Saphenous Vein Graft Stenting Research Articles

Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare-Metal Stents in Diseased Saphenous Vein Grafts: Results From the Randomized DELAYED RRISC Trial

We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial. We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES. A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization. Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively). In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).

Intravascular Ultrasound Comparison of Sirolimus-Eluting Stent Versus Bare Metal Stent Implantation in Diseased Saphenous Vein Grafts (from the RRISC [Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent] Trial)

The randomized Reduction of Restenosis In Saphenous Vein Grafts with Cypher Sirolimus-Eluting Stent trial compared angiographic outcomes of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) in saphenous vein grafts (SVG). Using intravascular ultrasound (IVUS) performed during 6-month follow-up angiography, we compared the vascular effects of the 2 types of stent on SVGs. Of 75 patients (96 lesions) included, 59 patients underwent IVUS in 61 SVGs; 29 patients received 40 SESs for 34 lesions, and 30 patients received 42 BMSs for 39 lesions. IVUS parameters (diameters, areas, and volumes) were compared in the 2 groups. A specific analysis was performed for overlapping SESs. Median neointimal volume was 1.3 mm(3) (interquartile range 0 to 13.1) in SESs versus 24.5 (7.8 to 39.5) in BMSs (p <0.001). Minimal incomplete stent apposition was detected at only 3 stent edges (2 BMSs, 1 SES) next to ectatic regions of the SVG. Compared with single SESs, overlapping SESs showed significant increases in neointimal reaction, with a neointimal volume of 0.6 mm(3)/mm of stent (0.1 to 1.8) versus 0 (0 to 0.4) in single SESs (p = 0.03), and this phenomenon was mainly localized in overlapping SES segments, where neointimal volume per millimeter of stent was 1.1 mm(3)/mm (0.6 to 4.4) versus 0 (0 to 1.3) in nonoverlapping segments (p = 0.05). In conclusion, SESs effectively inhibit neointimal hyperplasia volume compared with BMSs in diseased vein grafts, without evidence of increased incomplete apposition risk. The neointimal response to overlapping SES layers seems higher than to a single SES layer.

Acute and mid-term local vascular effects of compliant balloon inflation (GuardWire system) on saphenous vein bypass grafts: An angiographic analysis

Background The GuardWire distal protection device reduces the incidence of periprocedural complications during percutaneous stenting of diseased saphenous vein grafts. Its mechanism of action is based on the occlusion of the vessel distal to the lesion with an inflated compliant balloon before the intervention, and the aspiration of embolized material after stent implantation. Although no safety issues related to the compliant balloon have been reported in vein graft treatment, concerns related to the potential injury of the balloon on the vessel wall have been raised. We thus evaluated the angiographic outcome of the vein graft segment where the compliant balloon of the GuardWire distal protection device was inflated during percutaneous interventions of diseased vein grafts. Methods Forty consecutive patients undergoing vein graft stenting, all with successful delivery of the GuardWire system, were enrolled. All patients underwent 6-months follow-up angiography. Quantitative coronary angiographic analysis of the vein graft segment where the balloon was inflated was performed before and after the procedure, as well as at 6-month follow-up. Results No differences in reference vessel diameter, minimal luminal diameter and diameter stenosis were evident between the three measurements. In particular, the difference between post-procedural and follow-up minimal luminal diameter (namely late loss) was 0.003 ± 0.19 mm (95% confidence interval: − 0.06–0.06). Conclusions This prospective study supports for the first time the “angiographic safety” of low pressure inflations of a compliant balloon in saphenous vein grafts, suggesting the absence of acute and mid-term effects on the vein graft vessel wall.

Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Diseased Saphenous Vein Grafts: Six-Month Angiographic, Intravascular Ultrasound, and Clinical Follow-Up of the RRISC Trial

We sought to compare, in a randomized fashion, sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVGs). Sirolimus-eluting stents reduce restenosis and repeated revascularization in native coronary arteries compared with BMS. However, randomized data in SVG are absent. Patients with SVG lesions were randomized to SES or BMS. All were scheduled to undergo 6-month coronary angiography. The primary end point was 6-month angiographic in-stent late lumen loss. Secondary end points included binary angiographic restenosis, neointimal volume by intravascular ultrasound and major adverse clinical events (death, myocardial infarction, target lesion, and vessel revascularization). A total of 75 patients with 96 lesions localized in 80 diseased SVGs were included: 38 patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. In-stent late loss was significantly reduced in SES (0.38 +/- 0.51 mm vs. 0.79 +/- 0.66 mm in BMS, p = 0.001). Binary in-stent and in-segment restenosis were reduced, 11.3% versus 30.6% (relative risk [RR] 0.37; 95% confidence interval [CI] 0.15 to 0.97, p = 0.024) and 13.6% versus 32.6% (RR 0.42; 95% CI 0.18 to 0.97, p = 0.031), respectively. Median neointimal volume was 1 mm(3) (interquartile range 0 to 13) in SES versus 24 (interquartile range 8 to 34) in BMS (p < 0.001). Target lesion and vessel revascularization rates were significantly reduced, 5.3% versus 21.6% (RR 0.24; 95% CI 0.05 to 1.0, p = 0.047) and 5.3% versus 27% (RR 0.19; 95% CI 0.05 to 0.83, p = 0.012), respectively. Death and myocardial infarction rates were not different. Sirolimus-eluting stents significantly reduce late loss in SVG as opposed to BMS. This is associated with a reduction in restenosis rate and repeated target lesion and vessel revascularization procedures. (The RRISC Study; http://clinicaltrials.gov/ct/show; NCT00263263).

Comeback for glycoprotein IIb/IIIa inhibitors during percutaneous coronary interventions for saphenous vein bypass grafts: may be for distal protection with filter-based devices?The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.

This editorial refers to ‘Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: differential effects after randomization to occlusion or filter-based embolic protection’† by M. Jonas et al., on page 920 Long-term outcome of coronary bypass surgery (CABG) is limited by progressive and significant narrowing of vein grafts in about half the patients within 10 to 15 years after operation.1 Despite a reduced world-wide trend for bypass operations and more widespread utilization of arterial conduits during CABG, treatment of symptomatic patients with degenerated aorto-coronary bypass vein grafts will remain a challenge of interventional cardiology. Bare metal coronary stents have improved long-term outcome after percutaneous coronary intervention (PCI) for saphenous vein grafts (SVG), by reducing restenosis when compared with balloon angioplasty, whereas many devices such as covered stents have failed to show additional benefit. Stent placement in SVG, however, carries up to 20% incidence of procedure-related complications mainly because of distal embolization, especially in old, diffusely diseased vein grafts.2 Because of an even greater risk associated with surgical re-intervention, PCI is a tempting alternative for revascularization in the majority of patients with vein graft disease. Preliminary long-term results with increased utilization of drug eluting stents during vein graft PCI are encouraging.3 The SAFER trial demonstrated that acute atherothrombotic, embolic complications associated with vein graft PCI can be roughly halved by the use of distal protection based on balloon occlusion and aspiration system, even in a cost-effective way.2,4 Even though risk of adverse … *Corresponding author. Tel: +358 3 3116 4312; fax: +358 3 3116 4157. E-mail address : kari.niemela{at}pshp.fi

Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: differential effects after randomization to occlusion or filter-based embolic protection

Although embolic protection devices reduce complications during saphenous vein graft (SVG) stenting, adverse events still occur in approximately 10% of patients. IIb/IIIa antagonists have not been proven effective during SVG intervention. We hypothesized that adjunctive use of these agents might enhance the efficacy of embolic protection devices. In the prospective, multicentre FilterWire EX Randomized Evaluation trial, 651 patients undergoing SVG stenting were randomized to either filter-based FilterWire EX or balloon occlusion/aspiration GuardWire embolic protection devices. IIb/IIIa inhibitor use was at the discretion of the investigator, with randomization stratified by intended use. Patients pre-selected for IIb/IIIa inhibitor use (n = 345) had higher baseline risk, with increased 30-day major adverse cardiac events (MACE, 13.0 vs. 8.0%, P = 0.03). GuardWire assigned patients treated with IIb/IIIa inhibitors had higher 30-day MACE compared with those not treated with IIb/IIIa inhibitors (16.0 vs. 6.3%, P = 0.007). In contrast, MACE in high-risk FilterWire patients treated with IIb/IIIa inhibitors were similar to their lower risk, untreated counterparts (9.9 vs. 9.5%, P = 0.89). Multivariable analysis detected a borderline significant (P = 0.056) interaction for lower MACE between FilterWire and IIb/IIIa inhibitor use. Adjustment by the propensity to use IIb/IIIa inhibitors resulted in a significant (P = 0.023) interaction for lower MACE rates. IIb/IIIa inhibition in conjunction with FilterWire was associated with less abrupt closure, no reflow, or distal embolization. IIb/IIIa antagonists may improve procedural outcome during SVG stenting in high risk patients, utilizing filter-based embolic protection devices.

Should Degenerated Saphenous Vein Grafts Routinely Be Sealed with Drug‐Eluting Stents?

The percutaneous treatment of patients with obstructive atherosclerotic disease in degenerated coronary saphenous vein bypass grafts still remains one of the great challenges in interventional cardiology. In this review, we discuss the actual evidence-based knowledge for the percutaneous management of this lesion subset, focusing in particular on the devices that are actually considered the "gold standard" for this treatment: bare metal stents and distal protection devices. We also comment on the negative results of the randomized trials regarding the promising polytetrafluoroethylene-covered stent-grafts. We finally offer insights into the currently available evidence for the use of drug-eluting stents in saphenous vein grafts. These devices are potentially the principal promise for the long-term successful sealing of vein graft disease; however, clear and definitive data coming from controlled trials are requested.

A Randomized, Controlled Trial of Saphenous Vein Graft Intervention with a Filter‐Based Distal Embolic Protection Device: TRAP Trial

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5x) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.

Influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention

We sought to determine the influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention. From the Filterwire EX Randomized Evaluation trial, in which patients who underwent saphenous vein graft stenting were randomized to distal protection with the GuardWire or FilterWire EX, outcomes in 572 patients were examined in vessel size tertiles. The 30-day composite incidence of major adverse cardiac events (MACEs) increased with vessel size and was 6.9%, 9.7%, and 14.9% in the smallest, middle, and largest tertiles, respectively (p = 0.04). MACE rates were relatively vessel size independent for the GuardWire but increased steadily with vessel size with the FilterWire EX. In the smallest tertile, MACEs were reduced by 71% with the FilterWire EX compared with the GuardWire (p = 0.05), with the devices showing similar event rates in the other tertiles.

A novel, low-profile filter-wire (Interceptor) embolic protection device during saphenous vein graft stenting

A novel, low-profile filter embolic protection device was deployed in 26 patients who underwent stent deployment for saphenous vein graft stenoses in a multicenter trial. Major adverse cardiovascular events were observed in only 2 patients (7.7%) and angiographic flow grades were improved.

The Effect of Tirofiban and Clopidogrel Pretreatment on Outcome of Old Saphenous Vein Graft Stenting in Patients with Acute Coronary Syndromes

In spite of developments in interventional cardiology, the success rate of saphenous vein graft stenting is still low in patients with acute coronary syndromes. In this study, we aimed at finding out the effect of pretreatment with Tirofiban, a glycoprotein IIb/IIIa inhibitor, and clopidogrel, an adenosine diphosphate antagonist, on the outcome of saphenous vein graft stenting in patients with acute coronary syndrome. A total of 47 patients, who had lesions in saphenous vein grafts and acute coronary syndrome, could be randomized to treated group (n = 24), who received Tirofiban and clopidogrel for 48 hours before the intervention, and untreated group (n = 23), who did not receive Tirofiban and clopidogrel. In the untreated group, the intervention was performed just after the coronary angiography. All patients underwent stenting as the standard intervention. The groups were compared by Mann-Whitney's U-test or Chi-Square test. The level of statistical significance was set at 0.05. There were no significant differences regarding age, gender, and atherosclerotic risk factors between the two groups. In treated group, precutaneous coronary intervention was successful in all patients and no-reflow phenomenon occurred in only one patient. The rate of no-reflow or slow-flow phenomenon was significantly lower in treated group (one patient vs 9 patients, p = 0.004). One patient in untreated group experienced ventricular fibrillation, which was converted to sinus rhythm after defibrillation. During short-term follow-up, there were no acute myocardial infarction, coronary bypass surgery or death in both groups. There was no major bleeding. Minor bleeding was more frequent in treated group, but it did not achieve statistical significance (3 vs 1; p = 0.322). In conclusion, pretreatment with tirofiban and clopidogrel before percutaneous coronary intervention might result in better immediate outcomes in old saphenous vein grafts without any significant increase in bleeding complications.

1063-65 Coronary blood flow velocity and myocardial perfusion with balloon occlusion and filter-based distal protection devices in saphenous vein graft stenting: Early experience of two centers

1063-65 Coronary blood flow velocity and myocardial perfusion with balloon occlusion and filter-based distal protection devices in saphenous vein graft stenting: Early experience of two centers

830-2 Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: Differential effects after randomization to occlusion or filter-based embolic protection

830-2 Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: Differential effects after randomization to occlusion or filter-based embolic protection

830-6 Relationship between embolic material retrieval and adverse events with different distal protection devices during saphenous vein graft stenting

830-6 Relationship between embolic material retrieval and adverse events with different distal protection devices during saphenous vein graft stenting

Procedural results and distal embolization after saphenous vein graft stenting and angioplasty for in-stent restenosis of grafts.

Saphenous vein graft (SVG) angioplasty is associated with frequent periprocedural complications due to distal embolization and a high risk of restenosis. The purpose of this single-center, retrospective study was to determine the distal embolization incidences and outcomes of stenting for SVG lesions and percutaneous angioplasty for in-stent restenosis of these SVGs. We studied 48 consecutive patients (mean age, 62 +/- 7 years, 92% men) who had prior CABG and underwent stent deployment to SVG lesions detected at our institution over a period of 4 years. Mean lesion length was 12.4 +/- 3.2 mm. The minimal lumen diameter increased from 0.7 +/- 0.3 mm to 3.2 +/- 0.4 mm after stenting. Distal embolization as no reflow/slow flow phenomenon occurred in 5 (10%) patients. Angiographic success was achieved in 98% of the patients. Procedural success was achieved in 96% of the patients. No reflow/slow flow phenomenon was observed, particularly in patients with acute coronary syndrome. During the follow-up, 11 patients (23%) had angiographic evidence of restenosis. Lesions were treated with balloon angioplasty and the minimal lumen diameter increased from 2.6 +/- 1.1 mm to 3.1 +/- 0.3 mm. The angiographic and procedural success rates were both 100%. There were no cases of "no" reflow/slow flow. Restenosis was particularly frequent in patients with diabetes mellitus, hypercholesterolemia, and acute coronary syndrome. Stent implantation in patients with de novo SVG lesions can be achieved with a high rate of angiographic and procedural success. The distal embolization risk is lower during angioplasty of in-stent restenosis lesions of SVGs compared to de novo SVG lesions.

A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts

A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts

A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts

ObjectivesWe compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft. BackgroundThe use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts. MethodsThis prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography. ResultsAcute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93). ConclusionsThis controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.

First multi-center experience with a novel low-profile filter-wire distal protection device (Interceptor) during saphenous vein graft stenting

First multi-center experience with a novel low-profile filter-wire distal protection device (Interceptor) during saphenous vein graft stenting

Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy

Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy

Saphenous vein graft stenting using a novel filter device for distal protection

Embolic protection devices have recently been introduced as a means to prevent distal embolization during percutaneous saphenous vein graft (SVG) interventions. These embolic protection devices need to be placed distally to the target lesion, and they fall into 2 categories: balloon-occlusive devices1,2 and filter systems.3 The former may give rise to ischemia-related symptoms, particularly during prolonged interventions, whereas the latter potentially enables distal perfusion throughout the intervention. The present report was designed to assess the short-term safety and efficacy of such a filter device, namely, the Distal Protection Device ([DPD] Medtronic AVE, Maastricht, The Netherlands).