Franz R Eberli

Triemli City Hospital, Zürich, Zurich, Switzerland

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Publications (151)1033.9 Total impact

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    ABSTRACT: Aims: We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions. Methods and results: Patients were divided into three groups: chronic TO (CTO; n=256), non-chronic TO (n=292), and no occlusion (n=2,941). Clinical and safety outcomes assessed through two years included target lesion failure (TLF: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation) and Academic Research Consortium definite or probable stent thrombosis. The rate of TLF at two years was not significantly different among patients in the CTO (9.1%), TO (9.8%), and no occlusion (10.4%) groups (log-rank p=0.800); neither were the components of TLF. Definite or probable stent thrombosis occurred more frequently in the TO group (2.8% vs. 1.2% in the CTO and 1.1% in the group with no occlusion, p=0.027). There were 10 late and six very late stent thrombosis events. Conclusions: Apart from a higher rate of stent thrombosis in patients with TO, patients with totally occluded coronary arteries who receive revascularisation with an R-ZES have clinical outcomes comparable to those who receive a similar stent in non-occluded lesions.
    07/2014;
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    ABSTRACT: The tradeoff between stent thrombosis (ST) and major bleeding (MB) of 12- versus 6-months dual antiplatelet therapy (DAPT) after coronary stent implantation has not been clearly defined. Methods Definite/probable ST and MB (TIMI major and BARC ≥3) were compared in 2 subsequent trials with similar inclusion criteria but different DAPT duration, i.e., BASKET (6 months, n = 557) and BASKET-PROVE (12 months, n = 2,314), between months 0–6 (DAPT in both trials), 7–12 (DAPT in BASKET-PROVE only), and 13–24 (aspirin in both trials) using propensity score adjusted time-stratified Cox proportional-hazard models. Results Overall, event rates were low with fewer ST but similar MB in prolonged DAPT. Analysis of the 3 periods showed a uniform pattern for ST (interaction DAPT/period p = 0.145) but an inconsistent pattern for MB (interaction DAPT/period p < 0.001 for TIMI major and p = 0.046 for BARC ≥3), with more MB occurring during months 7–12 with prolonged DAPT. Considering observed case-fatality rates of 31% with ST and 11% with MB, the extrapolated prevention of 27 ST-deaths and the excess of 5 MB-deaths resulted in an expected benefit of 22 survivors/10’000 patients treated over 2 years with prolonged DAPT. Conclusion Despite overall low event rates, prolonged DAPT was associated with more MB during months 7–12 according to the interaction DAPT/period. Given the higher observed case fatality rates of ST vs. MB, 12-vs. 6-months DAPT was associated with an extrapolated reduction in mortality. Effective treatment periods and case fatality rates seem important in the analysis of different DAPT durations, specifically with regard to ongoing trials.
    American Heart Journal 07/2014; · 4.50 Impact Factor
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    ABSTRACT: Abstract OBJECTIVE: This study aimed to assess the impact of individual comorbid conditions as well as the weight assignment, predictive properties and discriminating power of the Charlson Comorbidity Index (CCI) on outcome in patients with acute coronary syndrome (ACS). METHODS: A prospective multicentre observational study (AMIS Plus Registry) from 69 Swiss hospitals with 29 620 ACS patients enrolled from 2002 to 2012. The main outcome measures were in-hospital and 1-year follow-up mortality. RESULTS: Of the patients, 27% were female (age 72.1±12.6 years) and 73% were male (64.2±12.9 years). 46.8% had comorbidities and they were less likely to receive guideline-recommended drug therapy and reperfusion. Heart failure (adjusted OR 1.88; 95% CI 1.57 to 2.25), metastatic tumours (OR 2.25; 95% CI 1.60 to 3.19), renal diseases (OR 1.84; 95% CI 1.60 to 2.11) and diabetes (OR 1.35; 95% CI 1.19 to 1.54) were strong predictors of in-hospital mortality. In this population, CCI weighted the history of prior myocardial infarction higher (1 instead of -0.4, 95% CI -1.2 to 0.3 points) but heart failure (1 instead of 3.7, 95% CI 2.6 to 4.7) and renal disease (2 instead of 3.5, 95% CI 2.7 to 4.4) lower than the benchmark, where all comorbidities, age and gender were used as predictors. However, the model with CCI and age has an identical discrimination to this benchmark (areas under the receiver operating characteristic curves were both 0.76). CONCLUSIONS: Comorbidities greatly influenced clinical presentation, therapies received and the outcome of patients admitted with ACS. Heart failure, diabetes, renal disease or metastatic tumours had a major impact on mortality. CCI seems to be an appropriate prognostic indicator for in-hospital and 1-year outcomes in ACS patients.
    Heart 01/2014; 100:288-294.
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    ABSTRACT: Background Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent. Methods We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Findings Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference −0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority <0·0004). No significant differences were noted in rates of definite stent thrombosis (9 [0·9%] vs 4 [0·4%], rate ratio [RR] 2·26, 95% CI 0·70–7·33, p=0·16). In pre-specified stratified analyses of the primary endpoint, biodegradable polymer sirolimus-eluting stents were associated with improved outcome compared with durable polymer everolimus-eluting stents in the subgroup of patients with ST-segment elevation myocardial infarction (7 [3·3%] vs 17 [8·7%], RR 0·38, 95% CI 0·16–0·91, p=0·024, p for interaction=0·014). Interpretation In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy, biodegradable polymer sirolimus-eluting stents were non-inferior to durable polymer everolimus-eluting stents for the combined safety and efficacy outcome target lesion failure at 12 months. The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study. Funding Clinical Trials Unit, University of Bern, and Biotronik, Bülach, Switzerland.
    Lancet. 01/2014;
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    ABSTRACT: Aims: We examined what type of STEMI patients are more likely to undergo multivessel PCI (MPCI) in a "real-world" setting and whether MPCI leads to worse or better outcomes compared with single-vessel PCI (SPCI) after stratifying patients by risk. Methods and results: Among STEMI patients enrolled in the Swiss AMIS Plus registry between 2005 and 2012 (n=12,000), 4,941 were identified with multivessel disease. We then stratified patients based on MPCI use and their risk. High-risk patients were identified a priori as those with: 1) left main (LM) involvement (lesions, n=263); 2) out-of-hospital cardiac arrest; or 3) Killip class III/IV. Logistic regression models examined for predictors of MPCI use and the association between MPCI and in-hospital mortality. Three thousand eight hundred and thirty-three (77.6%) patients underwent SPCI and 1,108 (22.4%) underwent MPCI. Rates of MPCI were greater among high-risk patients for each of the three categories: 8.6% vs. 5.9% for out-of-hospital cardiac arrest (p<0.01); 12.3% vs. 6.2% for Killip III/IV (p<0.001); and 14.5% vs. 2.7% for LM involvement (p<0.001). Overall, in-hospital mortality after MPCI was higher when compared with SPCI (7.3% vs. 4.4%; p<0.001). However, this result was not present when patients were stratified by risk: in-hospital mortality for MPCI vs. SPCI was 2.0% vs. 2.0% (p=1.00) in low-risk patients and 22.2% vs. 21.7% (p=1.00) in high-risk patients. Conclusions: High-risk patients are more likely to undergo MPCI. Furthermore, MPCI does not appear to be associated with higher mortality after stratifying patients based on their risk.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 12/2013; 9(8):909-15. · 3.17 Impact Factor
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    ABSTRACT: To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels. All 2314 BASKET-PROVE patients randomized to DES versus BMS were followed for 2years with a primary endpoint of major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction, target-vessel revascularization). Cox proportional hazard models were used to evaluate the relative risk for women and men, respectively. All comparisons were adjusted for vessel size. Age, risk factors and complexity of coronary artery disease differed between women and men. DES reduced MACE rates at 2years compared to BMS - in women: 4% vs. 15%, p<0.0001 with a hazard ratio (HR) of 0.27 (0.15-0.51), and men: 6% vs. 10%, p=0.003 (HR=0.60 (0.43-0.84)), respectively. The association persisted in both women (HR=0.25 (0.13-0.46)) and men (HR=0.60 (0.42-0.84)) following multivariable adjustments. A significant gender-treatment interaction was present (p=0.02). The reduced risk of MACE following DES vs. BMS implantation was present until 6months in both women (HR=0.15 (0.06-0.36)) and men (HR=0.32 (0.17-0.59)) and remained significant until 2years in women (HR=0.36 (0.15-0.87)), but not in men (HR=0.87 (0.49-1.55)). In women and men with similarly sized large coronary arteries, DES reduced 2-year MACE rates compared to BMS, but the significant gender-treatment interaction indicated a greater benefit of DES in women. Thus, factors other than vessel size seem to determine this gender difference.
    International journal of cardiology 09/2013; · 6.18 Impact Factor
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    ABSTRACT: This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).
    JACC. Cardiovascular Interventions 08/2013; 6(8):777-89. · 1.07 Impact Factor
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    ABSTRACT: Background: Few data are available concerning the impact of gender on temporal trends in patients with acute ST-segment elevation myocardial infarction (STEMI). Methods: All STEMI patients consecutively enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus project from 1997−2011 were included. Temporal trends in presentation, treatment and outcomes were analyzed using multiple logistic regressions with generalized estimations. Results: Of 21,620 STEMI patients, 5786 were women and 15,834 men from 78 Swiss hospitals. Women were 8.6 years older, presented 48 minutes later with less pain, but more dyspnea, and more frequently had atrial fibrillation (5.5 vs. 3.9%, p<0.001), heart failure (Killip class >2) (9.7 vs. 7.3%, p<0.001), and moderate or severe comorbidities (24.8 vs. 18.2%, p<0.001). Women were less likely to undergo primary reperfusion treatment after adjustment for baseline characteristics and admission year (OR 0.80, 95% CI 0.71−0.90, p<0.001) or receive early and discharge drugs, such as thienopyridines, angiotensin-converting-enzyme inhibitors, angiotensin II receptor antagonists, and statins. In 1997, thrombolysis was performed in 51% of male and 39% of female patients; its use rapidly decreased during the 1990s and has now become negligible. Primary percutaneous coronary intervention increased from under 10% in both genders in 1997 to over 70% in females and over 80% in males since 2006. Patients admitted in cardiogenic shock increased by 8% per year in both genders. The incidence of both reinfarction and cardiogenic shock developing during hospitalization decreased significantly over 15 years while in-hospital mortality decreased from 10 to 5% in men and from 18 to 7% in women. This corresponds to a relative reduction of 5% per year for males (OR 0.95, 95% CI 0.92−0.99, p=0.006) and 6% per year for female STEMI patients (OR 0.94, 95% CI 0.91−0.97, p<0.001). Despite higher crude in-hospital mortality, female gender per se was not an independent predictor of in-hospital mortality (OR 1.07, 95% CI 0.84−1.35, p=0.59). Conclusion: Substantial changes have occurred in presentation, treatment, and outcome of men and women with STEMI in Switzerland over the past 15 years. Although parallel trends were seen in both groups, ongoing disparities in certain treatments remain. However, these did not translate into worse risk-adjusted in-hospital mortality, suggesting that the gender gap in STEMI care may be closing.
  • David J Kurz, Franz R Eberli
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    ABSTRACT: Medical therapy following percutaneous coronary intervention aims at preventing first, coronary disease progression and its clinical manifestations, and finally, the two main complications of coronary stenting, stent thrombosis and restenosis. Prevention of in-stent restenosis is restricted to local drug delivery in the form of drug eluting stents (DES). Second generation DES have improved their efficacy and safety profile by innovations in drug coating, the polymer drug-delivery system and stent design. The mainstay of stent thrombosis prevention remains dual anti-platelet therapy with acetylsalicylic acid and a platelet ADP-receptor blocker, traditionally clopidogrel. Two new drugs, prasugrel and ticagrelor, provide faster, greater, and more consistent platelet inhibition than clopidogrel, and have been shown to be more efficacious in preventing ischemic events after PCI in acute coronary syndrome patients.
    Current Opinion in Pharmacology 02/2013; · 5.44 Impact Factor
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    ABSTRACT: Abstract Background: Data on temporal trends in outcomes, gender differences, and adherence to evidence-based therapy (EBT) of diabetic patients with ST-segment elevation myocardial infarction (STEMI) are sparse. Methods: We performed a retrospective analysis of prospectively acquired data on 3565 diabetic (2412 males and 1153 females) STEMI patients enrolled in the Swiss AMIS Plus registry between 1997 and 2010 and compared in-hospital outcomes and adherence to EBT with the nondiabetic population (n=15,531). Results: In-hospital mortality dramatically decreased in diabetic patients, from 19.9% in 1997 to 9.0% in 2010 (ptrend<0.001) with an age-adjusted decrease of 6% per year of admission. Similar trends were observed for age-adjusted reinfarction (OR 0.86, p<0.001), cardiogenic shock (OR 0.88, p<0.001), as well as death, reinfarction, or stroke (OR 0.92, p<0.001). However, the mortality benefit over time was observed in diabetic males (ptrend=0.006) but not females (ptrend=0.082). In addition, mortality remained twice as high in diabetic patients compared with nondiabetic ones (12.1 vs. 6.1%, p<0.001) and diabetes was identified as independent predictor of mortality (OR 1.23, p=0.022). Within the diabetic cohort, females had higher mortality than males (16.1 vs. 10.2%, p<0.001) and female gender independently predicted in-hospital mortality (OR 1.45, p=0.015). Adherence to EBT significantly improved over time in diabetic patients (ptrend<0.001) but remained inferior – especially in women – to the one of nondiabetic individuals. Conclusions: In-hospital mortality and morbidity of diabetic STEMI patients in Switzerland improved dramatically over time but, compared with nondiabetic counterparts, gaps in outcomes as well as EBT use persisted, especially in women.
    European Heart Journal. 01/2013;
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    European Heart Journal 10/2012; 33(20):2551-2567. · 14.72 Impact Factor
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    ABSTRACT: Few data are available concerning the impact of gender on temporal trends in patients with acute ST-segment elevation myocardial infarction (STEMI). All STEMI patients consecutively enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus project from 1997-2011 were included. Temporal trends in presentation, treatment and outcomes were analyzed using multiple logistic regressions with generalized estimations. Of 21,620 STEMI patients, 5786 were women and 15,834 men from 78 Swiss hospitals. Women were 8.6 years older, presented 48 minutes later with less pain, but more dyspnea, and more frequently had atrial fibrillation (5.5 vs. 3.9%, p<0.001), heart failure (Killip class >2) (9.7 vs. 7.3%, p<0.001), and moderate or severe comorbidities (24.8 vs. 18.2%, p<0.001). Women were less likely to undergo primary reperfusion treatment after adjustment for baseline characteristics and admission year (OR 0.80, 95% CI 0.71-0.90, p<0.001) or receive early and discharge drugs, such as thienopyridines, angiotensin-converting-enzyme inhibitors, angiotensin II receptor antagonists, and statins. In 1997, thrombolysis was performed in 51% of male and 39% of female patients; its use rapidly decreased during the 1990s and has now become negligible. Primary percutaneous coronary intervention increased from under 10% in both genders in 1997 to over 70% in females and over 80% in males since 2006. Patients admitted in cardiogenic shock increased by 8% per year in both genders. The incidence of both reinfarction and cardiogenic shock developing during hospitalization decreased significantly over 15 years while in-hospital mortality decreased from 10 to 5% in men and from 18 to 7% in women. This corresponds to a relative reduction of 5% per year for males (OR 0.95, 95% CI 0.92-0.99, p=0.006) and 6% per year for female STEMI patients (OR 0.94, 95% CI 0.91-0.97, p<0.001). Despite higher crude in-hospital mortality, female gender per se was not an independent predictor of in-hospital mortality (OR 1.07, 95% CI 0.84-1.35, p=0.59). Substantial changes have occurred in presentation, treatment, and outcome of men and women with STEMI in Switzerland over the past 15 years. Although parallel trends were seen in both groups, ongoing disparities in certain treatments remain. However, these did not translate into worse risk-adjusted in-hospital mortality, suggesting that the gender gap in STEMI care may be closing.
    European heart journal. Acute cardiovascular care. 09/2012; 1(3):183-91.
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    ABSTRACT: The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI. A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months. Patients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582). Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization at 1 year. Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P = .004). The difference was driven by a lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P = .01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P < .001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P = .53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P = .10) treated with bare-metal stents. Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI. clinicaltrials.gov Identifier: NCT00962416.
    JAMA The Journal of the American Medical Association 08/2012; 308(8):777-87. · 29.98 Impact Factor
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    ABSTRACT: Objectives:  The aim of this study was to assess whether transient atrial septal defect (ASD) occlusion and, if required, vasodilator therapy would improve the safety of percutaneous ASD closure in high-risk subsets. Background:  While percutaneous ASD closure is generally considered a low risk intervention, hypertensive and elderly patients may develop pulmonary edema following the procedure because of underlying left ventricular (LV) diastolic dysfunction. Methods:  Fifty-two consecutive patients who underwent successful percutaneous ASD closures were enrolled into a single-center prospective registry. Patients with arterial hypertension and/or >60 years of age (n = 15) were considered at risk for periprocedural pulmonary edema. Those patients were tested for an increase of LV filling pressures during transient ASD occlusion and, if this was the case, treated according to a prespecified algorithm. Clinical and echocardiography data were collected in-hospital and at 6 months follow-up. Results:  Shunt size was comparable in high and standard-risk patients (Qp:Qs 2.1 ± 0.8 vs. 2.1 ± 0.7, P = 0.82). High-risk patients had more often pulmonary hypertension (58% vs. 14%, P < 0.05) and were more frequently symptomatic. Among them, 4/15 (27%) demonstrated a significant rise of left-sided filling pressures during transient ASD balloon occlusion and underwent pharmacologic preconditioning prior to ASD closure. None of them developed periprocedural pulmonary edema. At follow-up, patients were less symptomatic (Pre: NYHA II n = 15, NYHA III n = 9; Post: NYHA II n = 15, NYHA III n = 0; P = 0.02) and right ventricular size decreased from 23 ± 5 cm(2) to 17 ± 5 cm(2) , P < 0.05. Conclusion:  Transient ASD occlusion and, if required, pharmacologic preconditioning prior to percutaneous closure may prevent periprocedural pulmonary edema in high-risk patients. (J Interven Cardiol 2012;25:505-512).
    Journal of Interventional Cardiology 06/2012; 25(5):505-12. · 1.50 Impact Factor
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    ABSTRACT: Early generation drug-eluting stents (DESs) reduce restenosis and repeat revascularization procedures. However, the long-term safety and efficacy of early generation DES according to diabetic status are poorly established. A total of 1,012 patients were randomly assigned to treatment with sirolimus-eluting (n = 503) or paclitaxel-eluting stents (n = 509). Serial angiographic follow-up at baseline, 8 months, and 5 years was available in 293 patients with 382 lesions. The primary end point was a composite of major adverse cardiac events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization). Clinical and angiographic outcomes through 5-year follow-up were compared between diabetic and nondiabetic patients. Major adverse cardiac events were more common among diabetic than nondiabetic patients at 5 years (25.9% vs 19.2%, hazard ratio [HR] 1.45, 95% CI 1.06-1.99, P = .02). The difference in disfavor of diabetic patients was largely determined by a higher rate of cardiac mortality (11.4% vs 4.3%, HR 2.86, 95% CI 1.69-4.84, P < .0001), whereas the risk of myocardial infarction (6.5% vs 6.8%, HR 1.00, 95% CI 0.55-1.84, P = .99) and ischemia-driven target lesion revascularization (14.4% vs 14.1%, HR 1.09, 95% CI 0.73-1.64, P = .67) was comparable. The risk of stent thrombosis was similar among diabetic and nondiabetic patients (definite or probable: 6.0% vs 4.6%, HR 1.36, 95% CI 0.71-2.67, P = .35). Among 293 patients undergoing serial angiography, very-late lumen loss amounted to 0.42 ± 0.63 mm in diabetic patients and 0.44 ± 0.68 mm in nondiabetic patients (P = .79). Diabetic patients remain at increased risk for mortality after revascularization with early generation DES during long-term follow-up. Conversely, diabetes is no longer associated with an increased risk of clinical and angiographic restenosis after revascularization with early generation DES.
    American heart journal 05/2012; 163(5):876-886.e2. · 4.65 Impact Factor
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    ABSTRACT: In the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination (BASKET-PROVE), drug-eluting stents (DESs) had similar 2-year rates of death and myocardial infarction but lower rates of target vessel revascularization and major adverse cardiac events compared with bare-metal stents (BMSs). However, comparative clinical effects of newest-generation DES with biodegradable polymers vs second-generation DES or newest-generation BMS with biocompatible coatings, all combined with a prasugrel-based antiplatelet therapy, on 2-year outcomes are not known. In BASKET-PROVE II, 2,400 patients with de novo lesions in native vessels ≥3 mm in diameter are randomized 1:1:1 to receive a conventional DES, a DES with a biodegradable polymer, or a BMS with biocompatible coating. In addition to aspirin, stable patients with BMS will receive prasugrel for 1 month, whereas all others will receive prasugrel for 12 months. The primary end point will be combined cardiac death, nonfatal myocardial infarction, and target vessel revascularization up to 2 years. Secondary end points include stent thrombosis and major bleeding. The primary aim is to test (1) the noninferiority of a biodegradable-polymer DES to a conventional DES and (2) the superiority of both DESs to BMS. A secondary aim is to compare the outcomes with those of BASKET-PROVE regarding the effects of prasugrel-based vs clopidogrel-based antiplatelet therapy. By the end of 2010, 878 patients (37% of those planned) were enrolled. This study will test the comparative long-term safety and efficacy of newest-generation stents on the background of contemporary antiplatelet therapy in a large all-comer population undergoing large native coronary artery stenting.
    American heart journal 02/2012; 163(2):136-41.e1. · 4.65 Impact Factor
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    ABSTRACT: Late acquired incomplete stent apposition (ISA) is more common after drug-eluting stent (DES) than bare metal stent (BMS) implantation and has been associated with vascular hypersensitivity and stent thrombosis (ST). We investigated the impact of incidentally discovered ISA as assessed by intravascular ultrasound (IVUS) 8 months after DES implantation on the long-term clinical outcome. A total of 194 patients with 221 lesions were prospectively followed through 5 years. At 8 months, IVUS showed evidence of ISA among 37 patients with 39 lesions (18%) (mean ISA(max) 4.7 ± 5.0 mm(2)), whereas no ISA was observed among 157 patients with 182 lesions. Incomplete stent apposition was more prevalent among segments treated with sirolimus-eluting (n = 103) than paclitaxel-eluting stents (n = 118) (27 vs. 9%, P = 0.001). Between IVUS investigation at the 8-month and 5-year follow-up, major adverse cardiac events occurred more frequently in patients with (18.9%, n = 7) than without ISA (7.0%, n = 11) (HR = 2.71, 95% CI: 1.05-6.96, P = 0.031). While there were no differences with respect to death, the rate of myocardial infarction was higher among patients with (13.5%, n = 5) than without ISA (1.9%, n = 3) (HR = 7.53, 95% CI: 1.79-31.6, P = 0.001). Very late ST was more common among patients with than without ISA [Academic Research Consortium-definite ST:13.5% (n = 5) vs. 0.6% (n = 1) HR = 23.2, 95% CI: 2.65-203, P < 0.001]. In the present study, the presence of ISA as assessed by IVUS 8 months after DES implantation was associated with a higher rate of myocardial infarction and very late stent thrombosis during long-term follow-up. The prognostic impact of ISA on long-term clinical outcomes requires further investigation.
    European Heart Journal 01/2012; 33(11):1334-43. · 14.72 Impact Factor
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    ABSTRACT: The effectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent inflammatory stimulus of durable polymers. We did a multicentre, assessor-masked, non-inferiority trial. Between Nov 27, 2006, and May 18, 2007, patients aged 18 years or older with coronary artery disease were randomly allocated with a computer-generated sequence to receive either biodegradable polymer biolimus-eluting stents (BES) or durable polymer sirolimus-eluting stents (SES; 1:1 ratio). The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation (TVR); patients were followed-up for 4 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389220. 1707 patients with 2472 lesions were randomly allocated to receive either biodegradable polymer BES (857 patients, 1257 lesions) or durable polymer SES (850 patients, 1215 lesions). At 4 years, biodegradable polymer BES were non-inferior to durable polymer SES for the primary endpoint: 160 (18·7%) patients versus 192 (22·6%) patients (rate ratios [RR] 0·81, 95% CI 0·66-1·00, p for non-inferiority <0·0001, p for superiority=0·050). The RR of definite ST was 0·62 (0·35-1·08, p=0·09), which was largely attributable to a lower risk of very late definite ST between years 1 and 4 in the BES group than in the SES group (RR 0·20, 95% CI 0·06-0·67, p=0·004). Conversely, the RR of definite ST during the first year was 0·99 (0·51-1·95; p=0·98) and the test for interaction between RR of definite ST and time was positive (p(interaction)=0·017). We recorded an interaction with time for events associated with ST but not for other events. For primary endpoint events associated with ST, the RR was 0·86 (0·41-1·80) during the first year and 0·17 (0·04-0·78) during subsequent years (p(interaction)=0·049). Biodegradable polymer BES are non-inferior to durable polymer SES and, by reducing the risk of cardiac events associated with very late ST, might improve long-term clinical outcomes for up to 4 years compared with durable polymer SES. Biosensors Europe SA, Switzerland.
    The Lancet 11/2011; 378(9807):1940-8. · 39.21 Impact Factor
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    ABSTRACT: The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES). One thousand seven hundred and seven patients were randomised to unrestricted use of BES (n=857) or SES (n=850) in an all-comers population. Three year follow-up was available in 95% of the patients, 812 treated with BES and 809 treated with SES. At three years, BES remains non-inferior to SES for the primary endpoint of major adverse cardiac events (composite of cardiac death, myocardial infarction (MI), or clinically-indicated target vessel revascularisation (CI-TVR) (BES 15.7% versus SES 19%; HR 0.82 CI 0.65-1.03; p=0.09). The MACE Kaplan Meier event curves increasingly diverge with the difference in events increasing from 1.4% to 2.4% and 3.3% at 1, 2 and 3 years, respectively in favour of BES. The rate of cardiac death was non-significantly lower 4.2% versus 5.2% (HR=0.81 CI 0.52-1.26; p=0.34) and the rate of myocardial infarction was equivalent 7.2% versus 7.1% (HR 1.01 CI 0.70-1.44; p=0.97) for BES versus SES, respectively. Thus BES was non-inferior to SES in all the safety endpoints. Clinically-indicated TVR occurred in 9.4% of BES treated patients versus 11.1% of SES treated patients (HR 0.84 CI 0.62-1.13; p=0.25). Rates of definite stent thrombosis were 2.2% for BES and 2.9% for SES (HR 0.78 CI 0.43-1.43; p=0.43), with the event rate increase of 0.2% from one to three years for BES and 0.9% for SES. For patients presenting with ST-elevation myocardial infarction BES was superior to SES in reducing MACE. The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 11/2011; 7(7):789-95. · 3.17 Impact Factor
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    ABSTRACT: The percentage of elderly treated with percutaneous coronary intervention (PCI) has been increasing year by year. Little is known about predictors of hospital mortality in elderly undergoing PCI for acute coronary syndromes (ACS) and stable angina. Between 2005 and 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the EHS Programme. For the present analysis patients were divided into four categories: ACS patients ≥ 75 (n=4,943) and < 75 years (n=19,446), and patients with stable angina ≥ 75 (n=3,393) and < 75 years (n=19,625). A multiple logistic regression analysis was conducted to detect independent predictors of mortality in patients ≥ 75 years undergoing PCI. In addition, differences in clinical characteristics, procedural details and in-hospital outcomes between the subgroups were evaluated. Patients ≥ 75 years had more co-morbidities, and more severe coronary pathology. The use of guideline-recommended adjunctive therapy and procedural success was high in all groups. The incidence of in-hospital death was highest in ACS patients ≥ 75 years (5.2%) and < 75 years (1.7%), followed by patients with stable angina ≥ 75 (0.5%) and < 75 years (0.2%). Haemodynamic instability and acute ST-elevation myocardial infarction were the strongest determinants of hospital mortality among patients ≥ 75 years with ACS, whereas interventional complications were the most meaningful predictors of death in older patients undergoing elective PCI. Patients ≥ 75 years undergoing PCI face a relatively low risk of hospital death. However, complication rates were significantly higher compared to younger patients, strongly influenced by clinical, angiographic and interventional variables.
    International journal of cardiology 09/2011; 151(2):164-9. · 6.18 Impact Factor

Publication Stats

4k Citations
1,033.90 Total Impact Points

Institutions

  • 2008–2014
    • Triemli City Hospital
      Zürich, Zurich, Switzerland
  • 2009–2013
    • Erasmus MC
      • Department of Cardiology
      Rotterdam, South Holland, Netherlands
    • University of Geneva
      • Division of Cardiology
      Genève, GE, Switzerland
    • UHN: Toronto General Hospital
      Toronto, Ontario, Canada
  • 2002–2012
    • Inselspital, Universitätsspital Bern
      • • Department of Cardiology
      • • Swiss Cardiovascular Center Bern
      Bern, BE, Switzerland
  • 1989–2012
    • University of Zurich
      • • Center for Integrative Human Physiology
      • • Internal Medicine Unit
      • • Institute of Physiology
      Zürich, Zurich, Switzerland
  • 2011
    • Kerckhoff Klinik
      Stadt Bad Nauheim, Hesse, Germany
    • Cardiocentro Ticino
      Lugano, Ticino, Switzerland
    • Academisch Medisch Centrum Universiteit van Amsterdam
      • Academic Medical Center
      Amsterdam, North Holland, Netherlands
  • 2007
    • Medical University of Vienna
      Wien, Vienna, Austria
  • 2001
    • University of Massachusetts Boston
      Boston, Massachusetts, United States
  • 1995–2001
    • Boston University
      • Department of Medicine
      Boston, MA, United States
  • 1995–2000
    • Whitaker Wellness Institute
      Newport Beach, California, United States
  • 1992–1993
    • Beth Israel Deaconess Medical Center
      Boston, Massachusetts, United States
    • University of Massachusetts Medical School
      Worcester, Massachusetts, United States