Search

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.Results: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; Pnoninferiority=0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P<0.0001).Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140. [ABSTRACT FROM AUTHOR]

Introduction: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients presenting with a DES or bare-metal stent (BMS) in-stent restenosis.Methods: The "Nordic Intravascular Ultrasound Study (NIVUS)" study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n=121 and BMS n=88) with in-stent restenosis were enrolled.Results: At the minimum lumen area site in the stented segment, the stent area (5.8±2.2mm2 vs. 7.6±2.4mm2, p<0.001) and intimal hyperplasia area (2.6±2.0mm2 vs. 5.0±2.2mm2, p<0.001) were significantly lower in patients treated with DES compared to BMS. The percentage of stents that did not have a minimum stent area of at least 5.0mm2 (under expansion) was higher in DES (58.7% vs. 37.7%, p=0.008) compared to BMS. Intimal hyperplasia covered 55.4±33.3% of the stent length in the DES compared to 90.7±17.4% in the BMS group, p<0.001. Focal in-stent restenosis was more often seen in DES treated patients compared to BMS treated patients (DES n=84 (59.9%) vs. BMS n=15 (17.0%), p<0.001).Conclusion: Stent underexpansion was more often seen in DES than BMS in-stent restenosis. DES more often had focal in-stent restenosis with less intimal hyperplasia. [ABSTRACT FROM AUTHOR]

Background: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.Objectives: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.Methods: Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.Results: At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).Conclusions: At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877). [ABSTRACT FROM AUTHOR]

The article discusses a study which investigated the effects of a biodegradable polymer biolimus-eluting stent and durable polymer-coated sirolimus-eluting stent in patients receiving percutaneous coronary intervention (PCI). Particular focus is given to the methodology used in the study. Findings revealed that the primary endpoint was met by 4.1% of patients in the biolimus-eluting stent and 3.1% in the sirolimus-eluting stent group.

Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients. [Copyright &y& Elsevier]

Objectives: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES). Background: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. Methods: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES. Results: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80). Conclusions: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877) [ABSTRACT FROM AUTHOR]

Abstract: Background: The healthy endothelium plays a key roll in vascular regulation. This function can be examined non-invasively by use of B-mode ultrasound on the brachial artery. The aim of this study was to measure the effect of low-dose and high-dose lipid-lowering treatment with rosuvastatin on the endothelial function evaluated with endothelium-dependent and endothelium-independent flow-mediated dilatation (FMD). Methods: 87 Statin-naive patients with ST-segment elevation myocardial infarction (STEMI) were randomized to 5mg or 40mg rosuvastatin. The FMD was assessed at baseline, 6months and after 12months of follow-up by use of B-mode ultrasound of the brachial artery. Results: Baseline low-density lipoprotein (LDL) cholesterol level was reduced by 31.8% in the low-dose group (from 3.1±0.7mmol/l to 2.0±0.4mmol/l, p <0.001) vs. 49.0% in the high-dose group (from 3.1±1.0mmol/l to 1.6±0.7mmol/l, p <0.001) (between groups p =0.001). Treatment with low-dose rosuvastatin did not change the endothelium-dependent FMD (−1.4±8.2%, p =0.32) whereas the endothelium-dependent FMD increased significantly in the high-dose group (3.7±11.0%, p =0.045) (between group p =0.029). No significant changes in endothelium-independent FMD were seen. Conclusion: In the present study treatment of statin-naive STEMI patients with high-dose rosuvastatin for 12months resulted in a significant increase in endothelium-dependent FMD of the brachial artery whereas no significant change was seen in the low-dose rosuvastatin group (Clinicaltrials.gov Identifier: NCT01223625). [Copyright &y& Elsevier]

Background--Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. Methods and Results--The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88). Conclusion--The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent. [ABSTRACT FROM AUTHOR]

Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval [CI] 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death. [Copyright &y& Elsevier]

Patients ≥80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and “ventricular arrhythmia or congestive heart failure” in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time. [ABSTRACT FROM AUTHOR]

Background: In patients with ST-segment elevation myocardial infarction (STEMI), delay between contact with the health care system and initiation of reperfusion therapy (system delay) is associated with mortality, but data on the associated risk for congestive heart failure (CHF) among survivors are limited. Objective: To evaluate the association between system delay and the risk for readmissions or outpatient contacts due to CHF after primary percutaneous coronary intervention (PPCI) in patients with STEMI. Design: Historical follow-up study using population-based medical registries. Setting: Western Denmark. Patients: Patients with STEMI who were transported by emergency medical service from 1 January 1999 to 7 February 2010 and treated with PPCI within 12 hours of symptom onset and who had a system delay of 6 hours or less (n = 7952). The median duration of follow-up was 3.1 years. Measurements: Cumulative incidence of readmissions or outpatient contacts due to CHF was determined by using competing-risk regression analysis, with death as the competing risk. Crude and adjusted cause-specific hazard ratios for readmissions or outpatient contacts due to CHF were determined for system delay and other covariates. Results: System delays of 60 minutes or less (n = 451), 61 to 120 minutes (n = 3457), 121 to 180 minutes (n = 2655), and 181 to 360 minutes (n = 1389) corresponded with long-term risks for readmissions or outpatient contacts due to CHF of 10.1%, 10.6%, 12.3%, and 14.1%, respectively (P < 0.001). In multivariable analysis, system delay was an independent predictor of readmissions or outpatient contacts due to CHF (adjusted hazard ratio per hour increase in delay, 1.10 [95% CI, 1.02 to 1.17]). Limitation: In any nonrandomized study, there are risks for selection bias and residual confounding. Conclusion: In patients with STEMI, shorter delay to PPCI is associated with lower risk for readmissions or outpatient contacts due to CHF during follow-up. [ABSTRACT FROM AUTHOR]

Background: The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, but its safety and efficacy has not been compared head-to-head with the everolimus-eluting stent. Method: The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non-inferiority design, power calculations estimated a needed enrolment of 2,678 patients. The primary endpoint is a composite of cardiac death, myocardial infarction, and stent thrombosis or target vessel revascularization after 9 months. Data on clinical events and mortality for all randomized patients will be obtained from national databases at 9 months. No clinical follow-up examination is scheduled. Conclusion: The SORT OUT IV trial will directly compare clinically relevant differences in efficacy and safety in two drug-eluting stents: a first-generation sirolimus-eluting stent versus a second-generation everolimus-eluting stent. The study makes use of clinical endpoints routinely collected in computerized healthcare registries, allowing complete follow-up of a large, well-defined population without scheduled angiographic examinations. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Patients with diabetes mellitus have worse outcomes after percutaneous coronary intervention than patients without diabetes mellitus. We compared the risk of stent thrombosis, myocardial infarction, death, and target lesion revascularization in diabetic and nondiabetic patients after implantation of drug-eluting stents or bare metal stents. In the Western Denmark Heart Registry, 12,347 consecutive patients (1,575 with and 10,772 without diabetes) were identified and followed up for 2 years. The 2-year risk of definite stent thrombosis was 0.52% in patients with diabetes mellitus and 0.71% in nondiabetic patients (adjusted relative risk [RR] 0.74, 95% confidence interval [CI] 0.41 to 1.34, p = 0.321). The 2-year risk of myocardial infarction was greater in the diabetic patients (6.9%) than in the nondiabetic patients (3.6%; adjusted RR 1.96, 95% CI 1.58 to 2.43; p <0.001). The all-cause 2-year mortality rate was almost twice as great for the diabetic patients compared to the nondiabetic patients (12.4% vs 6.7%; adjusted RR 1.91, 95% CI 1.63 to 2.23; p <0.001). The 2-year risk of target lesion revascularization was 8.5% in the diabetic patients and 6.8% in the nondiabetic patients (adjusted RR 1.28, 95% CI 1.10 to 1.49; p <0.001). In conclusion, 2 years after drug-eluting stent or bare metal stent implantation, diabetic patients had a greater risk than nondiabetic patients of myocardial infarction and death. Drug-eluting stent treatment reduced the risk of target lesion revascularization compared to bare metal stent treatment, regardless of diabetes status. [Copyright &y& Elsevier]

Patients with diabetes have an increased risk of in-stent restenosis after coronary stent implantation. Serial intravascular ultrasound was used to study chronic arterial responses and edge effects after implantation of Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) or Taxus (Boston Scientific, Maple Grove, Minnesota) stents in diabetic patients. Seventy-four diabetic patients were randomly assigned to Cypher or Taxus stent implantation. Intravascular ultrasound of 5-mm long segments immediately proximal and distal to the stent was performed after the procedure and at the 8-month follow-up. The increase in peri-stent external elastic membrane (EEM) volume was more pronounced in the Taxus group (292.4 ± 132.6 to 309.5 ± 146.8 mm3) than in the Cypher group (274.4 ± 137.2 to 275.4 ± 140.1 mm3; p = 0.005). Peri-stent plaque volume increased in the Taxus group (152.5 ± 73.7 to 166.1 ± 85.1 mm3), but was unchanged in the Cypher group (153.5 ± 75.5 to 151.5 ± 75.8 mm3; p = 0.002). In proximal and distal reference segments, mean lumen area decreased within the entire 5-mm edge segment (proximal and distal) because of plaque progression (distal, 5.5 ± 3.6 to 5.8 ± 3.7 mm2; p = 0.097; proximal, 8.1 ± 2.7 to 8.7 ± 2.9 mm2; p = 0.006) without remodeling (change in EEM) in the Taxus group. Conversely, there were no significant changes in reference-segment EEM or plaque areas in the Cypher group. In conclusion, in diabetic patients, Taxus stent implantation was associated with increased (1) peri-stent EEM volume and peri-stent plaque, and (2) stent edge plaque progression accompanied by lumen reduction without remodeling. These findings were not seen in Cypher stents. [Copyright &y& Elsevier]

Objectives: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). Background: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. Results: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. Conclusions: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients. [Copyright &y& Elsevier]

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 ± 0.54 vs 0.44 ± 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent. [Copyright &y& Elsevier]

Patients with diabetes have a higher risk for in-stent restenosis after coronary stent implantation. Drug-eluting stents (DES) are highly effective in reducing in-stent restenosis. Once neointimal hyperplasia is suppressed with DES, the impact of stent underexpansion becomes magnified. The aim of this study was to evaluate DES expansion in patients with diabetes. Ninety-five patients with diabetes were randomized to Cypher Select (n = 48) or Taxus Express-2 (n = 47) stent implantation. Intravascular ultrasound was performed after stent implantation. Stent expansion was defined as the ratio of measured to predicted minimum stent diameter. There was a trend for lower stent expansion in the Cypher Select stent group (0.74 ± 0.08 vs 0.78 ± 0.11 in the Taxus Express-2 stent group, p = 0.061). Cypher Select stents achieved a final minimal stent cross-sectional area of 5.5 ± 1. 8 mm2, compared with 6.4 ± 1.9 mm2 for Taxus Express-2 stents (p = 0.015). For stents with nominal diameters ≥2.75 mm (Cypher Select n = 40, Taxus Express-2 n = 38), 42.5% of the Cypher Select stents and 10.5% of the Taxus Express-2 stents did not achieve a final minimum stent area of 5 mm2 (p = 0.002). Insulin treatment (relative risk 0.31, 95% confidence interval 0.10 to 0.95, p = 0.041) and stent type (relative risk 0.15, 95% CI 0.04 to 0.53, p = 0.003) were independent predictors of not achieving a minimum stent area >5.0 mm2. In conclusion, an important percentage of DES in patients with diabetes fail to achieve the manufacturers'' predicted final minimal stent diameter. Cypher Select stent and insulin treatment were independent predictors of not achieving a minimum stent area >5.0 mm2. [Copyright &y& Elsevier]

During percutaneous coronary intervention, the reference segment is assessed angiographically. This report described the discrepancy between angiographic and intravascular ultrasound (IVUS) assessment of reference segment size in patients with type 2 diabetes mellitus. Preintervention IVUS was used to study 62 de novo lesions in 41 patients with type 2 diabetes mellitus. The lesion site was the image slice with the smallest lumen cross-sectional area (CSA). The proximal and distal reference segments were the most normal-looking segments within 5 mm proximal and distal to the lesion. Plaque burden was measured as plaque CSA/external elastic membrane (EEM) CSA. Using IVUS, the reference lumen diameter was 2.80 ± 0.42 mm and the reference EEM diameter was 4.17 ± 0.56 mm. The angiographic reference diameter was 2.63 ± 0.36 mm. Mean difference between the IVUS EEM diameter and angiographic reference diameter was 1.56 ± 0.55 mm. The mean difference between the IVUS reference lumen diameter and angiographic reference lumen diameter was 0.18 ± 0.44 mm. Plaque burden in the reference segment correlated inversely with the difference between IVUS and quantitative coronary angiographic reference lumen diameter (slope = −0.12, 95% confidence interval −0.17 to −0.07, p <0.001), but it was not related to the absolute angiographic reference lumen diameter. Thus, reference segment diameters in type 2 diabetic patients were larger using IVUS than angiography, especially in the setting of larger plaque burden. In conclusion, these findings combined with inadequate remodeling may explain the angiographic appearance of small arteries in diabetic patients. [Copyright &y& Elsevier]

Objectives: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). Background: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used. Results: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67). Conclusions: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents. [Copyright &y& Elsevier]

Objective: To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario. Design: From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus stent were consecutively registered and followed for 9 months. Re-intervention was driven by clinical symptoms. Setting: Western Denmark Heart Registry. Patients: 4432 patients with 6102 lesions treated with a Cypher (n = 3791 lesions) or Taxus (n = 2311 lesions) stent. Interventions: Percutaneous coronary intervention. Main outcome measures: TLR, defined as either new percutaneous coronary intervention or coronary artery bypass graft operation of the target lesion, within 9 months from the index procedure. Results: TLR within 9 months was performed in 2.5% of lesions treated with the Cypher stent and in 3.3% of lesions treated with the Taxus stent (OR 1.36, 95% CI 1.00 to 1.84). After adjustment by multivariate logistic regression, Taxus stent implantation was an independent predictor of TLR (OR 1.43, 95% CI 1 .05 to 1 .95). Implantation of >1 stent per lesion (OR 1.62, 95% Cl 1.13 to 2.33) and reference diameter <2.8 mm (OR 1.42, 95% CI 1.00 to 2.02) were also identified as independent predictors of TLR. Conclusions: These data from the registry reflect a real-world clinical scenario with operator-driven use of drug-eluting stents and symptom-driven re-intervention. In this setting, use of the Taxus stent, implantation of multiple stents per lesion and stent implantation in small vessels were independent predictors of TLR. [ABSTRACT FROM AUTHOR]

Intravascular ultrasound (IVUS) allows precise measurements of plaque plus media (P+M) volume and neointimal hyperplasia after coronary artery stenting. Conventional IVUS volumetric analysis is performed mostly without electrocardiographically gated acquisition, and the IVUS images are selected at 1-mm intervals, whereas the electrocardiographically gated approach consists of images in end-diastole. The accuracy in the luminal, P+M, and external elastic membrane (EEM) volumes between 2 pullbacks with the electrocardiographically gated and nongated approaches has not previously been compared. In 15 patients, 19 segments were studied with electrocardiographically gated and nongated IVUS systems. Two identical pullbacks were performed with each system using the same IVUS catheter. Volumes of the lumen, EEM, and P+M obtained using the electrocardiographically gated pullback technique did not differ significantly from the corresponding volumes obtained using the nongated pullback technique (lumen: 109.7 ± 47.7 vs 109.2 ± 45.0 mm3, p = NS; EEM: 242.6 ± 109.2 vs 235.0 ± 108.1 mm3, p = NS; P+M: 134.8 ± 67.7 vs 129.8 ± 69.1 mm3, p = NS). No significant differences were seen in changes between 2 electrocardiographically gated and 2 nongated pullbacks (lumen: 0.37 ± 1.76 vs −0.23 ± 2.32 mm3, p = NS; EEM: 0.25 ± 3.22 vs −0.94 ± 4.27 mm3, p = NS; P+M: −0.18 ± 3.42 vs −0.74 ± 3.88 mm3, p = NS). In conclusion, in moderate atherosclerotic or stented coronary arteries, electrocardiographically gated IVUS acquisition is not superior in accuracy to conventional nongated IVUS acquisition. [Copyright &y& Elsevier]

Background: Direct evidence of coronary artery remodeling can be derived only from serial changes in the external elastic membrane (EEM) and plaque area. The aim of the study was to assess the effect of simvastatin on coronary remodeling in serial intravascular ultrasound (IVUS) studies. Methods: In 39 male patients ECG-triggered transducer pullback IVUS was performed at baseline, after 3 months on a lipid-lowering diet (control period), and after another 12 months of simvastatin 40 mg/day. The lesion site was the image slice with maximum plaque burden at 3 months. Results: Absolute changes in the EEM area correlated significantly with changes in plaque area during the control period [B = 0.966, r = 0.792 (95% CI 0.71–1.22); p < 0.001] and during simvastatin treatment [B = 0.945, r = 0.822 (95% CI 0.73–1.16); p < 0.001], but there was no significant difference in the slope (ΔEEM/Δplaque) between the two time intervals. After 12 months of simvastatin, there was a significant reduction in the lesion EEM area of 4.6% (p = 0.006) and in the lesion plaque area of 5.9% (p < 0.001), but there was no change in reference measurements. As a result, the remodeling index was reduced by simvastatin from 1.01 ± 0.12 to 0.95 ± 0.09 (p < 0.001). Conclusion: Simvastatin decreases the remodeling index by reducing lesion, but not reference plaque and EEM area. However, simvastatin does not affect direct evidence of remodeling (ΔEEM/Δplaque) obtained using serial IVUS studies. Copyright © 2006 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Abstract: Background: Endothelium-dependent dilation (EDD) has often been studied in patients with hypercholesterolemia without overt coronary atherosclerosis where an improvement after statin treatment has been documented within few weeks. The aim of the study was to assess the short-term effect of diet as well as short- and long-term effect of simvastatin on EDD in patients with hypercholesterolemia and ischemic heart disease. Methods: In 43 male patients with hypercholesterolemia and ischemic heart disease, EDD of the brachial artery was measured at baseline, after 3 months on a lipid-lowering diet, and after another 1, 3 and 12 months on simvastatin at 40 mg/day. Results: Three months changes in EDD were neither influenced by diet nor short-term simvastatin therapy (4.9% vs. 4.9% vs. 4.8%, p =ns). Twelve months simvastatin treatment, however, significantly improved EDD by 32.7% (4.9% vs. 6.5%, p =0.007). By regression analysis an individual adjusted increase in EDD during the simvastatin treatment period was seen (coefficient 0.132 a month, p =0.002). A significant reduction in total cholesterol of 31.0% (6.1±0.8 vs. 4.2±0.7, p <0.001) and LDL cholesterol of 42.6% (4.0±0.8 vs. 2.2±0.6, p <0.001) was observed. Conclusion: EDD is improved after long-term simvastatin therapy; however, neither did 3 months diet or 3 months simvastatin therapy has influence on the EDD. [Copyright &y& Elsevier]

Objective To present the rate of target vessel revascularization (TVR) in a consecutive and unselected national population over 10 years. Design From 1989 to 1998 all percutaneous coronary interventions (PCIs) performed in Denmark were recorded in the Danish PTCA Registry. Results From 1989 to 1998 the annual rate of PCI rose from 46 to 753 per million inhabitants. From 1995 to 1998 TVR with PCI or coronary artery bypass grafting (CABG) within 9 months from the index PCI decreased significantly (p<0.001) from 21.2% in 1995 (CABG 8.6% vs PCI 12.6%) to 11.7% in 1998 (CABG 4.3% vs PCI 7.4%). Independent predictors for TVR were: coronary stenting (OR 0.60; 95% CI 0.52–0.69, p<0.001), primary success rate (OR 0.69; 95% CI 0.53–0.89, p<0.005), pre-PCI stenosis severity (OR 1.01; 95% CI 1.00–1.01, p=0.03), left anterior descending coronary artery (OR 2.35; 95% CI 1.73–3.19, p<0.001), right coronary artery (OR 1.61; 95% CI 1.17–2.20, p=0.003), sapheneous vein graft (OR 2.03; 95% CI 1.13–3.63, p=0.017) and age (OR 0.99; 95% CI 0.98–1.00, p=0.002). Conclusion Coronary stenting, primary success rate, pre-PCI stenosis severity, age and treated vessel were independent predictors for TVR. [ABSTRACT FROM AUTHOR]

Background: Intravascular ultrasound (IVUS) has several advantages compared to angiography when evaluating coronary atherosclerosis in the vessel wall. Methods: The accuracy, reproducibility, and short-time spontaneous variation in volume of vessel, plaque and lumen were studied by electrocardiographic-gated three-dimensional (3D) IVUS in 20 male patients with ischaemic heart disease (IHD). Results: The study lesions were angiographically insignificant, with a length of the analysed segment on 11.4±5.9 mm. At baseline the mean minimal lumen diameter was 2.41±0.59 mm, minimal lumen area 4.82±2.38 mm2, and maximal plaque burden 65.61±9.57%. Mean reference diameter was 3.1±0.6 mm. No significant changes were observed in volumes of total vessel, lumen or plaque. The coefficient of variation (CV) for two volume measurements at baseline was: vessel 0.8%, plaque 1.3%, and lumen 1.4%. For measurements recorded at baseline and after 12.6±1.5 weeks, CV was respectively 3.5%, 3.3% and 6.6%. Reproducibility and interobserver and intraobserver variation showed very high correlations. A linear correlation was present in percent changes over 12.6±1.5 weeks between vessel volume and lumen volume (r=0.804; p<0.001) and between percent changes in plaque volume and vessel volume (r=0.581; p=0.007). No correlation was found between changes in plaque volume and lumen volume (r=0.015; p=0.950). Conclusion: ECG-gated 3D IVUS is a highly reproducible method when applied on coronary artery atherosclerosis. CV for lumen volume over 12.6±1.5 weeks is twice that of plaque volume indicating the superiority of the 3D IVUS compared to coronary angiography (CAG). [Copyright &y& Elsevier]

Abstract: Implantation of coronary stents after percutaneous coronary intervention (PCI) may result in an inflammatory response with an increase in high sensitive C-reactive protein (Hs-CRP) and interleukin 6 (IL-6). In 25 patients Hs-CRP and IL-6 increased after coronary artery stenting, however, the increase in the inflammatory response did not differ between PES and BMS stents. The inflammatory response did not predict neointima hyperplasia measured by intravascular ultrasound after 6 months. [Copyright &y& Elsevier]

Background: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes–ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19. Methods: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April). Main outcomes are the incidences of primary PCI, delayed treatment, and in-hospital mortality. Results: A total of 6609 patients underwent primary PCI in 77 centers, located in 18 countries. Diabetes was observed in a total of 1356 patients (20.5%), with similar proportion between 2019 and 2020. During the pandemic, there was a significant reduction in primary PCI as compared to 2019, similar in both patients with (Incidence rate ratio (IRR) 0.79 (95% CI: 0.73–0.85, p < 0.0001) and without diabetes (IRR 0.81 (95% CI: 0.78–0.85, p < 0.0001) (p int = 0.40). We observed a significant heterogeneity among centers in the population with and without diabetes (p < 0.001, respectively). The heterogeneity among centers was not related to the incidence of death due to COVID-19 in both groups of patients. Interaction was observed for Hypertension (p = 0.024) only in absence of diabetes. Furthermore, the pandemic was independently associated with a significant increase in door-to-balloon and total ischemia times only among patients without diabetes, which may have contributed to the higher mortality, during the pandemic, observed in this group of patients. Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a similar reduction in primary PCI procedures in both patients with and without diabetes. Hypertension had a significant impact on PCI reduction only among patients without diabetes. We observed a significant increase in ischemia time and door-to-balloon time mainly in absence of diabetes, that contributed to explain the increased mortality observed in this group of patients during the pandemic. Trial registration number: NCT 04412655. [ABSTRACT FROM AUTHOR]

The authors discuss the safety and efficacy of drug-eluting stents (DES) in women during long-term follow-up and reference a study by Giulio Stefanini and colleagues on the subject, published within the issue. Topics addressed include sex differences shown by ischemic heart disease and the effects of percutaneous coronary interventions, and rates of death or myocardial infarction in women treated with DES and bare-metal stents. Also mentioned are rates of definite or probable stent thrombosis.

Presents a letter to the editor in response to the article "Prinzmetal's Variant Angina and Alterations in Coronary Flow Velocity Reserve" by Lisette Okkels Jensen and Thayssen in the journal of Cardiology.

The relation between the resting full cycle ratio (RFR) and fractional flow reserve (FFR) is not fully understood. This study aims to investigate the influence of coronary microvascular dysfunction, assessed by the index of microvascular resistance (IMR), on RFR compared to FFR in patients undergoing functional assessment for coronary stenosis. Two-hundred patients with borderline stenosis underwent functional assessment of RFR, FFR, coronary flow reserve (CFR) and IMR. Retriever operator curve analysis was performed to assess the diagnostic value of RFR in patients with (IMR ≥ 24) and (IMR < 24). Median RFR did not differ significantly in patients with IMR ≥ 24 compared to patients with IMR < 24: 0.89 (interquartile range (IQR) 0.84, 0.95) vs. 0.90 (IQR 0.84, 0.92), p = 0.29). FFR was significantly higher in patients with IMR ≥ 24 compared to patients with IMR < 24: median FFR 0.85 (IQR (0.76, 0.92)) vs. 0.82 (IQR 0.73, 0.86), p = 0.009, and median CFR was significantly lower 1.80 (IQR 1.40, 2.55) vs. 2.70 (IQR 1.80, 3.95), p < 0.001. The diagnostic value of RFR was high (Area under the curve (AUC) 0.89 95 % Confidence Interval: [0.85, 0.93]) and AUC did not differ between patients with IMR ≥ 24 compared to patients with IMR < 24: 0.89 vs. 0.90, p = 0.89. An overall optimal cut off of 0.88 was identified. The cut off did not differ significantly between patients with IMR ≥ 24 compared to patients with IMR < 24: 0.88 vs. 0.90, p = 0.397. In patients with coronary borderline stenosis, the coronary microvascular function did not influence on the cut off values or AUC of RFR compared to FFR. • Non-hyperemic pressure ratios (NHPR) is an adenosine-free option to fractional flow reserve (FFR). • There is good diagnostic agreement between NHPRs and FFR, but there is still disagreement in some cases. • Microvascular disease has been proposed as factor in disagreement between NHPR and FFR. • Our study found good diagnostic agreement between the NHPR resting full cycle ratio (RFR) and FFR. • Coronary microvascular dysfunction did not influence the cut off and the area under the curve of RFR compared to FFR. [ABSTRACT FROM AUTHOR]

Aims The objectives were to describe differences in self-reported health at discharge between women diagnosed with angina or unspecific chest pain and investigate the association between self-reported health and adverse outcomes within 3 years. Methods and results Data from a national cohort study were used, including data from the DenHeart survey combined with 3 years of register-based follow-up. The population included two groups of women with symptoms of angina but no diagnosis of obstructive coronary artery disease at discharge (women with angina and women with unspecific chest pain). Self-reported health measured with validated instruments was combined with register-based follow-up on adverse outcomes (a composite of unplanned cardiac readmissions, revascularization, or all-cause mortality). Associations between self-reported health and time to first adverse outcomes were investigated with Cox proportional hazard models, reported as hazards ratios with 95% confidence intervals. In total, 1770 women completed the questionnaire (49%). Women with angina (n = 931) reported significantly worse self-reported health on several outcomes compared to women with unspecific chest pain (n = 839). Within the 3 years follow-up, women with angina were more often readmitted (29 vs. 23%, P = 0.011) and more underwent revascularization (10 vs. 1%, P < 0.001), whereas mortality rates were similar (4 vs. 4%, P = 0.750). Self-reported health (physical and mental) was associated with adverse outcomes between both groups (on most instruments). Conclusion Women with angina reported significantly worse self-reported health on most instruments compared to women with unspecific chest pain. Adverse outcomes varied between groups, with women diagnosed with angina experiencing more events. Registration ClinicalTrials.gov (NCT01926145). [ABSTRACT FROM AUTHOR]

A 60-year old woman with non-ST-segment elevation myocardial infarction, underwent coronary angiogram combined with optical coherence tomography (OCT) revealing a long dissection in the right coronary artery. The patient experienced peri-procedural chest pain, the electrocardiogram showed ST-segment elevations, and compromised coronary blood flow, why mechanical revascularization with percutaneous coronary intervention (PCI) was indicated. At 1-month follow-up, OCT revealed early, competent vascular healing, and a distal stenosis was treated with PCI. The patient has been asymptomatic since the procedure for three years. [ABSTRACT FROM AUTHOR]

Neutrophil gelatinase-associated lipocalin (NGAL) is an inflammatory biomarker related to acute kidney injury (AKI). Including 1892 consecutive patients with ST-elevation myocardial infarction (STEMI), in which NGAL was measured in 1624 (86%) on admission and in a consecutive subgroup at 6–12 h (n = 163) and 12–24 h (n = 222) after admission, this study aimed to evaluate the prognostic value of NGAL in predicting AKI and mortality. Patients were stratified based on whether their admission NGAL plasma concentration was greater than or equal to/less than the median. The primary endpoint was a composite of the first occurrence of AKI or all-cause death within 30 days. AKI was classified by the maximal plasma creatinine increase from baseline during index admission as KDIGO1 (<200% increase) or KDIGO23 (≥200% increase) according to the Kidney Disease Improving Global Outcomes (KDIGO) system. Admission NGAL > the median was independently associated with a higher risk of severe AKI (KDIGO2-3) and 30-day all-cause mortality when adjusted for age, admission systolic blood pressure and high-sensitivity C-reactive protein, left-ventricular ejection fraction, known kidney dysfunction, and cardiogenic shock with an odds ratio (95% confidence interval) of 2.26 (1.18–4.51), p = 0.014. Finally, we observed increasing predictive values in a subgroup during the first day of hospitalization suggesting that assessment of NGAL should be delayed for optimal prognostic purposes. [ABSTRACT FROM AUTHOR]

An 81-year-old male patient with a severe de novo coronary artery stenosis in the proximal left anterior descending artery was treated with a BioFreedom stent (3.5×11mm), three months later, the patient was re-admitted with chest pain and slightly increased troponin. The angiogram showed a significant in-stent restenosis in the recently treated lesion. Optical coherence tomography revealed a fully expanded stent without areas of incomplete stent apposition. Severe immature neointimal hyperplasia without formation of thrombosis was visualized, causing a severe in-stent restenosis. An underlying plaque rupture within the mid-proximal part of the in-stent restenosis was evident. [ABSTRACT FROM AUTHOR]