Effectiveness and Safety of Sirolimus Stent Implantation for Coronary In-Stent Restenosis (original) (raw)
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Highlights from the 57th Annual Scientific Session of the American College of Cardiology
The Journal of Thoracic and Cardiovascular Surgery, 2008
A variety of conflicting reports regarding the long-term safety of drug-eluting stents (DES) have been released during the past 24 months. The data presented at the American College of Cardiology Scientific Session, however, supported the overall safety of DES compared with bare metal stents (BMS) on the basis of several randomized trials and large observational registries. Of particular interest was the analysis of the Massachusetts angioplasty registry exploring the use and outcomes of patients treated with coronary stents for acute myocardial infarction between 2003 and 2004. The researchers found that in 5258 matched patients, those treated with DES had lower rates of 2-year mortality, reinfarction, and repeat revascularization compared with patients treated initially with BMS. 1
Cardiology News /Recent Literature Review / Mid Quarter 2012
2012
The ESC Congress will be held in Munich, 25-29/8/2012 TCT Meeting will take place in Miami, 22-26/10/12 HCS Meeting to be held in Athens, 1-3/11/12 AHA 2012 is scheduled for Los Angeles, 3-7/11/12 TWENTE Trial: the Resolute Zotarolimus Eluting Stents are Noninferior to Xience V Everolimus Eluting Stents in Treating “Real-World” Patients with Complex Lesions and “Off-label” Indications for DES A total of 1,391 patients were randomly assigned to zotarolimus eluting stents (ZES) (n = 697) or everolimus eluting stents (EES) (n = 694). Acute coronary syndromes were present in 52% and “off-label” feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, target vessel failure (TVF) occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; p (noninferiority) = 0.001). The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = NS). Definite s...
Initial and Follow-Up Results of the Tenax Coronary Stent
Journal of Interventional Cardiology, 2001
The Tenax coronary stent is laser sculpted from high precision 316 L stainless steel using advanced production procedures. An a-Sic : H (hydrogen-rich amorphous silicon carbide) coating reduces its thrombogenicity and improves its biocomputibility. From April to July 1998, 266 stents were implanted in 241 patients (aged 62.7 2 10.8 years) in five centers. The clinical indication for intervention was unstable angina (33.2%) and recent myocardial infarction (29.8%) in many cases. Most lesions (83.8%) had complex characteristics (Class B2 or C). The target vessel was the LAD in 42.8% and the right coronary artery in 36.8% of all cases. Four primary stent deployment failures occurred and implantation was successjid in 289 (97.4%) of 266 stenis. No death and no Qwave myocardial infarction or emergency CABG occurred during hospital stay. Clinical success, defined as successful deployment without procedural or clinical event, was achieved in 230 (98.4%) of 241 patients. One-year clinical follow-up shows a low need for target lesion revascularization ( 1 7/237 [7.1 %] patients) and a 15.8% rate of major adverse cardiac events (36/237 patients). The clinical and angiographic outcomes of our study suggest that the hybrid, amorphous hydrogenated silicon carbide coated design is promising and merits further evaluation in larger clinical trials. (J Interven Cardiol 2001;14: 1-5) Address for reprints: Pr.
The American Journal of Cardiology, 2010
Restenosis is associated with acute myocardial infarction (MI) either at presentation or related to complications of target lesion revascularization (TLR). The cumulative late effect of TLR after drug-eluting or bare metal stent placement on cardiac death or MI is uncertain. Of the 1,057 patients with one native coronary lesion randomized to a sirolimus-eluting stent or bare metal stent in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) trial, the 983 who survived free of MI for the first 30 days were evaluated for the primary outcome of cardiac death or MI for 5 years. Patients with events occurring at or after TLR were assigned to TLR group. Cox proportional hazards regression analysis with TLR as a time-dependent variable and adjustment for baseline clinical and demographic covariates was used to assess the independent effect of TLR on the primary outcome. TLR occurred in 160 patients (16.3%) and was an independent predictor of the primary end point (hazard ratio 2.8, 95% confidence interval 1.7 to 4.5). This association was significant for sirolimus-eluting stents and bare metal stents. TLR was also associated with an increased risk of subsequent stent thrombosis and nontarget vessel revascularization. Intracoronary brachytherapy in the TLR group was associated with an increased risk of cardiac death or MI. In conclusion, restenosis requiring TLR was associated with an increased risk of cardiac death or MI occurring at TLR and during the subsequent 5 years.
Highlights from the American College of Cardiology Annual Scientific Sessions 2004: March 9–12, 2004
American Heart Journal, 2004
glycoprotein IIb/IIIa receptor blockade improves clinical outcomes after percutaneous coronary intervention (PCI). Only one study, 1 however, has formally evaluated adjunctive glycoprotein IIb/IIIa inhibition in the setting of coronary stent implantation, even though stents are now used in more than 80% of all percutaneous interventions. Moreover, in the clinical trials performed to date, eptifibatide, a nonimmunogenic and rapidly reversible inhibitor of the platelet receptor integrin IIb/IIIa, has appeared to be less potent than the monoclonal antibody abciximab. It has since been recognized that an approximately 4 times higher dose of eptifibatide than that used in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis-II (IMPACT-II) trial would be required to achieve maximal platelet inhibition in coronary interventions.The ESPRIT trial was designed to test the safety and efficacy of an adjunctive, highdose, double-bolus regimen of eptifibatide in coronary stenting. Patients with known coronary artery disease who were scheduled to undergo elective PCI with stent implantation in a native coronary artery and who, in the opinion of the treating physician, would not routinely be treated with a IIb/IIIa inhibitor, were eligible for inclusion. Patients with a myocardial infarction (MI) within 24 hours before randomization were excluded from the trial. Patients were randomly assigned to receive either placebo or eptifibatide started immediately before PCI. Eptifibatide was given as two 180-µg/kg boluses 10 minutes apart and as a continuous infusion of 2.0 µg/kg per minute (or 1.0 µg/kg per minute in patients with serum creatinine >2.0 mg/dL) started at the same time as the first bolus and continued for 18 to 24 hours.All patients received concomitant aspirin.A weight-adjusted heparin regimen was recommended (initial bolus of 60 U/kg, not to exceed 6000 U) with a target activated clotting time between 200 and 300 seconds.Treatment with ticlopidine or clopidogrel was strongly encouraged on the day of the procedure but not before then; the use of a loading dose was also encouraged.
2002
glycoprotein IIb/IIIa receptor blockade improves clinical outcomes after percutaneous coronary intervention (PCI). Only one study, 1 however, has formally evaluated adjunctive glycoprotein IIb/IIIa inhibition in the setting of coronary stent implantation, even though stents are now used in more than 80% of all percutaneous interventions. Moreover, in the clinical trials performed to date, eptifibatide, a nonimmunogenic and rapidly reversible inhibitor of the platelet receptor integrin IIb/IIIa, has appeared to be less potent than the monoclonal antibody abciximab. It has since been recognized that an approximately 4 times higher dose of eptifibatide than that used in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis-II (IMPACT-II) trial would be required to achieve maximal platelet inhibition in coronary interventions.The ESPRIT trial was designed to test the safety and efficacy of an adjunctive, highdose, double-bolus regimen of eptifibatide in coronary stenting. Patients with known coronary artery disease who were scheduled to undergo elective PCI with stent implantation in a native coronary artery and who, in the opinion of the treating physician, would not routinely be treated with a IIb/IIIa inhibitor, were eligible for inclusion. Patients with a myocardial infarction (MI) within 24 hours before randomization were excluded from the trial. Patients were randomly assigned to receive either placebo or eptifibatide started immediately before PCI. Eptifibatide was given as two 180-µg/kg boluses 10 minutes apart and as a continuous infusion of 2.0 µg/kg per minute (or 1.0 µg/kg per minute in patients with serum creatinine >2.0 mg/dL) started at the same time as the first bolus and continued for 18 to 24 hours.All patients received concomitant aspirin.A weight-adjusted heparin regimen was recommended (initial bolus of 60 U/kg, not to exceed 6000 U) with a target activated clotting time between 200 and 300 seconds.Treatment with ticlopidine or clopidogrel was strongly encouraged on the day of the procedure but not before then; the use of a loading dose was also encouraged.
The Journal of Thoracic and Cardiovascular Surgery, 2009
The SYNTAX investigators explored the quality of life and cost-effectiveness of the strategy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for left main or multivessel coronary artery disease in this international randomized study of over 1600 patients. The group had previously published the 1-year outcomes from the study, which demonstrated similar rates of death and myocardial infarction at 12 months, with increased rates of repeat revascularization for the patients treated with PCI. 1 Dr David Cohen reported that although angina relief was slightly better with CABG than drug-eluting stents (DES) at 6 and 12 months, the differences were very small, and the overall costs (including hospitalization and rehabilitation) were significantly higher at 1 year for the patients treated with CABG. The 1-year cost-effectiveness (based on US health care costs) significantly favored PCI for patients with low and moderate levels of angiographic complexity; CABG was economically attractive for patients with the most severe angiographic complexity (SYNTAX score > 32). Another cost-effectiveness analysis of the SYNTAX patients is planned when the 5-year follow-up data become available, which should allow some insight into the longterm cost-effectiveness of CABG versus PCI for patients with both multivessel coronary artery disease as well as left main coronary artery disease. 2
Impact of In-Stent Restenosis on Death and Myocardial Infarction
The American Journal of Cardiology, 2007
Although drug-eluting stents reduce restenosis and target lesion revascularization compared with bare metal stents (BMSs), the specter of late stent thrombosis has curbed enthusiasm for the widespread use of drug-eluting stents. Alternatively, increasing BMS use would increase restenosis and potentially increase adverse events. The presentation and outcomes of BMS restenosis are controversial. We evaluated 2,539 patients with BMS restenosis referred for repeat revascularization. Major adverse cardiac events, including mortality and myocardial infarction (MI), were assessed at clinical presentation, 30 days, and 6 months. Patients with acute presentation (i.e., unstable angina requiring hospitalization or MI) were compared with patients with stable presentation. At presentation, 19.2% of patients were asymptomatic, 27.5% had exertional angina, 46.6% had unstable angina, and 6.7% had MI. Mortality and MI rates were 1.1% and 1.4%, respectively, at 30 days and 3.3% and 4.5%, respectively, at 6 months. Patients with acute coronary syndrome (ACS) and those without ACS had similarly low mortality rates at 30 days (1.2% ACS vs 1.0% non-ACS, p ؍ 0.65) and 6 months (3.4% ACS vs 3.3% non-ACS, p ؍ 0.93) and MI rates at 30 days (1.3% ACS vs 1.4% non-ACS, p ؍ 0.87) and 6 months (4.7% ACS vs 4.3% non-ACS, p ؍ 0.65). Combined major adverse cardiac events were similar at 30 days (2.5% vs 2.1%, p ؍ 0.53) and 6 months (7.4% ACS vs 6.9%, non-ACS, p ؍ 0.65). In conclusion, although BMS restenosis often manifests as an ACS, it is associated with a low incidence of 6-month major adverse cardiac events and does not predict a negative outcome.