Anthony A. Bavry

Appropriate use of drug-eluting stents: balancing the reduction in restenosis with the concern of late thrombosis

Restenosis is a serious occurrence that can lead not only to recurrent angina and repeat revascularisation but also to acute coronary syndromes. Drug-eluting stents revolutionised interventional cardiology owing to their pronounced ability to reduce restenosis compared with bare-metal stents. Attention has now shifted to safety of these devices because of evidence suggesting an association with late stent thrombosis. Findings of randomised clinical trials have not shown that drug-eluting stents result in excess mortality after 4-5 years of follow-up. Current recommendations are that individuals with a drug-eluting stent should receive at least 12 months of uninterrupted dual antiplatelet treatment; patients must understand the importance of this long-term regimen. Patients assessment should focus on bleeding abnormalities, pre-existing disorders that need anticoagulation treatment, and possible future surgical procedures, since these factors could all contraindicate use of drug-eluting stents. Many people will do well with a bare-metal stent, whereas for individuals with a high likelihood of restenosis and late thrombosis, medical management or surgical revascularisation might be preferred options.

Incremental effect of clopidogrel on important outcomes in patients with cardiovascular disease: a meta-analysis of randomized trials.

ObjectivesTo quantify the impact of clopidogrel plus aspirin on the individual outcomes of death, myocardial infarction, or stroke in patients with established cardiovascular disease, or in patients with multiple risk factors for vascular disease.BackgroundRandomized trials have demonstrated a reduction in composite outcomes when clopidogrel is added to aspirin therapy in patients with coronary artery disease; however, the magnitude of benefit on individual outcomes is unknown.MethodsWe conducted a meta-analysis on randomized, controlled trials that compared aspirin plus clopidogrel with aspirin plus placebo for the treatment of coronary artery disease.ResultsThis analysis included five randomized trials (CURE, CREDO, CLARITY, COMMIT, and CHARISMA) in 79 624 patients. The incidence of all-cause mortality was 6.3% in the aspirin plus clopidogrel group versus 6.7% in the aspirin group (odds ratio [OR] 0.94; 95% CI 0.89, 0.99; p = 0.026). The incidence of myocardial infarction was 2.7% and 3.3% (OR 0.82; 95% CI 0.75, 0.89; p < 0.0001), and stroke was 1.2% and 1.4% (OR 0.82; 95% CI 0.73, 0.93; p = 0.002). Similarly, the incidence of major bleeding was 1.6% and 1.3% (OR 1.26; 95% CI 1.11, 1.41; p < 0.0001), and fatal bleeding was 0.28% and 0.27% (OR 1.04; 95% CI 0.76, 1.43; p = 0.79).ConclusionThe addition of clopidogrel to aspirin results in a small reduction in all-cause mortality in patients with ST-elevation myocardial infarction and a modest reduction in myocardial infarction and stroke in patients with cardiovascular disease. The overall incidence of major bleeding however is increased, although there is no excess of fatal bleeds or hemorrhagic strokes.

Development of Coronary Aneurysm after Drug-Eluting Stent Implantation

Background: The problem of drug-eluting stents increasing the risk for late thrombosis, especially when antiplatelet therapy becomes interupted, is a growing concern (1). Recently, a new association with these devices was observed at our institution (Cleveland Clinic, Cleveland, Ohio). Objective: To report cases of coronary aneurysm after drug-eluting stent implantation and to describe the different strategies used to treat the problem. Case Report: An aneurysm (8 mm in diameter by intravascular ultrasonography) was discovered in a 49-year-old woman 19 months after implantation of a sirolimus-eluting stent (CYPHER, Cordis Corp., Miami Lakes, Florida) (Figure 1). The patient underwent excision of the aneurysm with a bypass graft to the distal artery. Pathologic examination of the aneurysm revealed eosinophilic infiltration. Figure 1. Coronary aneurysm after stent implantation. A 44-year-old man had a coronary aneurysm (14 mm in diameter by intravascular ultrasonography) that was discovered 21 months after implantation of 2 paclitaxel-eluting stents (TAXUS, Boston Scientific, Natick, Massachusetts) (Figure 2). The patient underwent successful coiling of the aneurysm. Figure 2. Coronary aneurysm after stent implantation ( A ) and coronary aneurysm coiling ( B ). A 45-year-old man had an aneurysm that was discovered 6 months after implantation of a paclitaxel-eluting stent. After 12 months of clinical surveillance, repeated angiography revealed nearly complete resolution of the aneurysm (Figure 3). Figure 3. Stent implantation ( A ), coronary aneurysm after stent implantation ( B ), and nearly complete aneurysm resolution after stent implantation ( C ). A 49-year-old woman had a coronary aneurysm that was discovered 10 months after implantation of a sirolimus-eluting stent. Intravascular ultrasonography of the left main artery revealed an aneurysm without evidence of dissection or thrombus (Figure 4). The plan is for continued clinical surveillance. Figure 4. Left main artery aneurysm ( white arrow ) and dilatation of the left anterior descending sirolimus-eluting stent ( black arrow ). Discussion: The incidence of coronary aneurysm after the use of drug-eluting stents is currently unknown. In the Treatment of De Novo Coronary Disease Using a Single Paclitaxel Eluting Stent V (TAXUS-V) trial (2), the incidence was 1.4% with paclitaxel-eluting stents, compared with a 0.2% prevalence with bare metal stents (P= 0.07). Moreover, in 2 of our patients, no angiographic abnormalities with coexisting bare-metal stents were found. Late stent thrombosis and coronary aneurysm formation may share the same pathogenesis of localized hypersensitivity to drug-eluting stents (3). Similar inflammatory reactions have not been seen with bare-metal stents (4). Aneurysm formation was also not explained by obvious technical factors, such as the use of excessive pressure during stent deployment or the use of oversized stents. In all patients, stent size appeared to be well-matched to reference vessel diameter. Conclusion: Coronary aneurysm formation can occur in all coronary distributions after the use of drug-eluting stents. Currently, the natural history and best treatment for the problem is unknown; however, some aneurysms resolve. Because they may be serious problems, some aneurysms should be considered for surgical excision, percutaneous coiling, or placement of a covered stent.

Long-term benefit of statin therapy initiated during hospitalization for an acute coronary syndrome: a systematic review of randomized trials.

ObjectiveThis study sought to determine if the initiation of statin (HMG-CoA reductase inhibitor) therapy during acute coronary syndromes reduces long-term mortality and other adverse cardiac outcomes.BackgroundInitiation of statin therapy during acute coronary syndromes has not been shown to reduce mortality, myocardial infarction or stroke within 4 months of follow-up.MethodsClinical trials that randomized patients with acute coronary syndromes to early statin therapy compared with less intensive lipid reduction (placebo/lower-dose statin/usual care), and reported long-term outcomes were included for analysis.ResultsIn all, there were seven studies (L-CAD, PTT, FLORIDA, Colivicchi et al., PROVE-IT, ESTABLISH, and A-to-Z) with 9553 patients who started statin therapy within 12 days of hospital presentation. The incidence of all-cause mortality was 3.4% in the statin group versus 4.6% in the less intensive lipid reduction group over a weighted mean follow-up of 22.9 months (relative risk [RR] 0.74; 95% CI 0.61, 0.90; p = 0.003). The number of patients needed to treat to prevent one death was 84 patients. Similarly, the incidence of cardiovascular mortality in the statin versus the less intensive lipid reduction group was 2.4% versus 3.3% (RR 0.74; 95% CI 0.58, 0.93; p = 0.010), unstable angina 4.1% versus 5.0% (RR 0.81; 95% CI 0.68, 0.98; p = 0.027), revascularization 11.2% versus 12.9% (RR 0.86; 95% CI 0.78, 0.96; p = 0.006), stroke 1.1% versus 1.2% (RR 0.90; 95% CI 0.62, 1.30; p = 0.56), and myocardial infarction 6.6% versus 7.0% (RR 0.94; 95% CI 0.81, 1.09; p = 0.41).ConclusionsThe benefit of early initiation of statin therapy during acute coronary syndromes slowly accrues over time so that a survival advantage is seen around 24 months. Relatively few patients need to be treated to prevent one death over this time period. Furthermore, this approach significantly reduces unstable angina and the need for revascularization.

The effect of drug-eluting stents on intermediate angiographic and clinical outcomes in diabetic patients: Insights from randomized clinical trials

OBJECTIVEnImplantation of drug-eluting stents has emerged as the predominant percutaneous revascularization strategy in diabetic patients, despite limited outcomes data. Accordingly, our aim was to conduct a meta-analysis to assess the benefit and safety profile of drug-eluting stents in diabetic patients.nnnMETHODSnWe included randomized trials comparing either the paclitaxel- or sirolimus-eluting stent with a bare-metal stent or with each other in diabetic patients during a follow-up of at least 6 months.nnnRESULTSnA total of 16 studies were identified, which included 2951 diabetic patients who were followed up for 6 to 12 months. Target lesion revascularization was less frequently performed in patients who received drug-eluting stents compared with bare-metal stents (risk ratio [RR] 0.35, 95% CI 0.27-0.46, P < .0001). Similar reductions were noted in the incidence of major adverse cardiovascular events (RR 0.42, 95% CI 0.31-0.56, P < .0001), in-segment restenosis (RR 0.31, 95% CI 0.25-0.40, P < .0001), and non-Q-wave myocardial infarction (RR 0.57, 95% CI 0.32-0.99, P = .046). Event rates were similar for Q-wave myocardial infarction (RR 0.72, 95% CI 0.25-2.07, P = .54), death (RR 0.64, 95% CI 0.32-1.28, P = .20), and stent thrombosis (RR 0.41, 95% CI 0.13-1.27, P = .12).nnnCONCLUSIONSnIn conclusion, diabetic patients who receive drug-eluting stents have a significantly lower incidence of target lesion revascularization, in-segment restenosis and myocardial infarction at 6 to 12 months, compared with bare-metal stents. The rates of mortality and stent thrombosis are similar.

Is Clopidogrel Cardiovascular Medicine’s Double-Edged Sword?

Antiplatelet therapy with aspirin has been unequivocally demonstrated to reduce the risk of ischemic complications across a broad spectrum of patients with vascular disease.1 This agent is also an important pharmacological adjunct to percutaneous and surgical coronary revascularization procedures. Administration of aspirin after coronary bypass graft operations had been the standard of care for many years, although early experience suggested that this agent would increase hemorrhagic complications if administered before surgery.2 However, subsequent evidence showed that preoperative aspirin improves survival without an appreciable increase in surgical bleeding.3 More recently, concerns regarding surgical bleeding risk have resurfaced with the introduction into clinical practice of a newer class of platelet inhibitors: the thienopyridines, ticlopidine and clopidogrel.nnArticle p 1667 nnThienopyridines interfere with platelet activation by selectively and irreversibly blocking a subunit of the adenosine diphosphate receptor. This provides an antiplatelet effect that is additive to the inhibition of the thromboxane A2 pathway by aspirin. The clinical benefit derived from the combination of aspirin and a thienopyridine first became apparent with trials demonstrating the efficacy of these agents in preventing subacute thrombosis after coronary stenting.4 Subsequently, large-scale clinical studies showed that long-term therapy (9 to 12 months) with aspirin and clopidogrel reduces ischemic complications compared with aspirin alone among patients with acute coronary syndromes5 or after percutaneous coronary revascularization.6 In the population of patients with acute coronary syndromes, dual antiplatelet therapy begins to reduce adverse outcomes as early as 2 hours after administration, and the magnitude of benefit expands over the following 9 months.5 Moreover, several lines of evidence suggest that the greatest suppression of ischemic events among patients undergoing percutaneous coronary revascularization is achieved if a 300- to 600-mg loading dose of clopidogrel is administered 2 to 6 hours before the interventional procedure is …

Bare metal stent thrombosis 13 years after implantation

There has been a great deal of recent controversy regarding the risk of very late stent thrombosis with drug eluting stents, especially in the context of antiplatelet therapy cessation. We report a case of very late stent thrombosis of a bare metal stent initially implanted for treatment of a myocardial infarction. The patient presented thirteen years later with a recurrent myocardial infarction three days after discontinuing aspirin. Angiography demonstrated thrombotic occlusion and severe underlying restenosis of the stent. To our knowledge, this is the latest bare metal stent thrombosis described in the world medical literature.

Safety and efficacy of overlapping sirolimus-eluting versus paclitaxel-eluting stents☆☆☆

BACKGROUNDnThe short-term and long-term safety and efficacy of paclitaxel versus sirolimus-overlapping drug-eluting stents (DES) is unknown. We sought to examine the clinical consequences of overlapping sirolimus versus paclitaxel DES.nnnMETHODSnWe reviewed catheterization reports from April 2003 to May 2005 for all patients who underwent percutaneous coronary revascularization with DES. All patients were followed-up for at least 1 year. Patients were included if they received only 2 single-type overlapping stent (eg, sirolimus-sirolimus) during the index procedure. The end points included early (inhospital and 30-day) and late composite of all-cause mortality, stent thrombosis, myocardial infarction, and target lesion revascularization.nnnRESULTSnA total of 282 individuals met our study criteria. Of these, 188 had sirolimus and 94 had paclitaxel-overlapping DES. There were 78 events for a median follow-up of 24 months for the composite end point. No statistically significant differences between overlapping sirolimus and paclitaxel DES were seen for inhospital, 30-day (16% vs 23%, respectively; P = .13), and long-term (25% vs 33%, respectively; P = .16) composite end points. In addition, in Kaplan-Meier and Cox proportional hazard analysis, no significant differences for the composite end point were noted.nnnCONCLUSIONSnIn this analysis, there were no significant differences in safety or efficacy between the 2 types of overlapping DES. Trends toward more events with overlapping paclitaxel stents should be evaluated in an adequately powered randomized controlled trial.

Acute Coronary Syndromes in Clinical Practice

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Managing Acute Coronary Syndromes in Clinical Practice

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