Drug-eluting stents vs. bare metal stents in saphenous vein graft disease. Insights from a meta-analysis of 7,090 patients.

BACKGROUND: Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease. METHODS AND RESULTS: Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P<0.0001) and overall mortality (OR, 0.63; CI, 0.40-0.99; P=0.05), but similar rates of MI (OR, 0.92; CI, 0.64-1.33; P=0.7). Subgroup analysis highlighted differences between non-randomized studies, in which DES improved mortality rates, and randomized trials, in which benefit from DES was not evident. Meta-regression analysis showed that DES were more effective in the presence of older grafts and type 2 diabetes. CONCLUSIONS: The present meta-analysis showed that, in SVG disease, DES significantly reduced TVR, but did not provide clear benefits on mortality and MI, with an opposite direction of results in mortality observed from randomized and observational data.

Preventing restenosis after implantation of bare stents with oral rapamycin: a randomized angiographic and intravascular ultrasound study with a 5-year clinical follow-up.

OBJECTIVES: To establish the efficacy of oral rapamycin at a dose of 2 mg for 1 month at reducing the 6-month restenosis rate after the implantation of bare metal stents. METHODS: A prospective, 1:1 randomized, single-blind, placebo-controlled study was conducted in 108 consecutive patients assigned immediately after stent implantation to oral rapamycin (4 mg loading dose followed by 2 mg daily for 30 days) or a placebo. RESULTS: Rapamycin was maintained in 98% of patients. Angiographic in-stent binary restenosis was 14.3% in the rapamycin group versus 32.1% in the placebo group, with a relative risk (RR) of 0.45 (95% CI 0.24-0.84, p = 0.015). The rapamycin blood concentration at 15 days correlated with binary restenosis (p = 0.044). The volume obstructions found by intravascular ultrasound for the rapamycin and the placebo groups were 18.1+/-10.7 and 27.1+/-15.7% (p = 0.002), respectively. Major adverse cardiac events at a 5-year follow-up were 31.5% for the rapamycin group and 50.0% for the placebo group (RR 0.63, 95% CI 0.39-1.01, p = 0.078). CONCLUSIONS: Oral rapamycin significantly reduces the incidence of restenosis at follow-up compared to a placebo.We believe these findings deserve further testing in larger trials.

[Acute myocardial infarction after wasp sting without anaphylactic reaction]. / Infarto miocardico acuto da puntura di vespa in assenza di reazione anafilattica.

Bites of hymenopterans (bees, wasps and hornets) are very frequent phenomena that can stir up allergical reactions in venom-susceptible patients but that seldom provoke acute myocardial infarction. In the literature we can find case reports of myocardial infarction after bites of hymenopterans, and preceded by an allergic reaction (sometimes with angiographic evidence of undamaged coronary arteries). The pathophysiological determinant seems to be related to the chemical composition of hymenopterans venom, basically made up by vasoactive and thrombogenic substances able to create vasospasm and coronary thrombosis. Our report refers to a 65-year-old male patient without prior cardiological and allergic events who, bitten by a sharm of three bees, complains of an acute large anterior myocardial infarction with angiographic evidence of thrombotic lesion of the proximal left anterior descending artery treated with direct stenting with procedural success, without showing allergical symptoms. The pathophysiological determinant seems to be related to the release of vasoactive amines and thrombogenic substances contained into the hymenopterans venom, the former able to produce vasospasm, the latter able to create diffuse thrombosis. The use of adrenaline itself to counteract the possible systemic allergic reaction appears to advise against the treatment of patients with cardiological symptoms or coronary artery disease and because of its strong vasoactive activity (it leads, in fact, to vasoconstriction) and thrombogenic effects.

Similar anti-inflammatory effects of intracoronary and intravenous abciximab during primary percutaneous coronary intervention: a randomized study.

BACKGROUND: Intracoronary Abciximab administration during primary percutaneous coronary intervention (pPCI) could offer theoretical advantages over the intravenous route. Besides antiplatelet effects, Abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of our study was to assess whether the Abciximab administration route could influence its anti-inflammatory effects. METHODS: Eighty-nine consecutive ST elevation myocardial infarction patient candidates for pPCI were randomized to intracoronary (Group A-47 patients) or intravenous (Group B-42 patients) Abciximab bolus administration. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), vascular cell adhesion molecule 1 (VCAM-1) and inter-cellular adhesion molecule 1 (ICAM-1) levels. This study is registered with ClinicalTrials.gov, NCT01757457. RESULTS: Data are expressed in medians (interquartiles). In both groups, troponin levels were similar [baseline: 0.12 (0.03-0.94) vs. 0.27 (0.07-1.24) ng/ml, P = 0.73; postprocedural: 22.00 (14.75-69.43) vs. 31.96 (8.23-7.20) ng/ml, P = 0.83]. Both groups also showed similar baseline [0.31 (0.14-0.69) vs. 0.22 (0.09-0.59) mg/ml, P = 0.80] and postprocedural CRP levels [2.28 (1.37-4.23) vs. 2.16 (1.15-3.22) mg/dl, P = 0.69], similar baseline [272.5 (224.7-340.8) vs. 262.2 (221.2-306.4) ng/ml, P = 0.33] and postprocedural soluble ICAM-1 levels [281.5 (244.6-337.4) vs. 287.2 (226.9-359.2) ng/ml P = 0.71], and similar baseline [771.6 (620.9-971.0) vs. 748.6 (592.2-838.8) ng/ml, P = 0.30] and postprocedural soluble VCAM-1 levels [785.2 (671.6-947.1) vs. 745.9 (641.1-841.9) ng/ml, P = 0.17]. In-hospital and 6-month event rates were similar in the two groups. CONCLUSIONS: Our study suggests that Abciximab has similar anti-inflammatory effects irrespective of the administration route. It is unlikely that the potential clinical benefits of intracoronary Abciximab can be related to modulation of integrin receptors.

ORAl iMmunosuppressive therapy to prevent in-Stent rEstenosiS (RAMSES) cooperation: a patient-level meta-analysis of randomized trials.

OBJECTIVE: The role of oral immunosuppressive therapy (OIT) to prevent restenosis after percutaneous coronary intervention (PCI) and stenting is still controversial. This study evaluates the impact of oral administration of prednisone or sirolimus to prevent restenosis. METHODS: We conducted a meta-analysis of trials in which PCI-patients were randomized to bare metal stents (BMS) plus OIT (BMS + OIT group) versus BMS or drug-eluting stents alone (BMS/DES group). Primary endpoints were target lesion revascularization and death/myocardial infarction (MI). Secondary endpoints were death, MI, stent thrombosis and in-stent late lumen loss. Hazard ratio and weighted geometric mean difference [95% confidence intervals] served as summary statistics. RESULTS: Individual data of seven trials (1246 patients [BMS + OIT, n = 608 versus BMS/DES, n = 638] with 1456 coronary lesions) were merged. At a median follow-up of 360 days, BMS + OIT versus BMS/DES significantly reduced the risk of revascularization (0.49 [0.24-0.98], P = 0.04). In particular, BMS + OIT reduced the risk of revascularization (0.38 [0.21-0.67], P < 0.001) and late lumen loss (-0.39 mm [-0.67, -0.11], P < 0.001) as compared with BMS alone. BMS + OIT versus BMS/DES showed a similar risk of death/MI (0.67 [0.29-1.53], P = 0.34), death (0.82 [0.25-2.69], P = 0.71), MI (0.58 [0.24-1.39], P = 0.22) and stent thrombosis (0.43 [0.10-1.87], P = 0.26). CONCLUSION: In patients undergoing PCI the use of BMS and oral immunosuppressive therapy reduces the risk of revascularization as compared with BMS alone but not as compared with DES alone, while these therapies display a similar risk of death/MI. The advantage of adding oral immunosuppressive therapy to BMS is due to a lower risk of restenosis as compared with BMS alone.

Radial approach for percutaneous coronary intervention.

The transradial approach for percutaneous coronary intervention (both diagnostic and therapeutic procedures) has gained progressive acceptance in the last years. Transradial access has been shown, also, to have several advantages over transfemoral approach; the radial artery is easily compressible, thus bleeding is controllable and hemorrhagic complications are significantly reduced. Furthermore, periprocedural bleeding and vascular complications after percutaneous coronary intervention are associated with worse clinical outcomes and increased short and long - mortality. With increasing experience and availability of dedicated equipment this technique is now being increasingly used for complex catheter intervention. The main purpose of this review is to highlight the benefits, complications and problems with transradial approach compared with conventional transfemoral approach.

Different spectrum of vascular complications after angio-seal deployment or manual compression.

BACKGROUND: Reported complication rates after vascular closure device deployment or femoral manual compression (MC) are similar. However, the features and severity of such complications have never been thoroughly evaluated. METHODS AND RESULTS: A consecutive series of 1241 patients treated from 2008 to 2010 with Angio-Seal (AS) was prospectively evaluated for vascular complications (VC). As control group, we used a consecutive series of 672 patients treated with MC in the 7 months preceding AS adoption at our institution. VC were observed in 88 patients, 55 with AS and 33 with MC (relative risk, 0.90; 95% confidence interval, 0.59-1.38; P=.63). The clinical profile of complications observed in the 2 groups was different. Groin hematomas were more frequent with MC (100% vs 65.5%; P=.0005) and retroperitoneal bleedings were more common with AS (41.8% vs 6.1%; P=.0005). AS complications required more frequently transfusions (49.1% vs 18.2%; P=.006), while MC complications significantly delayed hospital discharge, in comparison to AS (4.3 ± 4.0 days vs 2.7 ± 1.9 days; P=.01). Differences in groin hematoma and retroperitoneal bleeding rates were confirmed after propensity score matching. Finally, a different allocation of diagnostic/therapeutic resources was observed in the 2 groups. CONCLUSION: AS and MC were associated with similar incidences of VC, with a higher prevalence of severe complications (retroperitoneal hemorrhages and transfusions) after using AS. However, complications after MC were associated with significantly prolonged hospital stay. Comparison between different hemostatic strategies should consider the logistic burden imposed by different vascular complications.

Comparison of the novel Angio-Seal Evolution with Angio-Seal STS closure device.

BACKGROUND: Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce deployment skills. It is unknown if these changes translated into better clinical results. METHODS AND RESULTS: Early VCD failure and major and minor vascular complications were prospectively assessed in 584 consecutive patients treated by ASE (ASE group) and in 633 consecutive patients treated by the older Angio-Seal STS (AS-STS group). Early VCD failure was rare (ASE 1.7% vs AS-STS 1.3%, P = .52). Major vascular complication risk was similar (odds ratio [OR] = 1.76, 95% confidence interval [CI] = 0.79-3.90, P = .17), but minor vascular complication rate was significantly higher in the ASE group (OR = 3.36, 95% CI = 1.57-7.21, P = .002). At logistic regression ASE was an independent predictor of vascular complications. Early VCD failure was associated with the highest risk for vascular complications. CONCLUSIONS: In a large unselected population, ASE-treated patients showed increased risk for minor vascular complications. Early VCD failure negatively affected short-term vascular prognosis.

Safety and efficacy of the new Angio-Seal Evolution™ closure device: a single-center experience.

BACKGROUND: The Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce the individual skills needed for deployment. A clinical comparison of ASE with manual femoral compression (MC) has never been reported. METHODS AND RESULTS: A total of 451 consecutive patients treated by ASE following cardiac catheterization were compared with 451 propensity-score matched controls treated by MC. Early failure of ASE and in-hospital major vascular complications (any retroperitoneal hemorrhage, limb-threatening ischemia or surgical repair) and minor vascular complications (any groin hematoma ≥ 5 cm or pseudoaneurysm) following ASE deployment were prospectively assessed. Early failure of ASE was rare (1.8%). In the two groups, the major vascular complication rate was similar [odds ratio (OR), 2.5; 95% confidence interval (CI), 0.5-13.0; p = NS]. However, patients treated by ASE showed a significantly higher risk for minor vascular complications (OR, 2.2; 95% CI, 1.1-4.3; p = 0.029). In comparison to successful deployment, early ASE failure was associated with a very high risk for both major (OR, 15.7; 95% CI, 1.56-158.7; p = 0.002) and minor (OR, 6.1; 95% CI, 1.2-31.8; p = 0.015) vascular complications. CONCLUSION: In a large, single-center experience, early ASE failure was rare and the rate of major vascular complications following ASE deployment was similar to controls. However, an excess of minor vascular complications (generally large groin hematomas) was observed in patients treated by ASE. Our study confirms that early ASE failure is an important risk factor for severe vascular complications.

Use of endothelial progenitor capture cell stent during percutaneous treatment of coronary bifurcations: a prospective angiographic registry.

BACKGROUND: The treatment of bifurcation lesions remains a challenge with poor immediate results and higher restenosis rate than in nonbifurcated lesions. Drug-eluting stents improve the outcome after coronary stenting, but are associated with a small but statistically significant increase in late and very late stent thrombosis. Thus, aim of the present study was to evaluate the angiographic and clinical results of a new type of stent (coated with murine monoclonal antihuman CD34 antibodies designed to attract circulating endothelial progenitor cells to rapidly establish a functional endothelial layer and promote healing stent implantation) in a cohort of consecutive patients with coronary bifurcation lesions. METHODS AND RESULTS: Between December 2007 and July 2008, a total of 43 consecutive patients were enrolled and 47 consecutive bifurcation lesions were treated with endothelial progenitor capture cell stents. The angiographic end points binary restenosis rate inside the stent (within 5 mm of the stent edges or in the segments treated with balloon angioplasty) was 5% (2.1% in the main branch and 10.5% in the side branch). No stent thrombosis was observed. Clinical follow-up was completed in all patients at mean time of 34.5 days after percutaneous coronary interventions by clinical evaluation and 12.3 months with a telephone contact. Angina at rest was present in 3 patients (7.9%). No in-hospital, 30-days, or 12-months major adverse cardiac events (death, myocardial infarction, and repeat revascularization coronary artery bypass graft or percutaneous coronary angioplasty) were reported. CONCLUSIONS: The use of endothelial progenitor capture cell in the setting of coronary bifurcation appears to be feasible and safe with no incidence of late stent thrombosis and a very low rate of repeated revascularization.

Update on glycoprotein IIb/IIIa: role in primary coronary intervention.

Coronary artery diseases continue to be the most common causes of mortality and morbidity in the industrialized world, especially in the setting of acute myocardial infarction. Platelets play a crucial role in thrombosis and haemostasis, which can be either beneficial or deleterious, depending on the circumstances. Platelet hyperreactivity is a multifactor process depending on genetic polymorphism, pathological state and lifestyle; it contributes to the activation of the thrombotic cascade. Under pathophysiological conditions platelets activation plays a critical role in arterial thrombosis including platelets aggregation, the basis of destabilization of coronary plaque. Despite the benefits observed in outcome when primary angioplasty is compared with thrombolysis for the treatment of acute myocardial infarction there is still some room for improvement; unfortunately the restoration of an "optimal" epicardial flow is not always related to an "optimal" myocardial reperfusion. In the recent, past several studies have shown significant benefits with the administration of glycoprotein IIb/IIIa inhibitors. Thus, the aim of the present review is to perform an update on factors associated with platelets hyperactivity and on adjunctive glycoprotein IIb - IIIa inhibitors in primary angioplasty.

Impact of acute renal failure following percutaneous coronary intervention on long-term mortality.

BACKGROUND: Acute renal failure (ARF) following percutaneous coronary intervention (PCI) has been shown to be associated with a worse outcome. Whether this event should be considered as a marker of disease severity or an independent contributor to mortality is still unclear. METHODS: In a multicenter, prospective cohort study we investigated the predictive variables and the impact of postprocedural ARF on 2-year all-cause mortality in 2860 consecutive patients (50% with stable angina and 50% with non-ST-elevation acute coronary syndromes) undergoing PCI. Serum creatinine determinations were made immediately before and 24 h after PCI. ARF was defined as an increase in serum creatinine of > or =0.5 mg/dl over baseline. RESULTS: One hundred and six patients (3.7%) experienced ARF. At logistic regression analysis, ARF was associated with pre-existing low values of estimated glomerular filtration rate, reduced left ventricular ejection fraction, hypertension, and prior coronary bypass surgery. Mortality data at 2 years were available for all patients: 119 patients (4.16%) had died, 3.9% of those without and 11.3% of those with ARF (univariate hazard ratio 3.16; 95% confidence interval 1.68-5.94; P = 0.0004). At Cox regression analysis, the significant predictors of mortality were age, ejection fraction, preprocedural estimated glomerular filtration rate, PCI failure, atrial fibrillation, diabetes mellitus, and fluoroscopy time. In this comprehensive mortality model, ARF maintained a borderline statistical significance (hazard ratio 1.83, 95% confidence interval 0.98-3.44; P = 0.06). CONCLUSIONS: ARF following PCI occurs almost exclusively in patients with chronic kidney disease or left ventricular dysfunction. These risk factors are also among the most powerful predictors of long-term mortality and are likely to explain most of the association between postprocedural ARF and long-term mortality. After correction for clinical determinants, however, postprocedural ARF maintains a clinically significant impact on mortality that must be taken into account for benefit vs. risk evaluation of PCI in individual patients.