Saphenous Vein Bypass Graft Lesions Research Articles

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial

Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. US Department of Veterans Affairs Cooperative Studies Program.

A multicenter, randomized trial of coronary angioplasty versus directional atherectomy for patients with saphenous vein bypass graft lesions: D.R. Holmes Jr., E.J. Topol, R.M. Califf, L.G. Berdan, F. Leya, P.B. Berger, P.L. Whitlow, R.D. Safian, A.G. Adelman, M.A. Kellert Jr., J.D. Talley III, J. Shani, R.S. Gottlieb, C.A. Pinkerton, K.L. Lee, G.P. Keeler, S.G. Ellis. Cardiac Care Unit, Mayo Clinic,

A multicenter, randomized trial of coronary angioplasty versus directional atherectomy for patients with saphenous vein bypass graft lesions: D.R. Holmes Jr., E.J. Topol, R.M. Califf, L.G. Berdan, F. Leya, P.B. Berger, P.L. Whitlow, R.D. Safian, A.G. Adelman, M.A. Kellert Jr., J.D. Talley III, J. Shani, R.S. Gottlieb, C.A. Pinkerton, K.L. Lee, G.P. Keeler, S.G. Ellis. Cardiac Care Unit, Mayo Clinic,

A Multicenter, Randomized Trial of Coronary Angioplasty Versus Directional Atherectomy for Patients With Saphenous Vein Bypass Graft Lesions

Directional coronary atherectomy and percutaneous transluminal coronary angioplasty have both been used in symptomatic patients with coronary saphenous vein bypass graft stenoses. The relative merits of plaque excision and removal versus balloon dilatation remain uncertain. We compared outcomes after directional coronary atherectomy or angioplasty in patients with de novo bypass graft stenoses. Fifty-four North American and European sites randomized 305 patients with de novo vein graft lesions to atherectomy (n = 149) or angioplasty (n = 156). Quantitative coronary angiography at a core laboratory assessed initial and 6-month results. Initial angiographic success was greater with atherectomy (89.2% versus 79.0%), as was initial luminal gain (1.45 versus 1.12 mm, P < .001). Distal embolization was increased with atherectomy (P = .012), and a trend was shown toward more non-Q-wave myocardial infarction (P = .09). Although the 6-month net minimum luminal diameter gain was 0.68 mm for atherectomy and 0.50 mm for angioplasty, the restenosis rates were similar, 45.6% for atherectomy and 50.5% for angioplasty (P = .491). At 6 months, there was a trend toward decreased repeated target-vessel interventions for atherectomy (P = .092); in addition, 13.2% of patients treated with atherectomy versus 22.4% of the angioplasty patients (P = .041) required repeated percutaneous intervention of the initial target lesion. Atherectomy of de novo vein graft lesions was associated with improved initial angiographic success and luminal diameter but also with increased distal embolization. There was no difference in 6-month restenosis rates, although primary atherectomy patients tended to require fewer target-vessel revascularization procedures.

710-2 Coronary Stents Versus Balloon Angioplasty for Aorto-Coronary Saphenous Vein Bypass Graft Disease: Interim Results of a Randomized Trial

The purpose of this interim analysis of the SAVED Restenosis Trial was to assess the acute results of balloon angioplasty (PTCA) and elective PalmazSchatz coronary stent placement in the treatment of de novo venous bypass graft lesions. As of August 1, 1994, 128 patients (60 PTCA, 68 Stent) have been enrolled at 13 centers. Baseline demographics were similar in both groups. Mean graft ages in the PTCA and Stent groups were 9.8 ± 4.2 vs 9.7 ± 4.5 years (p = ns). Initial angiographic results by core laboratory analysis and clinical events from 0 to 30 days were as follows: Angiographic results PICA Stent Clinical Events (%) PICA Stent Vessel diameter (mm) 3.21 3.18 Death 3.3 5.9 Baseline mid (mm) 0.98 0.93 O-wave MI 1.7 1.5 Final mid (mm) 2.12 2.85 Bypass Surgery 6.7 0 ** Final % diam stenosis 33 12 * Closure: ≥24 hrs 33 2.9 Procedure success (%) 85 96 ** &gt;24 hrs 1.7 0 * p &lt; 0.01 ** p &lt; 0.05 vs PICA One or more major clinical events occurred in 11.7% of PTCA patients vs 5.9% of Stent patients (p = ns). Crossover from assigned to alternative therapy (including bypass surgery) was 13.3% for the PTCA group vs 1.5% for the Stent group (p &lt; 0.01). In conclusion, the preliminary findings of this prospective trial indicate: (1) Elective stent placement in de novo saphenous vein bypass graft lesions achieves a superior initial angiographic result compared to balloon angioplasty; (2) Stents confer a salutary effect on early clinical events with less frequent need for alterna1e therapies including coronary bypass surgery.

Predictors of outcome of percutaneous excimer laser coronary angioplasty of saphenous vein bypass graft lesions

A total of 495 patients underwent treatment with excimer laser angioplasty for 545 saphenous vein graft stenoses. Clinical success was achieved in 455 of 495 patients (92%), as indicated by ≤50% residual stenosis at every target lesion and no complication during hospitalization. At toast 1 in-hospital complication occurred in 30 of 495 patients (6.1%): death (1.0%), bypass surgery (0.6%), and Q-wave (2.4%) or non-Q-wave (2.2%) myocardial infarction. Relative risk analysis showed that ostial lesions (n = 65) tended to have higher clinical success (success rate = 95%, adjusted odds ratio [OR] = 2.1 [95% confidence interval (CI) 0.62, 6.88]; p = 0.24) and lower complications (complication rate = 0%, OR = 0.10 [CI 0.01, 0.79]; p = 0.03) than lesions in the body of the vein graft. Lesions >10 mm (n = 131) had lower success (success rate = 84%, OR = 0.30 [CI 0.16, 0.56]; p = 0.001) and higher complications (complication rate = 12%, OR = 3.3 [CI 1.6, 6.6]; p = 0.004) than discrete lesions. Lesions in small vein grafts <3.0 mm (n = 76) tended to have increased success (success rate = 94%, OR = 1.55 [CI 0.70, 3.44]; p = 0.39) and tower complications (complication rate = 2.2%, OR = 0.31 [CI 0.10, 0.94]; p = 0.03). Thus, excimer laser-facilrtated angioplasty has the most favorable outcome for discrete lesions located at the ostium of all grafts and in the body of smaller saphenous vein grafts. Comparison of excimer laser angioplasty with other treatments for these types of saphenous vein graft lesions is required to establish the clinical usefulness of excimer laser treatment.