Paclitaxel-eluting vs. bare metal stent implantation in saphenous vein graft lesions: Very long-term follow-up of the SOS (Stenting of Saphenous vein grafts) trial

Sosa, Alan; Chao, Howard; Guerra, Andres; Han, Henry; Christopoulos, Georgios; Christakopoulos, Georgios E.; Tarar, Muhammad Nauman J; Lemos, James A. de; Obel, Owen; Addo, Tayo; Roesle, Michele; Haagen, Donald; Rangan, Bavana V.; Banerjee, Subhash; Brilakis, Emmanouil S.

doi:10.1016/j.ijcard.2015.03.267

Cited by 6 publications

(9 citation statements)

References 10 publications

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“…To date, 4 randomized controlled trials have compared DES vs BMS in SVGs (Table ) . The Reduction of Restenosis In Saphenous Vein Grafts With Cypher sirolimus‐eluting stent trial (RRISC) compared a sirolimus‐eluting stent (Cypher; Cordis, Warren, NJ) with a similar BMS in 75 participants and reported lower angiographic restenosis and TLR with DES at 6 months .…”

Section: Discussionmentioning

confidence: 99%

“…The Stenting Of Saphenous Vein Grafts (SOS) trial compared a paclitaxel‐eluting stent (Taxus; Boston Scientific, Natick, MA) with a similar BMS in 80 participants. SOS showed lower rates of angiographic restenosis and major adverse cardiac events with DES during both short‐ and long‐term follow‐up . The Is Drug‐Eluting Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?…”

Section: Discussionmentioning

confidence: 99%

“…SVG percutaneous coronary interventions (PCIs) represent approximately 6.0% of all PCIs in the United States and are limited by high rates of in‐stent restenosis. Whether drug‐eluting stents (DES) improve outcomes compared with bare‐metal stents (BMS) in SVG lesions has been examined in 4 prospective randomized trials that provided conflicting results (Table ) . These trials were limited by lack of blinding, performance of routine angiographic follow‐up, inconsistent use of embolic protection devices (EPDs), and use of first‐generation DES.…”

Section: Introductionmentioning

confidence: 99%

“…Whether drug-eluting stents (DES) improve outcomes compared with bare-metal stents (BMS) in SVG lesions has been examined in 4 prospective randomized trials that provided conflicting results ( Table 1). [6][7][8][9][10][11][12] These trials were limited by lack of blinding, performance of routine angiographic follow-up, inconsistent use of embolic protection devices (EPDs), and use of first-generation DES. The Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty trial (DIVA; NCT 01121224) was a multicenter, randomized clinical trial designed to address the limitations of prior studies and provide a contemporary robust assessment of optimal stent choice for SVG PCI.…”

Section: Introductionmentioning

confidence: 99%

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Rationale and design of the Drug‐Eluting Stents vs Bare‐Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

Brilakis

Banerjee

Edson

et al. 2017

Clinical Cardiology

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VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drugeluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare-metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site.At sites that did not routinely administer 12-months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open-label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12-month incidence of targetvessel failure (defined as the composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost-effectiveness of DES relative to BMS. Due to lower-thananticipated target-vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Rationale and design of the Drug‐Eluting Stents vs Bare‐Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

Brilakis

Banerjee

Edson

et al. 2017

Clinical Cardiology

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“…We assumed that MACE was equivalent for device‐oriented composite in the DIVA trial. In long‐term follow‐up, we did not include the Stenting of Saphenous Vein Grafts (SOS) trial's extended post hoc analysis, as there were fewer patients included and the analysis was restricted to those from the highest‐enrolling site …”

Section: Methodsmentioning

confidence: 99%

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

Kheiri

Osman

Abdalla

et al. 2018

Clinical Cardiology

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The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up.

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Medikamentenfreisetzende Koronarstents/-scaffolds und medikamentenbeschichtete Ballonkatheter

et al. 2017

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Paclitaxel-eluting vs. bare metal stent implantation in saphenous vein graft lesions: Very long-term follow-up of the SOS (Stenting of Saphenous vein grafts) trial

Cited by 6 publications

References 10 publications

Rationale and design of the Drug‐Eluting Stents vs Bare‐Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

Rationale and design of the Drug‐Eluting Stents vs Bare‐Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

Medikamentenfreisetzende Koronarstents/-scaffolds und medikamentenbeschichtete Ballonkatheter

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