Yves Louvard

Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions.

Background—A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. Methods and Results—This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). Conclusions—These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Stenting of bifurcation lesions: classification, treatments, and results.

Percutaneous transluminal balloon coronary angioplasty (PTCA) of coronary bifurcations is associated with a low success rate, high rate of complications, and high incidence of target vessel revascularization (TVR). The strategy of systematic coronary stenting in bifurcation lesions involving a side branch ≥ 2.2 mm in diameter was prospectively evaluated in a single‐center observational study during a 35‐month inclusion period. All patients meeting these criteria were consecutively included. Bifurcation lesions and treatment were predefined in the study. The study included 366 patients (12.1% of PTCA) with 373 bifurcation lesions, mean age 63.7 ± 11.6 years, 79.2% male, 46.7% with unstable angina, and 8.3% acute MI. The left anterior descending/diagonal bifurcation was involved in 55.2% of cases, circumflex/marginal 22.2%, PDA/PLA 10.4%, left main bifurcation in 6.8%, and others 5.4%. The main branch (2.78 ± 0.42 mm reference diameter) was stented in 96.3% of cases and the side branch (2.44 ± 0.43 mm) in 63.2% (the two branches were stented in 59.5% of cases). Procedural success was obtained in 96.3% in both branches and 99.4% in the main branch. At1‐month follow‐up, The major cardiac event rate (MACE) was 4.8% (death 1.1%, emergency CABG 0.6%, Q‐wave MI 0.9%, acute or subacute closure 1.4%, repeat PTCA 1.1%, and non‐Q–wave MI 2.3%). At 7‐month follow‐up, the total MACCE rate was 21.6%, including a TVR rate of 17.2%. Analysis of the 7‐month outcome according to two study periods (period I, 1 January 1996 to 31 August 1997, 182 patients; period II, 1 September 1997 to 30 June 1998, 127 patients) showed that the TVR rate decreased from 20.6% to 13.8% (P = 0.04) and the MACE rate from 29.2% to 17.1% (P < 0.01) in period I and II, respectively. This was associated by univariate analysis with an increasing use of tubular stents deployed in the main branch (94.2% vs. 59.1%, P < 0.001) and kissing balloon inflation after coronary stenting (75.4% vs. 18.1%, P < 0.001). Bifurcation lesions are frequent. Procedural success of coronary stenting is high with a low rate of in‐hospital MACE. TVR rate at follow‐up is relatively low. In‐hospital and follow‐up results are influenced not only by the learning curve but also by the use of tubular stents in the main branch and final kissing balloon inflation. Cathet. Cardiovasc. Intervent. 49:274–283, 2000.

Intracoronary Stent Implantation Without Ultrasound Guidance and With Replacement of Conventional Anticoagulation by Antiplatelet Therapy 30-Day Clinical Outcome of the French Multicenter Registry

BACKGROUND Stenting reduces both acute complications of coronary angioplasty and restenosis rates but increases subacute thrombosis rates and hemorrhagic complications when used with coumadin anticoagulation. METHODS AND RESULTS To simplify postcoronary stenting treatment and to reduce these drawbacks, we evaluated the 1-month outcome of a prospective registry of 2900 patients in whom successful coronary artery stenting was performed without coumadin anticoagulation. Patients received 100 mg/d aspirin and 250 mg/d ticlopidine for 1 month. Low-molecular-weight heparin (LMWH) treatment was progressively reduced in four consecutive stages, from 1-month treatment to none. Event-free outcome at 1 month was achieved in 2816 patients (97.1%). Major stent-related cardiac events were subacute closure in 51 patients (1.8%), including death in 12 (0.5%), acute myocardial infarction in 17 (0.6%), and coronary artery bypass graft surgery in 9 (0.3%). Stent thrombosis was more frequent with balloon size of < 3.0 mm (< or = 2.5 mm, 10%; 3.0 mm, 2.3%; > or = 3.5 mm, 1.0%; P < .001), bail-out situations (6.67% versus 1.38%, P < .001), and patients with unstable angina or acute myocardial infarction (2.2% versus 1.12%, P = .02). Bleeding complications that required transfusion, surgical repair, or both occurred in 55 patients (1.9%). Bleeding complications were related to female gender (4.0% versus 1.51%, P < .001), duration of LMWH treatment (3.83% in phase II/III versus 0.69% in phase IV/V, P < .001), sheath size (6F, 0.52%; 7F, 1.04%; > or = 8F, 4.23%; P < .001), bail-out situations (4.76% versus 1.67%, P < .01), and saphenous graft stenting (4.38% versus 1.75%, P = .04). CONCLUSIONS These results suggest that poststenting treatment by ticlopidine/aspirin is an effective alternative to coumadin anticoagulation, achieving low rates of subacute closure and bleeding complications. LMWH treatment does not improve subacute reocclusion rates but increases bleeding complications. Furthermore, as bleeding complications were independently related to sheath size, we suggest that stenting with 6F guiding catheters may prevent local complications. Furthermore, the ticlopidine/aspirin combination allows a low-cost stenting strategy without ultrasound assessment of stent deployment and permits short inhospital stay.

Six-Month Outcome of Emergency Percutaneous Coronary Intervention in Resuscitated Patients After Cardiac Arrest Complicating ST-Elevation Myocardial Infarction

Background— The outcome of resuscitated patients after cardiac arrest complicating acute myocardial infarction remains poor, primarily because of the relatively low success rates of cardiopulmonary resuscitation management. Existing data suggest potential beneficial effects of early myocardial reperfusion, but the predictors of survival in these patients remain unknown. Methods and Results— From 1995 to 2005, 186 patients (78% men; mean age, 60.4±13.8 years) underwent immediate percutaneous coronary intervention after successful resuscitation for cardiac arrest complicating acute myocardial infarction. Prompt prehospital management was performed by mobile medical care units in 154 of 186 patients, whereas 32 had in-hospital cardiac arrest. Infarct location was anterior in 105 patients (56%), and shock was present on admission in 96 (52%). Percutaneous coronary intervention (stenting rate 90%) was successful in 161 of 186 patients (87%). Six-month survival rate was 100 of 186 (54%), and 6-month survival free of neurological sequelae was 46%. By multivariate analysis, predictors of 6-month survival were a shorter interval between the onset of cardiac arrest and arrival of a first responder (odds ratio, 0.67; 95% CI, 0.54 to 0.84), a shorter interval between the onset of cardiac arrest and return of spontaneous circulation (odds ratio, 0.91; 95% CI, 0.87 to 0.96), and absence of diabetes (odds ratio, 7.30; 95% CI, 1.80 to 29.41). Conclusions— In patients with resuscitated cardiac arrest complicating acute myocardial infarction, prompt prehospital management and early revascularization were associated with a 54% survival rate at 6 months. A strategy including adequate prehospital management, early revascularization, and specific care in dedicated intensive care units should be strongly considered in resuscitated patients after cardiac arrest complicating acute myocardial infarction.

Coronary angiography through the radial or the femoral approach: The CARAFE study

In a previous study, the radial approach for coronary angiography was shown to be associated with a lower success rate and longer procedural and X‐ray times compared to the femoral approach. However, this approach is associated with a steep learning curve. A series of 210 consecutive nonselected patients were randomized to femoral versus right radial approach or femoral versus left radial approach by two experienced operators. Clinical characteristics were similar in the three groups. Technical failure occurred in one patient in the right radial group with subsequent crossover to left radial artery. The number of coronary catheters used was lower in the right radial group (1.4 ± 0.7 vs. 2.1 ± 0.4 for the two other groups). The procedural duration was longer with left radial (14.2 ± 3.3 min; P < 0.05) approach than with right radial (12.4 ± 5.8 min) and femoral (11.2 ± 3.3 min) without significant differences between femoral and right radial. X‐ray exposure was shorter in the femoral group (3.1 ± 1.7 min) than in both radial groups (right: 3.8 ± 2.2 min; left: 4.2 ± 1.7 min). The angiographic quality was not different between the three groups for RCA, but was less good for LCA through right radial approach. Bed rest and hospital stay were shorter in the two radial groups. The comfort was judged better with the transradial approach. An ad hoc PTCA was performed in 45.7% of femoral patients, 41.4% of right radial, and 44.3% of left radial with immediate sheath withdrawal (closure device for femoral group). There were no severe complications in the three groups, but two patients from the femoral group were discharged later because of vascular complications. The total cost of coronary angiography was higher in the femoral group. In conclusion, after the learning period, transradial coronary angiography can be performed with a high success rate, low rate of complication, and good angiographic quality. It is associated with a slight increase in procedural (LR) and fluoroscopy times, but permits earlier ambulation and discharge, improves patient comfort, and reduces the cost. Cathet Cardiovasc Intervent 2001;52:181–187.

Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology

Radial access use has been growing steadily but, despite encouraging results, still varies greatly among operators, hospitals, countries and continents. Twenty years from its introduction, it was felt that the time had come to develop a common evidence-based view on the technical, clinical and organisational implications of using the radial approach for coronary angiography and interventions. The European Association of Percutaneous Cardiovascular Interventions (EAPCI) has, therefore, appointed a core group of European and non-European experts, including pioneers of radial angioplasty and operators with different practices in vascular access supported by experts nominated by the Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology (ESC). Their goal was to define the role of the radial approach in modern interventional practice and give advice on technique, training needs, and optimal clinical indications.

Classification of coronary artery bifurcation lesions and treatments: Time for a consensus!

Background: Percutaneous coronary intervention (PCI) of coronary bifurcation lesions remains a subject of debate. Many studies have been published in this setting. They are often small scale and display methodological flaws and other shortcomings such as inaccurate designation of lesions, heterogeneity, and inadequate description of techniques implemented. Methods: The aim is to propose a consensus established by the European Bifurcation Club (EBC), on the definition and classification of bifurcation lesions and treatments implemented with the purpose of allowing comparisons between techniques in various anatomical and clinical settings. Results: A bifurcation lesion is a coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch. The simple lesion classification proposed by Medina has been adopted. To analyze the outcomes of different techniques by intention to treat, it is necessary to clearly define which vessel is the distal main branch and which is (are) the side branche(s) and give each branch a distinct name. Each segment of the bifurcation has been named following the same pattern as the Medina classification. The classification of the techniques (MADS: Main, Across, Distal, Side) is based on the manner in which the first stent has been implanted. A visual presentation of PCI techniques and devices used should allow the development of a software describing quickly and accurately the procedure performed. Conclusion: The EBC proposes a new classification of bifurcation lesions and their treatments to permit accurate comparisons of well described techniques in homogeneous lesion groups.

A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction

OBJECTIVES We sought to determine whether direct stenting might prevent the adverse events associated with stent implantation during primary angioplasty and to compare it with conventional stent implantation in patients with acute myocardial infarction (AMI). BACKGROUND No trial has demonstrated that stents favorably influence mortality rate. Recent studies have even suggested a negative impact of stents on coronary blood flow and clinical outcome. METHODS Of 409 patients treated by primary angioplasty with stent implantation in our center, 206 (50%) were enrolled in this randomized, single-center trial and allocated to direct stent implantation (n = 102) or stent implantation after balloon pre-dilation (n = 104). The study end points included angiographic results (final corrected Thrombolysis In Myocardial Infarction [TIMI] frame count and a composite end point of slow and no-reflow or distal embolization), an electrocardiogram marker of myocardial reperfusion assessment (ST-segment resolution) and in-hospital clinical outcome (death and recurrent infarction). RESULTS Direct stent implantation failed in eight patients but succeeded after pre-dilation in all. A non-significant increase in TIMI flow grade 3 was achieved after direct stenting (95.1% vs. 93.3%, p = 0.74) without significant difference in the corrected TIMI frame count (31.5 +/- 17 and 35.2 +/- 20 frames after direct and conventional stent, respectively, p = 0.42). The composite angiographic end point was significantly reduced by direct stent implantation (11.7% vs. 26.9%, p = 0.01). ST-segment resolution was also significantly improved after direct stent (no ST-segment resolution in 20.2% vs. 38.1% after direct and conventional stent, respectively, p = 0.01). Death and/or recurrent infarction occurred in six patients after conventional stent implantation and in two patients after direct stenting (p = 0.28). CONCLUSIONS In selected patients with AMI, direct stenting can be applied safely and effectively. This strategy may result in a significant reduction of microvascular injury, as suggested by improved ST-segment resolution after reperfusion with major potential clinical consequences.

Percutaneous coronary intervention for bifurcation coronary disease

Ever since coronary angioplasty was first undertaken, treatment of coronary bifurcation lesions has posed technical problems.w1 w2 Specific difficulties involving access to the side branch and the snow plough effect, as well as the role of kissing balloon inflation, have been rapidly identified even before the era of near universal stenting. Consequently, until the late 1980s, patients with bifurcation lesions were generally referred for surgery and seldom treated by percutaneous techniques. However, in cases where angioplasty was considered an option, the kissing dilatation technique was widely used in order to avoid recurrent problems of plaque shifting observed when the two branches were dilated separately.w3 The new tools developed in the early 1990s seemed likely at first to facilitate the approach to bifurcation lesions. However, the results achieved with the debulking technique alone (rotative or directional atherectomy) were rather disappointing. Conversely, coronary stenting through its scaffolding properties became the treatment of choice, at least for reducing the risk of acute complications. In the mid 1990s, the question remained as to how to perform optimal stenting of the main branch while preserving the side branch. The data collected from bench test studies proved crucial. They allowed the operators to understand stent behaviour and the effect of empirically implemented strategies, and to develop new concepts such as dedicated stents. Numerous techniques of stent deployment in bifurcation lesions have been described.1–5w4–w21 These techniques have been indexed6 in our institution and evaluated in vitro in a bench test mimicking coronary bifurcations with diameters of 3.5 mm for the main branch and 3.00 mm for the side branch. The pitfalls of such a model are the absence of stenosis, the constant longitudinal diameter of the main branch, and the impossibility to study other branch diameters. Nevertheless, the problem of access …

Consensus from the 7th European Bifurcation Club meeting.

1. Sussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom; 2. Department of Cardiology B, SkejbyHospital, University of Aarhus, Denmark; 3. Clinica San Rocco, Brescia, Italy; 4 Institut Cardiovasculaire Paris Sud, Massy,France; 5 Clinique Saint Augustin, Bordeaux, France; 6. Hospital Reina Sofia, Cordoba, Spain; 7 . Herz-Zentrum BadKrozingen, Bad Krozingen, Germany; 8. Institute for Cardiovascular Diseases, Clinical Center of Serbia, Belgrade, Serbia