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Abstract
Background: Evidence concerning the efficacy of the embolic protection devices (EPDs) in saphenous vein graft (SVG) percutaneous coronary intervention (PCI) is sparse. The study was designed to compare major cardiovascular events of all-comer population of SVG PCI with and without EPDs at one year of follow-up. Methods and results: A multi-center registry comparing PCI with and without EPDs in consecutive patients undergoing PCI of SVG. The group comprised 792 patients, among which 266 (33.6%) had myocardial infarction (MI). The primary composite endpoint was major adverse cardiac and cerebrovascular event (MACCE) defined as death, MI, target vessel revascularization (TVR), and stroke assessed at one year. After propensity score analysis, there were no differences in MACCE (21.9% vs. 23.9%; HR 0.91, 95% CI 0.57–1.45, p = 0.681, respectively) nor in secondary endpoints of death, MI, TVR, target lesion revascularization (TLR) and stroke at one year in EPDs PCI group vs. no-EPDs PCI group. Similarly, there were no differences between groups in the study endpoints at 30 days follow-up. Conclusions: There were no clinical benefit for routine use of EPDs during SVG PCI in short and long-term follow-up. Further studies are warranted to explore the effect of individual types of EPDs on clinical outcomes.
Highlights
Saphenous vein graft (SVG) failure affects 15–35% of patients within five years and 29–68% of patients ten years after the procedure [1,2]
Conflicting results from new studies translated to the recent amendment in European Society of Cardiology (ESC) guidelines [12], which gave a class II a recommendation to use embolic protection devices (EPDs) in saphenous vein graft (SVG) intervention [13]
At 30-days follow up, there were no differences in major adverse cardiac and cerebrovascular event (MACCE) in EPDs percutaneous coronary intervention (PCI) group vs. no-EPDs PCI group (4.2% vs. 5.3% HR 0.79, 95% CI 0.36–1.71, p = 0.545, respectively) nor in the other secondary endpoints such as death (1.1% vs. 1.8% HR 0.90, 95% CI 0.19–4.33, p = 0.895), myocardial infarction (MI) (1.1% vs. 1.3% HR 0.79, 95% CI 0.17–3.72, p = 0.765), target vessel revascularization (TVR) (1.6% vs. 1.0% HR 1.60, 95% CI 0.40–6.38, p = 0.509), target lesion revascularization (TLR) (1.6% vs. 0.5% HR 3.20, 95% CI 0.65–15.83, p = 0.155) and stroke (0.5 % vs. 0.7% HR 0.79, 95% CI 0.9–7.1, p = 0.833)
Summary
Saphenous vein graft (SVG) failure affects 15–35% of patients within five years and 29–68% of patients ten years after the procedure [1,2]. The rationale behind the use of embolic protection devices (EPDs) is to reduce the risk of distal embolization and improves SVG PCI outcomes. The results of several single-center studies evaluating clinical endpoints demonstrated benefits of EPDs, that were, not corroborated by other SVG PCI registries with no significant improvement when compared with no-EPDs [10,11]. In SVG PCI PROTECTA Study we decided to carry out an all-comer registry with short and long-term follow-up of patients with significant SVG stenosis treated with PCI and with or without EPD. Evidence concerning the efficacy of the embolic protection devices (EPDs) in saphenous vein graft (SVG) percutaneous coronary intervention (PCI) is sparse. The study was designed to compare major cardiovascular events of all-comer population of SVG PCI with and without EPDs at one year of follow-up. Further studies are warranted to explore the effect of individual types of EPDs on clinical outcomes
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