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Objective: To examine the effects of intracoronary PhotoPoint photodynamic therapy (PDT) with a new photosensitiser, MV0611, in the overstretch balloon and stent porcine models of restenosis. Methods: 28 pigs were injected with 3 mg/kg of MV0611 systemically 4 h before the procedure. Animals were divided into either the balloon overstretch injury (BI) group (n = 19) or the stented group (n = 9). After 81, a centred delivery catheter was positioned in the artery to cover the injured area, and light (532 nm, 125 J/cm²) was applied to activate the drug (n = 10). Control arteries (n = 9) were not activated by light. In the stented group, the drug was light activated before stent deployment. Serial sections of vessels were processed 14 days after treatment in the BI group and 30 days after treatment in the stented group for histomorphometric or immunohistochemical analysis. Results: Intracoronary PDT significantly reduced intimal thickness in both BI and stented arteries (about 65%: 0.22 (SEM 0.05) mm v 0.62 (0.05) mm, p < 0.01; and about 26%: 0.40 (0.04) mm v 0.54 (0.04) mm, p < 0.01, respectively). PDT increased luminal area by ⩽ 60% and 50% within BI and stented arteries (3.43 (0.27) mm² v 5.51 (0.52) mm², p < 0.05; 4.0 (0.02) mm² v 6.0 (0.16) mm², p < 0.01), respectively. Complete re-endothelialisation was observed by immunohistochemical and gross histological analyses in all PDT and control arteries. There were no cases of aneurysm formation or thrombosis. Conclusion: Intracoronary PhotoPoint PDT with MV0611 reduces intimal proliferation without suppressing re-endothelialisatiori in a porcine model of restenosis. [ABSTRACT FROM AUTHOR]

Worsening of heart failure in patients with myocardial infarction is seldom studied, elderly patients often are not included, and multivariate analysis is uncommon. The prospective PRIMA study (Prise en charge de l'Infarctus du Myocarde Aigu; management of acute myocardial infarction) sought to determine the incidence of worsening heart failure, its risk factors, and its prognostic importance in patients with myocardial infarction, regardless of age and hospital facilities, in the ‘real world’ in a region in France, using multivariate analysis. Data were prospectively collected in all patients with myocardial infarction admitted in all hospitals in three departments in the Rhône–Alpes region in France between 1 September 1993 and 31 January 1995. Among the 2507 patients included, 33% were in Killip classes II–IV at admission. After exclusion of patients with admission Killip class IV, 416 patients (17% of the cohort, 24% of women and 14% of men) had worsening of Killip class during the first 5 days. In-hospital mortality (overall, 14%) increased dramatically with Killip class at admission (9% in class I, 62% in class IV) and with worsening of Killip class during the first 5 days (36.5 vs. 8.5% if no worsening). In multivariate analysis, older age, diabetes mellitus and anterior Q-wave myocardial infarction were significant predictors of Killip class at admission and of its worsening; Killip class > I at admission was a significant predictor of Killip-class worsening. The significant predictors of in-hospital mortality were older age, Killip class III at admission and worsening of Killip class during the first 5 days. This large, unselected cohort revealed that, among patients with myocardial infarction, heart failure and its worsening are frequent, especially in the elderly, and dramatically worsen the in-hospital mortality. [ABSTRACT FROM PUBLISHER]

Percutaneous coronary intervention of saphenous vein grafts is associated with distal embolization. We aimed to compare potential differences in patients undergoing percutaneous coronary intervention for in-stent restenosis with de novo saphenous vein graft lesions. Myocardial necrosis was associated with higher mortality regardless of lesion type. [ABSTRACT FROM AUTHOR]

Intracoronary gamma radiation is effective in reducing recurrent in-stent restenosis (ISR) involving native coronary arteries. This study compares the effectiveness and safety of intracoronary gamma radiation for the treatment of ISR in saphenous vein grafts (SVGs) versus native coronary arteries. In the Washington Radiation for In-Stent restenosis Trial (WRIST) series of gamma radiation trials, 1,142 patients with ISR (230 in SVG and 912 in native coronary arteries) completed 6-month clinical follow-up. All patients underwent balloon angioplasty, atherectomy, and/or restenting. Different ribbon lengths containing 6 to 23 seeds of iridium-192 were used to cover lesion lengths <80 mm. The prescribed radiation doses were 14 or 15 Gy at 2-mm radial distance from the center of the source. Baseline demographics showed that patients with SVGs were older (65 +/- 13 vs 61 +/- 11 years, p <0.001), more likely male (79% vs 64%, p <0.001), had more multivessel coronary disease (81% vs 50%, p <0.001), and less diffuse lesions (17 +/- 10 vs 24 +/- 12 mm, p <0.001). At 6 months, event-free survival was similar for patients with SVG ISR and native coronary ISR (82% vs 84%, p = 0.35). The SVG ISR population had a low rate of late total occlusion (4.6%) and late thrombosis (3.5%). Thus, treatment of ISR with gamma radiation in SVGs had similar outcome to native coronary arteries. The use of gamma radiation for the treatment of ISR should expand to SVGs. [ABSTRACT FROM AUTHOR]

Background – Worsening of heart failure in patients with myocardial infarction is seldom studied, elderly patients often are not included, and multivariate analysis is uncommon.Aims – The prospective PRIMA study (Prise en charge de l'Infarctus du Myocarde Aigu; management of acute myocardial infarction) sought to determine the incidence of heart failure worsening, its risk factors, and its prognostic importance in patients with myocardial infarction, regardless of age and hospital facilities, in the « real world» in a region in France, using multivariate analysis.Methods – Data were prospectively collected in all patients with myocardial infarction admitted in all hospitals in three departments in the Rhoˆne-Alpes region in France between September 1, 1993 and January 31, 1995.Results – Among 2,507 patients, 33% were in Killip classes II–IV at admission. Four hundred and sixteen patients (17%) had worsening of Killip class during the first five days. In-hospital mortality (overall: 14%) increased dramatically with Killip class at admission (9% in class I; 62% in class IV) and with worsening of Killip class during the first five days (36% vs 8% if no worsening). In multivariate analysis, older age, diabetes mellitus and anterior Q-wave myocardial infarction were significant predictors of Killip class at admission and of its worsening. The significant predictors of in-hospital mortality were older age, Killip class III at admission and worsening of Killip class during the first five days.Conclusion – This large, unselected cohort revealed that among patients with myocardial infarction, heart failure and its worsening are frequent, especially in the elderly, and dramatically worsen the in-hospital mortality. [ABSTRACT FROM AUTHOR]

Background/Objectives : Despite procedural improvements, post-transcatheter aortic valve replacement (TAVR) conduction disorders remain high. Analyzing the data from a monocentric TAVR registry, this study aims to determine predictive factors for PPI (primary outcome), the indication for PPI, and long-term outcomes among these patients (secondary outcomes). Methods : Conducted at Clairval Hospital in Marseille, France, this retrospective study included all consecutive patients from June 2012 to June 2019. Clinical, electrocardiographic, echocardiographic, and procedural data were collected, with outcomes assessed annually. Logistic regression identified PPI predictors and survival analyses were performed. Results : Of the 1458 patients initially considered, 1157 patients were included. PPI was needed in 21.5% of patients, primarily for third-degree atrioventricular block (46.4%). Predictor factors for PPI included baseline right bundle branch block (ORadj 2.49, 95% CI 1.44 to 4.30; p = 0.001), longer baseline QRS duration (ORadj 1.01, 95% CI 1.00 to1.02, p = 0.002), and self-expandable valves (ORadj 1.82, 95% CI, 1.09 to 3.03; p = 0.021). Seven-year estimated mortality was higher in PPI (43.3%) vs. non-PPI patients (30.9%) (log rank p = 0.048). PPI was an independent predictive factor of death (ORadj 2.49, 95% CI 1.4 to 4.3; p = 0.002). Conclusions : This study reveals elevated rates of PPI post-TAVR associated with increased mortality. These results underscore the pressing necessity to refine our practices, delineate precise indications, and enhance the long-term prognosis for implanted patients.

Objectives: The aim of this study was to investigate the relationship between platelet reactivity (PR) after a loading dose (LD) of prasugrel and thrombotic events., Background: Post-treatment PR has been shown to be strongly associated with the occurrence of major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) in the clopidogrel era. Prasugrel is a new P2Y(12)-adenosine diphosphate receptor with a higher potency on PR., Methods: A prospective multicenter study included patients who underwent successful PCI for acute coronary syndromes and received prasugrel therapy. Vasodilator-stimulated phosphoprotein (VASP) index was measured after the prasugrel LD. High on-treatment PR was defined as a VASP index ≥50%. MACE included cardiovascular death, myocardial infarction, and definite stent thrombosis at 1 month., Results: Three hundred one patients were enrolled. The mean VASP index after 60 mg of prasugrel was 34.3 ± 23.1%. High on-treatment PR was observed in 76 patients (25.2%). Patients experiencing thrombotic events after PCI had significantly higher VASP indexes compared with those free of events (64.4 ± 14.4% vs. 33.4 ± 22.7%; range: 51% to 64% and 5% to 47.6%, respectively; p = 0.001). Kaplan-Meier analysis comparing good responders and patients with high on-treatment PR demonstrated a significantly higher rate of MACE in patients with suboptimal PR inhibition (log-rank p < 0.001). Receiver-operating characteristic curve analysis found a cutoff value of 53.5% of the VASP index to predict thrombotic events at 1 month (r = 0.86, p < 0.001). Patients with minor or major Thrombolysis In Myocardial Infarction unrelated to coronary artery bypass grafting bleeding and those without had similar VASP indexes (30 ± 17.8% vs. 34.3 ± 23%, p = 0.70)., Conclusions: Despite the use of prasugrel, a significant number of patients undergoing PCI in the setting of acute coronary syndromes do not achieve optimal PR inhibition. Such patients have a higher risk for MACE after PCI., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary computed tomography (CCT) detects coronary obstruction with high sensitivity and might be useful for diagnosis of angina pectoris., Aim: In this pilot study, we sought to prospectively evaluate the performance of CCT as initial work up and determine the significance of this strategy according to the pretest likelihood of having coronary artery disease (CAD)., Methods: One hundred and eighty patients with chest discomfort and suspected angina were prospectively referred for CCT with a 64-slice CT scan. Invasive coronary angiography (ICA) was performed on the basis of CCT findings (stenosis>50%). Patients were classified into tertiles according to estimated pretest probability of obstructive CAD using the Duke Clinical Score (low, intermediate and high). Strategy failure was defined as unnecessary ICA or major adverse cardiac event (MACE) within 6 months in patients without significant stenosis by CCT., Results: Pretest probability for CAD was 53 ± 29%. Significant stenosis was detected by CCT in 51 patients; 47 (26%) underwent ICA. Sixteen strategy failures were reported: 15 patients (10%) were referred for ICA that did not confirm significant coronary stenosis and one MACE occurred in a patient without significant stenosis by CCT. Strategy failures were 8% in low-probability, 1.7% in intermediate-probability and 15% in high-probability patients (P=0.03)., Conclusions: CCT as an initial step for angina diagnosis is most effective in patients with an intermediate probability of CAD. In patients with low or high likelihood, it is associated with a high rate of unnecessary ICA but not with adverse events., (Copyright © 2010 Elsevier Masson SAS. All rights reserved.)

Objectives: We sought to compare the adequacy of paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) expansion based on intravascular ultrasound (IVUS) imaging criteria at conventional delivery pressures., Methods: Forty-six patients underwent SES implantation and 42 patients underwent PES implantation for de novo native coronary lesions<33 mm in length with reference lumen diameters of 2.5-3.5 mm. Stents were serially expanded with gradual balloon inflations at 14 and 20 atm. IVUS imaging was performed prior to intervention and after each balloon inflation. Stent expansion (minimal stent cross-sectional area/reference lumen cross-sectional area) was measured. Inadequate stent expansion was defined using the MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen cross-sectional area>80% of the reference or >90% if minimal lumen cross-sectional area was <9 mm2)., Results: The baseline characteristics of the two groups were similar except for shorter lesion length, larger mean lumen cross-sectional area, larger lumen diameter, and lower plaque burden in the PES group. Stent expansion was inadequate in 80% of patients with SES versus 63% of patients with PES at 14 atm, although this was not statistically significant. After 20 atm, 48% of patients with SES remained underexpanded as compared with 35% of patients with PES., Conclusion: Drug-eluting stents showed significant underexpansion by MUSIC criteria at conventionally used inflation pressures. Higher balloon inflations are required especially during deployment of a SES. IVUS guidance is recommended to ensure optimal results and outcomes with both stents.

Background: Bivalirudin is replacing heparin in percutaneous coronary interventions (PCIs), including vascular brachytherapy (VBT). The aim of the study was to compare bivalirudin with eptifibatide in patients with in-stent restenosis (ISR) undergoing PCI and VBT., Methods: One hundred forty-four patients treated with bivalirudin as a single antithrombotic agent were compared with 150 patients treated with eptifibatide. Bivalirudin as a bolus of 0.75 mg/kg followed by 1.75 mg/kg/h infusion until the end of the procedure, and eptifibatide as a double bolus of 180 microg/kg followed by 2 microg/kg/min infusion for 18 h after the procedure were used. The main outcome measures were in-hospital events and 30-day clinical outcomes., Results: Baseline clinical characteristics were similar except that patients in the eptifibatide group were younger (P=.02) and had more saphenous vein graft lesions (P<.001). Patients in the bivalirudin group had a higher number of lesions in the right coronary artery (P<.001) and a higher number of vessels treated (P<.001). Postprocedure creatinine phosphokinase (CPK)-MB levels were significantly lower in the bivalirudin group (P<.03). In-hospital events showed significantly less minor bleeding (P=.01) and a trend toward lower major bleeding and major adverse cardiac events (MACE) in the bivalirudin group (P=.06). Thirty-day outcomes showed a significantly lower incidence of non-Q-wave myocardial infarction (MI) in the bivalirudin group (P=.004)., Conclusion: Bivalirudin, as a single antithrombotic agent during PCI and VBT, is associated with significantly lower postprocedural CPK-MB elevation, minor bleeding complications, 30-day non-Q-wave MI rates, and a trend toward lower major bleeding and in-hospital MACE when compared with eptifibatide.

Background: Bivalirudin is shown to be a competent substitute for heparin in percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in patients undergoing PCI and vascular brachytherapy (VBT) are not known. This study aimed to assess the safety and efficacy of bivalirudin as a single antithrombotic agent in patients undergoing PCI and VBT., Methods: A total of 152 patients enrolled in the Brachytherapy and Bivalirudin Evaluation Study underwent PCI and VBT with either gamma (n = 8) or beta radiation (n = 144). The main outcome measures were in-hospital events and 30-day clinical outcomes. All patients were treated with bivalirudin (0.75 mg/kg bolus and 1.75 mg/kg per hour infusion for beta radiation, 1 mg/kg bolus and 2.5 mg/kg per hour infusion for gamma radiation) as a single antithrombotic agent during the entire procedure., Results: Baseline clinical and angiographic characteristics were similar between the 2 groups. More than 90% of the patients received beta radiation. In-hospital events showed a higher prevalence of acute procedural intracoronary thrombosis in patients treated with gamma- vs beta radiation (25% vs. 0.7%, P < .001). Thirty-day outcomes including death, Q-wave, and non-Q-wave myocardial infarctions, subacute stent thromboses, and repeat revascularizations were similar in both groups., Conclusion: Bivalirudin, as a single antithrombotic agent during PCI and VBT with beta emitters, may be used safely, but its use in the setting of PCI and gamma radiation may not be acceptable due to an increased incidence of acute procedural intracoronary thrombosis.

The aim of this study was to compare intimal hyperplasia (IH) growth at 6 months in patients with de novo lesions treated with stents versus IH regrowth in patients with treated in-stent restenosis. Intravascular ultrasound was performed after intervention and at the 6-month follow-up visit as part of a standardized protocol across several clinical trials. At 6 months, the lumen was larger in the de novo group (mean lumen cross-sectional area [CSA] 6.31 +/- 2.2 vs 4.48 +/- 1.9 mm(2), p = 0.0001; minimum lumen CSA 4.2 +/- 1.8 vs 2.59 +/- 1.5 mm(2), p = 0.0001). However, the total increase in the mean IH CSA volume was the similar in the de novo and ISR groups (2.89 +/- 1.6 vs 2.64 +/- 1.94 mm(2), respectively; p = 0.11). We found that IH regrowth in restented in-stent restenosis lesions was similar to that in de novo stent implantation and that the final lumen CSA was an important component of in-stent restenosis recurrence.

Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization.

Sirolimus-eluting stents (SESs; Cypher) have demonstrated a significant reduction in restenosis rates when compared to bare metal stents (BMSs). The purpose of this study was to evaluate the strategy of exclusive use of two SESs versus the combination of one BMS and one SES for two-vessel coronary artery disease (CAD). It was found that the selective use of one SES combined with one BMS in patients undergoing percutaneous coronary intervention that requires more than one stent is safe, feasible, and associated with favorable procedural, 30-day, and 6-month clinical outcomes when compared to the exclusive use of SESs.

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions, and data on its usage in saphenous vein graft interventions are limited. This retrospective, observational study evaluated the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients who underwent saphenous vein graft intervention with distal protection devices. We found that bivalirudin use is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.

We aimed to assess the incidence of underexpansion and the relationship between delivery pressure and expansion with sirolimus-eluting stents. Adequate stent expansion contributes to early and late improved outcomes. In 51 patients (53 lesions) with native coronary artery narrowing, balloon-expandable sirolimus-eluting stents (Cypher) were serially expanded with gradual balloon inflations [14 atm, 20 atm, and in case of minimal stent cross-sectional area (CSA)/reference lumen CSA < 50% at 20 atm, postdilatation with 0.5 mm larger balloon]. Intravascular ultrasound (IVUS) imaging was performed before intervention and after each gradual balloon inflation. Stent expansion (minimal stent CSA/reference lumen CSA) was measured. Stent expansion was 72% +/- 16% after 14 atm balloon inflation, 90% +/- 18% after 20 atm balloon inflation (P < 0.001 vs. 14 atm), and 90% +/- 18% at the end of the procedure (including optional postdilatations with 0.5 mm larger balloon; P = NS vs. 20 atm). Stent expansion addressed by MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen CSA > 80% of the reference or > 90% if minimal lumen CSA was < 9 mm2) was adequate in 15% of the cases after 14 atm balloon inflation, in 60% after 20 atm balloon inflation (P < 0.001 vs. 14 atm), and in 60% at the end of the procedure (P = NS vs. 20 atm). Sirolimus-eluting stent underexpansion is common when deployed at conventional pressures. Increasing balloon delivery pressure or assessing stent expansion with IVUS seems warranted in order to ensure adequate sirolimus-eluting stent deployment., (Copyright 2005 Wiley-Liss, Inc)

The Washington Radiation for In-Stent Restenosis Trial in Saphenous Vein Grafts (SVG WRIST) demonstrated safety and efficacy of intravascular radiation therapy (IRT) for the treatment of in-stent restenosis (ISR) in SVG at 12 months. In this study, we aimed to examine whether the safety and efficacy of IRT is durable up to 36 months. One hundred twenty patients with diffuse ISR in SVG underwent balloon angioplasty, laser or atherectomy ablation, and/or additional stenting. After successful intervention, patients were randomly assigned in a double-blind fashion to intravascular treatment with a ribbon containing either iridium (Ir)-192 (n = 60) or nonradioactive seeds (n = 60). The prescribed dose at 2 mm from the source was either 14 or 15 Gy in vessels 2.5-4.0 mm or 18 Gy in vessels > 4.0 mm in diameter. At 36 months, target lesion revascularization (TLR; 43% vs. 66%; P = 0.02) and target lesion revascularization-major adverse cardiac event (TLR-MACE; 49% vs. 71%; P = 0.02) rates continued to be lower in the IRT group, but both target vessel revascularization (TVR; 59% vs. 71%; P = 0.17) and TVR-MACE (63% vs. 77%; P = 0.11) rates were not. In SVG WRIST, patients with ISR treated with IRT had a marked reduction in the need for repeat TLR at 36 months, with sustained clinical benefit at 3 years despite late recurrences, which were more pronounced in the radiation group., (Copyright 2005 Wiley-Liss, Inc)

Stent area assessed by intravascular ultrasound is a strong predictor of late outcome after percutaneous coronary intervention. Because sirolimus-eluting stents (SESs) prevent intimal regrowth within the stent, achieving a larger final stent area might no longer be noteworthy; therefore, the investigators sought to determine the relevance and impact of the final stent area with SESs.

Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in the hospital until CABG after clopidogrel is discontinued. We investigated whether any differences exist in the rates of surgical complications and outcomes between these two groups of patients. We conclude that continued hospitalization of clopidogrel pre-treated patients does not confer any safety benefit with regard to post-operative complications and 30-day mortality. Discharging these patients after CAG may reduce hospitalization costs.

This study aimed to compare the outcomes of patients with late total occlusion (LTO) versus patients with recurrence in the absence of LTO after intracoronary radiation therapy for in-stent restenosis. LTO, especially in the context of acute myocardial infarction, after intracoronary radiation therapy for in-stent restenosis, is associated with negative clinical outcomes after 6 and 12 months compared with in-stent restenosis without LTO.

Whether percutaneous coronary intervention (PCI) alone is safe in patients with moderate or severe aortic stenosis (AS) and coexisting coronary artery disease (CAD), and whether aortic valve replacement (AVR) can be deferred in patients with moderate AS by undergoing PCI alone is not known. We conducted a retrospective study of surgically inoperable patients with AS who underwent PCI (moderate AS, n = 28; and severe AS, n = 28) and compared to those with AVR (n = 55). The clinical characteristics, procedural complications, in-hospital and long-term clinical outcomes of PCI were compared. Baseline and procedural characteristics were similar except that lower age, hypertension, and renal impairment were seen in the AVR group. In-hospital complications were comparable among the 3 groups. Six-month and 1-year rates of myocardial infarction (MI), non-Q-wave MI, death and out-of-hospital death were similar between AVR and moderate AS patients (p = NS) and significantly high (p < 0.04) in patients with severe AS. On multivariate analysis, severe AS was the only significant predictor of 6-month and 1-year mortality. Our study suggests that PCI is safe in patients with moderate AS and coexisting CAD but is associated with poor outcomes in patients with severe AS.