The Year in Interventional Cardiology

Dixon, Simon; Grines, Cindy L.; O’Neill, William W.

doi:10.1016/j.jacc.2006.02.021

Cited by 29 publications

(5 citation statements)

References 338 publications

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“…In this small series, G-CSF prevented LV dilatation and improved EF (36). Conversely, other studies have found no benefit of G-CSF (37). To investigate this lack of benefit, Ripa et al (38) quantified and characterized the types of cells mobilized by G-CSF in the STEMMI (Stem Cells in Myocardial Infarction) trial.…”

Section: Acute Myocardial Infarction (Mi)mentioning

confidence: 91%

The Year in Interventional Cardiology

Dixon¹,

Grines²,

O’Neill³

2008

Journal of the American College of Cardiology

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Section: Acute Myocardial Infarction (Mi)mentioning

confidence: 91%

The Year in Interventional Cardiology

Dixon¹,

Grines²,

O’Neill³

2008

Journal of the American College of Cardiology

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“…Additional predictors for late stent thrombosis are included in Table 3. 115,[133][134][135][136][137] Several studies and registries have identified predictors of DES thrombosis. Of these, acute coronary syndrome, left ventricular ejection fraction Յ30%, bifurcation treatment, renal insufficiency, diabetes, and premature or standard discontinuation of antiplatelet therapy were the strongest predictors of cumulative stent thrombosis.…”

Section: Des and Stent Thrombosismentioning

confidence: 99%

Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention

Newsome¹,

Kutcher²,

Royster³

2008

Anesthesia &Amp; Analgesia

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The subspecialty of interventional cardiology has made significant progress in the management of coronary artery disease over the past three decades with the development of percutaneous coronary transluminal angioplasty, atherectomy, and bare-metal and drug-eluting stents (DES). Bare-metal stents (BMS) maintain vessel lumen diameter by acting as a scaffold and prevent collapse incurred by angioplasty. However, these devices cause neointimal hyperplasia leading to in-stent restenosis and requiring reintervention in more than 20% of patients by 6 mo. DES (sirolimus and paclitaxel) prevent restenosis by inhibiting neointimal hyperplasia. However, DESs also delay endothelialization, causing the stents to remain thrombogenic for an extended, yet unknown, period of time. Late stent thrombosis is associated with a 45% mortality rate. Premature discontinuation of antiplatelet therapy, particularly clopidogrel, is the strongest predictor of stent thrombosis. Sixty percent of patients receive stents for off-label (unapproved) indications, which also increases the frequency of stent thrombosis. Clopidogrel and aspirin are the cornerstone of therapy in the prevention of stent thrombosis in both BMS and DES. Recommendations pertaining to the optimal duration of dual-antiplatelet therapy have been debated. Both the Food and Drug Administration and the American Heart Association/American College of Cardiologists, in association with other major societies, have made recommendations to extend the duration of dual-antiplatelet therapy in patients with DES to 1 yr. The 6-wk duration of dual-antiplatelet therapy in patients with BMS remains unchanged. All patients with coronary stents must remain on life-long aspirin monotherapy. Since the introduction of percutaneous transluminal coronary angioplasty for the treatment of coronary atherosclerosis, the practice of percutaneous coronary intervention has undergone a dramatic transformation from simple balloon dilation catheters to sophisticated mechanical endoprostheses. These advancements have impacted the practice of perioperative medicine. In this series of two articles, in Part I we will review the evolution of percutaneous coronary intervention and discuss the issues associated with percutaneous transluminal coronary angioplasty and coronary stenting; in Part II we will discuss perioperative issues and management strategies of coronary stents during noncardiac surgery.

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“…Although randomized trials of off-label DES versus BMS have not yet been reported, numerous registries and randomized trials suggest that DES are safe and effective in subsets of patients and lesions that were not tested in the pivotal trials (13,14). Over the past year, several prospective randomized trials demonstrated improved angiographic and clinical outcomes comparing DES with BMS in complex lesion subsets (15), long lesions requiring overlapped stents (16), in-stent restenosis (17)(18)(19), saphenous vein grafts (20), chronic total occlusions (21), and 8 different primary PCI trials (22).…”

Section: Des Compared With Bms For Off-label Indicationsmentioning

confidence: 99%

Off-Label Use of Drug-Eluting Stents

Grines

2008

Journal of the American College of Cardiology

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Since Food and Drug Administration (FDA) approval of the first drug-eluting stent (DES) in April 2003, their use increased to 90% of all coronary stent procedures in the U.S. by 2006 (1). With restenosis virtually eliminated, DES were applied to increasingly more complex coronary lesions. However, over the past few years, reports of late stent thrombosis began to emerge. Additional reports of late stent thrombosis and increased mortality compared with baremetal stents (BMS) emerged from the European Society of Cardiology meeting in the fall of 2006 (2). These reports were eventually thought to be not entirely accurate owing to incomplete data and the methods of analysis. However, media attention, litigation concerns, and physician confusion resulted in a remarkable 42% decrease in the sales of DES over the next 6 months (3). Was the cardiology community overreacting, or was this drop in utilization of DES justified? See page 607The FDA ProcessTo address these concerns, the FDA convened the Circulatory System Devices Advisory Panel on December 7 and 8, 2006, to fully characterize the risk of DES thrombosis (4). They concluded that, compared with BMS, both types of FDA-approved DES (Cypher [Cordis, Miami Lakes, Florida] and Taxus [Boston Scientific, Natick, Massachusetts]) are associated with a small increase in stent thrombosis that emerges 1 year after stent implantation. However, this was not associated with an increased risk of death and MI (possibly owing to insufficient numbers or being offset by a reduction in events from prevention of restenosis and additional revascularization procedures). They concluded that concerns about thrombosis do not outweigh the benefits of DES when implanted for approved indication.The FDA panel also observed that at least 60% of current DES use is off-label, and off-label use is associated with increased events. However, they acknowledge that "with more complex patients there is an expected increased risk in adverse events" and noted that the FDA does "not regulate how [DES] are used by individual clinicians in the practice of medicine" (4).Although some have accused our regulatory agency of being too lenient, the FDA approval process is thought to be more arduous, expensive, and delayed than in most other countries (5). Even after initial FDA approval, expanding the approved indications is costly and requires 4 or more years of work (6). Some have estimated that excessive delays in FDA approval may have resulted in death in hundreds of thousands of patients and morbidity in millions of Americans (5).Although the current controversy surrounds off-label use of DES, even balloons and BMS have very limited indications (7). Moreover, aspirin, unfractionated heparin, and clopidogrel are not FDA approved for routine elective percutaneous coronary intervention (PCI). Clearly, an interventional cardiologist would not omit these important antithrombotic agents even though they are not FDA approved for PCI. Likewise, physicians must use their clinical judgment in deciding the best devic...

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The Year in Interventional Cardiology

Cited by 29 publications

References 338 publications

The Year in Interventional Cardiology

The Year in Interventional Cardiology

Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention

Off-Label Use of Drug-Eluting Stents

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