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1.
Ann Cardiol Angeiol (Paris) ; 63(6): 451-4, 2014 Dec.
Article in French | MEDLINE | ID: mdl-25450994

ABSTRACT

Platypnea-orthodeoxia is a rare clinical condition which must be examined as a differential diagnosis for any bout of faintness occurring during standing or dyspnea that is exacerbated by standing. This syndrome is often associated with a patent foramen ovale. Its physiopathology is not univocal and the association of many anatomical criteria seems to be mandatory. Contrast echocardiography confirms diagnosis and closure of the patent foramen ovale during interventional catheterization and is currently the therapeutic method of choice. After closure of the foramen ovale, clinical improvement is spectacular and durable.


Subject(s)
Dyspnea/etiology , Foramen Ovale, Patent/surgery , Hypoxia/etiology , Posture , Syncope/etiology , Aged , Cardiac Catheterization , Foramen Ovale, Patent/diagnosis , Humans , Male , Recurrence , Septal Occluder Device , Ultrasonography, Interventional
2.
Ann Cardiol Angeiol (Paris) ; 62(6): 384-91, 2013 Dec.
Article in French | MEDLINE | ID: mdl-24182849

ABSTRACT

Arterial hypertension is the largest single contributor to global mortality, and is poorly controlled in approximately 50% of patients despite lifestyle and pharmacologic interventions. Randomized clinical trials have demonstrated that catheter-based renal sympathetic denervation reduces blood pressure (BP) in patients with resistant hypertension. We sought to evaluate the efficacy of this novel therapy in "Real World" clinical practice. Consecutive patients with treatment-resistant primary hypertension, as defined as home BP>160 mmHg despite treatment with ≥3 antihypertensive drugs, were selected for denervation following renal artery screening. Ambulatory and home BP monitoring was performed in all patients prior to and following percutaneous renal sympathetic denervation. In total, 35 patients were selected for catheter-based renal sympathetic denervation. The mean age was 63.6 ± 11.7 years, 37.1% were women, 37.1% were diabetic, and 11.4% had renal impairment (GFR<45 mL/min). The basal BP (home or ambulatory) was 179.1 ± 20.75/99.66 ± 19.76 mmHg, despite an average of 4.91 ± 0.98 medications per patient. Successful bilateral sympathetic denervation was performed in 33/35 patients (1 renal artery stenosis on angiography [not ablated], 1 patient with renal artery spasm [unilateral denervation]), with an average 5.9 ± 1.6 ablations per renal artery. No procedural complications occurred. At 6 months, blood pressure was 15.5 ± 22.37/87.76 ± 13.97 mmHg (P<0.01). At 2 years follow-up, systolic blood pressure (ABPM or Home BP) was 143.8 ± 15.30 mmHg (P<0.0001) and diastolic 83.42 ± 12.80 mmHg (P=0.0004). There were no adverse events during follow-up, and no deterioration in renal function was observed. Catheter-based renal denervation is safe and efficacious treatment, which results in significant reductions in blood pressure in patients with treatment-resistant hypertension, stable at 2 years follow-up. These results are applicable to real-world patient populations.


Subject(s)
Hypertension/surgery , Renal Artery/surgery , Sympathectomy , Aged , Antihypertensive Agents/therapeutic use , Catheter Ablation , Diabetes Mellitus, Type 2/complications , Female , Follow-Up Studies , France , Humans , Hypertension/drug therapy , Hypertension/etiology , Kidney/innervation , Male , Middle Aged , Randomized Controlled Trials as Topic , Renal Artery/innervation , Risk Factors , Sympathectomy/methods , Treatment Outcome
3.
Ann Cardiol Angeiol (Paris) ; 62(6): 392-7, 2013 Dec.
Article in French | MEDLINE | ID: mdl-24182850

ABSTRACT

BACKGROUND: The mother and child "5-in-6" technique using the Heartrail II catheter is a novel tool allowing stent delivery in challenging lesions, when conventional techniques have failed. METHODS: A total of 147 consecutive patients underwent percutaneous coronary intervention (PCI) using the "5-in-6" Heartrail II catheter was restrospectively identified in the Institut Cardiovasculaire Paris Sud, (Jacques-cartier hospital), Institut hospitalier Claude-Galien (Claude-Galien hospital) and European hospital of Paris between July 2009 and September 2012. RESULTS: Ten interventional cardiologists treated 147 patients with the new device. The patients mean age was 68.5 ± 21.5 years, 78% were men. Radial access was used in 128 cases (87.9%). The treated vessels were the right coronary artery in 82%, left anterior descending in 22%, left circumflex in 18%, marginal branch in 9%, the posterior descending artery in three patients, retroventricular artery in one patient and a saphenous graft in two patients. Most lesions (70%) had American Heart Association/American College of Cardiology (AHA/ACC) type B2 or C, and greater than 50% were located in distal vessel segments. Mean lesion length was 16 ± 4 mm, which is indicative of long lesion. Most (62%) lesions were moderately to heavily calcified and 22 (14%) were chronic total occlusions. Problems with stent delivery were due to poor guide catheter support or excessive calcification. Introduction of the "Heartrail II" catheter allowed successful stent delivery in 139 cases (94%). CONCLUSION: The "5 in 6" Heartrail II catheter is a simple and easy-to-use device that can improve the success of stent delivery in challenging coronary interventions.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Cardiology/instrumentation , Coronary Artery Disease/therapy , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/methods , Equipment Design , Female , Humans , Male , Middle Aged , Paris , Retrospective Studies , Treatment Outcome
4.
Ann Cardiol Angeiol (Paris) ; 61(6): 405-12, 2012 Dec.
Article in French | MEDLINE | ID: mdl-23092523

ABSTRACT

BACKGROUND: Transradial intervention of coronary lesion is increasing in frequency and is associated with lower major vascular access site complications. However, the small size of the radial artery is a major limitation of this technique, especially for bifurcation lesions, because 6-French guiding catheters are necessary to optimize the technique. A Sheathless guiding catheter has recently been introduced, optimizing a large lumen with a small size. OBJECTIVES: The aim of this study is to report our preliminary experience performing bifurcated transradial interventions using a 6.5 French Sheathless guide catheter. PATIENTS AND METHODS: From March 2009 to February 2012 in three hospitals, 46 consecutive patients were enrolled in this study who underwent transradial approach (TRA) for percutaneous bifurcation coronary interventions using the 6.5 French Sheathless Eaucath guiding catheter system because of small radial artery caliber. RESULTS: In this study, 46 patients were enrolled with mean age of 72.13 ± 16.41 years. The majority of patients were females with sex-ratio 0.53. Procedural success using the 6.5 French Sheathless guide catheter system was 100 % with no cases requiring conversion to a conventional guide and catheter system. During procedures, adjunctive devices used in this cohort included IVUS (2 patients), 35 bifurcated lesions were treated with a kissing-balloon technique in the group of 46 patients undergoing bifurcation PCIs, one patient required rotational atherectomy, thrombus-aspiration catheters had used in four patients, FFR-guided angiography in four patients. We report one case of chronic total occlusion bifurcated lesion successfully treated using this hydrophilic catheter. There were no radial artery site complications. CONCLUSION: The treatment of coronary bifurcation lesions with 6.5 French Sheathless guiding catheter by transradial approach is feasible and appears safe in this multicenter study.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Atherectomy, Coronary/instrumentation , Cardiac Catheters , Coronary Artery Disease/therapy , Aged , Aged, 80 and over , Algorithms , Angioplasty, Balloon, Coronary/methods , Atherectomy, Coronary/methods , Cohort Studies , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/pathology , Feasibility Studies , Female , France , Humans , Male , Middle Aged , Radial Artery , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Treatment Outcome
5.
Ann Cardiol Angeiol (Paris) ; 60(6): 354-60, 2011 Dec.
Article in French | MEDLINE | ID: mdl-22040858

ABSTRACT

Arterial hypertension is a major healthcare issue affecting between 30 and 40% of the adult population in industrialized countries. Despite the availability of numerous pharmaceutical treatments, arterial hypertension often remains uncontrolled. A non-negligible percentage of patients are refractory to multiple-drug therapy, which exposes them to an increased risk of cardiovascular events. Percutaneous, renal denervation using a catheter connected to a low energy radiofrequency generator has proven effective in decreasing arterial pressure in patients resistant to medical therapy, by reducing afferent nerve activity. In order to be eligible for this therapeutic approach, patients must have uncontrolled essential hypertension despite treatment with a combination of three anti-hypertensive drugs including a diuretic agent, and ≥ 45mL/min glomerular filtration rate. The initial registry study demonstrated that catheter-based sympathetic renal denervation was a simple and safe procedure resulting in a significant and durable reduction in arterial pressure. Subsequently, a randomized controlled trial (the Symplicity HTN-2 trial) showed a mean 32/12 mmHg decrease in blood pressure measurements in the group of patients who underwent renal denervation whereas no difference was observed in the control group. The reduction in blood pressure was still present at 24-month follow-up. No procedure-related complications were reported and no instances of renal artery stenosis or aneurysmal dilatation were evidenced during the follow-up period. No cases of renal function impairment or deterioration were recorded. This technique seems to be a promising strategy in patients suffering from this serious condition. In order to demonstrate the actual benefit of this technique, we report the case of two patients who underwent renal denervation in our institution.


Subject(s)
Hypertension/surgery , Renal Artery/innervation , Renal Artery/surgery , Sympathectomy , Adult , Antihypertensive Agents/therapeutic use , Blood Pressure/drug effects , Blood Pressure Monitoring, Ambulatory , Diuretics/therapeutic use , Drug Therapy, Combination , Female , Follow-Up Studies , Glomerular Filtration Rate , Humans , Hypertension/drug therapy , Hypertension/physiopathology , Kidney/innervation , Kidney/surgery , Male , Middle Aged , Neurosurgical Procedures , Renal Artery/physiopathology , Risk Factors , Sympathectomy/methods , Treatment Outcome
6.
Ann Cardiol Angeiol (Paris) ; 57(6): 371-5, 2008 Dec.
Article in French | MEDLINE | ID: mdl-18986644

ABSTRACT

The cardiovascular risk is the main cause of mortality and is increasing with age in women. In old women, this risk is similar to men. Many cardiovascular treatments are used in women without a clear demonstration of their efficiency in this population. It is only extrapolations of studies enrolling a large majority of males (more than 85%). It is very important to improve our therapeutic strategies in women, for all clinical presentations (stable angina or acute coronary syndromes), to perform dedicated studies. In fact, the rate of success of coronary angioplasty in women is similar to men but the prognosis is worse. This is partly explained by a waiting-game in the strategy and some anatomic differences such as smaller vessels diameters and also a high rate of vascular complications. To decrease this risk of vascular complications, the use of transradial seems to be a good solution. In another hand, in women, the use of drug eluting stent (DES) gives good results comparable to men. But no study has been dedicated to this group of patients.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease/therapy , Acute Coronary Syndrome/therapy , Angina Pectoris/therapy , Female , Humans , Sex Factors
7.
Heart ; 94(3): 322-8, 2008 Mar.
Article in English | MEDLINE | ID: mdl-17761505

ABSTRACT

BACKGROUND: The impact of incomplete stent apposition (ISA) after drug-eluting stent implantation determined by intravascular ultrasound (IVUS) on late clinical events is not well defined. OBJECTIVE: To evaluate the clinical impact of ISA after sirolimus-eluting stent (SES) placement during a follow-up period of 4 years. DESIGN: Pooled analysis from the RAVEL, E-SIRIUS and SIRIUS trials, three randomised, multicentre studies comparing SES and bare-metal stents (BMS). METHODS: IVUS at angiographic follow-up was available in 325 patients (SES: n = 180, BMS: n = 145). IVUS images were reviewed for the presence of ISA defined as one or more unapposed stent struts. Clinical follow-up was available for a 4-year period in all patients. Frequency, predictors and clinical sequel of ISA at follow-up after SES and BMS implantation were determined. RESULTS: ISA at follow-up was more common after SES (n = 45 (25%)) than after BMS (n = 12 (8.3%), p<0.001). Canadian Cardiology Society class III or IV angina at stent implantation (odds ratio (OR) = 4.69, 95% CI 2.15 to 10.23, p<0.001) and absence of diabetes (OR = 3.42, 95% CI 1.05 to 11.1, p = 0.041) were predictors of ISA at follow-up after SES placement. Rate of myocardial infarction tended to be slightly higher for ISA than for non-ISA patients. When SES patients only were considered, major adverse cardiac event free survival at 4 years was identical for those with and without ISA at follow-up (11.1% vs 16.3%, p = 0.48). CONCLUSIONS: ISA at follow-up is more common after SES implantation than after BMS implantation. Considering the current very sensitive IVUS definition, ISA appears to be an IVUS finding without significant impact on the incidence of major adverse cardiac events even during long-term follow-up.


Subject(s)
Coronary Restenosis/prevention & control , Coronary Thrombosis/etiology , Drug-Eluting Stents , Angioplasty, Balloon, Coronary/adverse effects , Coronary Angiography/methods , Coronary Restenosis/diagnostic imaging , Coronary Thrombosis/diagnostic imaging , Drug-Eluting Stents/adverse effects , Epidemiologic Methods , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Sirolimus/administration & dosage , Time Factors , Tubulin Modulators/administration & dosage , Ultrasonography, Interventional/methods
8.
Arch Mal Coeur Vaiss ; 100(9): 729-35, 2007 Sep.
Article in French | MEDLINE | ID: mdl-18032999

ABSTRACT

The extent of gadolinium enhancement assessed by cardiac MRI is an accepted marker of myocardial necrosis. The correlation between late enhancement and other parameters of infarct size after myocardial infarction have previously been described. However, the prognostic value of the extent of late enhancement in terms of myocardial recovery remains controversial especially in revascularised infarcts analysed by early MRI. In order to clarify this question the authors compared the results of MRI at two days and four months after myocardial infarction benefiting from early revascularisation. Between July 2002 and November 2004, the authors included patients with myocardial infarction treated by primary angioplasty and examined by MRI (Siemens Symphony 1.5 T) at two days and three to five months after myocardial infarction. The left ventricular ejection fraction, volume, mass and wall thickness were measured. Perfusion at first passage (PP) and late enhancement were analysed after injection of 20 cc of gadolinium. An eight segment short axis model was used for PP and analysis of late enhancement. Each segment was assessed for transmural or subendocardial hypoperfusion for PP assessment and the wall thickness with late enhancement (1-25%, 26-50%, 51-75%, and 76-100%) was measured to calculate the percentage of myocardial mass showing late enhancement. Thirty-nine patients (thirty three men) were included. The average age was 59 +/- 10 years. TIMI III flow was obtained in all but one (TIMI II) patient. Cardiac MRI was performed 2.1 +/- 1.5 days and 4.6 +/- 1.7 months after myocardial infarction. The ejection fraction increased from 48.7 +/- 12.6% to 54.2 +/- 11.1%, p<0.05, and was related to infarct size (p<0.01). Forty-eight per cent of dysfunctional segments at the initial MRI improved their contractility and the extent of transmural late enhancement was inversely correlated with wall thickening at initial (p<0.01) and four month MRI (p<0.01). The PP improved significantly (regression from 9.5 +/- 8.2% to 2.8 +/- 4.1% of segments with abnormal myocardial perfusion, p<0.01). The late enhancement with respect to total myocardial mass decreased from 20.0 +/- 10.7% to 13.0 +/- 8.1%, p<0.01). Despite restoring TIMI III flow, early myocardial reperfusion is incomplete and improves in the medium term. The authors also observed a reduction in late enhancement at four months, indicating that the results immediately after myocardial infarction may overestimate the infarct size and that this sign does not represent necrotic tissue alone but also viable myocardium with a potential for recovery.


Subject(s)
Angioplasty , Heart/physiopathology , Magnetic Resonance Imaging , Myocardial Infarction/surgery , Myocardial Revascularization , Myocardium/pathology , Coronary Circulation , Female , Humans , Male , Middle Aged , Time Factors
9.
Arch Mal Coeur Vaiss ; 100(10): 827-32, 2007 Oct.
Article in French | MEDLINE | ID: mdl-18033012

ABSTRACT

Renal artery angioplasty using the same techniques employed for coronary arteries has developed considerably. A register was set up in France to evaluate the efficacy of this treatment for improving renal function and lowering blood pressure in cardiac patients. Between 2001 and 2005, 205 patients (234 lesions) were treated in 14 centres (mean age: 69.2 +/- 10.4 years, 59% male). All of the patients had hypertension and the majority of them (171) had renal failure (creatinine clearance<90 ml/min). Direct implantation of a stent was performed in 75.2% of the cases, successfully in 196 patients (96%) with 220 lesions (95.2%). The complications encountered were segmental renal infarction in two patients (0.9%), and four cases of minor vascular complications at the puncture site (2%). The mean value for pre-implantation creatinine clearance was 54.6 +/- 32.8 ml/min and 58.1 +/- 36.0 post- implantations. The duration of follow up was 5.9 +/- 2.7 months. Mortality was 3.5% (seven patients, of whom two died from renal causes). The mean systolic and diastolic blood pressure was 142.2 +/- 16.2 and 78.9 +/- 9.5 respectively versus 164.9 +/- 25.2 and 89.1 +/- 14.8 before treatment (p<0.0001). A non-significant improvement in creatinine clearance at six months was also observed in patients with renal failure prior to treatment: 48.7 +/- 17.1 ml/min vs. 69.2 +/- 160.3. Renal artery stenting in cardiac patients with renal artery stenosis is associated with a very high success rate, with few complications and an improvement in hypertension and renal function.


Subject(s)
Renal Artery Obstruction/surgery , Stents , Aged , Aged, 80 and over , Female , France , Humans , Hypertension/complications , Male , Middle Aged , Renal Insufficiency/complications
10.
Heart ; 91(4): 507-12, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15772214

ABSTRACT

OBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. DESIGN: Multicentre, double blind, randomised trial. SETTING: Percutaneous coronary intervention for single de novo coronary lesions. PATIENTS: 238 patients with stable or unstable angina. INTERVENTIONS: Randomisation to sirolimus eluting stent or bare stent implantation. MAIN OUTCOME MEASURES: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. RESULTS: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166. CONCLUSIONS: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined.


Subject(s)
Coronary Stenosis/therapy , Immunosuppressive Agents/administration & dosage , Sirolimus/administration & dosage , Stents/economics , Coronary Angiography/economics , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/economics , Coronary Restenosis/prevention & control , Coronary Stenosis/economics , Cost-Benefit Analysis , Disease-Free Survival , Double-Blind Method , Female , Humans , Immunosuppressive Agents/therapeutic use , Male , Metals , Netherlands , Sirolimus/therapeutic use , Surface Properties
13.
J Invasive Cardiol ; 10(8): 457-463, 1998 Oct.
Article in English | MEDLINE | ID: mdl-10762822

ABSTRACT

Coronary stenting is now an established technique which is associated with improved acute and long-term results and prevents restenosis in comparison to balloon angioplasty in selected patients. However, subacute thrombosis and vascular complications associated with conventional anticoagulant therapy (warfarin for one month, with 4Ð5 days of IV heparin) remain of concern. By means of a prospective, multi-center registry, we sought to demonstrate that the use of ticlopidine and aspirin as the sole post-stenting treatment was safe by reducing bleeding complications without increasing the risk of major cardiac events. A total of 260 patients with stable and unstable angina and a short, single de novo lesion were enrolled in this registry. Successful stent deployment without ultrasound guidance was achieved in 259 patients. All patients were treated with aspirin ³ 100 mg daily for 6 months and ticlopidine 250 to 500 mg daily according to body weight for 1 month. The primary endpoint was safety, defined by the occurrence of death, myocardial infarction (MI), coronary bypass surgery (CABG) or repeat angioplasty (PTCA) within 30 days of the procedure, in addition to subacute stent thrombosis and bleeding and vascular complications within 30 days of the intervention. During hospital stay there were no deaths; 8 patients experienced MI, 1 patient underwent urgent CABG and 4 patients had repeat PTCA. Therefore, the clinical success rate was 96.0%. Bleeding complications requiring blood transfusion or vascular repair occurred in 2 patients. Treatment was discontinued in one patient because of mild reversible leucopenia. At 6 months, event-free survival was 90.3%. Major events involved CABG in 4 patients and a second PTCA at the same site in 14 patients. The target vessel revascularization rate at 6 months was 6.2%. This study demonstrates that Palmaz-Schatz stenting of single de novo lesions with length < 15 mm, without ultrasound guidance but with the routine use of high-pressure balloon dilatation, and with ticlopidine and aspirin as the sole treatment post intervention, is feasible and safe both in terms of clinical outcome and hematologic adverse side-effects. This registry demonstrates that six-month event-free survival exceeding 90% can be achieved.

14.
J Invasive Cardiol ; 10(7): 380-384, 1998 Sep.
Article in English | MEDLINE | ID: mdl-10973354

ABSTRACT

Contradictory data concerning the use of non-ionic contrast media during percutaneous coronary angioplasty (PTCA) have been published. Many clinical studies have suggested that a higher rate of PTCA complications (using balloon angioplasty) was observed using non-ionic versus ionic contrast media. In order to verify these results in the era of coronary stenting, we compared the in-hospital outcome of 384 patients (pts) dilated using ionic contrast media (ioxaglate) and 387 pts dilated with non ionic contrast media (iopamidol). From October 15th 1993 to July 15th 1994, 773 consecutive pts were included in this study. At the beginning of the procedure, the pts received a first bolus of heparin (7500 IU for pts who had not been pretreated with heparin and 5000 IU for pts already treated with heparin). After the first bolus the activated clotting time (ACT) was measured and the pts received an additional bolus of 2500 IU when the ACT was below 300 sec. When the procedure exceeded one hour an additional bolus of 5000 IU was injected. The main characteristics of the 2 groups (Ioxaglate vs Iopamidol) were comparable (demographic data, indication of PTCA, procedural data, first dose of heparin, total dose of heparin). The final ACT was higher in the ioxaglate group (634 +/- 111 vs. 474 +/- 310, p < 0.001). During the hospital course, blood transfusion or vascular surgery was necessary in 1.6 vs. 1.0% (NS), acute closure occurred in 2.1 vs. 4.9% (p = 0.03), acute Q-wave myocardial infarction in 0.5 vs. 0.75% (p = NS), emergency bypass surgery in 0 vs. 0.5% (NS), death in 0.8 vs. 0.3% (NS) and major cardiac event (death, myocardial infarction, coronary artery bypass surgery) in 0.8 vs. 1.6% (NS). Stents were less frequently used in the Ioxaglate group (21.5 vs. 28.5%, p = 0.03) especially in the subset of bailout stenting (2.0 vs. 4.9%, p = 0.04). CONCLUSION: This study suggests that PTCA with provisional stenting can be performed safely using ionic or non-ionic contrast media. However, the ACT obtained with the same dosage of heparin is significantly higher with the ionic contrast media whereas the risk of acute closure and the rate of bail-out coronary stenting is lower.

15.
Int J Cardiovasc Intervent ; 1(1): 19-27, 1998.
Article in English | MEDLINE | ID: mdl-12623410

ABSTRACT

Preliminary experience with primary stenting in myocardial infarction has suggested a greater benefit in clinical outcome than has been obtained with direct balloon angioplasty. However, subacute thrombosis (SAT) remains a limitation for this new mode of therapy. In the BENESTENT II Pilot and main trials, the incidence of SAT with the heparin-coated Palmaz-Schatz stent was only 0.15%. Therefore, as a preamble to a large randomized trial, the feasibility and safety of the use of the Heparin-Coated Palmaz-Schatz trade mark Stent in Acute Myocardial Infarction (AMI) was tested in 101 patients enrolled between April and September 1996 in 18 clinical centres. In 101 stent-eligible AMI patients, as dictated by protocol, a heparin-coated stent was implanted. The primary objectives were to determine the in-hospital incidence of major adverse cardiac events (MACE: death, MI, target lesion revascularization) and bleeding complications, while the secondary objectives were the procedural success rate and the MACE, the restenosis and reocclusion rates at 6.5 months. Stent implantation (n 3 129 stents) was successful in 97 patients of the 101 who were included in this trial. During their hospital stay, two patients died and no patient experienced re-infarction, ischaemia prompting re-PTCA or CABG. Four patients suffered a bleeding complication, three major and one minor, of whom three required surgical repair. At 210 days follow-up, 81% of the patients were event free. At 6.5 months restenosis was documented in 18% of the 88 patients who underwent follow-up angiography, including three total occlusions. The results, both with respect to QCA and the occurrence of MACE, compare favourably with studies using elective stenting in both stable and unstable angina patients. As a result of this pilot study, a large randomized trial comparing direct balloon angioplasty with direct stenting in 900 patients with AMI was initiated in December 1996.

17.
J Invasive Cardiol ; 8 Suppl E: 8E-9E, 1996.
Article in English | MEDLINE | ID: mdl-10785788
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