Determinants of 30-day adverse events following saphenous vein graft intervention with and without a distal occlusion embolic protection device

Giugliano, Gregory R.; Kuntz, Richard E.; Popma, Jeffrey J.; Cutlip, Donald E.; Baim, Donald S.

doi:10.1016/j.amjcard.2004.08.090

Cited by 45 publications

(31 citation statements)

References 9 publications

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“…5 This study showed consistent benefit, independent of glycoprotein IIb/IIIa antagonist use, across lesion subgroups at varying risk for MACE based on angiographic quantification of graft degeneration and estimated lesion plaque volume. 7 It established embolic protection as the standard of care for SVG stenting, with favorable cost-benefit profile. 8 Subsequently the TriActiv device (Kensey Nash) distal balloon occlusion device was approved by the FDA on the basis of the Protection During Saphenous Vein Graft Intervention to Prevent Distal Embolization (PRIDE) trial, which demonstrated noninferiority of this device as compared with the GuardWire or FilterWire devices in the prevention of MACE during SVG PCI.…”

Section: Distal Occlusion Devicesmentioning

confidence: 99%

“…In the case of EPDs, however, it is clear that the observed rate of MACE is also influenced strongly by patient factors such as the extent of the graft that is diseased and the estimated volume of plaque in the lesion being stented. 7 A risk model based on those variables was developed from the SAFER trial to predict MACE 7 and has now been refined and validated in more than 2500 SVG patients (Coolong et al, unpublished data, 2006). This now resembles the situation that existed with bare metal stents once their basic performance was understood and the patient-specific predictors of restenosis were identified.…”

Section: Clinical Evaluation Of Newer Epd Technologymentioning

confidence: 99%

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Devices for Distal Protection During Percutaneous Coronary Revascularization

2006

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Despite early perceptions that distal embolization of atherosclerotic plaque contents was a rare event during balloon angioplasty, it has now become clear that manipulation of atherosclerotic lesions with wires, balloons, atherectomy catheters, or stents does liberate plaque debris. The tendency of this liberated debris to cause clinical manifestations depends on the amount of debris, the size of particles, and the sensitivity of the perfused organ. Additionally, clinical experience with various embolic protection devices (EPDs) has shown that the capture and retrieval of potentially embolic debris reduce adverse events in situations where the amount of debris is largest (eg, saphenous vein grafts [SVGs]) and where the end organ is most sensitive (myocardium, with no reflow and creatine kinase [CK]-MB release; brain with new lesions on magnetic resonance imaging or clinical stroke). In contrast, other adjunctive medical therapies such as glycoprotein IIb/IIIa receptor antagonists, which have been shown to reduce overall rates of CK-MB release during other coronary interventional procedures, have failed to mitigate the impact of distal embolization in SVG intervention. 1-3 Embolic protection is thus now firmly established as a routine component of SVG and carotid stenting, although randomized trials have not been performed for the latter indication. 4,5 Although it is almost certain that atherosclerotic or atherothrombotic debris is released during other interventions on peripheral, renal, and native coronary arteries, the link between such embolization and clinical events (and hence the rationale for embolic protection) has been more difficult to demonstrate. This may be due to smaller amounts of embolic debris, less sensitive metrics of end-organ damage, or less complete capture of debris by devices tested to date in those locales. For example, initial trials of distal embolic protection in native coronaries during primary angioplasty for acute myocardial infarction have shown retrieval of smaller amounts of debris than seen during SVG intervention, 6 in a clinical setting where the background elevation of CK and size of infarction may make it more difficult to discern any incremental reduction provided by embolic protection. Moreover, early generations of EPDs were themselves burdened by large-sized delivery systems and incomplete retrieval of liberated debris (due to poor wall apposition, stagnant pools of debris liberated after device retrieval, shunting of debrisladen blood into proximal side branches, etc). The purpose of the present review is to examine the classes of EPDs, consider specific examples therein, and summarize clinical evidence with regard to their use.

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Section: Distal Occlusion Devicesmentioning

confidence: 99%

Section: Clinical Evaluation Of Newer Epd Technologymentioning

confidence: 99%

Devices for Distal Protection During Percutaneous Coronary Revascularization

2006

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“…The 2 novel angiographic risk factors proposed, estimated plaque volume and SVG degeneration score, are conceptually intriguing and appear to be clinically sound. 5 However, consistency and reproducibility in their measurement in practice may need to be further demonstrated before their acceptance. It also appears that these variables are not entirely objective, despite being measured by a quantitative coronary angiography system.…”

Section: Implementing the Prediction Model For New Epdsmentioning

confidence: 99%

Regulatory Perspective on Embolic Protection Device Approval for Saphenous Vein Graft Stenting With a Single-Arm Trial Using Risk-Adjusted Prediction Model

2008

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T he article by Coolong et al 1 in this issue of Circulation identifies potential predictors of 30-day major adverse cardiac events (MACE) after saphenous vein graft (SVG) percutaneous coronary intervention (PCI) with embolic protection devices (EPDs). These predictors, angiographic estimates of plaque volume and SVG degeneration, were derived from patient-level data on 3958 patients enrolled in 6 clinical trials of SVG EPDs. As discussed in their article, the authors have incorporated these predictors into a model that seeks to accurately predict 30-day MACE rates for such devices. The authors make an intriguing proposal that their covariateadjusted, historically derived model could be used to construct an objective performance goal for the evaluation of novel EPDs. The implementation of such a model seems an attractive goal not only because of savings in time and cost for future clinical trials but also because of the potential to allow effective devices to reach patients more expeditiously. However, putting the model into practice will likely need some additional forethought and further collaborative effort to ensure that the effectiveness and safety of these devices are adequately evaluated. Although the investigators did not submit the actual predictive model within their article, we appreciate this opportunity to provide our insight into how such a model could potentially be integrated into future trials supporting regulatory approval. Article p 790 Regulatory Approaches to SVG EPDs for PCIThe Food and Drug Administration (FDA) regulates devices in 3 classes, with the highest-risk devices in class III, moderate-risk devices in class II, and lowest-risk devices in class I. Medical devices in class III support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. These devices reach the market through the premarket approval process. Because of the level of risk associated with class III devices, the FDA has determined that adequate clinical trials are required to ensure the safety and effectiveness of class III devices. Class II devices, which involve moderate risk, generally require 510(k) premarket submission. The 510(k) submission must demonstrate that the device to be marketed is at least as safe and effective as, ie, substantially equivalent to, a legally marketed device, or "predicate device," that is not subject to premarket approval. About 10% of devices submitted to the FDA through the 510(k) process require clinical data.EPDs used during PCI in SVGs are regulated as class II devices, requiring clearance of a 510(k) before marketing. Although 510(k) devices may be shown through laboratory and bench testing to be substantially equivalent to a marketed device, clinical data also may be needed to establish safety and effectiveness and therefore substantial equivalence. In line with this regard, the FDA required adequate clinical trials to ensure reasonable safety and effectiveness for EPDs used in t...

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“…The assessment of atherosclerotic plaque by angiography, as used in this study, was described by Giuliano et al 22 and does not have the limitations described above. The mathematical formula proposed estimates the plaque volume based on the reference diameter, minimal luminal diameter and lesion length.…”

Section: Mace -Major Cardiovascular Events Ami -Acute Myocardial Infmentioning

confidence: 99%

“…The assessment of plaque volume by an estimate based on angiography has been recently described 22 . However, the influence of atherosclerotic plaque volume assessed by angiography on clinical outcomes in patients undergoing coronary stent implantation has not been studied and is purpose of this study.…”

mentioning

confidence: 99%