Rnal.pone.0056348.tReal world data are of paramount importance when different

Rnal.pone.0056348.tReal world data are of paramount importance when different treatment strategies are evaluated. This is especially true for coronary stents, which are very often used “off-label” when the implantation takes place outside the scope of the approved indication. We evaluated death, stent occlusion and restenosis rate in relation to the applied stent pressure in all patients treated by coronary artery stent implantation during 46 months from 2008 and onwards, as recorded in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).Methods Study populationOur study included all patients in Sweden who had received coronary stents from January 1, 2008, to October 26, 2011. The analyses were based on maximal stent inflation pressure at the first recorded procedure during this time period.registered for patients undergoing any subsequent coronary angiography on a Title Loaded From File clinical indication since March 1, 2004 and information on stent thrombosis since May 1, 2005. Long-term follow-up was obtained by merging the SCAAR database with other national registries based on all Swedish citizens’ unique 10digit personal identification number. Vital status and date of death was obtained from the National Population registry and was available until October 15, 2011. Merging of the registries was performed by the Epidemiologic Centre of the Swedish National board of Health and Welfare and approved by the ethics committee at Uppsala University. Because the data are anonymised written informed consent from each patient was not needed. Monitoring and verification of registry data have been performed in all hospitals since 2001 by comparing 50 entered variables in 20 randomly selected interventions per hospital and year with the patients’ hospital records. The overall correspondence of data during the study period was 95.2 .The SCAAR dataSCAAR, which is a part of the national SWEDEHEART registry, holds data on all consecutive patients from all centers (n = 29) that perform coronary angiography and PCI in Sweden. The registry is sponsored by the Swedish Health Authorities and is independent of commercial funding. The technology is developed and administered by the Uppsala Clinical Research Center. Since 2001, SCAAR has been Internet-based, with recording of data online through a Web interface in the catheterization laboratory; data are transferred in an encrypted format to a central server at the Uppsala Clinical Research Center. Information on restenosis in any previously implanted stent anywhere in Sweden has beenDefinitionsIn the results, “stent inflation pressure” refers to the maximal inflation pressure in atm used when a stent was deployed. “Postdilatation” refers to one or more additional dilatations Title Loaded From File within the stent area following stent deployment. An acute definite stent thrombosis is defined in SCAAR as an angiographic occlusion of a previously implanted stent with an acute clinical presentation [10]. A restenosis is defined as a clinically relevant angiographic stenosis in a previously implanted stent assessed by visual estimate (.50 diameter stenosis) or as a significant reduction in fractional flow reserve [11].Stent Inflation PressureTable 2. PCI data.PCI dataPre-procedure medication Acetylsalicylic acid – no. ( ) Clopidogrel – no. ( ) Warfarin – no. ( ) Procedure-related medication Heparin – no. ( ) LMWH – no. ( ) Bivalirudin – no. ( ) Glucoprotein IIb/IIIa inhibitor – no. ( ) Stented artery – no ( ) De novo lesion Restenosi.Rnal.pone.0056348.tReal world data are of paramount importance when different treatment strategies are evaluated. This is especially true for coronary stents, which are very often used “off-label” when the implantation takes place outside the scope of the approved indication. We evaluated death, stent occlusion and restenosis rate in relation to the applied stent pressure in all patients treated by coronary artery stent implantation during 46 months from 2008 and onwards, as recorded in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).Methods Study populationOur study included all patients in Sweden who had received coronary stents from January 1, 2008, to October 26, 2011. The analyses were based on maximal stent inflation pressure at the first recorded procedure during this time period.registered for patients undergoing any subsequent coronary angiography on a clinical indication since March 1, 2004 and information on stent thrombosis since May 1, 2005. Long-term follow-up was obtained by merging the SCAAR database with other national registries based on all Swedish citizens’ unique 10digit personal identification number. Vital status and date of death was obtained from the National Population registry and was available until October 15, 2011. Merging of the registries was performed by the Epidemiologic Centre of the Swedish National board of Health and Welfare and approved by the ethics committee at Uppsala University. Because the data are anonymised written informed consent from each patient was not needed. Monitoring and verification of registry data have been performed in all hospitals since 2001 by comparing 50 entered variables in 20 randomly selected interventions per hospital and year with the patients’ hospital records. The overall correspondence of data during the study period was 95.2 .The SCAAR dataSCAAR, which is a part of the national SWEDEHEART registry, holds data on all consecutive patients from all centers (n = 29) that perform coronary angiography and PCI in Sweden. The registry is sponsored by the Swedish Health Authorities and is independent of commercial funding. The technology is developed and administered by the Uppsala Clinical Research Center. Since 2001, SCAAR has been Internet-based, with recording of data online through a Web interface in the catheterization laboratory; data are transferred in an encrypted format to a central server at the Uppsala Clinical Research Center. Information on restenosis in any previously implanted stent anywhere in Sweden has beenDefinitionsIn the results, “stent inflation pressure” refers to the maximal inflation pressure in atm used when a stent was deployed. “Postdilatation” refers to one or more additional dilatations within the stent area following stent deployment. An acute definite stent thrombosis is defined in SCAAR as an angiographic occlusion of a previously implanted stent with an acute clinical presentation [10]. A restenosis is defined as a clinically relevant angiographic stenosis in a previously implanted stent assessed by visual estimate (.50 diameter stenosis) or as a significant reduction in fractional flow reserve [11].Stent Inflation PressureTable 2. PCI data.PCI dataPre-procedure medication Acetylsalicylic acid – no. ( ) Clopidogrel – no. ( ) Warfarin – no. ( ) Procedure-related medication Heparin – no. ( ) LMWH – no. ( ) Bivalirudin – no. ( ) Glucoprotein IIb/IIIa inhibitor – no. ( ) Stented artery – no ( ) De novo lesion Restenosi.