2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry).
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.
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Comment In: J Am Coll Cardiol. 2009 Feb 24;53(8):665-619232898
2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial.
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).
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.
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.
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).
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.
Analyze clinical, temporal and procedural characteristics from 7,528 consecutive percutaneous coronary intervention (PCI) patients in one of the largest published contemporary European PCI-database during a 6-year period.
Retrospective study design.
1998-2004. Temporal and referral changes in a Danish PCI-registry were analyzed. Demographic and angiographic variables were compared with data from randomized clinical trials, US-registries and current guidelines.
22,214 patients were examined with coronary angiography and 7,528 patients were treated with PCI. The annual number of PCI's increased by 15%. Over time, the fraction of patients with risk factors increased, median age increased from 61 to 64 years and the coronary pathology was significantly worsened. ST-elevation myocardial infarction patients primarily admitted to hospitals without facilities for primary angioplasty, were less likely to receive primary PCI. Baseline-data were in general in par with randomized clinical trial study populations and large-scale US data-registries. Interestingly, 14% of all PCI-procedures were performed on patients with a clinical presentation, for which coronary artery bypass grafting would be recommended by guidelines.
PCI is performed in an increasingly sicker population, but generally in accordance with randomized trials and similar to US tradition. However, 14% were treated with PCI even though coronary artery bypass grafting was recommended by guidelines.
A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial).
We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.
There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.
We randomized 213 patients with diabetes and coronary artery disease to EES (n?=?108) or SES (n?=?105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.
At 10-month angiographic follow-up, in-stent late lumen loss was 0.20?±?0.53 mm and 0.11?±?0.49 mm (P?=?0.28), and angiographic restenosis rate was 3.8% and 5.2% (P?=?0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P?=?0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P?=?0.28).
EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
PURPOSE: To compare the outcome of endovascular aneurysm repair (EVAR) versus conventional open repair (OR) in patients with a short, angulated or otherwise challenging proximal neck. METHODS: The definition of a challenging proximal neck was based on diameter (>or=28 mm), length (or=60 degrees ), shape (reverse tapered or bulging), and thrombus lining (>50%). Between January 2005 and December 2007, 187 consecutive patients (159 men; mean age 73 years, range 48-92) operated for asymptomatic abdominal aortic aneurysm (AAA) were identified as having challenging proximal neck morphology. Of these, 61 patients were treated with OR at center I (group A), 71 with standard EVAR (group B; 45 center I, 29 center II) and 52 with fenestrated EVAR (group C) at center II. Clinical examination and computed tomography were performed at 1 month and yearly thereafter. RESULTS: There was no statistically significant difference between groups A, B, and C regarding primary technical success rate, 30-day mortality, or late AAA-related mortality. The mean length of follow-up was 19.5 months (range 0-40). Freedom from reintervention at 3 years was 91.8%, 79.7%, and 82.7% for groups A, B, and C, respectively (p = 0.042). The only statistically significant difference between standard and fenestrated EVAR was a higher incidence of late sac expansion [9 (12.2%) versus 1 (1.9%), p = 0.036] in the standard stent-graft group. Reinterventions were more frequent after EVAR (p = NS), but open reinterventions were more common after OR. Reinterventions after EVAR were related to the presence of an angulated (p = 0.039) or short neck (p = 0.024). CONCLUSION: The results of EVAR and OR were similar for AAAs with a challenging proximal neck. Endovascular reinterventions were more frequent after EVAR, particularly in patients with an angulated or short neck. Open reinterventions were more common after OR. More patients and long-term data are needed to confirm these findings.
Endovascular grafts are a new, experimental surgery for AAAs that alleviates the need for open abdominal surgery. They offer an important alternative for high risk patients who would be at a greater risk with the more invasive surgical procedure. However, this is based on limited evidence, and more randomized controlled trials are needed. The procedure may be cheaper than open surgery, because of the lengthy hospital stay and operating room time with the latter, provided that the costs of the devices are low enough. However, there is insufficient data on the outcomes with endovascular grafts in different patient groups. As with many new or minimally invasive techniques, there is a "learning curve" which will affect costs and outcomes. Endovascular grafting is no exception, and repeated practical applications are needed for competence, expertise and good outcomes. Continued monitoring of this technique is needed. A registry of elective AAA patients now has 10-year follow-up data on about a third of the Canadian patients operated on in 1988. Further development of such registries will provide more accurate information on success rates, costs, and long-term complications.
An observational study determining the long-term impact of chronic kidney disease (CKD) on patients undergoing percutaneous coronary intervention at a tertiary cardiac referral center. CKD is associated with poor in-hospital outcomes after percutaneous coronary intervention, but its effect beyond 1 year, particularly in the drug-eluting stent (DES) era, has not been reported.
Baseline creatinine was available for 11,953 patients entered into a prospective registry (April 2000 to September 2007). Patients were stratified: those with or without at least moderate CKD (creatinine clearance,
to estimate the effect of decompressive stented drainage of biliary anastomosis on incidence of biliary complications.
294 patients aged from 5 months to 61 years (mean 13.8±0.81) were enrolled. They underwent liver fragments transplantation in the Department of Liver Transplantation of Petrovsky Russian Research Center of Surgery for the period from March 1997 to January 2016. Decompressive stented drainage tubes were used in 28 (9.5%) patients. Reconstruction without drainage was applied in 266 (90.5%) cases. In the group of biliobiliary reconstruction drainage was used in 18 out of 89 cases (20.2%), in the group of biliodigestive reconstruction - in 10 out of 202 cases (4.9%). Incidence of specific biliary complications was assessed.
There was significant direct correlation of stented drainage of biliodigestive anastomosis with various biliary complications including bile leakage (r= -0,1253; p=0.06), obturation of anastomosis (r=0.045; p=0.501), stricture of anastomosis (r= -0.0665; p=0.320), other strictures of intrahepatic bile ducts (r= -0.0291; p=0.664), hepatolithiasis (r=0.0857; p=0.199). However significant direct correation was observed between stented drainage and incidence of intrahepatic bile ducts strictures (r=0.2117; p=0.046) and anastomosis obturation (r=0.2330; p=0.028) in case of biliobiliary reconstruction. Significant correation with other biliary complications was absent (p>0.05).
Unconstrained stented drainage during primary biliary reconstruction is associated with increased incidence of biliary complications and should not be indicated routinely. Clear need for drainage should be determined in further investigations.
The purpose was to estimate the proportion of current open aortic arch reconstructions that might be feasible for endovascular repair. From all elective repair made in Southern Sweden in one center between 2005 and 2012, 129 open and eight endovascular aortic arch repairs were identified. The anatomy of the ascending arch and descending aorta as well as the arch vessels was categorized from multiplanar and axial computed tomography scans. Of 129 open cases, only two (1.5%) were suitable for endovascular repair. Among 137 all arch open and endovascular arch reconstructions performed during the study period, only 10 (7%) were candidates for endovascular repair. The most common exclusion for endovascular repair was an excessively large ascending aortic diameter. In conclusion, only a small proportion of patients having an open arch repair are suitable for endovascular arch repair, a finding related to the large diameter of the ascending aorta.
