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Background Myocardial infarction with non-obstructive coronary arteries (MINOCA) is a common disorder characterized by the presence of clinical criteria for acute myocardial infarction in the absence of obstructive coronary artery disease on angiography. We aim to investigate the relationship between myocardial bridging (MB) and MINOCA. Methods and results An observational retrospective study was conducted on 15 036 patients who had been referred for coronary angiography and who fulfilled the Fourth Universal Definition of Myocardial Infarction. The study population was divided into ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) patients, from which we defined two main groups: the MINOCA group and the coronary artery disease (CAD) group. Statistical analyses were carried out by using SPSS, version 20. The prevalence of angiographic MB among the groups was significantly greater in the MINOCA group (2.9% vs. 0.8%). MINOCA accounted for 14.5% of spontaneous myocardial infarction, and the clinical presentation was more frequently NSTEMI rather than STEMI (84.3% vs. 15.7%). After adjusting for confounders, multivariate analyses showed a positive association between MB and MINOCA [odds ratio = 3.28, 95% CI (2.34; 4.61) P Conclusion MB is a risk factor for MINOCA. Because MB prevalence differed significantly between the controls (CAD group) and cases (MINOCA group), which were positively associated to MB, it seems likely that MB would be a potential cause of MINOCA. Investigations for MB in MINOCA cases and especially in NSTEMI patients seem necessary.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.

Background: Because rotational atherectomy (RA) is associated with arterial trauma and platelet activation, patients treated with RA may benefit from more potent antiplatelet drugs. The aim of this trial was to assess the superiority of ticagrelor over clopidogrel in reducing post procedure troponin release. Methods: TIRATROP (TIcagrelor in Rotational Atherectomy to reduce TROPonin enhancement) is a multicenter double-blind randomized controlled trial that included 180 patients with severe calcified lesions requiring RA who received either clopidogrel (300 mg loading dose, then 75 mg/d) or ticagrelor (loading dose 180 mg then 90 mg twice daily). Blood samples were collected at the beginning (T0), and 6, 12, 18, 24 and 36 h after the procedure. Primary end point was troponin release within the first 24 h using area under the curve analysis (troponin level as a function of time). Results: The mean age of patients was 76 ± 10 years, 35% had diabetes. RA was used to treat 1, 2 or 3 calcified lesions in 72%, 23% and 5% of patients, respectively. Troponin release within the first 24 h was similar in both the ticagrelor (adjusted mean ±SD of ln AUC 8.85 ± 0.33) and the clopidogrel (8.77 ± 0.34, p = 0.60) arms. Independent predictors for troponin enhancement were acute coronary syndrome presentation, renal failure, elevated C-Reactive protein and multiple lesions treated with RA. Conclusion: Troponin release did not differ among treatment arms. Our results suggest that greater platelet inhibition does not affect periprocedural myocardial necrosis in the setting of RA.

International audience; Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.Funding: ACTION Study Group and AstraZeneca.

Background The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that for patients with diabetes mellitus (DM) and multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in reducing the rate of major adverse cardiovascular and cerebrovascular events after a median follow-up of 3.8 years. It is not known, however, whether CABG confers a survival benefit after an extended follow-up period. Objectives The purpose of this study was to evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial. Methods The FREEDOM trial randomized 1,900 patients with DM and MVD to undergo either PCI with sirolimus-eluting or paclitaxel-eluting stents or CABG on a background of optimal medical therapy. After completion of the trial, enrolling centers and patients were invited to participate in the FREEDOM Follow-On study. Survival was evaluated using Kaplan-Meier analysis, and Cox proportional hazards models were used for subgroup and multivariate analyses. Results A total of 25 centers (of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range 0 to 13.2 years). Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On). The all-cause mortality rate was significantly higher in the PCI-DES group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths]; hazard ratio: 1.36; 95% confidence interval: 1.07 to 1.74; p = 0.01). Of the 943 patients with extended follow-up, the all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (hazard ratio: 1.32; 95% confidence interval: 0.97 to 1.78; p = 0.076). Conclusions In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450)

Item does not contain fulltext BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], pinteraction=0.019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0.66) and no linear trend across SYNTAX score tertiles (ptrend=0.30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

Background Mean gradient (MG) elevation can be detected immediately post-procedure or secondarily during follow-up. Comparison between these two parameters and impact on outcomes has not previously been investigated. Objectives The study aimed to identify incidence, influence on prognosis and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (DMGI), in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. Methods The registry includes all consecutive symptomatic patients with severe aortic stenosis. Three groups were analyzed: 1) PPMG 10 mmHg (control); 2) PPMG 10 mmHg (group 1); 3) PPMG ≥20 mmHg (group 2). Results From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. The control group comprised 2078 patients; the group 1, 131 patients; and the group 2, 144 patients. DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-year mortality than in control group (32.6% vs. 40.1%, p=0.27, respectively). PPMG was at least 20 mmHg in 6.1%, and was associated with higher 4-year mortality than in control group (48.7% versus 40.1%, p=0.005, respectively) (Figure 1). Two-thirds of patients with initial PPMG ≥20 mmHg had finally a MG Conclusions Patients with PPMG >20 mmHg 1 year post-TAVI had higher 4-year mortality than the general population of the registry, unlike patients with MG normalization at 1 year. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): French National Society of Cardiology

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

BACKGROUND Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p = 2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in < 2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time. (J Am Coll Cardiol 2016; 68: 1637-47) (C) 2016 by the American College of Cardiology Foundation.

BACKGROUND: Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding.METHODS: In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also tested for the noninferiority of dual therapy with dabigatran (both doses combined) to triple therapy with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization.RESULTS: The incidence of the primary end point was 15.4% in the 110-mg dual-therapy group as compared with 26.9% in the triple-therapy group (hazard ratio, 0.52; 95% confidence interval [CI], 0.42 to 0.63; PCONCLUSIONS: Among patients with atrial fibrillation who had undergone PCI, the risk of bleeding was lower among those who received dual therapy with dabigatran and a P2Y12 inhibitor than among those who received triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events. (Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864 .).

The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients.The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented.In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component.Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding.Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.

Obesity in patients with heart failure (HF) is a factor of better prognosis, supposedly partly because of the particular epidemiology of HF in this population. This study expected to compare the parameters of severity and mortality in patients with and without obesity, to better understand the origin of this paradox.Two hundred twenty-two patients with nonischemic HF and systolic dysfunction were divided into two groups according to their body mass index (≥ 30 vs.30 kg/m(2), respectively) and explored for functional parameters and prognosis.B-type natriuretic peptide (BNP) levels were lower and peak oxygen consumption higher in patients with obesity. Patients with obesity had a better prognosis than patients without obesity with a 4-year mortality of 11.1% and 26.4%, respectively (P = 0.009). By univariate analysis, obesity was associated with a reduced risk of death: HR 0.52 [0.28-0.99]. This protective effect was no longer present after adjusting for VO2max and BNP level.The obesity paradox is probably partly due to an overestimation of the severity of HF in patients with obesity because of the multifactorial nature of their dyspnea. Obesity no longer has a protective effect after adjustment for the usual prognostic parameters of HF.

To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions.Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance.Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume.Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm(3) for total population. There were no definite and probable stent thromboses up to 12 months.Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation.

We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES.Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR.Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months.281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES.In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end-point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow-up MLD and immediate and net gain favored SES.

ARTS-II was designed to evaluate the sirolimus-eluting stent (SES) versus ARTS-I. The objective of this analysis is to assess the safety and efficacy of the SES in diabetic patients with multivessel disease (MVD) versus both arms of ARTS-I.The ARTS studies included 367 diabetic patients (ARTS-II: 159; ARTS-I-CABG: 96; ARTS-I-PCI: 112). Baseline characteristics showed a more diseased patient population in the ARTS-II study: 50.3% with 3VD vs. 35.4% (ARTS-I-CABG) and 30.8% (ARTS-I-PCI) (p=0.003). Treated or anastomosed lesions were 3.2+/-1.2 (ARTS-II), 2.8+/-0.8 (ARTS-I-CABG) and 2.5+/-1.1 (ARTS-I-PCI). At 30 days there was a significant difference in MACCE between ARTS-II (4.4%) and ARTS-I-PCI (12.5%) (p=0.02). At 1-year, the death rate was 2.5% (ARTS-II) vs. 3.1% (ARTS-I-CABG) and 6.3% (ARTS-I-PCI) without significant differences. Myocardial infarction rate was 0.6% (ARTS-II) vs. 2.1% (ARTS-I-CABG; p=0.56) and 6.3% (ARTS-I-PCI; p=0.01). The need for repeat revascularization was 12.6% (ARTS-II) vs. 4.2% (ARTS-I-CABG; p=0.027) and 22.3% (ARTS-I-PCI; p= 0.046). MACCE-free survival was 84.3% (ARTS-II) vs. 85.4% (ARTS-I-CABG; p=0.86) and 63.4% (ARTS-I-PCI; p0.001). Also at 1 year, the overall MACCE rate in patients with diabetes was significantly higher than in nondiabetic patients, 15.7% vs. 8.5%, respectively [RR 1.85, 95%CI (1.16,2.97), p=0.015), due to a higher incidence of death and need for repeat revascularization, 2.5% vs. 0.4 and 12.5% vs. 5.6% in diabetes vs. nondiabetes groups, respectively.Despite more extensive and treated disease, the overall MACCE-free survival in diabetic patients at 1 year in ARTS-II is similar to ARTS-I-CABG.

The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus.The optimal method of revascularization in diabetic patients remains in dispute.The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm).At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG.At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients.

During 2005, the evolution of interventional cardiology has largely been dominated by the trial of active endoprostheses, whose advantage has been consistently shown by various studies, mete-analyses and surveys. Extending their use to new indications and evaluating new drugs have also been studied. In parallel, clinical trials have been performed in the promising field of percutaneous treatment of valvular heart disease, particularly mitral insufficiency and calcified aortic stenosis in the adult.

The aim of this study was to compare quantitatively uptake of 99mTc-Sestamibi at rest and that of late redistribution of 201Tl in the same patients with severe ischaemic left ventricular dysfunction, and to correlate the uptake of the tracer to regional ventricular dysfunction studied by ECG grated 99Tc-Sestamini. A double isotope myocardial scintigraphy, 201 Thallium at rest/redistribution and 99Tc-Sestamibi at rest and on exercise, was performed in 28 patients with severe postinfarction ischaemic cardiomyopathy (EF= 29 +/- 4%). Quantitative analysis for each patient and each isotope were performed with respect to the number of hits expressed in percentage of the activity of a normal zone in 17 circumferential profiles distributed in 4 zones, that is to say in 476 segments. A score allowed counting of viable and non-viable segments and evaluation of contractile function of the 17 segments with respect to wall motion and systolic thickening. Total concordance of global uptake of the two isotopes was observed in 430 of the 476 segments (90.3%) (r= 0.814, p0.0001), but the 99mTc-Sestamibi uptake was less than 201 Th (71 +/- 23% vs 73 +/- 21%, p= 0.0001). With respect to left ventricular wall motion, uptake of 99mTc-Sestamibi was greater than that of 201Tl in normal or hypokinetic segments but less in akinetic and dyskinetic segments. The difference between the two isotopes was most marked in segments with very severe contractile dysfunction. The authors conclude that the uptake of 99mTc-Sestamibi is correlated with that of late distribution of 201Tl when left ventricular contraction is not too poor and should no longer be considered as only a marker of perfusion but can also be useful in the investigation of myocardial viability.

The risk of thromboembolism in patients taking estrogen-progestagen oral contraceptive drugs has apparently increased since the introduction of third-generation progestagens (desogestrel, gestodene). We examined the clinical features, risk factors and outcome of pulmonary embolism in this context.We reviewed 11 cases of thromboembolism in patients on oral contraception and hospitalized in emergency situations in 1995 and 1996 for pulmonary embolism in order to determine the gravity of the thromboembolic event, risk factors and type of drug used.Early clinical signs had preceded the onset of embolism by 2 to 164 days. PaO2 was below 70 mmHg in 4 patients. Diagnosis was achieved with pulmonary scintigraphy (11 cases), spiral CT (3 cases) and angiopneumography (2 cases). Duplex Doppler visualized the phlebitis in 7 patients. Given heparin (with fibrinolysis in 3 cases) then anti-vitamin K, and after withdrawal of the oral contraceptive, outcome was favorable in all cases. There were no recurrences. The nature of the oral contraceptive varied. Five patients were taking third-generation progestagens. In two cases, embolism had occurred following a change from a second-generation to a third-generation progestagen. Family history of phlebitis and/or abnormal laboratory findings were observed in 6 patients: resistance to activated protein C (2 patients), protein C deficiency (2 patients), anticardiolipin (2 patients) and low-titre antinuclear antibodies (2 patients).Pulmonary embolism in patients on oral contraceptives persists despite changes in the hormone content of the drugs. Diagnosis is often delayed. Family history of thrombosis or biological risk factors are often found.

Management of major risk factors (smoking, hypercholesterolaemia, hypertension), in the context of secondary prevention, has an impact on recurrence and life expectancy. However, there is a delay between the publication of therapeutic trials and their diffusion within the medical community. The objective of this study was to evaluate the prevalence and management of the main risk factors in a sample of 500 men, with a mean age of 55.1 +/- 7.5 years, presenting with stable coronary artery disease. 11% of subjects had a family history of premature myocardial infarction. Smoking was frequent: 21% of smokers, 60% of ex-smokers. Hypercholesterolaemia (LDL-C3.4 mmole/l or treatment) was present in 82% of subjects. Only 45% of treated subjects had an LDL-C3.4 mmole/l. Hypertension (systolic blood pressureor = 140 mmHg or diastolic blood pressureor = 90 mmHg or treatment) was present in 61% of subjects. Only 33% of treated subjects were controlled. Non-insulin-dependent diabetes mellitus (blood glucoseor = 7.7 mmole/l or treatment) was present in 21% of subjects. Only 43% of treated subjects were controlled. Calculation of the distribution of major risk factors (smoking, pathological obesity, hypercholesterolaemia, hypertension, diabetes) showed that 90% of coronary patients presented at least two risk factors. Overall, the prevalence and management of risk factors in patients with stable coronary artery disease is far from optimal.

CT patterns of a relapsing polychondritis affecting the laryngeal cartilages are reported in a 42-year-old man with a 10-year medical history of this disease, corresponding to an irregular enlargement of the cricoid, thyroid cartilages and tracheal rings, with a moderate endoluminal narrowing. CT is useful to differentiate this rare inflammatory disease from others causes of airway narrowing, and could help in certain cases of diagnosis of beginning polychondritis.

A mixed hamartoma of the liver in a 39 year old man is reported. Abdominal ultrasound revealed a 4 cm inhomogeneous echogenic mass with acoustic shadowing. MRI T1 weighted images showed a inhomogeneous low intensity mass with lower gadolinium enhancement than normal liver, a moderate low signal intensity on proton density weighted images, and heterogeneous isosignal intensity on T2 weighted images. Peripheric calcifications were found on pathologic examination.

Retrogression of a renal artery stenosis after a six months follow-up is reported in a 43 years old woman who stopped smoking after the first angiography and was treated with antiplatelet, suggesting spontaneous atherosclerosis injury revision.

To determine variations of serum creatinine level immediately after percutaneous angioplasty for renal artery stenosis. After technical success of unilateral or bilateral percutaneous angioplasty for renal artery stenosis in 91 patients (mean age 62.7 years) in whom ioxaglate was always used (90 to 300 ml, mean 195), serum creatinine levels immediately before and 48 hours after dilatation were compared. In the whole population, no significant variation was observed in the overall population. No significant difference was observed between unilateral and bilateral renal angioplasty. The volume of contrast media did not influence creatinine level, nor did iodine injection performed during (n = 4) or more than 3 days before angioplasty. A significant difference was observed with or without diabetes mellitus (n = 15, p = 0.05). In patients without diabetes mellitus technically successful percutaneous angioplasty for renal artery stenosis when using ioxaglate do not significant alter serum creatinine level 48 hours later.

The isoforms of creatinine kinase (CK) and myoglobin were analysed by serial samplings in 45 patients admitted consecutively for myocardial infarction treated by thrombolysis according to the usual indications. Angiographic controls were carried out systematically in the first 24 hours, including 20 cases at the end of thrombolysis. The patients were divided into two groups according to the patency of the infarct related artery: Group I (n = 35) with a patent vessel and Group II (n = 10) with an occluded vessel; 4 patients in Group II were successfully revascularised by angioplasty. The total CK had a higher peak value in Group II (2,393 +/- 1,991 UI/l at 547 +/- 247 min versus 2,888 +/- 2,189 IU/l at 584 +/- 395 min) but the difference was not statistically significant. The analysis of CK isoforms showed the MM3/MM1 ratio to be higher at the 2nd hour in Group I (3.74 +/- 2.37 versus 3.09 +/- 1.43) with a faster increase, without attaining statistical significance. A fourth CK MM fraction was observed at the 2nd hour in 71% of patients in Group I compared with only 20% of patients in Group II. Analysis of myoglobin showed a significantly earlier peak value in Group I (1,218 +/- 1,117 micrograms/l at 133 +/- 62 min versus 1,309 +/- 1,549 micrograms/l at 210 +/- 84 min). The sensitivity and specificity of these different markers were respectively 40%, 86%, 77%, and 60%, 70% and 67% for the CK (peak before 8 hours), the MM3/MM1 ratio (increase of over 35% in the first hour) and myoglobin (peak before 2 hours).(ABSTRACT TRUNCATED AT 250 WORDS)

Three hundred and twenty eight patients (238 men, 90 women) with an average age of 63.5 +/- 18 years admitted consecutively for acute myocardial infarction over a 24 month period (March 1989-March 1991) were followed up at one year by out-patient appointment, questionnaire or telephonic enquiry. The average delay before hospital admission was 6.7 +/- 44 hours (1 h-48 h). The infarct was transmural in 82% of cases, anterior in 45.3%, inferior in 46.3% and lateral in 8.4% of cases. Forty eight per cent had one or several complications during the hospital period with a 10.4% hospital mortality rate. Thirty eight per cent of patients underwent primary thrombolysis and 9% had primary angioplasty. Seventy four per cent of patients had coronary angiography; 41% underwent deferred angioplasty and 6% surgical revascularisation. The global 1 year survival rate was 81.4%. At follow-up, 52.6% of patients were asymptomatic, 31% had signs of cardiac failure and 18% had residual angina. Sixty five per cent were treated with 2 or 3 drugs; 6% underwent secondary angioplasty and 2.8% secondary coronary bypass surgery. Of the 34% of active subjects, 61.4% declared having returned to full-time professional activity. Therefore, in 1992, a continuous reduction of infarct-related mortality and morbidity was observed.

The anti-ischemic and cardioprotective effects of various angina drugs have been evaluated during angioplasty. This special situation of transitory regional ischemia was used to test verapami given by intra-coronary injection in 15 patients undergoing balloon dilatation of the left anterior descending artery, suffering from stable angina and with normal left ventricular kinetics. Each patient serving as his own control, parameters indicating oxygen consumption and clinical and electrocardiographic (ST segment changes) markers were measured during two successive inflations. Continuous monitoring of comparative variations between a first inflation without treatment and a second inflation after intra-coronary administration of 1 mg of verapamil revealed, following 60 seconds of ischemia, the absence of any change in heart rate, a moderate fall in mean blood pressure (101.7 as against 96.8 mmHg, p = 0.033) and a notable 60% reduction in the amplitude of maximal ST depression (5.07 +/- 3.08 mm as against 2.07 +/- 1.44 mm, p = 0.0002). These results confirm the anti-ischemic properties of verapamil, the action of which is based upon an indirect peripheral vasodilator model but also on a probable direct cardioprotective effect on anoxic myocardial regions.