Population trends in percutaneous coronary intervention: 20-year results from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry).

OBJECTIVES: The aim of this study was to describe the characteristics and outcome of all consecutive patients treated with percutaneous coronary intervention (PCI) in an unselected nationwide cohort over the past 2 decades. BACKGROUND: Over the last 20 years, treatment with PCI has evolved dramatically, but the change in patient characteristics has not been well described. METHODS: We included all patients undergoing a PCI procedure for the first time between January 1990 and December 2010 from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry). Patients were divided into different cohorts on the basis of the year of the first PCI procedure. RESULTS: A total of 144,039 patients was included. The mean age increased from 60.1 ± 9.9 years in 1990 to 1995 to 67.1 ± 11.2 years in 2009 to 2010. The proportion of patients presenting with unstable coronary artery disease and ST-segment elevation myocardial infarction increased from 27.4% and 6.2% to 47.7% and 32.5%, respectively. Diabetes mellitus and multivessel disease were more often present in the later-year cohorts. The 1-year mortality increased from 2.2% in 1990 to 1995 to 5.9% in 2009 to 2010, but after adjustment for age and indication, a modest decrease was shown, mainly in ST-segment elevation myocardial infarction patients. CONCLUSIONS: Characteristics of PCI patients have changed substantially over time, reflecting the establishment of new evidence. The increasing age and proportion of patients undergoing PCI for acute coronary syndromes greatly influence outcome. Understanding the changing patient characteristics is important for the translation of evidence to real-world clinical practice.

Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

BACKGROUND: The safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry. METHODS: The Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression. RESULTS: A total of 13,577 stents (Promus Element, n=2724, Cypher, n=782; Endeavor, n=747; Taxus Liberté, n=1393, Xience V/Promus, n=4832, Resolute, n=1566, Xience Prime, n=4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR:1.17, 95% CI: 0.75-1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26-0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025-1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08-0.67). CONCLUSIONS: In a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST.

Sickness absence following coronary revascularisation. A national study of women and men of working age in Sweden 1994-2006.

BACKGROUND: Evidence based and gender specific knowledge about sickness absence following coronary revascularisation is lacking. The objective was to investigate sickness absence after a first coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) among women and men in a national Swedish study. MATERIALS AND METHODS: All patients 30-63 years of age, who underwent a first CABG (n = 22,985, 16% women) or PCI (40,891, 22% women) in Sweden between 1994 and 2006 were included. Information on sickness absence, co-morbidity, and other patient characteristics was obtained from national registers. Long-term sickness absence (LTSA) was defined as >180 and >90 sick-leave days in the first sick-leave spell following CABG and PCI, respectively. Prevalence ratio (PR) and 95% confidence interval (CI) of LTSA were calculated. FINDINGS: LTSA followed the interventions in 41% and 36% for CABG and PCI patients, respectively. Women had more often LTSA compared with men, (CABG PR = 1.23: 95% CI 1.19-1.28 and PCI PR = 1.19; 95% CI 1.16-1.23). A history of sickness absence the year before the intervention increased the risk for LTSA after the intervention in both genders. Among women, older age, or being self employed or unemployed was associated with a lower risk for LTSA. Among men previous cardiovascular disease, diabetes and low socio-economic position increased the risk. During the observation period, there was no change in sickness absence rates among PCI patients but an increase among CABG patients adjusting for patient characteristics. CONCLUSION: This national study covering a 13-year period shows that long-term sickness absence following coronary revascularisation is common in Sweden, especially among women, and is associated with socio-economic position, co-morbidity, and sickness absence during the year before the intervention. Gender specific scientific knowledge about use and effects of sickness absence following coronary revascularisation is warranted for the patients, the treating physicians, the healthcare sector, and the society.

Impact on image quality and radiation exposure in coronary CT angiography: 100 kVp versus 120 kVp.

BACKGROUND: The risk of radiation-induced cancer has become a major concern with the increasing use of computed tomography (CT). PURPOSE: To compare image quality and radiation doses when decreasing X-ray tube peak kilovoltage (kVp) from 120 to 100 kVp in patients undergoing coronary CT angiography (CCTA). MATERIAL AND METHODS: Patients referred for evaluation of suspected coronary artery disease (CAD) underwent 64-channel detector CCTA using a tube voltage of either 120 kVp (n = 46) or 100 kVp (n = 82). The individual volume CT dose index (CTDI(vol)) and dose length product (DLP) were recorded and effective radiation dose was estimated on the basis of DLP. Subjective image quality was assessed by two radiologists on per-patient based consensus. Vascular density and image noise were quantified in the left main coronary artery (LMCA) and proximal ascending aorta (AA). Mean density in the adjacent perivascular tissue was also quantified. Contrast-to-noise ratio (CNR) was calculated. Corresponding invasive coronary angiography (ICA) was performed, which constituted the gold standard. RESULTS: Mean values in the 100/120 kVp cohorts regarding CNR in the LMCA were 12.7/16.0 (P<0.0001)) and in the AA 13.2/17.2 (P<0.0001), CTDI(vol) 34.4/57.4 mGy (a 40% reduction, P<0.0001), DLP 578/1125 mGy × cm (P<0.0001), and estimated effective dose 9.6/20.2 mSv (P<0.0001). There was no statistically significant difference in subjective image quality between the two cohorts. The sensitivity to detect significant coronary stenoses was 88% (120 kVp) and 84% (100 kVp) and the specificity was 71% (120 kVp) and 74% (100 kVp), respectively. CONCLUSION: By reduction of tube voltage from 120 to 100 kVp at CCTA, while keeping all other scanning parameters unchanged, the radiation dose to the patient can be almost halved while keeping the diagnostic image quality at a clinically acceptable level.

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).

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.

Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden.

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.

Coronary angiography of patients with a previous coronary artery by-pass operation is associated with a three times increased risk for neurological complications. A report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

OBJECTIVES: This study aimed to determine the incidence of complications of diagnostic coronary angiography that was not followed by percutaneous coronary interventions and to compare differences in complication rates between patients with or without previous coronary artery by-pass surgery. DESIGN: We evaluated major complications due to diagnostic coronary angiography by merging the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), the Swedish Hospital Discharge Registry and the National Population Registry. RESULTS: A total of 1 115 complications were recorded (2.2%). There was a higher incidence of any complications in patients with a previous coronary by-pass surgery in uni-variable analysis (2.7% vs. 2.1%, p=0.003) but not in multi-variable analysis after adjustment for differences in background and procedural factors. Neurological complications were not common (0.20%) but after adjustment for differences in background and procedural factors, the risk of neurological complications was nearly three times higher in patients with a previous CABG compared to patients without previous CABG, odds ratio 2.89 (95% CI 1.68-4.97). CONCLUSION: Neurological complications are significantly more common in patients with previous by-pass surgery. Considering the risk for neurological complications the risk-benefit ratio may be higher when compared with patients without previous by-pass surgery.

Outcome of drug-eluting versus bare-metal stenting used according to on- and off-label criteria.

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.

Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden.

BACKGROUND: Recent reports have indicated that there may be an increased risk of late stent thrombosis with the use of drug-eluting stents, as compared with bare-metal stents. METHODS: We evaluated 6033 patients treated with drug-eluting stents and 13,738 patients treated with bare-metal stents in 2003 and 2004, using data from the Swedish Coronary Angiography and Angioplasty Registry. The outcome analysis covering a period of up to 3 years was based on 1424 deaths and 2463 myocardial infarctions and was adjusted for differences in baseline characteristics. RESULTS: The two study groups did not differ significantly in the composite of death and myocardial infarction during 3 years of follow-up. At 6 months, there was a trend toward a lower unadjusted event rate in patients with drug-eluting stents than in those with bare-metal stents, with 13.4 fewer such events per 1000 patients. However, after 6 months, patients with drug-eluting stents had a significantly higher event rate, with 12.7 more events per 1000 patients per year (adjusted relative risk, 1.20; 95% confidence interval [CI], 1.05 to 1.37). At 3 years, mortality was significantly higher in patients with drug-eluting stents (adjusted relative risk, 1.18; 95% CI, 1.04 to 1.35), and from 6 months to 3 years, the adjusted relative risk for death in this group was 1.32 (95% CI, 1.11 to 1.57). CONCLUSIONS: Drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. This trend appeared after 6 months, when the risk of death was 0.5 percentage point higher and a composite of death or myocardial infarction was 0.5 to 1.0 percentage point higher per year. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.

Percutaneous coronary interventions in Europe 1992-2003.

AIMS: The purpose of this registry is to collect data on trends in interventional cardiology within Europe. Special interest focuses on relative increases and ratios in newer revascularization approaches and its distribution in different regions in Europe. We report the data of the year 2003 and give an overview of the development of coronary interventions since 1992, when the first data collection was performed. METHODS AND RESULTS: Questionnaires were distributed yearly to delegates of all national societies of cardiology represented in the European Society of Cardiology to collect the case numbers of all local institutions and operators. The overall numbers of coronary angiographies increased from 1992 to 2003 from 684,000 to 1,993,000 (from 1,250 to 3,500 per million inhabitants). The respective numbers for percutaneous coronary interventions (PCI-coronary angioplasty) and coronary stenting procedures increased from 184,000 to 733,000 (from 335 to 1,300) and from 3,000 to 610,000 (from 5 to 1,100), respectively. Germany has been the most active country for the past years with 653,000 angiographies (7,800), 222,000 angioplasties (2,500), and 180,000 stenting procedures (2,200) in 2003. The indication has shifted towards acute coronary syndromes, as demonstrated by raising rates of interventions for acute myocardial infarction over the last decade. The procedures are more readily performed and safer, as shown by increasing rate of "ad hoc" PCI and decreasing need for emergency coronary artery bypass surgery (CABG). In 2003, use of drug-eluting stents had further increased. However, an enormous variability is reported with the highest rate in Portugal (55%). CONCLUSION: Interventional cardiology in Europe is still expanding, mainly but not exclusively due to rapid growth in the eastern European countries. A number of new coronary revascularization procedures introduced over the years have all but disappeared. Only stenting has experienced an exponential growth. The same can be forecast for drug-eluting stenting.

[PCI is now a refined method for treatment of coronary stenoses]. / PCI är idag en förfinad metod för behandling av kranskärlsförträngningar.

The technique of Percutaneous Coronary Intervention (PCI) has improved considerably over the last decades. Important developments have been the introduction of stents and better anticoagulation treatment. PCI is used most commonly in the treatment of unstable angina pectoris or non ST-elevation myocardial infarction. In Sweden today, more than half of the patients with ST-elevation myocardial infarction are treated primarily with PCI. Despite the high degree of opening of the infarct-related artery, the reduction in mortality is modest compared with treatment with thrombolysis indicating that there is room for considerable improvement. There is a need for randomised studies of adjunctive therapies but it can be speculated that thrombectomy devices and specific reperfusion injury therapy might reduce mortality in PCI treatment of ST-elevation myocardial infarction.

Response of serum C-reactive protein to percutaneous coronary intervention has prognostic value.

BACKGROUND: Data are sparse regarding the association between C-reactive protein (CRP) and percutaneous coronary intervention (PCI) in long-term prognosis. Previous studies have shown that PCI evokes an inflammatory response. We tested the hypothesis that the CRP response to PCI has a prognostic value. METHODS: We investigated 891 consecutive patients presenting with stable or unstable angina pectoris, with serum concentrations of cardiac troponin T < or =0.03 microg/L, who were undergoing a variety of PCIs. Serum concentrations of CRP and cardiac troponin T were determined before and the day after PCI. The mean follow-up time after PCI was 2.6 years, and the endpoint was death or nonfatal myocardial infarction. RESULTS: Seventy-six patients reached the endpoint (4.6% death, 3.9% nonfatal myocardial infarction), whereas 21% developed myocardial infarction during the procedure. CRP increased more than 2-fold after the procedure. Patients in the third tertile of the CRP response to PCI had an increased risk for death or nonfatal myocardial infarction in multivariate analysis. CONCLUSIONS: Increased serum CRP in response to PCI is an independent predictor of death or nonfatal myocardial infarction independent of myocardial injury during the procedure. CRP determinations might be of value in risk stratification after PCI.

ST-segment analyses and residual thrombi in the infarct-related artery: a report from the ASSENT PLUS ST-monitoring substudy.

BACKGROUND: Evolution of the ST segment during ST-elevation myocardial infarction (STEMI) has been shown to yield more information on prognosis than widely used invasive measurements. With continuous ST monitoring, even very occasional dynamic changes can be analyzed. We have recently suggested that ST variability during the reperfusion-phase is of prognostic importance. We wanted to further investigate this and relate it to angiographic findings. METHODS: A total of 177 patients with STEMI were examined in the ST-monitoring substudy of the ASessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) PLUS trial, comparing dalteparin with heparin as adjunctive therapy to t-PA. Patients underwent 24 hours of ST monitoring. These recordings were blindly analyzed by 2 independent observers. A coronary angiogram was performed on days 4 to 7, also blindly evaluated by 2 persons. RESULTS: Occurrence of ST re-elevations during and after the reperfusion-phase was significantly associated with residual thrombi and TIMI-flow in the infarct-related artery. Patients without any ST re-elevations showed a thrombus in only 5% of cases, as compared with 86% of patients with prolonged (lasting >30 minutes) ST re-elevations. In a multivariate comparison including baseline-data and treatment, most information on persistence of thrombi was contributed by the presence of any ST re-elevations (odds ratio, 5.8; 95% CI, 1.3-26). CONCLUSION: ST re-elevations during the first day of an acute myocardial infarction are associated with residual thrombi in the infarct-related artery even 4 to 7 days after the STEMI.

Inequality in access to coronary revascularization in Sweden.

OBJECTIVES: To investigate social and gender equality in access to coronary revascularization for those treated for coronary heart disease in Sweden between 1991 and 2000. DESIGN: All Swedish residents between 25 and 74 years old with a hospital stay for coronary heart disease were eligible for the study, in total about 153,000 persons. The Swedish Hospital Discharge Register from 1988 through 2000 was used to define the study population. Poisson regression analyses were used to estimate the effect of socio-economic status on the likelihood for coronary artery bypass grafting (CABG) within 2 years. In the analysis of gender differences, the likelihood for percutaneous coronary intervention (PCI) was also included. RESULTS: Males were 1.5 times more likely to undergo revascularization procedures than females even after adjusting for confounding factors and the fact that women are less eligible for interventions. The analyses also showed significant socio-economic inequalities in access to CABG among men, but not among women. CONCLUSIONS: There are gender and socio-economic inequalities in access to cardiac procedures in Sweden.

Comparison of effects of a thrombin-based femoral artery closure device with those of a mechanical compression device on serum C-reactive protein and amyloid A after percutaneous coronary intervention.

The present study evaluates whether the closing procedure of the femoral artery after percutaneous coronary intervention influences the degree of inflammation related to the procedure as measured by C-reactive protein (CRP) and serum amyloid A (SAA). A thrombin-based device (Duett sealing device) was compared with a mechanical compression device (FemoStop).

Low molecular weight heparin (dalteparin) compared to unfractionated heparin as an adjunct to rt-PA (alteplase) for improvement of coronary artery patency in acute myocardial infarction-the ASSENT Plus study.

BACKGROUND: Current thrombolytic-antithrombotic regimens in acute myocardialinfarction (AMI) are limited by incomplete early coronary reperfusion and by reocclusion and reinfarction. We compared the effects of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) as an adjunct to recombinant tissue-plasminogen activator (alteplase) on coronary artery patency and clinical outcomes in AMI. METHODS: Patients with AMI treated with alteplase (n=439) were randomised to either subcutaneous dalteparin (120 IU/kg every 12h) for 4-7 days or intravenous infusion of UFH for 48 h. Coronary angiography was performed between day 4 and hospital discharge. Clinical events and safety were evaluated until day 30. RESULTS: Overall there were higher thrombolysis in myocardial infarction (TIMI) flows in the infarct related coronary artery in the dalteparin group (p=0.016). The predefined primary end-point, TIMI grade 3 flow, did not reach statistical significance (dalteparin 69.3% versus heparin 62.5%; p=0.163). However, TIMI 0-1 flow (13.4 versus 24.4%; p=0.006) and its combination with intraluminal thrombus (27.9 versus 42.0%; p=0.003) were less common in the dalteparin group. During the period of randomised treatment there were less myocardial reinfarctions in the dalteparin group(p=0.010) but after cessation of dalteparin there were more reinfarctions resulting in no difference in death or MI at 30 days. There were no significant differences in major bleeding or stroke after 30 days. CONCLUSIONS: In alteplase treated AMI adjunctive dalteparin for 4-7 days seems to reduce the risk of early coronary artery occlusion and reinfarction. However, early after cessation of treatment there is a raised risk of events, which might eliminate any long-term gains.