Rotational Atherectomy Versus Intravascular Lithotripsy for Calcified In-Stent Restenosis: A Single-Center Study With 1-Year Follow-Up.

Although rotational atherectomy (RA) and intravascular lithotripsy (IVL) have been proved to be effective for calcified de novo coronary lesions, their use in patients with in-stent restenosis (ISR) is still controversial. No comparison of these techniques in patients with ISR has been published so far. We sought to evaluate safety and feasibility of RA and IVL in patients with calcified ISR. Furthermore, we aimed to compare in-hospital and 1-year clinical outcomes between both groups. This is a retrospective single-center study evaluating patients with calcified ISR treated with RA (between 2012 and 2021) and IVL (between 2019 and 2021). Inhospital and 1-year clinical outcomes were compared between IVL and RA patients. In total, 28 patients with ISR who underwent RA were compared with 24 ISR subjects after IVL. The procedural success rate was 100% in both the groups. Quantitative coronary analysis demonstrated a similar degree of stenosis prior (66.4 ± 11.4 vs 68.8 ± 19.7, p = nonsignificant [NS]), and after the procedure (21.5 ± 20.5 vs 22.8 ± 12.1, p = NS) with no difference in acute luminal gain (1.34 ± 0.60 vs 1.38 ± 0.59, p = NS). There was one in-hospital major adverse cardiovascular event in the RA group. At 1-year follow-up, no difference was observed with respect to major adverse cardiovascular event rate (14.3% vs 16.7%, p = NS) and target vessel revascularization (7.1% vs 12.5%, p = NS). In conclusion, RA and IVL are safe and feasible techniques for calcified ISR yielding comparable results at 1-year follow-up. Further clinical studies are warranted to confirm our findings and shed more light on patient and lesion characteristics associated with the best outcomes.

Clinical outcomes of coronary intravascular lithotripsy in patients with stent failure (COIL registry).

BACKGROUND: Intravascular lithotripsy (IVL) has been demonstrated to be an effective treatment of calcified de novo coronary lesions. Safety data on the use of IVL within stented segments are lacking. We sought to evaluate the safety, feasibility, and long-term outcomes of IVL in patients with stent failure. METHODS: This was a retrospective multi-centre registry that included consecutive patients with stent failure who had undergone IVL treatment. The primary efficacy endpoint was procedural success defined as residual stenosis <30% (determined by quantitative coronary angiography analysis) in patients who survived hospital admission without in-hospital adverse events. Major adverse cardiovascular events (MACE) were defined as the composite endpoints of cardiovascular death, spontaneous myocardial infarction, and target vessel revascularisation at one-year follow up. RESULTS: 102 patients were included in this study. Mean age was 73 ± 9 years and 81% were male. The duration from previous stent implantation and IVL treatment was 24 (interquartile range 7-76) months, of which 10.8% received IVL for acute under-expanded stent. IVL treatment allowed significant improvement in both minimal lumen diameter (1.14 ± 0.60 to 2.53 ± 0.59, P < 0.001) and degree of stenosis (66.8 ± 19.9 to 20.3 ± 11.3%, P < 0.001). The rate of procedural success was 78.4% (80/102 of patients). The one-year MACE was 15.7%. Ostial disease (HR 5.16; 95% CI 1.19 to 22.33; P = 0.028) and lesion length (HR 1.05; 95% CI 1.01 to 1.10; P = 0.010) were independently associated with one-year MACE. CONCLUSIONS: In patients with stent failure, IVL is a safe and feasible treatment for this high-risk group.

Percutaneous mitral annuloplasty with the Carillon device: Outcomes in proportionate and disproportionate functional mitral regurgitation.

BACKGROUND: It has been suggested that the disparity of outcomes between the studies of transcutaneous edge-to-edge repair (TEER) for functional mitral regurgitation (FMR) in heart failure with reduced ejection fraction (HFrEF) could be due to systematic differences in the populations studied. One proposal is that there are 2 broad groups: those with proportional FMR who respond less favorably, and those in whom the FMR is greater than expected (disproportionate) FMR where edge-to-edge TEER seems to be more effective. Whether this grouping is relevant for other percutaneous interventions for FMR is unknown. OBJECTIVES: We sought to compare clinical and echocardiographic outcomes of patients with HFrEF and proportionate and disproportionate FMR treated with indirect annuloplasty using the Carillon device. METHODS: This is a pooled analysis from 3 trials of patients with FMR. Key patient eligibility in these trials specified persistent grade 2+ to 4+ FMR with >5.5 cm left ventricular (LV) end-diastolic diameter (LVEDD) and reduced ejection fraction. Patients with an effective regurgitant orifice area/LV end-diastolic volume (EROA/LVEDV) ratio under 0.15 were assigned to the proportionate FMR group (n = 74;65%) and those with a ratio above 0.15 were classed as having disproportionate FMR (n = 39;35%). RESULTS: At 12 months following treatment, both groups showed improvements in all MR variables including regurgitation volume, EROA and vena contracta. Moreover, in patients with proportionate MR there were clinically relevant and statistically significant improvements in LV volumes and diameters. There was no independent relationship between the degree of proportionality as a continuous variable and the remodeling response to Carillon therapy (change in LVEDV r = 0.17; change in LVESV r = 0.14). CONCLUSION: Percutaneous mitral annuloplasty with the Carillon device reduces MR in patients with both proportionate and disproportionate FMR, and also results in LV reverse remodeling in those with proportionate FMR. The effect on remodeling remains to be verified in a large-scale trial.

Comparison of outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The BioFreedom France study.

BACKGROUND: The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers' population. METHODS: We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition. RESULTS: Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001). CONCLUSION: In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI.

BACKGROUND: Contrast-induced nephropathy (CIN) can occur after cardiovascular procedures using contrast media, which is associated with increased morbidity and mortality. RenalGuard is a closed-loop system designed to match intravenous hydration with diuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials. OBJECTIVES: The STRENGTH (Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI) study assessed whether RenalGuard (PLC Medical Systems) is superior to standard intravenous hydration for CIN prevention in patients with chronic kidney disease undergoing complex cardiovascular procedures. METHODS: STRENGTH is a multicenter, international, open-label, postmarket, prospective, randomized (1:1) study monitored by the Cardiovascular European Research Center (Massy, France) that included a total of 259 patients with moderate to severe chronic kidney disease (estimated glomerular filtration 15-40 mL/min/m2) requiring a complex coronary, structural, or peripheral procedure with an expected contrast injection of at least 3 times the estimated glomerular filtration rate. Patients were randomized to either RenalGuard or intravenous saline hydration according to current guidelines. RESULTS: The primary endpoint, the incidence of CIN at day 3 after the procedure, was similar between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in the control group; P = 0.62). In addition, none of the secondary endpoints differed between the 2 groups. CONCLUSIONS: In high-risk patients undergoing complex cardiovascular interventions in experienced centers, furosemide-induced high urine output with matched hydration using the RenalGuard system did not reduce the risk of CIN and adverse outcomes at 12 months compared with conventional intravenous hydration.

Mid-term outcome of de novo lesions vs. in stent restenosis treated by intravascular lithotripsy procedures: Insights from the French Shock Initiative.

BACKGROUND: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion. METHODS: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately. RESULTS: A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group. CONCLUSIONS: In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted.

Clinical Outcomes in Patients Treated With Biodegradable-Polymer Biolimus-Eluting Stents and 6 Months of Dual-Antiplatelet Therapy: The French eBiomatrix 6-Month DAPT Registry.

BACKGROUND: Dual-antiplatelet treatment (DAPT) has conventionally been prescribed for 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Recent evidence suggests that a duration of only 6 months may be equally safe and effective when using contemporary DES options. OBJECTIVE: The aim of this study was to assess clinical outcomes in patients treated with the BioMatrix biodegradable-polymer coated biolimus-eluting stent (BP-BES; Biosensors International) who received only 6 months of DAPT. METHODS: This prospective "all-comers" registry enrolled 2038 patients in France. Following PCI, DAPT was started for a recommended period of 6 months. Patients were followed up at 6 and 24 months. The primary endpoint of major adverse cardiac and cerebrovascular event (MACCE) was a composite of all-cause death, cerebrovascular accidents, non-fatal myocardial infarction, or clinically driven target-vessel revascularization. Secondary endpoints included stent thrombosis (ST) and major bleeding (MB). RESULTS: The mean age of the study population was 67 ± 10.5 years and 77% of patients were male. Follow-up data were available in 96.9% and 95.3% of patients at 6 and 24 months, respectively. At 6 months, the incidences of MACCE, ST, and MB were 3.1%, 0.3%, and 0.4%, respectively. At 24 months, 21.2% of patients were still on DAPT and the cumulative incidences of MACCE, ST, and MB were 9.7%, 0.54%, and 0.79%, respectively. CONCLUSIONS: In this unselected population of patients undergoing PCI with a BP-BES, a 6-month duration of DAPT after implantation is safe and effective.

Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation.

AIMS: To determine the effects of percutaneous mitral annuloplasty on symptoms, walk distance and left ventricular (LV) structure and function in patients with mild or moderate secondary mitral regurgitation (SMR). METHODS AND RESULTS: This was a pooled analysis of patients (n = 68) who, despite guideline-directed medical therapy had symptomatic heart failure (HF) with mild (n = 25) or moderate (n = 43) SMR treated with percutaneous mitral annuloplasty as part of the TITAN, TITAN II, or REDUCE-FMR trials. Primary outcomes were changes in symptoms, 6-min walk distance, and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) after 1 year. Secondary analyses included changes in LV structure and function. At 1 year, New York Heart Association class status was maintained (48%) or improved (46%) in most patients, mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to17; P < 0.01] and mean 6-min walk test distance increased by 34 m (95% CI 12 to 57; P < 0.01). SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of -7 mL (95% CI -11 to -3; P < 0.001), vena contracta -0.11 cm (95% CI -0.20 to -0.02; P < 0.05), and effective regurgitant orifice area -0.03 cm2 (95% CI -0.06 to -0.01; P < 0.05). There were non-significant improvements in LV ejection fraction and volumes. Survival over 1 year was 89% with no difference between mild (96%) and moderate (86%) SMR (log-rank P = 0.22). Progression-free survival was 70% (82% in mild vs. 63% in moderate SMR; P = 0.16). Freedom from HF hospitalization was 73% (87% in mild SMR vs. 66% in moderate SMR; P = 0.07). CONCLUSION: Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.

Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial.

AIMS: The objective of this study was to compare functional outcomes through 1 year in patients with core-lab verified moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control in the blinded sham-controlled REDUCE-FMR (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation) study. METHODS AND RESULTS: The main outcomes of this analysis were the change in 6 min walk test (6MWT) distance, incidence of heart failure hospitalization or death, change in New York Heart Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 1 year of follow-up. The minimum clinically important difference (MCID) was defined as a ≥30 m increase in 6MWT distance, an NYHA decrease in ≥1 class, and a ≥3 point increase in KCCQ score. The proportion of patients achieving the MCID in each treatment group was compared using Fisher's exact test, and the number needed to treat (NNT) with the Carillon device was calculated. Among 83 patients (62 Carillon and 21 sham), no statistically significant group differences were observed in the baseline characteristics. All outcomes at 1 year numerically favoured the Carillon group, including MCID for the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3). CONCLUSIONS: REDUCE-FMR was the first blinded sham-controlled trial to report outcomes with percutaneous therapy for the treatment of FMR. Trends towards improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with the Carillon device. A substantially higher number of patients achieved MCID for all patient-centred outcomes with the Carillon device compared with the sham procedure.

Transcatheter treatment of functional mitral valve regurgitation.

Functional mitral regurgitation is a clinical entity with increasing prevalence and significant impact on morbidity and mortality. Because of the unsatisfactory results of medical therapy and high perioperative risk resulting in low referral/high denial rates for surgical treatment, benefits of which still remain controversial, novel minimally invasive transcatheter techniques are under development. Herein, in the present review, we discuss the recent progress in the emerging field of catheter-based techniques for functional mitral regurgitation.

Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience.

AIMS: This study aims to report long-term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS AND RESULTS: This was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline-directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. Surviving patients were evaluated for long-term follow-up post-procedure, averaging 6.9 years. Fifteen (15) patients (mean age 72 years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4+) were treated with the Carillon device. The Kaplan-Meier mortality rate was 40% at 6 years of follow-up. Long-term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non-survivors from baseline to 1 year follow-up, -9.0 ± 5.6 vs. -1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow-up between survivors versus non-survivors, P = 0. 05) which was sustained throughout follow-up. All patients at 6 year follow-up had ≤2+ MR, with 6 of 7 having 0-1+ MR. Left ventricular end-diastolic volume was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL at 6 year follow-up, P = 0.03 in survivors with both measurements. CONCLUSIONS: Among patients with congestive heart failure treated with the Carillon device, long-term survival is associated with favourable 1 year and sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status.

Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device.

PURPOSE: To report long-term survival and to identify potential determinants of survival among patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS: This was a post hoc analysis in which we pooled prospectively collected data from three studies of the Carillon device with available long-term vital status data. Patient eligibility in these trials specified symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction. Echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. RESULTS: A total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon device. Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling. The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. CONCLUSIONS: Among patients with congestive heart failure and grade 2 to 4 FMR who were symptomatic despite guideline-directed medical therapy, transcatheter mitral valve repair with the Carillon device resulted in a favorable 5-year survival rate. The survival benefit was greatest among patients with improvement in clinical and hemodynamic parameters during the first year of follow-up.

The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.

OBJECTIVES: This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling. BACKGROUND: Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis. METHODS: In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis. RESULTS: Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: -11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to 13.6]; p = 0.04). CONCLUSIONS: The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830).

Biolimus A9 polymer-free coated stents in high bleeding risk patients undergoing complex PCI: evidence from the LEADERS FREE randomised clinical trial.

AIMS: The LEADERS FREE trial has demonstrated that a polymer-free Biolimus A9-coated stent (BA9-DCS) is superior to a bare metal stent (BMS) for high bleeding risk (HBR) patients when treated with one month of dual antiplatelet therapy (DAPT). This analysis aimed to determine the impact of PCI procedure complexity on the two-year results. METHODS AND RESULTS: Six hundred and sixty-seven (667) patients enrolled in the LEADERS FREE (BA9-DCS 346, BMS 321) underwent a complex PCI, defined by one or more of eight characteristics: total stent length ≥60 mm, ≥3 vessels or lesions treated, ≥3 stents implanted, bifurcation lesion treated with ≥2 stents, chronically occluded, restenotic or saphenous vein graft lesion. Patients undergoing complex PCI were older, more often male, and presented with more ACS, diabetes, renal insufficiency, anaemia and multivessel disease. They derived major benefit from DCS over BMS for safety (16.2% vs. 21.7%, HR 0.70 [0.49-0.99], p<0.05) and for efficacy (10.8% vs. 18.1%, HR 0.54 [0.35-0.83], p<0.005). For the 1,746 patients with non-complex PCI, DCS demonstrated superior efficacy (5.3% vs. 9.9%, HR 0.52 [0.36-0.75], p<0.001, p for interaction NS) and similar safety to BMS (11.1% vs. 12.6%, NS, p for interaction NS). CONCLUSIONS: Compared to BMS, the BA9-DCS maintained both efficacy and safety benefits when used in complex PCI procedures.

A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure-Trial design of the REDUCE FMR study.

The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.

Safety and efficacy outcomes of 3rd generation DES in an all-comer population of patients undergoing PCI: 12-month and 24-month results of the e-Biomatrix French registry.

OBJECTIVES: The French Ebiomatrix registry aimed to confirm the results of the Leaders trial in an all-comer population in France. BACKGROUND: The Leaders trial showed the Biolimus-eluting-sent (BES) to be equivalent to the Cypher stent in terms of safety and efficacy at 1 year and superior regarding stent thrombosis after 1 year. METHODS: BES recipients were enrolled in 42 French centers with up to 24-month clinical follow up. RESULTS: 2365 patients were included. Mean age: 65.7 ±11.2 years, 76.1% males, 31.8% had diabetes, 36.5% ACS (28.7% non-ST-elevation MI and 7.8% with ST-elevation MI). 1.7 ± 1.0 stents/patient were implanted and procedural success was 99.5%. 12-month follow-up was completed in 94.3% patients and 24 months in 91.4%. MACCE rates at 12 and 24 months were 5.8% and 9% (all cause-death 1.5% and 2.2%; stent thrombosis definite/probable 0.4% and 0.6%), respectively. MACCE were not significantly higher in diabetic patients compared with non-diabetics but cardiac death was higher (1.6% vs. 0.6%, P = 0.01 at 1 year and 1.9% vs. 0.6, P = 0.005 at 2 years) as was stent thrombosis (0.9% vs. 0.2%, P = 0.009 and 1.2 vs. 0.3% P = 0.008). Compared with non-ACS patients, MACCE was significantly higher in the ACS subgroup (7.5% vs. 4.8%, P = 0.001 at 1 year and 10.3% vs.8.1%, P = 0.07 at 2 years). CONCLUSION: In this large real-world registry, the BES with biodegradable polymer showed excellent acute and mid-term outcomes with a 5.8% and 9% rate of MACCE at one and 2 years and a very low rate of stent thrombosis between 1 and 2 years (0.2%), thus demonstrating the replicability of the LEADERS trial in a registry population. © 2017 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial.

OBJECTIVE: Functional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR. METHODS: 36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant. RESULTS: There was 1 major adverse event within 30 days-a death (not device related)-occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study. CONCLUSIONS: The modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk.

BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).