Papers by Bernhard Witzenbichler
Journal of the American College of Cardiology, 2015
Journal of the American College of Cardiology, 2014
Background: The new InspironÔ (Scitech, Brazil) is a thin-strut (75 mm) cobaltchromium stent, abl... more Background: The new InspironÔ (Scitech, Brazil) is a thin-strut (75 mm) cobaltchromium stent, abluminally coated with a thin (4.4 mg) PLA-PLGA polymeric layer, eluted with low-dose sirolimus. The present study aims to evaluate the safety and efficacy profile of the novel drug-eluting-stent in a very high-risk population treated in a tertiary university hospital. Methods: Up to May 2014, a total of 276 all-comers, without any specific anatomical or clinical restriction, have been treated with the novel sirolimus-eluing stent implantation and comprise this study population. Patients were maintained in dual antiplatelet therapy for a minimum of 6 months and aspirin was prescribed indefinitely thereafter. Patients have been clinically followed-up at 1, 6 and 12 months postprocedure. Results: For the entire cohort, a total of 342 lesions were treated with 429 InspironÔ stents. The included population had a very high risk profile. Overall 53.6% were diabetics, 70.7% had multivessel disease, 39.5% were admitted with acute coronary syndromes, heart failure was present in 16.7%, and 19.2% had previous coronary surgery. Most lesions were type B2/C (79.8%), 31.7% were bifurcations, and 17.6% were restenosis of a previously implanted stent. After a mean follow-up of 136 AE 101 days, the rate of target lesion-related death was 0.5%, myocardial infarction 4.9%, and target lesion revascularization 2.3%. There was only one episode of (probable) stent thrombosis (total any thrombosis rate at 140 days was 0.4%). Conclusions: The interim results of this real life registry demonstrate promising midterm safety and efficacy results for the novel InspironÔ sirolimus-eluing stent in the treatment of highly complex patients. TCT-609 Comparison of one year outcomes in real world patients treated with a polymer free amphilimus eluting coronary stent versus second generation everolimus eluting stents
JACC: Cardiovascular Interventions, 2013
Descriptive analysis was performed on all variables. Univariate analysis and propensity matched a... more Descriptive analysis was performed on all variables. Univariate analysis and propensity matched analysis were performed to determine differences between the 2 cohorts. Results: E had more hypertension and a higher angiographic complexity than Y patients as judged by SYNTAX scoring (E 22.4 Ϯ 14.2; Y 17.5 Ϯ 12.5, p ϭ 0.026). A higher prevalence of smoking, obesity and family history of premature heart disease was seen in Y patients. At 2 years follow up, Y vs. E patients had the following outcomes respectively: TLF 27.7% and 25.5% (pϭ0.711), TLR (24.8% vs. 21.4%, pϭ0.518), cardiac death (3.4% vs. 2.5%, pϭ0.750) and definite and probable stent thrombosis (2.0% vs. 1.0%). Propensity matched analysis showed a statistically similar TLF and TVF between the Y and E cohorts respectively (31.3% vs. 21.9% (pϭ0.317) and 46.2% vs. 32.3% (pϭ0.150) respectively). The EES had lower TLR than PES in the E (15.7% vs. 27.7%, pϭ0.055) but similar outcomes between the 2 stents were seen in the Y cohort. Conclusion: In this cohort of patients receiving EES and PES, and when compared to young patients (Ͻ 65 years), elderly patients (Ն 65 years) had more complex angiographic disease but statistically similar outcomes at 2-year follow-up. EES appears to have lower TLR in elderly patients than PES.
Journal of the American College of Cardiology, Oct 1, 2012
ST-segment elevation resolution (STR) has been shown to correlate with infarct- related artery pa... more ST-segment elevation resolution (STR) has been shown to correlate with infarct- related artery patency and prognosis post myocardial infarction (MI). However, which STR method best predicts infarct size is unclear. The INFUSE-AMI trial randomized patients with STEMI due to proximal or mid LAD
Journal of the American Heart Association, Jan 3, 2023
BACKGROUND: Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associat... more BACKGROUND: Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associated with increased risk of ischemic events after percutaneous coronary intervention, but whether the HPR-associated risk of adverse ischemic events differs by diabetes mellitus status is unknown. METHODS AND RESULTS: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. HPR was defined as P2Y12 reaction units >208 by the VerifyNow point-of-care assay. Cox multivariable analysis was used to assess whether HPR-associated risk of major adverse cardiac events (MACE; cardiac death, myocardial infarction, or stent thrombosis) varied for patients with insulin-treated diabetes mellitus (ITDM), non-ITDM, and no diabetes mellitus. Diabetes mellitus and HPR were included in an interaction analysis. Of 8582 patients enrolled, 2429 (28.3%) had diabetes mellitus, of whom 998 (41.1%) had ITDM. Mean P2Y12 reaction units were higher in patients with diabetes mellitus versus without diabetes mellitus, and HPR was more frequent in patients with diabetes mellitus. HPR was associated with consistently increased 2-year rates of MACE in patients with and without diabetes mellitus (P interaction =0.36). A significant interaction was present between HPR and non-insulin-treated diabetes mellitus versus ITDM for 2-year MACE (adjusted hazard ratio [HR] for non-ITDM, 2.28 [95% CI, 1.39-3.73] versus adjusted HR for ITDM, 1.02 [95% CI, 0.70-1.50]; P interaction =0.01). CONCLUSIONS: HPR was more common in patients with diabetes mellitus and was associated with an increased risk of MACE in both patients with and without diabetes mellitus. In patients with diabetes mellitus, a more pronounced effect of HPR on MACE was present in lower-risk non-ITDM patients than in higher-risk patients with ITDM.
Journal of the American College of Cardiology, Apr 1, 2011
Background: Inflammatory and thrombotic biomarkers can help identify patients at high risk for su... more Background: Inflammatory and thrombotic biomarkers can help identify patients at high risk for subsequent major adverse cardiovascular events (MACE). However, their utility in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI), especially with DES has not been evaluated. Methods: 23 inflammatory and thrombotic biomarkers were measured at enrollment and just prior to discharge in 502 STEMI patients enrolled in a formal substudy of the HORIZONS-AMI trial, and analyzed in a central core laboratory. All patients underwent primary PCI with TAXUS paclitaxeleluting stents. We divided patients in tertiles based on biomarker levels and explored associations between biomarkers and MACE (composite of death, reinfarction, target vessel revascularization for ischemia, and stroke) up to 3 years follow-up. For biomarkers measured at discharge, only out-of hospital events were analyzed. Results: The 3-Year MACE rate was 17.6% (n=87). Brain natriuretic peptide (BNP), cystatin-C, d-dimer, measured at baseline, and adiponectin, angiotensinogen, and myeloperoxidase measured at discharge were predictive of 3-year MACE (Table 1). No association was found between hs-CRP and 3-year MACE. Multivariate analysis models will be available at time of presentation. Conclusion: BNP, cystatin-c, d-dimer, measured at enrollment, and adiponectin, angiotensinogen, and myeloperoxidase upon discharge may be associated with 3-year MACE after STEMI.
Journal of the American College of Cardiology, Apr 1, 2011
Background: Inflammatory and thrombotic biomarkers can help identify patients at high risk for su... more Background: Inflammatory and thrombotic biomarkers can help identify patients at high risk for subsequent major adverse cardiovascular events (MACE). However, their utility in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI), especially with DES has not been evaluated. Methods: 23 inflammatory and thrombotic biomarkers were measured at enrollment and just prior to discharge in 502 STEMI patients enrolled in a formal substudy of the HORIZONS-AMI trial, and analyzed in a central core laboratory. All patients underwent primary PCI with TAXUS paclitaxeleluting stents. We divided patients in tertiles based on biomarker levels and explored associations between biomarkers and MACE (composite of death, reinfarction, target vessel revascularization for ischemia, and stroke) up to 3 years follow-up. For biomarkers measured at discharge, only out-of hospital events were analyzed. Results: The 3-Year MACE rate was 17.6% (n=87). Brain natriuretic peptide (BNP), cystatin-C, d-dimer, measured at baseline, and adiponectin, angiotensinogen, and myeloperoxidase measured at discharge were predictive of 3-year MACE (Table 1). No association was found between hs-CRP and 3-year MACE. Multivariate analysis models will be available at time of presentation. Conclusion: BNP, cystatin-c, d-dimer, measured at enrollment, and adiponectin, angiotensinogen, and myeloperoxidase upon discharge may be associated with 3-year MACE after STEMI.
Circulation-cardiovascular Interventions, Dec 1, 2012
W orsening renal function after administration of radioiodinated contrast material is a well-know... more W orsening renal function after administration of radioiodinated contrast material is a well-known complication of invasive cardiovascular procedures. Numerous studies have established that the development of contrast-induced acute kidney injury (CI-AKI) after percutaneous coronary intervention (PCI) is strongly associated with increased rates of end-stage renal failure, myocardial infarction, repeat revascularization, and early and late mortality. 1-3 CI-AKI occurs even more frequently after urgent coronary revascularization in patients with ST-segment-elevation myocardial infarction (STEMI) and non-STEMI. 4 Identification of patients with STEMI who are likely to develop CI-AKI may in the future allow administration of therapeutic interventions capable of preventing CI-AKI. 2,5-8 Several risk markers are known to be associated with CI-AKI, and based on these factors different scores have been developed. 9-11 However, for the patient with STEMI in the emergency room, these scores may be less useful as a complete medical history is often unknown and the coronary anatomy and left ventricular function have not yet been assessed. Thus, there is a need for additional objective measures readily obtainable in the emergency room to improve identification of Background-Contrast-induced acute kidney injury (CI-AKI) after percutaneous coronary intervention is associated with adverse short-and long-term outcomes. However, identification of patients at risk for CI-AKI is challenging. Using a large contemporary randomized trial database of patients with ST-segment-elevation myocardial infarction, we therefore sought to examine whether admission B-type natriuretic peptide (BNP) levels predict the development of CI-AKI. Methods and Results-A total of 979 ST-segment-elevation myocardial infarction patients enrolled in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial had BNP levels measured in the emergency room prior to primary percutaneous coronary intervention as part of the study protocol. CI-AKI was defined as a relative increase in serum creatinine of ≥25%, or an absolute increase of ≥0.5 mg/dL, occurring within 48 hours after contrast administration. Logistic regression analysis was used to estimate the association of admission BNP with development of CI-AKI. CI-AKI occurred in 131 patients (13.3%). Baseline BNP was a significant univariable correlate of CI-AKI (odds ratio 1.31, 95% confidence interval, 1.14-1.51; P=0.0001). After multivariable adjustment for clinical, laboratory, and angiographic variables, BNP remained a significant independent predictor of CI-AKI (1.29 [1.10, 1.51]; P<0.001). Significant net reclassification improvement was achieved by addition of BNP to the current clinical risk prediction model (net reclassification improvement=0.177; P<0.001) and to the Mehran Risk Score (net reclassification improvement=0.100; P=0.015). Conclusions-Measurement of serum BNP at hospital admission may help identify patients who are at risk for developing CI-AKI after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction.
Journal of the American College of Cardiology, Mar 1, 2013
Background: While atherosclerosis rarely develops within a muscle bridge (MB), it has been hypoth... more Background: While atherosclerosis rarely develops within a muscle bridge (MB), it has been hypothesized that the presence of a MB may accelerate atherosclerosis in adjacent coronary artery segments.
Coronary Artery Disease, May 1, 2017
Objective Previous intravascular ultrasound (IVUS) studies have not established a relationship be... more Objective Previous intravascular ultrasound (IVUS) studies have not established a relationship between chronic statin use and plaque morphology and composition in patients undergoing percutaneous coronary intervention (PCI). We sought to use pre-PCI grayscale and virtual histology (VH)-IVUS to assess plaque morphology and composition in patients treated with chronic statin therapy compared with patients who were not taking statins before admission and PCI. Methods In a prespecified substudy of the Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents study, pre-PCI grayscale and VH-IVUS were performed in 780 patients with 916 culprit and 765 nonculprit lesions. Results Overall, 338 patients were treated with chronic statin therapy before admission. Statin-treated patients were older and had a higher prevalence of coronary risk factors. Statin-treated patients were more likely to present with stable angina, whereas non-statin-treated patients more frequently presented with acute myocardial infarction. Grayscale and VH-IVUS findings showed that lesions in statin-treated patients had a smaller plaque burden, but more dense calcium. Statin-treated patients had more calcified thick-cap fibroatheromas (9.2 vs. 3.7%, P = 0.0007), but fewer VH-defined thin-cap fibroatheromas (45.2 vs. 56.1%, P = 0.001) or plaque ruptures (26.6 vs. 38.4%, P = 0.0001). In a propensity-matched population (n = 249 in each group), similar results were obtained as regards clinical presentation and grayscale and VH-IVUS findings. Conclusion Chronic statin use in patients with coronary artery disease was associated with more stable clinical presentation and IVUS findings consistent with greater lesion stability (fewer VH-thin-cap fibroatheromas and plaque ruptures and more calcified thick-cap fibroatheromas).
American Journal of Cardiology, Nov 1, 2019
Circulation-cardiovascular Interventions, Nov 1, 2019
Background: Smoking is a potent risk factor for coronary artery disease; however, prior studies d... more Background: Smoking is a potent risk factor for coronary artery disease; however, prior studies describe increased platelet inhibition with clopidogrel among smokers, and some studies report improved outcomes among smokers, a finding described as the smoker’s paradox. This study assessed the relationship between platelet reactivity and clinical outcomes after percutaneous coronary interventions among current smokers and nonsmokers. Methods: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. Platelet reactivity was assessed by the VerifyNow point-of-care assay; high on-treatment platelet reactivity (HPR) was defined as P2Y12 reaction units &gt;208. A propensity-adjusted multivariable analysis was performed to determine the relationship between current smoking, platelet reactivity, and subsequent adverse events. Results: Among 8582 patients, 22.6% were active smokers at the time of their percutaneous coronary intervention procedure. Current smokers were younger and had fewer comorbidities compared with nonsmokers. Current smokers had lower mean P2Y12 reaction units and lower rates of HPR compared with nonsmokers. Current smokers had similar rates of adverse events compared with nonsmokers. HPR was associated with higher rates of adverse events for both smokers and nonsmokers; however, there was evidence of interaction between smoking status and the effect of HPR. Smokers with HPR had significantly higher rates of stent thrombosis. Adverse event rates were highest among current smokers with HPR. Conclusions: Current smoking was associated with lower P2Y12 reaction units and lower rates of HPR on average; however, the combination of current smoking and HPR was associated with high rates of stent thrombosis. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00638794.
Journal of the American College of Cardiology, Oct 1, 2015
Journal of the American College of Cardiology, Mar 1, 2015
background: An increasing calcium burden is thought to be associated with adverse procedural and ... more background: An increasing calcium burden is thought to be associated with adverse procedural and clinical outcomes. methods: ADAPT-DES study was a prospective multicenter, registry of 8,582 consecutive pts undergoing successful percutaneous coronary intervention (PCI) using drug-eluting stents. A pre-specified virtual histology intravascular ultrasound (VH-IVUS) sub-study enrolled 638 culprit lesions (638 pts having only one culprit lesion) with both pre and post-PCI VH-IVUS. We divided lesions into tertiles according to pre-PCI %dense calcium volume (DCV%=dense calcium/plaque volume×100). results: Increasing DCV% was associated with older pt age, more female pts, longer lesion length, a larger arc of superficial calcium, and more advanced lesion morphology such as thin-cap fibroatheromas (TCFA). The largest DCV% tertile achieved a stent area that was only minimally smaller than tertiles with less calcium, despite a more frequent use of rotational atherectomy and higher maximum inflation pressure (Table). There was no significant association between pre-PCI DCV% and clinical driven target lesion revascularization or major adverse cardiac events (cardiac death, MI, or stent thrombosis) at 2-year follow up. Conclusion: Increasing coronary artery calcification was associated with more advanced, complex VH-IVUS lesion morphology, but was not associated with adverse clinical outcomes, perhaps due to more aggressive PCI techniques that optimized stent expansion.
Journal of the American College of Cardiology, Oct 1, 2013
Results: Population consisted of 78% of males, mean age: 66 yrs AE 11 yrs. Indications were 55.9 ... more Results: Population consisted of 78% of males, mean age: 66 yrs AE 11 yrs. Indications were 55.9 % stable angina or silent ischemia and 33.1% ACS. Risk factors were well balanced between the 2 populations: hypertension (68.0% P vs. 68.6% X), hypercholesterolemia (63.0% P vs. 63.4% X), diabetes (30.1% P vs. 28.1% X), insulin-treated diabetes (7.8% P vs. 7.1% X), current smoking (22.0% P vs. 20.9% X). Mean number of stents implanted per patient was 1.7 AE1.1. Procedural success was very high in both groups: 97.6% in recipients of PROMUS ElementÔ stents and 97.8 % for XIENCE PRIMEÔ. At 30 days, clinical events were TVF 1.2% in P vs. 0.8% in X (p¼0.56) including all death 0.6% in P vs.0.5% in X (p¼0.99), MI 0.7% in P vs. 0.5% in X (p¼0.74) and TVR 0.1 % in P vs. 0.1 in X (p¼0.85), Stent Thrombosis (definite and probable) was 0.6% in P vs. 0.2% in X (p¼0.21). Conclusions: Non inferiority in 30-day outcome was observed between the 2 stents; the primary endpoint (12-month outcome) will be available for the meeting.
Jacc-cardiovascular Interventions, Apr 1, 2022
OBJECTIVES The purpose of this study was to assess the extent to which the association between pr... more OBJECTIVES The purpose of this study was to assess the extent to which the association between premature dual antiplatelet therapy (DAPT) discontinuation and excess risk of thrombotic events varies according to the reason and timing of DAPT discontinuation and whether high on-treatment platelet reactivity (HPR) influences the risk of thrombotic events after premature DAPT discontinuation. BACKGROUND DAPT after percutaneous coronary intervention (PCI) suppresses platelet reactivity, and HPR on clopidogrel after PCI is associated with an increased risk of thrombotic events. METHODS ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients successfully treated with coronary drug-eluting stents that assessed HPR on clopidogrel. For patients who discontinued aspirin or clopidogrel at any time during the study, the reasons for discontinuation were systematically categorized. RESULTS Planned DAPT discontinuation occurred within 2 years in 3,203 (37.3%) patients. One thousand four hundred eighteen (16.5%) patients discontinued DAPT for unplanned reasons, including surgery or trauma (n = 768 [8.9%]), patient nonadherence (n = 321 [3.7%]), bleeding complications (n = 264 [3.1%]), and drug allergy or hypersensitivity (n = 113 [1.3%]). Unplanned but not planned DAPT discontinuation was associated with an increased risk of a major adverse cardiac event (MACE, defined as the composite of cardiac death, myocardial infarction, or stent thrombosis); with highest risk within 3 months after PCI (adjusted HR: 7.65, 95% CI: 2.77-21.10 vs adjusted HR: 2.47, 95% CI: 1.70-3.58 for unplanned DAPT discontinuation ≥3 weeks after PCI). MACE risk after DAPT discontinuation was not moderated by HPR (Pinteraction = 0.91). CONCLUSIONS In this large-scale all-comers registry, premature DAPT discontinuation for unplanned reasons occurred in approximately 1 of 6 patients after DES implantation and was associated with a markedly increased risk of MACEs. (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents [ADAPT-DES]; NCT00638794).
Journal of the American College of Cardiology, Oct 1, 2019
Journal of the American College of Cardiology, Mar 1, 2018
Background: Proximal LAD (PLAD) vessel diameter is rarely <3 mm. We hypothesized that pts who und... more Background: Proximal LAD (PLAD) vessel diameter is rarely <3 mm. We hypothesized that pts who undergo PCI with an undersized stent would have worse outcomes compared to an appropriately sized stent, and that the impact of undersized stents would be greatest in the PLAD. Methods: ADAPT-DES was a prospective, non-randomized, multicenter all-comer registry of pts treated with DES. We studied pts undergoing single lesion PCI, assessing a primary composite endpoint of definite or probable stent thrombosis (ST) or clinically-indicated target vessel revascularization (TVR) at 2 years. Results: Among 8,582 pts, 5,033 underwent single lesion PCI. The lesion was in the PLAD, a non-proximal LAD and a non-LAD location in 900, 1,264 and 2,869 pts respectively. After adjusting for clinical and procedural factors, the hazard ratio (HR) for 2-year TVR+ST was increased in all coronary segments when treated with smaller compared to larger diameter stents (including post-dilatation), although to a greater extent in the PLAD (Figure). Comparing maximum stent size <3 mm vs ≥3 mm as cutoff , 2-year TVR+ST occurred in 14.1% vs 5.9% in proximal LAD lesions (adjHR 2.94 (95%CI, 1.48, 5.84), p=0.002), compared to 10.2% vs 6.2% (adjHR:1.63 [1.07, 2.48], p=0.02) in non-proximal LAD lesions and 8.8% vs 6.6% (adjHR:1.46 [1.07, 1.98], p=0.02) in non-LAD lesions. Conclusion: Small stent diameter is associated with an increase in clinically-driven TVR+ST. This increase in adverse events is most pronounced with small device use in the PLAD.
Journal of the American College of Cardiology, Mar 1, 2017
Journal of the American College of Cardiology, Apr 1, 2014
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Papers by Bernhard Witzenbichler