| 1. |
- Carlsson, Jorg, et al.
(författare)
-
Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria
- 2009
-
Ingår i: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. - : Elsevier BV. - 0735-1097 .- 1558-3597. ; 53:16, s. 1389-1398
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives The aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use. Background DES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations. Methods The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics. Results There were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications. Conclusions In contemporary Swedish practice, neither on-nor off-label use of DES is associated with worse outcome than use of BMS.
|
|
| 2. |
- Frobert, Ole, et al.
(författare)
-
Differences in Restenosis Rate With Different Drug-Eluting Stents in Patients With and Without Diabetes Mellitus A Report From the SCAAR (Swedish Angiography and Angioplasty Registry)
- 2009
-
Ingår i: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. - : Elsevier BV. - 0735-1097 .- 1558-3597. ; 53:18, s. 1660-1667
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives Our aim was to evaluate restenosis rate of drug-eluting stents (DES) in patients with and without diabetes mellitus (DM) in a real-world setting. Background DES seem less effective in patients with DM. Methods The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) includes all patients undergoing percutaneous coronary intervention in Sweden. From April 1, 2004, to April 20, 2008, all restenoses detected at a subsequent angiography and all DES types implanted at more than 500 occasions were assessed using Cox regression. Results Four DES types qualified for inclusion. In total, 35,478 DES were implanted at 22,962 procedures in 19,004 patients and 1,807 restenoses were reported over a mean 29 months follow-up. In the entire population, the restenosis rate per stent was 3.5% after 1 year and 4.9% after 2 years. The adjusted risk of restenosis was higher in patients with DM compared with that in patients without DM (relative risk [RR]: 1.23, 95% confidence interval [CI]: 1.10 to 1.37). In patients with DM, restenosis was twice as frequent with the zotarolimus-eluting Endeavor stent (Medtronic, Minneapolis, Minnesota) compared with that in the other DES types. The Endeavor stent and the sirolimus-eluting Cypher stent (Cordis, Johnson & Johnson, Miami, Florida) had higher restenosis rates in patients with DM compared with those in patients without DM (RR: 1.77, 95% CI: 1.29 to 2.43 and RR: 1.25, 95% CI: 1.04 to 1.51). Restenosis rate with the paclitaxel-eluting Taxus Express and Liberte (Boston Scientific, Natick, Massachusetts) stents was unrelated to DM. Mortality did not differ between different DES. Conclusions Restenosis rate with DES was higher in patients with DM compared with that in patients without DM. There seem to be important differences between different brands of DES.
|
|
| 3. |
- James, Stefan K., 1964-, et al.
(författare)
-
Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden
- 2009
-
Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 360:19, s. 1933-1945
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The long-term safety and efficacy of drug-eluting coronary stents have been questioned. METHODS: We evaluated 47,967 patients in Sweden who received a coronary stent and were entered into the Swedish Coronary Angiography and Angioplasty Registry between 2003 and 2006 and for whom complete follow-up data were available for 1 to 5 years (mean, 2.7). In the primary analysis, we compared patients who received one drug-eluting coronary stent (10,294 patients) with those who received one bare-metal stent (18,659), after adjustment for differences in clinical characteristics of the patients and characteristics of the vessels and lesions. RESULTS: Analyses of outcome were based on 2380 deaths and 3198 myocardial infarctions. There was no overall difference between the group that received drug-eluting stents and the group that received bare-metal stents in the combined end point of death or myocardial infarction (relative risk with drug-eluting stents, 0.96; 95% confidence interval [CI], 0.89 to 1.03) or the individual end points of death (relative risk, 0.94; 95% CI, 0.85 to 1.05) and myocardial infarction (relative risk, 0.97; 95% CI, 0.88 to 1.06), and there was no significant difference in outcome among subgroups stratified according to the indication for stent implantation. Patients who received drug-eluting stents in 2003 had a significantly higher rate of late events than patients who received bare-metal stents in the same year, but we did not observe any difference in outcome among patients treated in later years. The average rate of restenosis during the first year was 3.0 events per 100 patient-years with drug-eluting stents versus 4.7 with bare-metal stents (adjusted relative risk, 0.43; 95% CI, 0.36 to 0.52); 39 patients would need to be treated with drug-eluting stents to prevent one case of restenosis. Among high-risk patients, the adjusted risk of restenosis was 74% lower with drug-eluting stents than with bare-metal stents, and only 10 lesions would need to be treated to prevent one case of restenosis. CONCLUSIONS: As compared with bare-metal stents, drug-eluting stents are associated with a similar long-term incidence of death or myocardial infarction and provide a clinically important decrease in the rate of restenosis among high-risk patients.
|
|
| 4. |
- Lagerqvist, Bo, 1952-, et al.
(författare)
-
Stent thrombosis in Sweden : a report from the Swedish Coronary Angiography and Angioplasty Registry
- 2009
-
Ingår i: Circulation: Cardiovascular Interventions. - 1941-7640 .- 1941-7632. ; 2:5, s. 401-408
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The objective was to evaluate the role of risk factors and stent type for stent thrombosis (ST) using a large real world registry. METHODS AND RESULTS: We evaluated all consecutive coronary stent implantations in Sweden from May 1, 2005, to June 30, 2007. All cases of ST, documented in the Swedish coronary angiography and angioplasty registry until September 21, 2008, were analyzed. ST was registered in 882 of 73 798 stents. Acute coronary syndromes, insulin-treated diabetes mellitus, smoking, previous coronary intervention, warfarin treatment, small stent diameter, and stenting in restenotic, complex, or bypass graft lesions had the strongest association with ST in the multivariable statistical model. There were considerable differences in the frequency of ST between different stent brands. The overall risk of ST was lower in drug-eluting stents compared with bare metal stents (adjusted risk ratio, 0.79; 99% CI, 0.63 to 0.99). However, from 6 months after stent implantation and onward, the risk for ST was higher in drug-eluting stents compared with bare metal stents (adjusted risk ratio, 2.02; 99% CI, 1.30 to 3.14). CONCLUSIONS: ST is a multifactor disease, and the incidence varies considerably between patients based on clinical, vessel, and stent characteristics. For drug-eluting stents compared with bare metal stents, the risk pattern was biphasic; initially, bare metal stents demonstrated a higher risk of ST; whereas after the first months, ST risk was higher with drug-eluting stents. Our findings highlight the need for prospective randomized studies with head-to-head comparisons between different stents.
|
|
| 5. |
- Stenestrand, Ulf, et al.
(författare)
-
Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus : long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
- 2010
-
Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 31:2, s. 177-186
-
Tidskriftsartikel (refereegranskat)abstract
- AIMS: Patients with diabetes mellitus have more extensive coronary artery disease, more disease progression, and restenosis. The use of drug-eluting stents (DES) in these patients is widespread, despite uncertain long-term safety and efficacy. METHODS AND RESULTS: All consecutive patients with diabetes mellitus in Sweden who underwent percutaneous coronary intervention were entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2003-06 with complete follow-up for 1-4 years (median 2.5). Patients who received at least one DES (n = 4754) were compared with those who received only bare metal stents (BMS) (n = 4956) at the index procedure. Combined outcome of death or myocardial infarction (MI) showed no difference for DES vs. BMS, relative risk (RR), 0.91 [95% confidence interval (CI), 0.77-1.06]. Myocardial infarction was significantly less common with DES in patients who received only one stent RR, 0.80 (95% CI, 0.66-0.96). The restenosis rate was 50% lower in DES-treated patients RR, 0.50 (95% CI, 0.35-0.70) and was associated with a higher adjusted RR of MI, RR, 5.03 (95% CI, 4.25-5.97). DES was associated with reduced restenosis rates in all subgroups of diabetic patients with the greatest benefit in stent diameters <3 mm or stent length >20 mm. The number of lesions treated with DES to prevent one restenosis ranged from 11 to 47 in various subgroups. CONCLUSION: This real-life registry study shows that restenosis was halved by DES in diabetic patients with stable or unstable coronary disease, with similar risk of death or MI up to 4 years compared with BMS.
|
|
