[stent thrombosis : A won battle ? (data from the France PCI registry)]. / Thrombose de stent : une bataille gagnée ? (Données du registre France PCI).

GOAL: The aim of the study is to assess the incidence, risk factors and prognosis of definite stent thrombosis (ST) at 1 year in the France PCI multicenter prospective registry. PATIENTS AND METHODS: Only patients who underwent coronary angioplasty with at least one stent implantation between 1st January 2014 and 31 December 2019 were included. The population was separated into 2 groups: the "ST" group with stent thrombosis and the "control" group without stent thrombosis. RESULTS: 35,435 patients were included. 256 patients (0.72%) presented a ST at 1 year. The rate of ST decreased significantly in acute coronary syndrome (1.5% in 2014 vs. 0.73% in 2019; p = 0.05) but not in chronic coronary syndrome (0.46% in 2014 vs 0.40%; p = 0.98). The risk factors are young age (65.8 years vs 68.2; p = 0.002), clinical context (35.27% vs 16.68%; p = 0.0001), diabetes (35.2 % vs 26.4%; p = 0.002), renal failure (11.7% vs 8%; p = 0.009) and history of coronary angioplasty (28.63% vs 21.86%; p = 0.009) and peripheral arterial disease (14.5% vs 10.1%; p = 0.021), LV dysfunction (37% vs 27.5%; p = 0.003), mean length (39.6 mm vs 31, 7mm; p <0.0001) and the mean number of stents per procedure (1.9 vs 1.6; p <0.0001), a TIMI flow ≤1 pre procedure (21.5% vs 12.4%; p <0.0001) and an intrastent restenosis (11% vs 6%; p <0.0001). The 1-year mortality of the ST group was significantly higher than that of the control group (19.14% vs 5.82%; p <0.0001). CONCLUSION: Since 2014, the incidence of ST at 1 year has been decreasing but remains stuck at a floor level of 0.54% in 2019. The battle for ST seems to have been partly won and its risk factors well identified, but its mortality is still high.

Position paper of French Interventional Group (GACI) for TAVI in France in 2018.

Aortic stenosis is a frequent disease in the elderly. Its prevalence is 0.4% with a sharp increase after the age of 65, and its outcome is very poor when the patient becomes symptomatic. The interventional procedure known as TAVI (trans-catheter aortic valve implantation), which was developed in France and carried out for the first time in Rouen by Prof. Alain Cribier and his team in 2002, has proven to be a valid alternative to surgical aortic valve replacement. At first, this technique was shown to be efficient in patients with contra-indications to surgical treatment or deemed to be at high surgical risk. Given the very promising outcomes achieved as a result of close heart team collaboration, appropriate patient selection, simplified procedures and reduced complication rates, transfemoral (TF) TAVI is now preferred in symptomatic intermediate risk patients>75 years old according to the latest ESC guidelines. In 2017, in France, TAVI is currently performed in 50 centers with on-site cardiac surgery. The 2016 TAVI outcomes recorded in the French national TAVI registry (France TAVI) are very encouraging and show that for 7133 patients treated (age 83.4±7 years, logistic Euroscore 14%), 87% of whom via the TF approach, cross-over to surgery was very low (0.5%) with a 3.0% in-hospital mortality rate. The substantial increase in TAVI indications and the improvement of its outcomes may in the near future call for a reconsideration of the number of high volume centers authorized to carry out this technique.

Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial).

OBJECTIVE: The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR). METHODS: In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stay RESULTS: A total of 53 patients were enrolled. After a blinded review, 10 patients were defined as protocol violation because restenosis occurred more than 2 years after stent implantation. Procedures were performed in 55 limbs, 48 (87%) for claudication and 7 (13%) for critical limb ischaemia. The mean diameter and length of PEB were 6 ± 0.57 mm and 86 mm ± 32 mm, follow-up was 17 months (range 1-19). At 1 year, the survival rate was 96 ± 2.7% and freedom from TLR and TER were 90.2 ± 4.2% and 85 ± 5%, respectively. Sustained primary and secondary clinical improvements were 78.6 ± 5.7% and 92.0 ± 3.8%, respectively. At 1 year, the primary patency rate was 83.7 ± 5.0%. Prior to the procedure, the mean EQ-5D score was 66 ± 14 and 74 ± 16 at 1 year (p = .10). Two patients died during follow-up; one patient died 33 days after the procedure because of limb ischaemia. CONCLUSION: PEB for the treatment of FP ISR is associated with a low rate of re-interventions and restenosis. Clinical improvement is maintained at 18 months.

[Role of angioplasty in the treatment of renal artery stenosis]. / Place de l'angioplastie des artères rénales.

Atherosclerotic renal artery stenosis is frequent and is associated with a high incidence of morbidity and mortality, with a strong correlation with coronary artery disease, (Kalra et al., 2005; Cheung et al., 2002; Guo et al., 2007 [1-3]). The atherosclerotic renal artery stenosis is an independent predictive factor of death (Conlon et al., 1998 [4]). The treatment of this lesion does not have strong evidence. A lot of studies in this area suggest the angioplasty is superior in a big majority between surgery, and angioplasty with stent is superior between balloon angioplasty, but some studies fail to prove the superiority of angioplasty versus medical treatment. These studies have sadly a lot of mistakes and nowadays we don't know what is the treatment for our patients in a lot of cases. The angioplasty is indicated when there is a failure of antihypertensive medications for control of blood pressure, when it is associated with a renal insufficiency quickly progressive or when there is a lesion on each renal artery. Other studies must be organized for prove the superiority of angioplasty when there is a real stenosis, maybe with the use of fractional flow reserve.

Endovascular procedures for below the knee arteries in diabetics.

Patients with below the knee (BTK) lesions may present either with intermittent claudication (IC) or with critical limb ischemia (CLI). Generally, these patients with a high incidence of diabetes have a high rate of myocardial infarction and mortality. So, even if, the surgery is potentially a very good technique with excellent results when the best conduit as a vein graft is used, the ratio benefice/risk seems too low for the IC patients. On another hand for the CLI patients a lot of reasons contraindicate or are unfair to the surgical option: lack of conduit, bad or unclear run-off or distal outflow site, bad local cutaneous conditions. Endovascular option by specialists with experience of coronary devices should be the treatment of choice. We review the different techniques and their recent upgrades in order to improve the percutaneous endovascular treatment of BTK lesions.

Usefulness and clinical impact of a fractional flow reserve and angiographic targeted strategy for coronary artery stenting: FROST III, a multicenter prospective registry.

BACKGROUND: Fractional flow reserve (FFR) is correlated with angiographic and intravascular ultrasound assessments of stent placement. Post-stenting FFR has been described as a good predictor of clinical events after 6 months. OBJECTIVE: To evaluate the feasibility and clinical impact of targeting an FFR > 0.95 via incremental in-stent inflation pressures. METHODS: In this multicenter prospective study, 100 consecutive patients underwent FFR measurement at baseline, after balloon predilatation, and after stenting with 4-atm inflation pressure increments from 8 to 20 atmospheres. Inflations were stopped when FFR increased above 0.95 and angiographic stenosis was less than 20%. RESULTS: FFR > 0.95 was achieved in 81% of cases; this FFR target was reached at 8 atm in 47% of patients, 12 atm in 16 %, 16 atm in 15%, and 20 atm in 3%. Fifty percent of patients with adequate angiographic result had an FFR less than 0.95 and needed further higher inflations. FFR was correlated with residual stenosis when the total procedure was evaluated, and this correlation persisted when in-stent inflations alone were considered. Final FFR was significantly correlated with anginal status after 6 months. CONCLUSIONS: Angiography guided PCI does not allow optimization of FFR. Since optimal post stenting FFR is correlated to better anginal status at 6-months, this suggests that FFR guided PCI is required to achieve optimal functional results of PCI.

[Acute myocardial infarction in myocardial bridge treated by coronary stent]. / Infarctus du myocarde aigu sur pont myocardique traité par l'implantation d'endoprothèses. Résultats immédiats et suivi à long terme.

The authors report the case of a symptomatic myocardial bridge treated in the acute phase of anterior wall myocardial infarction by classical stenting of the mid and distal left anterior descending artery. One and a half months later, intrastent restenosis at the two dilated sites, led to another angioplasty procedure with implantation of sirolimus-eluding stents. The outcome was good with no recurrence of angina at 16 months and control coronary angiography was totally normal at the 8th month.

[Biochemical markers of myocardial damage after high-energy radiofrequency ablation of atrial flutter. Value of troponin I]. / Marqueurs biochimiques de souffrance myocardique après ablation du flutter auriculaire par radiofréquence de haute énergie. Intérêt de la troponine I.

Creatinine phosphokinase and its MB iso-enzyme do not allow assessment of the degree of tissue necrosis after radiofrequency ablation. Cardiac Troponin I and myoglobin, new markers of myocardial lesions, are rarely used in this indication. The aim of this prospective study was to measure and compare serum markers of myocardial damage after high energy radiofrequency ablation of atrial flutter with an 8 mm distal electrode catheter. The authors measured serum cardiac Troponin I, myoglobin, creatinine phosphokinase and its MB iso-enzyme levels before and 4, 12 and 24 hours after radiofrequency ablation of common atrial flutter in 23 consecutive patients. The same markers were also measured in a control group of 9 patients undergoing electrophysiological investigation without radiofrequency ablation. All ablation procedures were simple with an average of 12.6 +/- 6 applications of radiofrequency. Bidirectional isthmic block was obtained in 22 of the 23 patients. The mean Troponin I levels were 0.01 microgram/l before ablation, 0.87 +/- 0.77 at the 4th hour (p < 0.001 versus control), 1.16 +/- 1.2 at the 12th hour (p < 0.001 versus control) and 0.7 +/- 0.63 microgram/l at the 24th hour (p < 001 versus control) after ablation. Only 13% of patients had cardiac troponin levels greater than the threshold of significant myocardial damage (> 2 micrograms/l) with a higher average number of radiofrequency applications than the rest of the group: 15.2 +/- 1 versus 11.5 +/- 5.1 (p < 0.05). An abnormally high level of markers was found in the ablation group for 19 patients (84%) with Troponin I (> 0.4 microgram/l), for 10 patients (43%) with the MB iso-enzyme (> 8 Ul/L), and for 1 patient (4%) with myoglobin (> 90 micrograms/l), and in no patient for creatinine phosphokinase (> 290 IU/L). All values were normal in the control group. The authors conclude that cardiac Troponin I is the most sensitive marker for myocardial cellular damage after high energy radiofrequency ablation of atrial flutter. The level of cardiac Troponin I seems to correlate with the number of applications of radiofrequency.

Is coronary stent deployment and remodeling affected by predilatation? An intravascular ultrasound randomized study Stenting with or without predilation: an IVUS study.

In this intravascular ultrasound (IVUS) randomized trial we compared a strategy of direct stenting (DS) without predilation (n = 30) vs. conventional stenting with predilation (SWP) (n = 30) in patients with suitable type A or B non-calcified lesions in native vessels > or = 3 mm. Optimal deployment was achieved using angiographic criteria without interactive IVUS. The goal of our study was to determine whether stent expansion and coronary remodeling were similar. Maximal pressure inflation was comparable in the two groups (11.4 +/- 2.2 vs. 11.8 +/- 1.9 atm; NS). Stent deployment was obtained in all patients with complete apposition to the vessel wall. DS and SWP resulted in comparable lumen enlargement (5.4 +/- 2.5 vs. 5.5 +/- 2.1 mm2) with an identical mechanism: 66% of lumen enlargement was due to increased enlarged elastic membrane (EEM)-cross sectional area (CSA) (delta = 3.7 +/- 2.1 mm2 and delta = 2.4 +/- 6.8 mm2, respectively, p < 0.49) and 34% was due to a reduced P + M-CSA (delta = 0.02 +/- 6.9 mm2 and delta = 1.2 +/- 6.3 mm2, respectively, p < 0.50). We conclude that at the same maximal pressure inflation the mechanisms of stent expansion are similar in both DS and SWP groups. In this observational study, the IVUS data showed clearly under-expansion of stents in both groups in comparison with previously published CSA values (minimum stent CSA of 7.5 mm2).

Clinical and angiographic performance of a new-generation modular stent design for treatment of de novo coronary lesions.

The objectives of the Race Car study were to assess the safety and efficacy of the Medtronic AVE S670 stent, a new-generation stent with a modular design consisting of interconnected sinusoidal rings allowing improved flexibility with good conformability and scaffolding. A total of 285 stents were implanted in 267 patients with (un)stable angina pectoris who underwent angioplasty of a single de novo lesion in a native coronary artery with a diameter between 3.0 and 4.0 mm. Available stent lengths were 9, 12, and 15 mm. The primary endpoint was the 6-month restenosis rate. Secondary endpoints were device and procedural success and major adverse cardiac event (MACE)-free survival at 1 and 6 months. All patients received the study stents and no other stents were used (angiographic success: 100%). Eight patients experienced a MACE during hospital admission (Q-wave MI in 2, non-Q-wave MI in 4, TLR in 2). A procedural success was obtained in 97% of the patients. There were no additional events at 1 month. The clinical endpoints encountered at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angioplasty in 25 (MACE-free survival: 86.5%). Quantitative angiographic results were the minimum lumen diameter increased from 1.05 +/- 0.32 before to 2.73 +/- 0.39 mm after stent implantation. At follow-up, the loss in diameter was 0.74 +/- 0.50 mm. The loss index was 0.45 +/- 0.31 and restenosis rate was 13.4%. This study has demonstrated that the S670 stent in patients with (un)stable angina pectoris requiring intervention of a single lesion has a low acute and 6-month major event rate and a low angiographic restenosis rate.

Stent placement compared with balloon angioplasty for small coronary arteries: in-hospital and 6-month clinical and angiographic results.

BACKGROUND: Stenting has been demonstrated to be superior to balloon angioplasty in de novo focal lesions located in large native vessels. However, in small vessels, the benefit of stenting remains questionable. METHODS AND RESULTS: A total of 381 symptomatic patients with de novo focal lesion located on a small coronary segment vessel (<3 mm) were randomly assigned to either stent implantation (192 patients; 197 lesions) or standard balloon angioplasty (189 patients; 198 lesions). The primary end point was the angiographic restenosis rate at 6 months, as determined by quantitative coronary angiography. On intention-to-treat analysis, angiographic success rate and major adverse cardiac events were comparable: 97.9% and 4.6% versus 93.9% and 5.8% in the stent group and the balloon group, respectively. After the procedure, a larger acute gain was achieved with stent placement (1.35+/-0.45 versus 0.94+/-0.47 mm, P=0.0001), resulting in a larger minimal lumen diameter (2.06+/-0.42 versus 1.70+/-0.46 mm, P=0.0001). At follow-up (obtained in 91% of patients), angiographic restenosis rate was 21% in the stent group versus 47% in the balloon group (P=0.0001), a risk reduction of 55%. Repeat target lesion revascularization was less frequent in the stent group (13% versus 25%, P=0.0006). CONCLUSIONS: Elective stent placement in small coronary arteries with focal de novo lesions is safe and associated with a marked reduction in restenosis rate and subsequent target lesion revascularization rate at 6 months.

Randomised comparison of coronary stenting with and without balloon predilatation in selected patients.

BACKGROUND: The SWIBAP (stent without balloon predilatation) prospective randomised trial was designed to compare direct coronary stenting with stenting preceded by lesion predilatation with an angioplasty balloon. OBJECTIVE: To determine the feasibility and safety of direct stenting in non-complex coronary lesions in a prospective study. PATIENTS AND DESIGN: All patients < 76 years of age scheduled to undergo angioplasty of a non-complex, non-calcified lesion in a coronary artery of > 3.0 mm, who granted their informed consent, were randomised into the trial. In group I, the stent was placed without balloon predilatation, while in group II stent implantation was preceded by balloon predilatation. The primary end point was the angiographic result according to procedure assigned by randomisation. An intravascular ultrasound substudy was performed in 60 patients. RESULTS: Stent implantation was successful without predilatation in 192 of the 197 group I patients (97.5%), and with predilatation in 197 of the 199 group II patients (99%) (NS). No in-hospital stent thrombosis or death occurred. Overall procedural times, fluoroscopy times, and volumes of contrast agent given (mean (SD)) in group I v group II were 23.50 (13.54) min v 27.96 (15.23) min (p = 0.002), 6.04 (4.13) min v 6.67 (3.65) min (NS), and 135 (65) ml v 157 (62) ml (p < 0.001), respectively. No major adverse cardiovascular events had occurred by 30 days. CONCLUSIONS: The feasibility and safety of direct stenting of selected and non-complex coronary lesions is confirmed. This technique was as successful as the conventional approach and was associated with a minor reduction in fluoroscopic exposure and procedure time and the administration of less contrast agent.

[Antithrombotic treatment protocols in interventional cardiology]. / Mise au point des protocoles de traitement antithrombotique en cardiologie interventionnelle.

The use of coronary stents has become routine in interventional cardiology, for which anti-platelet drugs are part of the daily antithrombotic routine. The association of ticlopidine and aspirin may be replaced definitively by that of clopidogrel and aspirin. A rapid biological test of the efficacy of these thienopyridines would allow identification of possible drug resistance. The anti-GP IIb/IIIa agents with an immediate onset of action are also widely used in the acute phase of MI and in acute coronary syndromes without ST elevation when the troponin levels could enable selection of high risk patients more likely to benefit from an aggressive antithrombotic strategy. Finally, the superiority of enoxaparin over unfractionated heparin must be emphasised in these same acute coronary syndromes.

The French Randomized Optimal Stenting Trial: a prospective evaluation of provisional stenting guided by coronary velocity reserve and quantitative coronary angiography. F.R.O.S.T. Study Group.

OBJECTIVES: We sought to make a prospective comparison of systematic stenting with provisional stenting guided by Doppler measurements of coronary velocity reserve and quantitative coronary angiography. BACKGROUND: Despite the increasing use of stents during percutaneous transluminal coronary angioplasty, it is unclear whether systematic stenting is superior to a strategy of provisional stenting in which stents are placed only in patients with unsatisfactory results or as a bail-out procedure. METHODS: Two hundred fifty-one patients undergoing elective coronary angioplasty were randomly assigned either to provisional stenting (group 1, in which stenting was performed if postangioplasty coronary velocity reserve was <2.2 and/or residual stenosis > or =35% or as bail-out) or to systematic stenting (group 2). The primary end point was the six-month angiographic minimal lumen diameter (MLD). Major adverse cardiac events were secondary end points (death, acute myocardial infarction and target lesion revascularization). RESULTS: Stenting was performed in 48.4% of patients in group 1 and 100% of patients in group 2 (p<0.01). Six months after angioplasty, the MLD did not differ between groups (1.90+/-0.79 mm vs. 1.99+/-0.70 mm, p = 0.39), as was the rate of binary restenosis (27.1% vs. 21.4%, p = 0.37). Among patients with restenosis, 13/32 (40.6%) in group 1 but 100% (25/25) in group 2 had in-stent restenosis (p<0.01). Target lesion revascularization (15.1% vs. 14.4% in groups 1 and 2 respectively, p = 0.89) and major adverse cardiac events (15.1% vs. 16.0%, p = 0.85) were not significantly different. CONCLUSIONS: Systematic stenting does not provide superior angiographic results at six months as compared with provisional stenting.

Emergency coronary artery bypass surgery following coronary angioplasty and stenting: results of a French multicenter registry.

This study investigates the influence of coronary stenting on the risk of emergency bypass surgery performed within 24 hr of percutaneous transluminal coronary angioplasty (PTCA) with particular concern for incidence and indication. Since 1995, coronary stenting has been increasingly performed in France during angioplasty procedures, altering significantly the role of emergency bypass surgery. The outcome of elective stenting and widespread use of coronary stenting and its influence on emergency surgery have not been evaluated so far. Through a retrospective (1995) and prospective (1996) registry, we analyzed the incidence, indication and results of emergency bypass surgery performed within 24 hr of PTCA in 68 and 57 centers, respectively, accounting for nearly half of all angioplasty procedures in France. Data were collected through questionnaires consisting of separate forms for every case report that were sent to every center. Over the two years, 26,885 and 27,497 procedures were investigated with a stenting rate of 46% and 64%, respectively. The observed need for emergency surgery was constantly low throughout this period (0.38% and 0.32%, respectively). Indications for surgery included complications directly due to stent in 37% of cases in the 2-year period. Outcome remained poor, with in-hospital mortality in 10% and 17% and myocardial infarction in 27% and 25% of cases, respectively. A comparison of the results in centers with and without surgical facilities showed no differences in outcome, despite a longer time to surgery (359 min +/- 406 min vs. 170 min +/- 205 min, P = 0.0001) and a lower incidence of emergency surgery (0.25% vs. 0.44%, P = 0.0001) in centers without on-site surgery backup. The French multicenter registry reveals an increase in the use of stents together with a dramatic decrease in the incidence of emergency bypass surgery (below 0.5%) following PTCA. There has been a significant evolution in the indication, and stent implantation now accounts for a third of the indications for emergency bypass surgery.

Coronary-to-bronchial artery communication: report of two patients successfully treated by embolization.

We report two cases of coronary-to-bronchial artery communication responsible for coronary steal. In both cases the anastomosis originated from the proximal circumflex artery and developed because of bronchiectasis. In both cases closure of the anastomosis was achieved successfully by embolization. To date, the patients remained free from symptoms.

Clinical and angiographic results of stenting for long coronary arterial atherosclerotic lesions.

A prospective registry of 187 patients who underwent percutaneous coronary angioplasty with attempted long NIR stent delivery was performed. A successful stent delivery was achieved in 93% of cases with a low rate of major cardiovascular events, and 6-month follow-up showed low rates of clinical events, new revascularization procedures, and angiographic restenosis.