The matryoshka procedure.

We present the case of a 73-year-old male patient undergoing a modified Bentall-DeBono procedure in 2015 due to aortic stenosis and aortic aneurism involving the root. A bioprosthetic stented conduit made with a stented Edwards Perimount 21-mm bioprosthesis and a Vascutek Valsalva 28-mm Dacron graft was implanted along with a mitral annuloplasty. Five years later, due to early degeneration of the bioprosthesis and a progression of the mitral disease, he underwent a second surgical procedure where a Medtronic Mosaic 27-mm valve prosthesis was implanted in mitral position and a sutureless Livanova Perceval 23-mm valve in aortic position. Because of the difficulty in removing the previously implanted aortic prosthesis, the Perceval valve was inserted inside the frame of the PeriMount as an open "valve-in-valve" procedure. In October 2020, the patient underwent a ViV TAVI with a 23-mm Edwards Sapien 3 (Edwards Lifescience). After induction of general anesthesia and heparin administration, the procedure was performed via right femoral artery approach with preimplantation of two Proglides. After transfemoral insertion of a 14-French sheath, the aortic valve was crossed with a 0.035-in. straight guide-wire, taking care to avoid crossing the crowns of Perceval frame. After exchange of the standard wire with an extra-stiff 0.035-in. Safari wire, the Sapien-3 valve was advanced across the two previously implanted surgical valves and deployed at the level of the Perceval ring. After bioprosthesis deployment, peak-to-peak left ventricular aortic gradient was reduced from 51 to 16 mmHg.

Long-Term Outcomes of Coronary and Carotid Artery Disease Revascularization in the FRIENDS Study.

OBJECTIVES: The aim of this study is to assess long-term-outcomes of patients with concomitant CAD and COD treated with different revascularization strategies. BACKGROUND: Multisite artery disease is common and patients with combined disease have poor prognosis. The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. METHODS: This observational registry enrolled, between January 2006 and December 2012, 1022 consecutive patients from high volume institutions with concomitant CAD and COD suitable for endovascular, surgical, or hybrid revascularization in both territories selected by consensus of a multidisciplinary team. RESULTS: The cumulative incidence of 5-year major cardiovascular events (MACCE) including cardiovascular death, myocardial infarction (MI), or stroke in the overall population was 12%. The incidence of 5-year MACCE was not statistically different in the surgical, endovascular, or hybrid patients group (10.1% vs. 13.0% vs. 13.2%, P = .257, respectively). However, the hybrid group exhibited rates of myocardial infarction, chronic kidney disease, and cumulative incidence of all clinical events higher than the surgical group. After propensity score matching, the incidence of 5-year MACCE was similar in the three groups (13.0% vs. 15.0% vs. 16.0%, p = .947, respectively). CONCLUSIONS: An individualized revascularization approach of patients with combined CAD and COD yields very good results at long-term follow-up, despite the high risk of this multilevel population even when the baseline clinical features are equalized.

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.

Vascular complications after transcatheter aortic valve implantation: treatment modalities and long-term clinical impact.

OBJECTIVES: Vascular complications (VC) are the most frequent drawback of transcatheter aortic valve implantation (TAVI), affecting up to 20% of overall procedures. Data on the treatment and their long-term impact are scarce. The goal of this study was to report on the incidence, management and impact on the long-term outcomes of VC following TAVI. METHODS: This was a multicentric retrospective analysis of consecutive patients undergoing TAVI. The primary endpoint was freedom from major adverse cardiac and cerebrovascular events at long-term follow-up. Adverse events were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS: A total of 2145 patients were included: VC occurred in 188 (8.8%); of which 180 were limited to the access site. Two-thirds of the VC were minor; 8% required surgical treatment; the remaining were repaired percutaneously. The major adverse cardiac and cerebrovascular events-free survival at 2 years was 83.0% for patients with VC and 86.7% for those without (P = 0.143), but 71.9% for patients with major compared to 89.0% in those with minor VC (P = 0.022). Major VC and diabetes mellitus independently predicted worse outcomes at 2 years. The major adverse cardiac and cerebrovascular events-free survival rate and the occurrence of vascular adverse events in the long term among patients with VC at the access site treated by endovascular techniques (covered stent implantation or angioplasty) were similar to those without VC (84.2% vs 86.7%; P = 0.635). CONCLUSIONS: Major but not minor VC impact long-term survival after TAVI. Covered stents implanted to manage VC at the access site have no impact on the long-term clinical outcome of TAVI.

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.

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices.

New-generation devices such as Evolut and Portico have provided favorable results in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, but their comparative effectiveness remains debated, despite its relevance when envisioning TAVI in low-risk patients. We evaluated the safety and efficacy of 2 leading TAVI devices (Evolut and Portico) used by the same team of experienced TAVI operators, focusing on long-term outcomes, including major adverse events (i.e., the composite of death, stroke, myocardial infarction, major vascular complication, or major bleeding). Unadjusted and propensity score-adjusted analyses were carried out. A total of 233 patients were included, 119 (51.1%) receiving Evolut and 114 (49%) Portico. Baseline and procedural data showed significant between-device differences, including functional class, surgical risk, chronic obstructive pulmonary disease, renal function, transesophageal guidance, device size, postdilation, and procedural time (all p <0.05). Yet, acute and in-hospital outcomes were not significantly different (all p >0.05). Follow-up status was ascertained in 228 (98%) patients after 15.0 ± 7.6 months. Unadjusted analysis showed similar rates of major adverse events, as well as the individual risk of death, stroke, myocardial infarction, major vascular complication, major bleeding, and pacemaker implantation (all p >0.05). Even at propensity score-adjusted analysis outcomes were not significantly different with Evolut and Portico (all p >0.05). In conclusion, Evolut and Portico devices yield similarly favorable results at long-term follow-up when used by experienced TAVI operators.

Propensity-score-adjusted comparison of Evolut vs. Portico devices for transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation has become an established treatment for severe aortic stenosis, thanks to key improvements achieved by new-generation devices. Their comparative effectiveness and safety are, however, still uncertain. METHODS: We queried a prospective registry on transcatheter aortic valve implantation to compare Evolut and Portico devices, focusing on procedural, in-hospital, and mid-term outcomes. Unadjusted and propensity-adjusted analyses were carried out. RESULTS: In all, 233 patients were included, 119 (51.1%) receiving Evolut and 114 (48.9%) Portico. Several differences in baseline and procedural features were evident, including comorbidities, device size, and postdilation (all P < 0.05). Unadjusted analysis for procedural results showed significant differences in fluoroscopy time, left ventricular ejection fraction, and aortic regurgitation (all P < 0.05), whereas device and procedural success rates were not significantly different (both P > 0.05). In-hospital outcomes were not significantly different (all P > 0.05). Survival analysis for mid-term follow-up (6 ±â€Š7 months) outcomes showed no significant differences in death, stroke, myocardial infarction, major vascular complication, or major bleeding (all P > 0.05). Conversely, Evolut appeared associated with lower peak and mean aortic gradients (both P < 0.05), but higher rate of permanent pacemaker implantation (P = 0.043). Propensity-score-adjusted analysis largely confirmed the similar performance of the two devices, including peak and mean aortic gradients (both P > 0.05). However, Evolut continued to be associated even at adjusted analysis with an increased risk of pacemaker implantation (P = 0.018). CONCLUSION: The acute and mid-term comparative safety and effectiveness of Evolut and Portico in experienced hands are similar, with the notable exception of a lower risk of permanent pacemaker implantation with Portico.

Impact of Predilation Before Transcatheter Aortic Valve Implantation with New-Generation Devices.

BACKGROUND: Significant aortic stenosis can be effectively treated with transcatheter aortic valve implantation (TAVI) in patients at high or intermediate surgical risk. Predilation is often performed to facilitate TAVI implantation, but its risk-benefit balance with new-generation devices is detabed. We aimed to appraise whether predilation is still needed with new-generation devices for TAVI. METHODS/MATERIALS: We queried the prospective multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study, comparing patients with vs without predilation receiving Acurate, Evolut, Lotus, Portico, or Sapien3. Baseline, procedural features and early clinical and echocardiographic results were compared with unadjusted and adjusted analyses. RESULTS: A total of 1409 subjects were included, 1055 (74.9%) receiving predilation, and 354 (25.1%) undergoing direct TAVI. Several baseline and procedural differences were evident at unadjusted analysis between the two groups, including device success, procedural success, contrast volume, procedural time, mean post-procedural gradient, and prevalence of aortic regurgitation 2+ (all p < 0.05). Adjusted analysis showed that only procedural time remained significantly impacted by predilation (average reduction in procedural time with predilation of -12.9 [95% confidence interval -21.0; -4.8] minutes, p = 0.002). Subgroup unadjusted and adjusted analysis showed that predilation was associated with shorter procedural times only when Evolut or Portico devices were used (all p < 0.05). Clinical and echocardiographic follow-up up to 1 month showed similar results irrespective of predilation at both unadjusted and adjusted analysis. CONCLUSION: TAVI without predilation is not associated with adverse procedural, clinical or echocardiographic results when new-generation devices are used. Predilation may however reduce procedural time with Evolut and Portico devices.

Outcome of Patients Undergoing Transcatheter Aortic Valve Implantation After Prior Balloon Aortic Valvuloplasty.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an effective treatment for severe aortic stenosis. Yet, balloon aortic valvuloplasty (BAV) is still occasionally offered to apparently inoperable patients as bridge or destination therapy, with some eventually receiving TAVI. We aimed to determine whether prior BAV would unfavorably impact TAVI. METHODS: The RISPEVA dataset was analyzed to compare the outcomes of non-BAV subjects undergoing TAVI vs those with prior BAV. Outcomes of interest were procedural results, hospital stay, and in-hospital outcomes, including major adverse events. Unadjusted and propensity-matched analyses were performed. RESULTS: A total of 1683 patients were included (1541 [91.6%] non-BAV and 142 [8.4%] prior BAV). Device success, procedural success, major adverse events and their individual components were all similar in the two groups, in both unadjusted and propensity-matched analyses. However, non-BAV patients had significantly shorter intensive/coronary care unit stay (8.1 ± 23.0 days vs 13.4 ± 35.2 days; P=.03) and total hospital stay (12.4 ± 22.1 days vs 17.2 ± 32.7 days; P=.02). Similar findings were obtained even in the propensity-matched groups (6.3 ± 11.9 days vs 13.6 ± 35.5 days [P=.05] and 10.5 ± 13.8 days vs 17.4 ± 33.1 days [P=.03], respectively). No significant interaction was found between device type and prior BAV status. CONCLUSION: BAV continues to offer a palliative solution to patients with unclear or poor prognosis and deemed at too high risk for emergent TAVI or surgery. Subjects undergoing BAV and surviving the post-BAV period can undergo TAVI without a significantly increased risk of in-hospital adverse events in comparison with non-BAV patients.

Comparison between sirolimus- and paclitaxel-eluting stent in T-cell subsets redistribution.

We sought to investigate the effects of 2 different coronary drug-eluting stents on the distribution of central or effector memory T cells circulating in the coronary sinus of patients with coronary artery disease who underwent percutaneous coronary revascularization. We randomly assigned 43 patients (mean age 65.4 +/- 4.3 years; 34 men) presenting with stable coronary disease and angiographically proved stenosis of the left anterior descending artery to treatment with sirolimus- or paclitaxel-eluting stents. Heparinized blood samples were obtained from the coronary sinus before and 20 minutes after stent implantation. Analysis of surface phenotype was performed by 4-color flow cytometry, and data are expressed as the percentage of positive cells. The percentages of CD8+ and CD4+ effector memory T cells, as defined by the CD3+CD45RO+CD27- phenotype, were significantly reduced in patients who received a sirolimus-eluting stent compared with the basal values. Conversely, the percentages of CD8+, but not CD4+, central memory T cells (CD3+CD45RO+CD27+) were increased in the same treatment group after the revascularization procedure. No changes in the percentages of memory T-cell populations in the paclitaxel-eluting stent group were observed. These findings show that sirolimus-eluting stents rapidly induced a redistribution of memory T lymphocytes, with a significant decrease of proinflammatory effector memory T cells circulating within the coronary sinus.

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.

Effects of abciximab and preprocedural glycemic control in diabetic patients undergoing elective coronary stenting.

BACKGROUND: In diabetic patients, the combination of abciximab with stenting has been demonstrated to be the standard of care to reduce target vessel revascularization (TVR) and mortality. Moreover, a preprocedural hyperglycemia has been associated with a higher rate of TVR after an elective stent implantation. We sought to evaluate the effects of abciximab and/or preprocedural glycemic control on 30 and 180 days of TVR and on 1-year major adverse cardiac events (MACE-cardiac mortality, TVR, and myocardial infarction) in diabetic patients undergoing elective coronary stenting. METHODS: From January 2002 through May 2003, diabetic patients undergoing elective stenting of de novo coronary artery lesions were randomized to abciximab or placebo infusion. Preprocedural hyperglycemia was defined as fasting plasma glucose >or=126 mg/dL (7.0 mmol/L) immediately before the procedure. RESULTS: A total of 122 consecutive patients with diabetes (62.4 +/- 10.2 years, 80 men) were enrolled in the study. Sixty-nine (56.5%) were randomly assigned to receive abciximab (34 with and 35 without preprocedural hyperglycemia) and 53 (43.5%) to placebo (23 with and 30 without hyperglycemia). Target vessel revascularization was significantly lower in diabetic patients who received abciximab at 30 days (2.9% and 2.8% vs 8.7% and 6.6% in nonabciximab group with or without hyperglycemia, respectively, P < .01) but not at 6 months (31.4% and 26.5% vs 30% and 28.7%, P = NS). Conversely, the cumulative incidence of MACE was significantly higher among diabetic patients with preprocedural hyperglycemia (64.7% and 65.2%) versus diabetic patients with preprocedural glycemic control (37.1% and 40%), treated with or without abciximab, respectively (P < .05). CONCLUSIONS: A preprocedural hyperglycemia is associated with a higher rate of MACE, regardless of the use of abciximab, in diabetic patients undergoing elective coronary stenting.

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.

Persistent enhanced platelet activation in patients with acute myocardial infarction and coronary microvascular obstruction: clinical implications.

About 30% of patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing recanalisation of the infarct-related coronary artery do not achieve valid myocardial reperfusion (no-reflow phenomenon or coronary microvascular obstruction [MVO]). The mechanisms of MVO are incompletely understood. In this study we investigated the role platelet activation in the pathogenesis of coronary MVO in STEMI patients. We enrolled 48 STEMI patients (age 56.2 ± 11 years; 31 men), treated by primary percutaneous coronary intervention (PCI) followed by double anti-platelet treatment, and 20 control patients with stable coronary artery disease (CAD) on single anti-platelet treatment (age 57.5 ± 6 years, 12 men). STEMI patients were divided into two groups: 35 patients with complete myocardial reperfusion (MR) and 13 patients with coronary MVO despite successful PCI. Platelet activation was assessed on admission and at one-month follow-up by measuring platelet receptor expression and monocyte-platelet aggregates (MPAs). Platelet receptor expression, platelet receptor conformational change for fibrinogen binding availability and MPA formation were increased in STEMI patients with MVO compared to both STEMI patients with MR and stable CAD patients, both on admission and at one-month follow-up (p<0.05 for all).Among STEMI patients, platelet activation is greater in those who display coronary MVO, compared to those with MR, after successful PCI, both on admission and one month after STEMI, suggesting that enhanced platelet activation might be involved in the pathogenesis of MVO. The persistence of enhanced platelet activation despite double classical anti-platelet therapy suggests that new anti-platelet strategies should be considered in patients with coronary MVO.

Early and long-term outcomes after combined percutaneous revascularization in patients with carotid and coronary artery stenoses.

OBJECTIVES: This study sought to evaluate the 30-day and long-term clinical outcomes of patients with carotid obstructive disease (COD) and concomitant coronary artery disease (CAD) undergoing a combined percutaneous revascularization, in 4 high-volume centers skilled for the treatment of multilevel vascular disease. BACKGROUND: The optimal management of patients with COD and concomitant CAD remains controversial. A variety of therapeutic strategies, including coronary artery bypass grafting, alone or in combination with carotid artery revascularization, have been reported. METHODS: Between January 2006 and April 2010, 239 consecutive patients with COD (symptomatic carotid stenosis in 20.5%) and concomitant CAD were treated with staged or simultaneous carotid artery stenting and percutaneous coronary intervention, and enrolled in this prospective registry. The primary endpoint was the incidence of major cardiac and cerebrovascular events, including any death, myocardial infarction, or stroke occurring between the first revascularization procedure and 30 days after treatment of the second vascular territory affected. RESULTS: The incidence of the primary endpoint at 30 days was 4.2% (95% confidence interval [CI]: 2.02 to 7.56). The rate of death, myocardial infarction, and stroke at long-term follow-up (median 520 days) was 4.2%, 2.1%, and 3.8%, respectively. At long-term follow-up, patients with previous cardiovascular disease had significantly higher rates of major cardiac and cerebrovascular events than did patients with a first clinical episode (17% vs. 6%, hazard ratio: 3.34; 95% CI: 1.46 to 7.63; p = 0.004). CONCLUSIONS: In patients with COD and concomitant CAD, a combined percutaneous treatment compares favorably with previous surgical or hybrid experiences. Such strategy may be particularly suited to complex patients at high surgical risk.

[Feasibility and safety of immediately returning patients transferred for percutaneous coronary intervention in a large metropolitan area]. / Fattibilità e sicurezza dell'immediato reinvio al centro di provenienza dei pazienti sottoposti ad angioplastica coronarica in una vasta area metropolitana.

BACKGROUND: Hospitals without percutaneous coronary intervention (PCI) capabilities are used to transfer patients who need coronary angiography and/or PCI to other centers. In order to optimize economic resources and hospital bed management, PCIs might be performed with an in-service organization, with re-transfer to the community hospital immediately after the procedure. The aim of our study was to evaluate the safety of a consecutive, unselected series of in-service PCIs compared to PCIs performed in patients admitted to hospitals with cath-lab capabilities. METHODS: During 2008, 1030 PCI procedures were performed at the European Hospital and Aurelia Hospital: 905 in patients admitted to a hospital with PCI capabilities (Group I) and 125 (12%) with an in-service strategy (Group II) referring from the Città di Roma Hospital. All treatment protocols were preventively uniformed and standardized. RESULTS: The two groups were statistically comparable in terms of baseline clinical characteristics and/or procedural findings, with the exception for older age (66 +/- 10 vs 70 +/- 10 years, p = 0.004) and a higher prevalence of acute coronary syndromes (56 vs 88%, p < 0.001) and femoral vascular access (94 vs 98%, p = 0.03) in Group II. The rate of left ventricular ejection fraction < or = 35% (20 vs 13%, p = 0.06), multivessel PCI (23 vs 19%, p = 0.4), and glycoprotein IIb/IIIa inhibitor use (15 vs 13%, p = 0.5) was similar between the two groups. Among patients treated with an in-service strategy, 2 (1.6%) were not transferred to the community hospital, because of hemodynamic instability. The in-hospital rate of major clinical events (death for cardiovascular causes, cerebrovascular events, urgent revascularization, stent thrombosis) was 0.75% and 0.8% (p = 0.8), 1.8% and 1% (p = 0.4) for periprocedural myocardial infarction, 1.7% and 1.9% (p = 0.5) for major bleeding, 1.1% and 1.6% (p = 0.6) for vascular complications, in Group I and II, respectively. Left ventricular dysfunction was the only independent predictor of major clinical events (p = 0.003). CONCLUSIONS: A strategy of in-service organization for PCI presents a similar rate of in-hospital clinical events and complications compared to an overnight stay into a hospital with PCI capabilities. Such a strategy may be utilized in order to optimize economic resources and hospital bed management.

Clinical outcome after endovascular, surgical or hybrid revascularisation in patients with combined carotid and coronary artery disease: the Finalised Research In ENDovascular Strategies Study Group (FRIENDS).

AIMS: To assess the 30-day clinical outcome of endovascular and surgical revascularisation procedures in patients with carotid obstructive disease (COD) and concomitant coronary artery disease (CAD). METHODS AND RESULTS: Between January 2006 and December 2009, 659 patients with COD and concomitant CAD were treated. The incidence of the primary endpoint (composite of death, MI and stroke) was 4.25% (0.9%, 1.1% and 2.3%, respectively). Acute renal insufficiency occurred in 2.4% and major bleedings in 4.4% of patients. According to the treatment forms patients were divided into three groups: surgical, 185 patients (28.1%), endovascular, 378 (57.4%), and hybrid, 89 (13.5%). Seven patients (1%) were managed medically only. The primary endpoint of the study occurred in 4.8%, 2.4% and 8.6%, respectively, p=0.01. The secondary endpoint, that included the occurrence of renal or respiratory insufficiency and major bleedings occurred in 10.1%, 6.5% and 23.8%, respectively, p<0.001. At multivariate logistic regression analysis renal insufficiency (OR=2.517; 95%CI=1.077-5.883, p=0.03) and treatment group (endovascular: OR=0.369; 95%CI=0.168-0.813, p=0.01 or hybrid: OR=3.098; 95%CI=1.359-7.060, p=0.007) predicted the primary endpoint. CONCLUSIONS: Surgical and endovascular treatments yield very good immediate results; the later being less invasive, may be particularly suited to these fragile and complex patients. Long-term follow-up is under assessment.

Impact of abciximab on coronary restenosis in diabetic patients undergoing elective paclitaxel-eluting stent implantation. A prospective, randomized, placebo-controlled study.

AIMS: Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stent. We sought to evaluate whether abciximab may reduce in-segment late luminal loss (LLL), in patients with diabetes mellitus undergoing elective drug-eluting stents (PES) implantation. METHODS AND RESULTS: We conducted a prospective, randomized, double-blind study on diabetic patients after a paclitaxel-eluting stent (PES) implantation on de novo coronary artery lesions. 132 consecutive patients with diabetes (mean age 63.1+/-7.4 years, 82 males) were randomized to abciximab (n=66) or placebo (n=66). Among the 124 (93.9%) patients who underwent a 6-months angiographic follow-up, the mean difference in in-segment LLL between patients who received abciximab and placebo was 0.02 mm (P=0.8). In addition, the rates of angiographic in-segment restenosis were comparable between the two groups (14.3 versus 9.8%, P=0.5). Cumulative rates of clinical events did not differ (death: 1.5 versus 1.5, P=0.9 and MI: 1.5 versus 3%, P=0.8) between abciximab and placebo group, respectively. Similarly, the incidence of target lesion revascularization was 9.1% and 6.1% (P=0.7) at six months, in the two groups. CONCLUSIONS: Abciximab does not seem to have any impact on the extent of in-segment LLL in diabetic patients undergoing an elective PES implantation.