Sebastian Kufner

Abstract: BACKGROUND: Patients with diabetes mellitus remain at higher risk for adverse events following percutaneous coronary intervention and the identification of the optimum drug eluting stents (DES) in these patients is of high clinical relevance. We compared effectiveness of everolimus-eluting stents (EES; Xience) versus sirolimus-eluting stents (SES; Cypher) in patients with diabetes mellitus enrolled in the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial. METHODS: In the setting of the ISAR-TEST-4 trial, 1304 patients with broad inclusion criteria were randomized to treatment with EES or SES. The focus of the present analysis is on a cohort of 377 patients with diabetes mellitus assigned to receive EES (n = 184) or SES (n = 193). The primary endpoint was the composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target lesion revascularization (TLR) at 3-year follow-up. Secondary endpoints were parameters of angiographic and clinical restenosis (in-stent late lumen loss, binary restenosis, and TLR), all-cause mortality and definite/probable stent thrombosis. RESULTS: EES was comparable to SES concerning the incidence of the primary endpoint (21% vs. 24%, respectively; relative risk = 0.87; 95% CI, 0.57-1.34; P = 0.53). Concerning the secondary endpoint, TLR at 3 years with EES versus SES stents was not statistically different (14.7% vs. 16.6%, respectively; relative risk = 0.85; 95% CI, 0.51-1.43; P = 0.55). In terms of angiographic outcomes patients treated with EES as compared to SES had significantly lower late lumen loss (0.22 ± 0.46 mm vs. 0.44 ± 0.66 mm, respectively; P < 0.001) and binary restenosis (8.4% vs. 17%, respectively; P = 0.02) at 6- to 8-month angiographic follow-up. EES was comparable to SES concerning the incidence of all-cause death (10% vs. 16%, respectively; relative risk = 0.66; 95% CI, 0.37-1.18; P = 0.16) and stent thrombosis (1.1% vs. 3.1%, respectively; P = 0.19). CONCLUSIONS: In patients with diabetes mellitus enrolled in a real-world randomized control trial, EES is comparable to SES in terms of clinical efficacy and safety out to 3 years; angiographic markers of antirestenotic efficacy favored EES. © 2013 Wiley Periodicals, Inc.

Abstract: There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).

Abstract: Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy.

Abstract: The association between ST-segment resolution and clinical outcome in patients with acute ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PPCI) remains unclear. Recent studies on the association between ST-segment resolution and mortality have given conflicting results. We undertook this study to assess whether ST-segment resolution in electrocardiograms recorded 90-120 min after initiation of PPCI predicts long-term mortality in patients with STEMI.

Abstract: Background: In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus-eluting stent to permanent polymer (PP) sirolimus/everolimus-eluting stent (Cypher/Xience-V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR-TEST-4 patients with paired angiographic studies. Methods: Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in-stent late lumen loss, in-segment binary restenosis, and restenosis morphology at 6-8-month follow-up angiogram. Results: Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST-4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6-8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in-stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in-segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79). Conclusion: Angiographic characteristics of restenosis after BP-based limus-eluting stents are similar to those of PP-based limus-eluting stents. © 2011 Wiley-Liss, Inc.

Abstract: Abciximab reduced the combined endpoint of death, myocardial infarction (MI) and target vessel revascularization in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) with stent implantation after a 600-mg loading dose of clopidogrel. The aim of the present study was to investigate the impact of abciximab on the evolution of left ventricular ejection fraction (LVEF) in these patients.

Abstract: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients.

Abstract: Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking.

Abstract: To assess the impact of reperfusion after primary percutaneous coronary intervention (PCI) on myocardial salvage and outcome of patients with acute ST-segment elevation myocardial infarction (STEMI).

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Abstract: First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients.

Abstract: In ISAR-REACT 3, 30-day outcomes in 4570 biomarker negative patients undergoing percutaneous coronary intervention (PCI) > or =2 h after pre-treatment with 600 mg of clopidogrel revealed less bleeding with bivalirudin compared with unfractionated heparin, but no difference in 30-day net clinical benefit. The objective of the present analysis was to assess the impact of bivalirudin vs. heparin on 1-year outcomes in ISAR-REACT 3.

Abstract: For patients with sirolimus-eluting stent (SES) restenosis requiring reintervention, we compared a strategy of repeat SES (Cypher, Cordis, Miami Lakes, Florida) implantation with paclitaxel-eluting stent (PES) (Taxus, Boston Scientific, Natick, Massachusetts) implantation.

Abstract: The relationship between microcirculatory myocardial perfusion grade (MPG), myocardial salvage and long-term mortality after acute ST-segment elevation myocardial infarction (STEMI) and full restoration of epicardial blood flow by primary percutaneous coronary intervention (PCI) remains poorly understood.

Abstract: BACKGROUND: Drug-eluting stent (DES) platforms devoid of durable polymer have potential to enhance long-term safety outcomes. The ISAR-TEST-3 study was a randomised trial comparing three rapamycin-eluting stents with different coating strategies. The present study examined 2-year outcomes of these patients and is the first large-scale trial to report longer-term outcomes with biodegradable polymer and polymer-free DES. METHODS: Patients with de novo coronary lesions in native vessels were randomly assigned to receive biodegradable polymer (BP; n = 202), permanent polymer (PP; Cypher; n = 202) and polymer-free (PF; n = 201) stents. The 2-year endpoints of interest were target lesion revascularisation (TLR), death/myocardial infarction (MI), stent thrombosis and delayed angiographic late luminal loss (LLL) between 6-8 months and 2 years. RESULTS: There were no significant differences in TLR (8.4%, 10.4% and 13.4% for BP, PP and PF stents, respectively; p = 0.19), death/MI (5.9%, 6.4% and 6.5% with BP, PP and PF respectively; p = 0.97) or stent thrombosis (definite/probable 0.5%, 1.0% and 1.0% with BP, PP and PF, respectively; p = 0.82). Paired angiographic follow-up at 6-8 months and 2 years was available for 302 patients (69.0% of eligible patients). Delayed LLL was significantly different across the treatment groups: 0.17 (0.42) mm, 0.16 (0.41) mm and -0.01 (0.36) mm for BP, PP and PF stents, respectively (p<0.001). CONCLUSION: Clinical antirestenotic efficacy was maintained with all three platforms between 1 and 2 years, although angiographic surveillance showed ongoing delayed LLL with both BP and PP stent platforms. At 2 years there was no signal of a differential safety profile between the three stent platforms.

Abstract: We sought to investigate the long-term efficacy of oral sirolimus therapy and its impact on the incidence of de novo malignancies in the OSIRIS (Oral Sirolimus to Inhibit Recurrent In-Stent Stenosis) trial population.

Abstract: Although biodegradable polymer drug-eluting stent (DES) platforms have potential to enhance long-term clinical outcomes, data concerning their efficacy are limited to date. We previously demonstrated angiographic antirestenotic efficacy with a microporous, biodegradable polymer DES. In the current study, we hypothesized that at 12 months, its clinical safety and efficacy would be non-inferior to that of permanent polymer DES.

Abstract: BACKGROUND: It is not known whether there exists a sex-dependent difference in the clinical benefit of abciximab in patients with acute coronary syndromes (ACS) undergoing a percutaneous coronary intervention (PCI). METHODS: We performed this retrospective analysis of 2022 patients (498 women) with ACS enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 2 trial and randomized to receive abciximab or placebo during a PCI procedure. The incidence of major adverse cardiac events (MACE) during the 30 days after PCI was the primary end point of the study. RESULTS: Among men, the 30-day incidence of MACE was 8.6% in the abciximab group compared with 12.6% in the placebo group, relative risk (RR) 0.69 (95% confidence interval [CI] 0.50-0.94), P = .01. The 30-day incidence of MACE in women was 9.7% in the abciximab group compared with 9.9% in the placebo group, RR 0.98 (95% CI, 0.56-1.72), P = .97. After adjustment for baseline clinical and angiographic characteristics, there was no significant interaction between sex and abciximab (P = .71); adjusted RR was 0.70 (95% CI, 0.34-1.34) in women and 0.60 (95% CI, 0.40-0.90) in men. The incidence of major bleeding was significantly greater in women (3.6%) than in men (0.7%), RR 5.5 (95% CI, 2.54-11.9), P < .001, without any dependence on the form of therapy received. CONCLUSIONS: In patients with non-ST elevation ACS undergoing a PCI, the benefit with abciximab is greater in men than in women. This is apparently the result of sex-based differences in risk profile.