Jonathan Michel

Validation of the DAPT score in patients randomized to 6 or 12 months clopidogrel after predominantly second-generation drug-eluting stents

The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort of patients with 6 or 12 months DAPT after implantation of predominantly second-generation drug-eluting stents. We analyzed data of patients enrolled in the ISAR-SAFE trial. Patients were classified into low (<2) or high (≥2) DAPT score groups. Primary ischaemic (all-cause death, myocardial infarction, definite stent thrombosis or stroke) and bleeding (TIMI major or minor) outcomes were analyzed in the low and high DAPT score groups. Data of 3976 patients were available for DAPT score calculation. 2407 patients (60.5 %) were classified in the low DAPT score group and 1569 patients (39.5 %) in the high DAPT score group. In the low DAPT score group there were no significant differences between 6 and 12 months DAPT regarding ischaemic (1.0 % vs. 1.4 %, HR=0.74, 95 % CI, 0.35-1.57; p=0.43) or bleeding outcomes (0.3 % vs. 0.8 %, HR=0.44, 95 % CI, 0.13-1.42; p=0.17). In the high DAPT score group there were also no significant differences between 6 and 12 months DAPT regarding ischaemic (1.9 % vs. 1.8 %, HR=1.02, 95 % CI, 0.49-2.14; p=0.96) or bleeding (0.3 % vs. 0.5 %, HR=0.51, 95 % CI, 0.09-2.78; p=0.44) outcomes. In conclusion, the DAPT score failed to show a differential treatment effect in patients receiving 6 or 12 months DAPT after contemporary drug-eluting stent implantation.

Standardized Minimalistic Transfemoral Transcatheter Aortic Valve Replacement (TAVR) Using the SAPIEN 3 Device: Stepwise Description, Feasibility, and Safety from a Large Consecutive Single-Center Single-Operator Cohort

ABSTRACT Background: To describe our updated minimalist approach (MA) for transfemoral transcatheter aortic valve replacement (TF-TAVR) using the SAPIEN 3 device and its evolution, as well as associated safety and efficacy parameters from a large cohort of patients. Methods: A stepwise description of the MA technique for TAVR for 300 consecutive patients was detailed. Safety and efficacy parameters were assessed using the VARC-2 criteria at the in-hospital and 30-days follow-up. Results: A total of 300 consecutive patients (80 ± 7 years; median Logistic EuroSCORE of 11.4% [7.5–17.8]) between January 2014 and May 2016 were evaluated. TF-TAVR was performed under conscious sedation in 247 (82%) patients. Device success was achieved in 286 (95.6%) patients, and intended prosthesis performance in 289 (96.3%) patients. Significant paravalvular leak (PVL) graded more than mild was noted in 7 (2%) patients. No patient had severe PVL. All-cause mortality was noted in one (0.3%) patient in-hospital and in 2 (0.7%) patients at the 30-days follow-up. Major stroke occurred in 4 (1.3%) patients. 9 (3%) patients had major vascular complications at 30-days follow up. MACCE (VARC-2 criteria) were observed in 21 (7%) in-hospital and 25 (8.3%) at 30 days. A new permanent pacemaker implantation was required in 29 (10.7%) patients, and was reduced from 18% to 5.6% (p = 0.001) in a subgroup analysis considering higher implantation position of the valve after the first year of experience. Conclusion: MA of TF-TAVR, when simplified and standardized, is reproducible, safe and efficient, and should be encouraged to be accepted as the standard method of care.

Impact of stent size on angiographic and clinical outcomes after implantation of everolimus-eluting bioresorbable scaffolds in daily practice: insights from the ISAR-ABSORB registry.

AIMS We sought to evaluate the impact of stent size on angiographic and clinical outcomes after implantation of everolimus-eluting bioresorbable stents (BRS) in routine clinical practice. METHODS AND RESULTS All consecutive patients undergoing BRS implantation at two centres in Munich, Germany, were included prospectively. The patient population was divided according to the diameter of the implanted BRS. Angiographic surveillance was scheduled at six to eight months after stent implantation and films were analysed in a core laboratory. A BRS with 2.5 mm diameter was implanted in 101 patients and BRS >2.5 mm diameter in 318. Baseline patient characteristics were similar in both groups. Reference vessel diameter was 2.36±0.22 mm in patients with an implanted 2.5 mm BRS and 3.03±0.40 mm in the other group (p<0.001). At angiographic follow-up, in-stent late luminal loss (0.28±0.47 mm vs. 0.25±0.52 mm, p=0.74) was similar in both groups, though binary angiographic restenosis was numerically higher in patients treated with a 2.5 mm BRS (12.5% vs. 6.1%, p=0.05). After 12 months, the rate of the composite of death, myocardial infarction or target lesion revascularisation was 15.7% vs. 12.3% (p=0.49). Definite stent thrombosis was detected in 1.0% vs. 3.1% (p=0.31). CONCLUSIONS In patients treated with BRS in routine clinical practice, angiographic and clinical outcomes were comparable in patients treated with a 2.5 mm stent as compared with those treated with a larger stent size.

Emergency extracorporeal membrane oxygenation in transcatheter aortic valve implantation: A two-center experience of incidence, outcome and temporal trends from 2010 to 2015

Although the incidence of periprocedural complications has decreased in transcatheter aortic valve implantation (TAVI), life‐threatening complications occur and emergency veno‐arterial extracorporeal membrane oxygenation (vaECMO) can provide immediate circulatory stabilization. We report our two‐center experience of vaECMO during life‐threatening complications in TAVI.

Prognostic Value of Cardiac Troponin T and Sex in Patients Undergoing Elective Percutaneous Coronary Intervention

Background In patients with stable coronary artery disease undergoing elective percutaneous coronary intervention, the prognostic value of high‐sensitivity cardiac troponin T (hs‐cTnT) and the influence of sex remain poorly defined. Methods and Results Consecutive patients with stable coronary artery disease who underwent elective percutaneous coronary intervention were included. Primary endpoint was all‐cause mortality. Unadjusted hazard ratio (HR) in overall and sex‐specific population and multivariable adjusted HR were calculated by using Cox proportional hazard models. In a total of 5626 patients, elevated hs‐cTnT levels, more than the sex‐specific 99th percentile upper reference limit of normal (URL), were observed in 2221 patients (39%) at baseline. During follow‐up (median, 14.5 months; 25th–75th percentiles, 6.4–27.2 months), 265 patients died. Mortality was higher in patients with the sex‐specific 99th percentile URL compared to those with normal hs‐cTnT (17.3% vs 3.4%; HR=6.10; 95% CI, 4.58–8.14; P<0.001). hs‐cTnT was an independent predictor of mortality in multivariable adjusted models. The C‐statistic was significantly increased by adding hs‐cTnT to the basic prediction model for mortality (0.793–0.815; P<0.001). There was a significant interaction between hs‐cTnT and sex on mortality. Differences in all‐cause mortality between patients with more than the sex‐specific 99th percentile URL and those with normal hs‐cTnT were numerically larger in male than female patients (male, HR=6.45; 95% CI, 4.68–8.87, P<0.001; female, HR=4.29, 95% CI, 2.36–9.03; P<0.001). Conclusions In patients with stable coronary artery disease undergoing elective percutaneous coronary intervention, preprocedural hs‐cTnT was a strong predictor of mortality in both men and women.

TCT-207 Extended validation of a decision tool (DAPT score) in patients randomized to 6 or 12 months dual antiplatelet therapy after percutaneous coronary intervention with predominantly second-generation drug-eluting stents.

TCT-206 Tailoring the Intensity of Antiplatelet Pharmacotherapy to Ischemic and Bleeding Risk: A Cost Optimizing Simulation From PARIS Daniel Leisman, Usman Baber, David Cohen, C. Michael Gibson, Stuart Pocock, Timothy Henry, Philippe Gabriel Steg, George Dangas, David Moliterno, Bernhard Witzenbichler, Annapoorna Kini, Mitchell Krucoff, Jeffrey Bruckel, Antonio Colombo, Alaide Chieffo, Roxana Mehran Icahn School of Medicine at Mount Sinai, New York, New York, United States; Mount Sinai Medical Center, New York, New York, United States; Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, United States; Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States; London School of Hygiene and Tropical Medicine, London, United Kingdom; Cedars Sinai Heart Institute, Los Angeles, California, United States; Groupe Hospitalier Bichat – ClaudeBernard, Paris, France; Mount Sinai Medical Center, New York, New York, United States; University of Kentucky, Lexington, Kentucky, United States; Helios Amper-Klinikum, Dachau, Germany; Unknown, New York, New York, United States; Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina, United States; University of Rochester Medical Center; San Raffaele Scientific Institute, Milan, Italy; San Raffaele Scientific Institute, Milan, Italy; Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine, New York, New York, United States

Biomarker-based diagnosis of pacemaker and implantable cardioverter defibrillator pocket infections: A prospective, multicentre, case control evaluation

Background The use of cardiac implantable electronic devices (CIED) has risen steadily, yet the rate of cardiac device infections (CDI) has disproportionately increased. Amongst all cardiac device infections, the pocket infection is the most challenging diagnosis. Therefore, we aimed to improve diagnosis of such pocket infection by identifying relevant biomarkers. Methods We enrolled 25 consecutive patients with invasively and microbiologically confirmed pocket infection. None of the patients had any confounding conditions. Pre-operative levels of 14 biomarkers were compared in infected and control (n = 50) patients. Our selected biomarkers included white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), lipopolysaccharide binding protein, high-sensitivity C-reactive protein (HS-CRP), polymorphonuclear-elastase, presepsin, various interleukins, tumor necrosis factor α (TNF-α), and granulocyte macrophage colony-stimulating factor (GM-CSF). Results Of the 25 patients with isolated pocket infection (70±13years, 76% male, 40% ICDs), none presented with leukocytosis. In contrast, they had higher serum levels of HS-CRP (p = 0.019) and PCT (p = 0.010) than control patients. Median PCT-level was 0.06 ng/mL (IQR 0.03–0.07 ng/mL) in the study group versus 0.03 ng/mL (IQR 0.02–0.04 ng/mL) in controls. An optimized PCT cut-off value of 0.05 ng/mL suggests pocket infection with a sensitivity of 60% and specificity of 82%. In addition TNF-α- and GM-CSF-levels were lower in the study group. Other biomarkers did not differ between groups. Conclusion Diagnosis of isolated pocket infections requires clinical awareness, physical examination, evaluation of blood cultures and echocardiography assessment. Nevertheless, measurement of PCT- and HS-CRP-levels can aid diagnosis. However, no conclusion can be drawn from normal WBC-values. Clinical trial registration clinicaltrials.gov identifier: NCT01619267

Prognostic impact of anemia and iron-deficiency anemia in a contemporary cohort of patients undergoing transcatheter aortic valve implantation

INTRODUCTION Anemia is frequent in patients undergoing transcatheter aortic valve implantation (TAVI) with a strong negative prognostic impact. The prevalence and prognosis of anemia and separately of iron-deficiency anemia in contemporary patients are unclear. METHODS AND RESULTS In total, 549 consecutive patients undergoing transfemoral TAVI were included in the single-center study. Baseline anemia was defined as a hemoglobin level <13g/dL in men and <12g/dL in women. In an unselected subgroup of anemic patients (n=115), a complete iron status was obtained and anemia was classified as iron-deficiency versus non-iron-deficiency. The primary endpoint was death or re-hospitalization for worsening heart failure within one year after TAVI. Anemia was present in 45% (249/549) of the population and was significantly associated with a higher rate of the primary endpoint (25% (63/249) vs. 8% (25/300); p<0.001). In a multivariable model adjusted for variables associated with the primary endpoint, baseline anemia was an independent predictor of the primary endpoint (hazard ratio 2.81, 95% confidence interval [1.69-4.67]; p<0.001). Iron-deficiency anemia was present in 79% (91/115) of the subgroup and the rate of the primary endpoint was comparable to non-iron-deficiency anemia (31% (28/91) vs. 21% (5/24); p=0.338). CONCLUSION In contemporary TAVI patients, anemia remains a common comorbidity and independently predicts adverse outcome. In an unselected subgroup of anemic patients, iron-deficiency was common and had similar clinical outcome compared to non-iron-deficiency. Whether correction of iron-deficiency anemia impacts prognosis remains to be investigated.

Angiographic and clinical outcomes of patients treated with drug-coated balloon angioplasty for in-stent restenosis after coronary bifurcation stenting with a two-stent technique.

AIMS We conducted this study to evaluate the efficacy of drug-coated balloon therapy for in-stent restenosis after coronary bifurcation stenting. METHODS AND RESULTS Patients who underwent angioplasty with at least one paclitaxel-coated balloon for in-stent restenosis after bifurcation intervention using a two-stent approach were included. Two types of paclitaxel-coated balloon were used, with either an iopromide (iopromide-PCB) or a butyryl tri-n-hexyl citrate (BTHC-PCB) excipient. Angiographic surveillance was planned at six to eight months. Quantitative coronary angiography analysis was carried out with dedicated bifurcation analysis software. Clinical follow-up was performed to one year. In total, 177 patients were included in this study. Information on the type of stent technique used at the time of the index intervention was available for 145 (81.9%) patients: the culotte technique was used in 123 (69.5%) and T-stenting in 22 (12.4%) patients. Iopromide-PCB and BTHC-PCB were used in 124 (70%) and 53 (30%) patients, respectively. Of 125 patients who underwent angiographic follow-up, 30 cases (24%) of binary restenosis were observed. At one year, the composite endpoint of death, myocardial infarction or target lesion revascularisation was observed in 35 patients (24%). There was no significant difference in the incidence of angiographic and clinical outcomes between iopromide-PCB versus BTHC-PCB. CONCLUSIONS In the setting of in-stent restenosis after coronary bifurcation stenting, drug-coated balloons demonstrated good clinical efficacy without the requirement for further stent implantation. There were similar outcomes between iopromide-PCB and BTHC-PCB.

Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis

In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41–1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group; HR 1.00, 95% CI 0.14–7.09, P = >0.99. Major bleeding occurred in 3 patients (0.4%) receiving 6 months clopidogrel and 5 (0.6%) receiving 12 months; HR 0.60, 95% CI 0.15–2.49, P = 0.49. There was no significant difference in net clinical outcomes after DES implantation in ACS patients treated with 6 versus 12 months clopidogrel. Ischaemic and bleeding events were low beyond 6-months.