The year in interventional cardiology

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

doi:10.1016/j.jacc.2005.01.006

Cited by 45 publications

(23 citation statements)

References 132 publications

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“…Other recent randomized trials comparing thrombectomy with the X-Sizer device and conventional angioplasty have shown a higher rate of MBG-3 and Ͼ50% ST-segment resolution in patients treated with thrombus removal (25,26). Two randomized studies using AngioJet (POSSIS Medical Inc., Minneapolis, Minnesota) have shown controversial results in myocardial reperfusion and infarct size reduction (29,30). Differences in patient selection (inclusion of patients with previous infarction, bypass surgery, or treatment with fibrinolytic agents), procedural duration, and type of device could explain in part these discrepancies.…”

Section: Discussionmentioning

confidence: 99%

“…However, several studies suggest that STR failure indicates inadequate myocardial reperfusion and is associated with poor recovery of left ventricular function and increased mortality, even in the presence of patent IRA (18,20 -24). In recent years, controversial results on myocardial reperfusion have been reported with different strategies of mechanical distal protection or thrombus removal (25)(26)(27)(28)(29)(30). This study was designed to test the hypothesis that thrombus aspiration before standard PPCI may improve myocardial reperfusion as compared with the standard procedure.…”

mentioning

confidence: 99%

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Thrombus Aspiration Before Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction

Silva-Orrego

Colombo

Bigi

et al. 2006

Journal of the American College of Cardiology

231

136

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Thrombus Aspiration Before Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction

Silva-Orrego

Colombo

Bigi

et al. 2006

Journal of the American College of Cardiology

231

136

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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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“…A comprehensive summary of the year in interventional cardiology was published in the Journal earlier this year (115). Here, we focus on new findings with respect to the early invasive management of patients with NSTE-ACS.…”

Section: Early Invasive Treatment Strategymentioning

confidence: 99%