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.
Comment In: J Am Coll Cardiol. 2009 Feb 24;53(8):665-619232898
Technological developments in percutaneous coronary interventions (PCI) allow the possibility for less invasive revascularization in an increasing number of patients with atherosclerotic coronary artery disease. Bare-metal stents (BMS) have considerably improved the efficacy of PCI in addition to greatly reducing restenosis. However, even with standard stents, restenosis has remained a significant limitation of this revascularization technique. The advent of drug-eluting stents (DES) has dramatically reduced in-stent restenosis and, as a result, the need for repeat revascularization. However, their potential thrombogenicity has raised concerns about their clinical utility and long-term safety. Indeed, there is a possible higher rate of late stent thrombosis (LST) with DES compared with BMS. Antiplatelet therapy has been shown to be efficient in preventing DES thrombosis. Nevertheless, in the future, significant improvement will occur to improve the safety and efficacy of this therapy. This article will summarize the pathophysiology and the epidemiology of stent thrombosis (ST). Definitions of definite, probable and possible ST will be described. Furthermore, clinical risk factors for ST will be clearly enumerated. Then, the various antiplatelet therapeutic strategies used to prevent ST will be taken in consideration. Finally, a summary of the major recommendations about antiplatelet therapy made by some of the most prestigious learned societies will be presented.
The present work was aimed at comparative assessment of efficacy and risk factors of carotid endarterectomy and carotid stenting in patients suffering from symptomatic stenoses of the internal carotid arteries, with due regard for the degree of the accompanying cardiac pathology, the presence of contralateral occlusion, and severity of chronic cerebrovascular insufficiency. We examined and treated a total of 142 patients diagnosed with stenoses of the internal carotid arteries and symptoms of chronic cerebrovascular insufficiency. In the cohort of those subjected to carotid endarterectomy we performed a total of 76 operations in 73 patients, and in the group of carotid stenting 71 operations of stenting of the internal carotid artery with cerebral protection in 69 patients. Postoperatively we assessed the following parameters: «stroke+lethality», incidence of transitory ischaemi? attacks, incidence rate of cerebrovascular neuropathy, and acute myocardial infarction. In the carotid endarterectomy group, we revealed increased risk for the development of neuropathy of the craniocerebral nerves (OR=0.0564, 95% CI 0.9953, P=0.049). In the group of stenting, we revealed increased risk for the development of transitory ischaemia.
Patients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring offers the opportunity to improve outcomes after coronary stenting by individualizing therapy.
We randomly assigned 2440 patients scheduled for coronary stenting at 38 centers to a strategy of platelet-function monitoring, with drug adjustment in patients who had a poor response to antiplatelet therapy, or to a conventional strategy without monitoring and drug adjustment. The primary end point was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization 1 year after stent implantation. For patients in the monitoring group, the VerifyNow P2Y12 and aspirin point-of-care assays were used in the catheterization laboratory before stent implantation and in the outpatient clinic 2 to 4 weeks later.
In the monitoring group, high platelet reactivity in patients taking clopidogrel (34.5% of patients) or aspirin (7.6%) led to the administration of an additional bolus of clopidogrel, prasugrel, or aspirin along with glycoprotein IIb/IIIa inhibitors during the procedure. The primary end point occurred in 34.6% of the patients in the monitoring group, as compared with 31.1% of those in the conventional-treatment group (hazard ratio, 1.13; 95% confidence interval [CI], 0.98 to 1.29; P=0.10). The main secondary end point, stent thrombosis or any urgent revascularization, occurred in 4.9% of the patients in the monitoring group and 4.6% of those in the conventional-treatment group (hazard ratio, 1.06; 95% CI, 0.74 to 1.52; P=0.77). The rate of major bleeding events did not differ significantly between groups.
This study showed no significant improvements in clinical outcomes with platelet-function monitoring and treatment adjustment for coronary stenting, as compared with standard antiplatelet therapy without monitoring. (Funded by Allies in Cardiovascular Trials Initiatives and Organized Networks and others; ARCTIC ClinicalTrials.gov number, NCT00827411.).
Comment In: N Engl J Med. 2013 Feb 28;368(9):87123445102
Carotid artery disease is a major cause of the disability and mortality associated with strokes. Ischemic stroke remains the major cause of adult disability and third-leading cause of adult mortality, and carotid revascularization currently remains the principal surgical tool in the prophylaxis of this disease.
The literature representing the current body of evidence for carotid revascularization and the authors' current practices in the management of this disease are summarized in this review.
We provide an evidence-based narration of the development and current status of carotid artery stenting (CAS) by reviewing 1) the evidence for carotid revascularization from early carotid endarterectomy (CEA) trials; 2) the randomized trials comparing CEA and CAS, with a special emphasis on the recently published results of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which have been a "game-changer," tipping the balance towards accepting CAS as a safe, equally effective, and durable alternative to CEA for all patients requiring carotid revascularization; and 3) the technical advances in CAS after enrollment of patients in the CREST.
CAS and CEA are complementary procedures. Judicious selection of the procedure is made on a case-by-case basis.
Reports addressing treatment of in-stent restenosis (ISR) are principally derived from clinical trials.
To characterize the spectrum of ISR in an unselected population, and to explore clinical and angiographic factors determining management.
During a prespecified six-month period before the introduction of drug-eluting stents, consecutive cases of ISR that were identified during clinically driven cardiac catheterization at five hospitals offering all approved treatment modalities for ISR were prospectively registered.
ISR was identified in 363 patients; 301 (84%) had one ISR lesion and 62 (16%) had multiple lesions. Unstable clinical presentations accounted for 51%, including 15% with ST-elevation myocardial infarction. The median interval (25th, 75th percentiles) from stent insertion to angiographic diagnosis of ISR was eight months (Q1,Q3: 4,15), with a median stented length of 18 mm (Q1,Q3: 15,28). The majority of lesions (60%) displayed a diffuse ISR pattern (Mehran types 2 and 3). ISR type was independent of time to re-presentation, diabetes, arterial territory and total stent length. Treatment included percutaneous coronary intervention (PCI) alone (n=139 [38%]), PCI with brachytherapy (n=105 [29%]), medical therapy (n=60 [17%]) and coronary artery bypass graft surgery (n=59 [16%]). Medical therapy was associated with small vessel size and recurrent ISR, and coronary artery bypass graft surgery was associated with multiple lesions, as well as diffuse, occlusive and recurrent ISR. For patients treated percutaneously, PCI treatment alone was more common for focal restenosis and after ST-elevation myocardial infarction, and brachytherapy was the more common treatment for diffuse and recurrent ISR, and stable angina.
These data provide a benchmark description of the spectrum of ISR with which the impact of drug-eluting stents may be compared and better understood.
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BACKGROUND: The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark. METHODS AND RESULTS: A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjusted RR=6.74; 95% CI=1.23 to 37.00; P=0.03). The 2-year incidence of myocardial infarction was similar in the 2 groups, 5.2% in the DES group versus 6.3% in the BMS group (P=0.28; adjusted RR=1.13; 95% CI=0.81 to 1.59; P=0.47). All-cause 2-year mortality was 7.8% in the DES group and 11.4% in BMS group (P
Department of Cardiology, Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie, affilié à l'Université Laval, 2725, Chemin Ste Foy, Québec, Canada, G1V 4G5. firstname.lastname@example.org
This study compared acute and late outcomes following a strategy of selective drug-eluting stent (DES) use guided by a set of 4 criteria defining higher risk of in-stent restenosis compared to an exclusive DES strategy in 362 patients with multilesion (n = 900) percutaneous coronary interventions.
At a mean follow up of 412 +/- 110 days, major adverse cardiac events (death, myocardial infarction, revascularization) were 16.8% in the exclusive DES group compared to 18.4% in the selective DES group (p = 0.78). By univariate analysis, revascularization rates (9.9% in the exclusive DES group versus 10.5% in the selective DES group; p = 1.0) and target lesion revascularization (TLR) rates (5.5% versus 6.2%; p = 0.77) were similar in the 2 groups. By multivariate analysis adjusted by propensity score to account for differences in baseline characteristics, the strategy of exclusive DES use was not associated with lower risks of revascularization (hazard ratio [HR]: 0.91, 95% confidence interval [CI] 0.64-1.29) or TLR (HR: 0.81, 95% CI 0.59-1.08) compared with selective DES use. Using the Academic Research Consortium criteria, stent thrombosis occurred in 6/161 (3.7%) cases in the exclusive DES group and in 1/201 (0.5%) case in the selective DES group (p = 0.03).
In patients with multiple coronary lesions, a selective DES strategy for lesions at higher risk of restenosis and bare-metal stents for other lesions was safe and effective when compared to the exclusive use of DES. A large, prospective, randomized trial is required to validate a criteria-based selective DES strategy compared to systematic DES use.