Jörg Carlsson

Outcomes 1 Year after Thrombus Aspiration for Myocardial Infarction

BACKGROUND Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration. METHODS We randomly assigned 7244 patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone, in a registry-based, randomized clinical trial. The primary end point of all-cause mortality at 30 days has been reported previously. Death from any cause at 1 year was a prespecified secondary end point of the trial. RESULTS No patients were lost to follow-up. Death from any cause occurred in 5.3% of the patients (191 of 3621 patients) in the thrombus-aspiration group, as compared with 5.6% (202 of 3623) in the PCI-only group (hazard ratio, 0.94; 95% confidence interval [CI], 0.78 to 1.15; P=0.57). Rehospitalization for myocardial infarction at 1 year occurred in 2.7% and 2.7% of the patients, respectively (hazard ratio, 0.97; 95% CI, 0.73 to 1.28; P=0.81), and stent thrombosis in 0.7% and 0.9%, respectively (hazard ratio, 0.84; 95% CI, 0.50 to 1.40; P=0.51). The composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis occurred in 8.0% and 8.5% of the patients, respectively (hazard ratio, 0.94; 95% CI, 0.80 to 1.11; P=0.48). The results were consistent across all the major subgroups, including grade of thrombus burden and coronary flow before PCI. CONCLUSIONS Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis at 1 year. (Funded by the Swedish Research Council and others; TASTE ClinicalTrials.gov number, NCT01093404.).

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.

Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI

Background The instantaneous wave‐free ratio (iFR) is an index used to assess the severity of coronary‐artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events. Methods We conducted a multicenter, randomized, controlled, open‐label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary‐artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure. Results A primary end‐point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], ‐1.5 to 2.8; P=0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P=0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target‐lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure. Conclusions Among patients with stable angina or an acute coronary syndrome, an iFR‐guided revascularization strategy was noninferior to an FFR‐guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months. (Funded by Philips Volcano; iFR SWEDEHEART ClinicalTrials.gov number, NCT02166736.)

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)

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 Liberté (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.

Stent Thrombosis in Sweden A Report From the Swedish Coronary Angiography and Angioplasty Registry

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. Received December 16, 2008; accepted July 16, 2009.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.

Stent Thrombosis in SwedenCLINICAL PERSPECTIVE

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. Received December 16, 2008; accepted July 16, 2009.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.

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.

Outcome of percutaneous coronary intervention in hospitals with and without on-site cardiac surgery standby

Objective: To compare characteristics and outcome of patients undergoing percutaneous coronary intervention (PCI) in clinics with (WSB) or without (NOSB) on-site cardiac surgery backup. Design: Analysis according to hospital, type of prospectively collected data of all patients who underwent PCI during 2000–3. Setting: The Swedish Coronary Angiography and Angioplasty Registry covers all PCI procedures performed in Sweden. Patients: 34 363 patients underwent PCI between January 2000 and December 2003. 8838 procedures were performed in NOSB (mean age of patients was 64.5 years) hospitals and 25 525 in WSB (mean age of patients was 64.1 years) hospitals (p = 0.002). Results: More patients in NOSB hospitals had diabetes (17.8% vs 16.8%; p = 0.03). Other clinical characteristics (previous infarct, previous coronary artery bypass graft (CABG)) also showed a tendency towards worse patients being treated in NOSB hospitals. However, there was a higher percentage of patients with ST-segment elevation myocardial infarction (18% vs 9.7%; p<0.01) in WSB hospitals. After adjusting for differences in baseline risk no significant differences regarding outcome (30-day mortality, 1-year mortality, stroke and emergency CABG) were observable between WSB and NOSB hospitals. This applied to elective and non-elective procedures. Conclusions: On the basis of these data it does not seem warranted to recommend against percutaneous transluminal coronary angioplasty in NOSB hospitals.

Cardiovascular and Cancer Mortality in Very Elderly Post-Myocardial Infarction Patients Receiving Statin Treatment

OBJECTIVES The purpose of this study was to determine whether statin treatment is effective and safe in very elderly (80 years and older) acute myocardial infarction (AMI) patients. BACKGROUND Elderly individuals constitute an increasing percentage of patients admitted to hospitals for AMI. Despite that these patients have a higher mortality risk, the application of evidence-based medicine remains much lower than for younger patients. METHODS We included all patients 80 years and older who were admitted with the diagnosis of AMI in the Register of Information and Knowledge About Swedish Heart Intensive Care Admissions between 1999 and 2003 (n = 21,410). Of these, complete covariate and follow-up data were available for 14,907 patients (study population A). To limit the bias related comorbidity on statin therapy, we also performed analyses excluding patients who died within 14 days of the acute event (study population B) and all patients who died within 365 days (study population C). A propensity score was used to adjust for initial differences between treatment groups. RESULTS All-cause mortality was significantly lower in patients receiving statin treatment at discharge in study population A (relative risk: 0.55, 95% confidence interval: 0.51 to 0.59), in study population B (relative risk: 0.65; 95% confidence interval: 0.60 to 0.71), and in study population C (relative risk: 0.66; 95% confidence interval: 0.59 to 0.76). Similar observations were made for cardiovascular mortality as well as for AMI mortality. There was no increase in cancer mortality in statin-treated patients. CONCLUSIONS Statin treatment is associated with lower cardiovascular mortality in very elderly post-infarction patients without increasing the risk of the development of cancer.

Prognosis of elderly patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention in 2001 to 2011 : A report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) registry

BACKGROUND Elderly patients constitute a growing part of the population presenting with ST-elevation myocardial infarction (STEMI). The use of primary percutaneous coronary intervention (PCI) in this high-risk population remains poorly investigated. METHODS Using the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), we identified consecutive patients with STEMI 80 years or older undergoing primary PCI during a 10-year period. Temporal trends in care and 1-year prognosis were investigated, and long-term outcome was compared with a reference group of patients with STEMI aged 70 to 79 years. Relative survival was calculated by dividing the observed survival rate with the expected survival rate of the general population. Adjusted end points were calculated using Cox regression. RESULTS In total, 4,876 elderly patients with STEMI were included. During the study period, average age and presence of comorbidity increased, as well as the use of antithrombotic therapy. Procedural success remained constant. One-year mortality was exclusively reduced between the most recent vs the earliest cohort, whereas the risk of reinfarction, heart failure, stroke, and bleeding remained similar. The risk of death was higher for elderly patients early after PCI, after which the prognosis was slightly better compared with the general population. Long-term risk of adverse events increased markedly with age. CONCLUSIONS The prognosis of patients older than 80 years treated with primary PCI for STEMI was relatively unchanged during the 10-year inclusion period, despite changes in patient characteristics and treatment. Advanced age increased the risk of adverse events, but survivors of the early phase after PCI had a slightly improved prognosis compared with the general population.