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Jean Marco

Publications and source records attributed to Jean Marco.

At least 19 recordsLinked to original sources
PubMed2006

Improving patient access to novel medical technologies in Europe.

The European Society of Cardiology (ESC) organized a one-day workshop with clinicians, health economic experts, and health technology appraisal experts to discuss the equity of patient access to novel medical technologies in Europe. Two index technologies were considered: implantable cardioverter defibrillators (ICDs) and drug-eluting stents (DES). The use of ICDs range from 35 implants/million population in Portugal to 166 implants/million population in Germany, whereas for implants of DES (as percentage of total stents) it is lowest in Germany at 14% and high in Portugal at 65%. These differences can in part be explained by a lack of structured implementation of guidelines, the direct cost in relation to the overall healthcare budget, and to differences in procedures and models applied by Health Technology Assessment (HTA) agencies in Europe. The workshop participants concluded that physicians need to be involved in a more structured way in HTA and need to become better acquainted with its methods and terminology. Clinical guidelines should be systematically translated, explained, disseminated, updated, and adopted by cardiologists in Europe. Clinically appropriate, consistent and transparent health economic models need to be developed and high-quality international outcome and cost data should be used. A process for funding of a technology should be developed after a positive recommendation from HTA agencies. Both the ESC and the national cardiac societies should build-up health economic expertise and engage more actively in discussions with stakeholders involved in the provision of healthcare.

Defibrillators, Implantable↗
PubMed2005

Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice.

BACKGROUND: Intracoronary polymer-based stent delivery of paclitaxel has been shown to be effective in reducing restenosis in simple coronary lesions, but the evidence base for contemporary use in longer, more complex coronary stenoses is lacking. METHODS AND RESULTS: TAXUS VI is a prospective, multicenter, double-blind, randomized trial assessing clinical and angiographic outcomes of the TAXUS Moderate Release paclitaxel-eluting stent in the treatment of long, complex coronary artery lesions. Four hundred forty-eight patients at 44 sites were randomized (1:1) between a drug-eluting TAXUS Express2 and an uncoated Express2 control stent. Per protocol, the 9-month follow-up included an angiographic reevaluation in all patients. The primary end point was the rate of target-vessel revascularization 9 months after the study procedure; secondary end points included the rate of target-lesion revascularization and binary restenosis at follow-up. Mean lesion length in the study was 20.6 mm, with a mean stent-covered length of 33.4 mm. Of all lesions, 55.6% were classified as complex lesions (type C of the AHA/ACC classification). At 9 months, target-vessel revascularization was 9.1% in the TAXUS group and 19.4% in the control group (P=0.0027; relative reduction, 53%). Target-lesion revascularization was reduced from 18.9% to 6.8%, respectively (P=0.0001). The incidence of major adverse cardiac events was similar in the 2 groups, 16.4% and 22.5% in TAXUS and control, respectively (P=0.12), including comparable rates for acute myocardial infarction. Binary restenosis in the stented area was reduced from 32.9% in the control group to 9.1% in the TAXUS patients (P<0.0001). CONCLUSIONS: The finding that the TAXUS Moderate Release stent system is safe and effective in the treatment of long, complex coronary artery lesions provides the evidence base for the more widespread use of drug-eluting stents in contemporary clinical practice.

Adult↗
PubMed2005

Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology.

In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients' preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a 'heart attack centre' observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients' outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly--independent of 'maximal' medical therapy.

Angioplasty, Balloon, Coronary↗
PubMed2004

Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial.

OBJECTIVES: We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary lesions. BACKGROUND: Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation. METHODS: The multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 microg/cm(2) of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory. RESULTS: The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction. CONCLUSIONS: The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

Aged↗
PubMed2004

The alpha1-adrenergic blocker urapidil improves contractile function in patients 3 months after coronary stenting: a randomized, double-blinded study.

BACKGROUND: The recovery of left ventricular function (LVF) after revascularization takes time. alpha-Adrenergic blockade acutely improves coronary blood flow and LVF, whereas the effects of more prolonged alpha-adrenergic blockade on LVF recovery after stenting are unknown. METHODS: In 32 patients (age 58 +/- 12 y) with an 82% +/- 6% stenosis, ejection fraction (EF) and systolic thickening (%Th) were measured by transthoracic echocardiography before and 30 minutes to 2 hours after revascularization. In a double-blinded protocol, either 200 microg/kg urapidil or placebo was given intravenously, and LVF was measured 10 minutes later. Two hours later, oral treatment with 30 mg/d drug or placebo was started, and LVF measured again after 24 hours and 3 months. RESULTS: Before revascularization, EF was 49.4% +/- 8.5% (+/-SD) and 51.3% +/- 8.8% in the urapidil-treated and the placebo groups, respectively. Thirty minutes to 2 hours after coronary stenting, EF was unchanged. After intravenous drug administration, EF increased to 56.5% +/- 9.7%). At 24 hours and 3 months after revascularization, EF became 59.5% +/- 7.9% and 59.6% +/- 8.2% in the urapidil-treated group, respectively, whereas EF in the placebo group did not change (50.4% +/- 5.7% and 49.7% +/- 4.9%, respectively). Revascularization did not acutely improve %Th. Intravenous urapidil improved %Th from 31.4% +/- 17.6% to 44.2% +/- 11.6%, whereas there was no change in the placebo group. At 3 months, %Th was 49.5% +/- 12.9% in the urapidil-treated group and 39.7% +/- 8.9% in the placebo group. CONCLUSIONS: These data suggest that long-term alpha-adrenergic blockade might improve LVF at midterm after coronary revascularization.

Adrenergic alpha-Antagonists↗
PubMed2004

[Prognosis after acute coronary syndrome. Lack of difference according to the sex].

Acute coronary syndromes (ACS) represent a continuum from unstable angina to non-ST-elevation myocardial infarction. ACS is the preferred diagnostic term for non transmural myocardial infarction. The different forms of ACS share a common anatomic substrate consisting of atherosclerotic plaque rupture or erosion, with variable degrees of thrombus formation and compromised blood flow to viable myocardium. Patients with ACS have a heterogeneous profile of short- and mid-term adverse outcomes and require a tailored approach. Recent major advances in the management of ACS have emphasized the importance of earlier identification of higher-risk patients, whose outcome might be improved by aggressive revascularization. However, during the past several years, numerous studies have shown a significant difference in the prognosis of women and men with ACS. Some reports have concluded that women have a worse prognosis than men after thrombolytic therapy and/or coronary angioplasty with stenting for myocardial reperfusion. The aim of our retrospective study was to determine sex differences in outcomes after early percutaneous intervention (PCI) in high-risk patients with acute coronary syndromes (ACS). A total of 694 consecutive patients (151 women with 233 treated lesions and 543 men with 850 treated lesions) were included. Enrollments were limited to ACS patients judged to be at high risk [unstable angina/non ST-elevation myocardial infarction with recurrent ischemia/dynamic ST segment changes (53.6% vs 52.4%) or post-infarction unstable angina (46.4% vs 47.6%)] who underwent PCI within 24 hours of admission if the coronary anatomy was deemed suitable. The two groups were well matched for clinical and lesion characteristics, except that the women, as in other studies, were older (67.9 +/- 11.3 vs 62.3 +/- 12.3 years) and had a higher prevalence of hypertension. All the lesions were treated by stent implantation, and glycoprotein IIb/IIIa inhibitors were used similarly in the two sexes (27.1% of women, 30.5% of men). The success rates were similar (94% and 93.7%), with a similar incidence of in-hospital MACE (4% vs 3.8%, p = 0.56). After a mean follow-up of 564 +/- 294 days, the two groups had similar rates of mortality (2% vs 3.2%), myocardial infarction (6.7% vs 7.1%) and repeated revascularization (7.2% vs 8.3%). The respective event-free survival rates were 88 +/- 60.3% and 83 +/- 0.3% at 1 year and 87% vs 78 +/- 0.2% at 2 years (p = 0.58). Previous studies have shown increased morbidity and mortality associated with recurrent ischemia and myocardial infarction in women after acute revascularization for ACS. Our study confirms that aggressive revascularization offers a comparable survival benefit in the two sexes. Women with ACS who are at high risk derive the same benefit as men from early angioplasty and coronary stenting of the culprit lesion, with satisfactory in-hospital and mid-term outcomes.

Acute Disease↗
PubMed2003

Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial.

Clinical trials have shown that coronary stenting is associated with a high level of complications at the access site. Arterial sealing devices have proven their efficacy in obtaining immediate hemostasis after sheath removal, in allowing early ambulation, and in improving patient comfort. However, there is no report showing a reduction of local complications related to their use. The purpose of this multicenter study was to compare randomly the efficacy of Angio-Seal versus compression methods of hemostasis in reducing the rate of access site complications after coronary angioplasty in 612 selected patients with higher risk of local events satisfying at least one of the following high-risk criteria: age > 70, previous puncture at the same site, history of hypertension, treatment with ticlopidine at least 2 days before the procedure, use of abciximab, 8 Fr access, prolonged heparin treatment after the angioplasty, and use of lytics if fibrinogen > 1 g/l. Group A (n = 306) had immediate sheath removal, Angio-Seal implantation, and cessation of bed rest 4 hr after the intervention. Group B (n = 306) had sheath removal according to local practice and cessation of bed rest 6-18 hr after the hemostasis procedure, also according to local practice. Clinical follow-up was done at 1 hr, 4 hr, 24 hr, discharge, and 7 days and a systematic color flow duplex sonography was performed to confirm diagnosis of access site complication. In group A, device deployment and immediate hemostasis were obtained in, respectively, 96.8% and 87% of patients. Time to hemostasis was shorter in group A: 5 vs. 52 min (P < 0.001). Cessation of bed rest was dramatically reduced in group A (438 +/- 450 min) vs. group B (952 +/- 308 min; P < 0.001). The cumulative rate of complications, using a composite primary endpoint, at 7 days was significantly different between the two groups: 5.9% of group A patients and 18% of group B patients (P < 0.001). This difference was mainly due to the dramatic reduction of prolonged bleeding in group A patients. Angio-Seal device use in high-local-risk patients allows immediate sheath removal and hemostasis with a reduction of local event rate despite a higher level of anticoagulation, compared to regular compression techniques, directly related to a dramatic decrease of prolonged bleeding.

Adult↗
PubMed2003

Impact of restenosis and disease progression on clinical outcome after multivessel stenting in diabetic patients.

Clinical outcome after percutaneous coronary intervention (PCI) is significantly worse in diabetic patients in comparison to nondiabetic patients. The subset of diabetic patients in the ARTS trial treated with multivessel stenting had the lowest 1-year event-free survival. We examined our experience of multivessel PCI in diabetics to assess clinical outcome outside clinical trials and to determine if repeat revascularizations are the result of restenosis or the progression of nontreated disease. Between January 2000 and December 2001, we performed multivessel PCI in 99 diabetic patients. Our group was well matched with those in the ARTS trial, with mean age of 69 +/- 8 years, male sex 70%, hypertension 68%, hypercholesterolemia 51%, and mean LV ejection fraction 60%. The mean number of diseased segments treated was 2.8 +/- 0.9 and 56% of the patients had three-vessel disease. There were 2.3 +/- 0.6 stents implanted per patient. Target vessels included the LAD in 90%, LCx in 77%, and the RCA in 87% of cases. The in-hospital MACE rate was 8%, which included eight nonfatal MI but no deaths or repeat revascularizations. After a mean follow-up of 14 +/- 8 months, there were 4 deaths (4%), no further MIs, and 21 (21%) repeat revascularizations (2 CABG; 19 PCI), giving a 1-year event-free survival of 67%. There were 18 repeat revascularizations (2 CABG; 16 PCI) for restenosis, but in 9 of the 18 (50%) patients treatment was also required for progression of disease. Three further patients had PCI for symptomatic disease progression without restenosis. Thus, disease progression contributed to 57% of repeat revascularization procedures. The medium- and longer-term success of multivessel PCI in diabetic patients is limited principally by the need for repeat revascularization. However, it is important to realize that these revascularizations are performed not only for restenosis but also for disease progression in more than 50% of patients. Consequently, even if drug-eluting stent technology can eliminate restenosis, disease progression will continue to impact the clinical outcome of diabetic patients after PCI.

Aged↗
PubMed2003

Catheter-induced left main dissection: a treatment dilemma.

Diagnostic angiography is a routine diagnostic procedure in modern day cardiological practice. However, there are potential life threatening complications which can occasionally occur. We describe one such complication and detail the management and clinical outcome.

Adult↗
PubMed2003

Direct stenting.

Stents have ameliorated the outcome of percutaneous coronary interventions. Improved design, profile and flexibility of the currently available stents now permit to deliver the stent without pre-dilatation. In western European countries, stent implantation now occurs in up to 80% of all percutaneous revascularization procedures. In selected cases the safety and feasibility of direct stenting over conventional balloon-predilatation stenting has been demonstrated, in association with slightly superior outcome. This likely results from reduced vessel wall damage-dissections are sealed at the moment they are created-and distal embolization is reduced. In addition, a significant reduction in terms of costs and duration of procedures was demonstrated, while restenosis rate is not reduced with direct stenting.

Angioplasty, Balloon, Coronary↗
PubMed2003

Direct stent implantation using the EXPRESS Coronary Stent System: results of a multi-center feasibility study.

The aim of this prospective, multicenter, single arm study was to assess the safety and feasibility of EXPRESS Coronary Stent implantation in native coronary arteries without balloon predilatation. Forty-two patients with de novo or restenotic lesions were enrolled, of which 38 were eligible for analysis. The coronary lesions were predominantly complex, occurring in arteries with a mean reference diameter of 2.80 +/- 0.49 mm. Technical and procedural success were achieved in 89.5% and 84% of the cases respectively. The mean minimal lumen diameter increased from 1.08 +/- 0.26 mm to 2.55 +/- 0.44 mm and diameter stenosis decreased from 61 +/- 7% to 13 +/- 8%. The primary endpoint of major adverse cardiac events at 30 days was 2.6% and was limited to only one event (target vessel revascularization, nontarget lesion). No other MACE were observed during the three-month follow-up period. Based on the findings of this study, direct stenting with the EXPRESS Stent appears feasible and is well tolerated.

Aged↗