) in the S+M group, and 38% (19/50) in the CTR group. The following differences were significant: group CTR versus groups S, M, and S+M with values of p = 0.002, p = 0.007 and p < 0.0001, respectively; and group S+M versus groups S and M with p = 0.04 and p = 0.01, respectively. CONCLUSIONS: Incidence of AF after coronary operation was significantly reduced by the administration of sotalol alone and magnesium alone; more importantly, the incidence was further reduced by combining these agents.