Saphenous Vein Graft Stenting Research Articles

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

ObjectivesThe aim of this study was to evaluate the clinical, angiographic, and technical factors related to successful stenting of diseased saphenous vein grafts (SVGs) using a novel filter-based distal protection device. BackgroundProtection of the distal microvasculature with a balloon occlusion and aspiration system has been shown to reduce atherothrombotic embolization and peri-procedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) in SVGs. The safety, efficacy, and technical factors relating to procedural success with filter-based distal protection devices are unknown. MethodsPercutaneous coronary intervention was performed in 60 lesions in 48 patients undergoing SVG intervention with the FilterWire EX distal protection system in a phase I experience at six sites. A larger phase II study was then performed in 248 lesions in 230 SVGs at 65 U.S. centers. ResultsCumulative adverse events to 30 days occurred in 21.3% of patients in phase I, including a 19.1% rate of MI. Numerous anatomic, device-specific, and operator-related contributors to these adverse events were identified, resulting in significant changes to the protocol and instructions for use. Subsequently, despite similar clinical and angiographic characteristics to the phase I patients, the 30-day adverse event rate in phase II was reduced to 11.3% (p = 0.09), due primarily to a lower incidence of peri-procedural Q-wave and non–Q-wave MI. ConclusionsDistal protection during SVG PCI with the FilterWire EX is associated with a low rate of peri-procedural adverse events compared to historical controls. A unique set of anatomic, technical, and operator-related issues exist with distal filters which, if ignored, may reduce their effectiveness.

Clinical outcome in patients undergoing stenting of saphenous vein grafts using the TriActiv™ balloon-protection system: initial U.S. and European experience

Clinical outcome in patients undergoing stenting of saphenous vein grafts using the TriActiv™ balloon-protection system: initial U.S. and European experience

Long-term clinical outcome and predictors of major adverse cardiac events after percutaneous interventions on saphenous vein grafts

OBJECTIVESThe purpose of this study was to examine the long-term clinical outcome after percutaneous intervention of saphenous vein grafts (SVG) and to identify the predictors of major adverse cardiac events (MACE).BACKGROUNDPercutaneous interventions of SVGs have been associated with more procedural complications and higher restenosis rates compared with interventions on native vessels.METHODSFrom 1993 to 1997, 1,062 patients underwent percutaneous intervention on 1,142 SVG lesions. Procedural, in-hospital and long-term clinical outcomes were recorded in a database and analyzed.RESULTSIn-hospital MACE occurred in 137 patients (13%) including death (8%), Q-wave myocardial infarction (MI) (2%) and coronary artery bypass surgery (3%). Late MACE occurred in 565 patients (54%) including death (9%), Q-wave MI (9%) and target vessel revascularization (36%). Any MACE occurred in 457 (43%) patients. Follow-up was available in 1,056 (99%) patients at 3 ± 1 year. Univariate predictors were restenotic lesion (odds ratio [OR]: 2.47, confidence interval [CI]: 1.13 to 3.85, p = 0.0003), unstable angina (OR: 1.99, CI: 1.27 to 2.91, p = 0.04) and congestive heart failure (CHF) (OR: 1.97, CI: 1.14 to 3.24, p = 0.02) for in-hospital MACE, and peripheral vascular disease (PVD) (OR: 2.18, CI: 1.34 to 3.44, p = 0.002), intra-aortic balloon pump placement (OR: 2.08, CI: 1.13 to 3.85, p = 0.02) and previous MI (OR: 1.97, CI: 1.14 to 3.25, p = 0.007) for late MACE. Independent multivariate predictors for late MACE were restenotic lesion (relative risk [RR] 1.33, p = 0.02), PVD (RR: 1.31, p = 0.01), CHF (RR: 1.42, p = 0.01) and multiple stents (RR: 1.47, p = 0.004). Angiographic follow-up was available for 422 patients. Angiographic restenosis occurred in 122 (29%) of stented SVGs and 181 (43%) of nonstented SVGs (p = 0.04). Stent implantation did not confer a survival benefit.CONCLUSIONSDespite the use of new interventional devices, SVG interventions are associated with significant morbidity and mortality; SVG stenting is not associated with better three-year event-free survival. This may be due to progressive disease at nonstented sites.

Long-term (≥8 years) outcome after palmaz-schatz stent implantation

The purpose of this single-center study was to evaluate the long-term (≥8 years) outcome of Palmaz-Schatz intracoronary stenting and to identify independent predictors of outcome. Although short-term results of Palmaz-Schatz intracoronary stenting have been promising, with a reduction in both angiographic restenosis and clinical cardiac events up to 3 years, longer-term follow-up has not been established. We analyzed clinical outcome in 426 consecutive patients at least 8 years after coronary stenting. Demographic, clinical, and procedural predictors of restenosis, survival, and event-free survival, defined as freedom from death, myocardial infarction (MI), and coronary revascularization (target stented site, target vessel, and any revascularization) were analyzed. Before discharge, 28 patients (6.6%) sustained at least 1 major cardiovascular event: 3 deaths (0.7%), 18 MIs (4.2%), and 17 repeat revascularizations. Surviving patients were followed for 8.9 years (interquartile range 8.4 to 9.4). After discharge, 59 patients (13.9%) died, 47 (11.1%) sustained an MI, and 188 (44.4%) underwent coronary revascularization. The 8-year event-free survival (freedom from death, freedom from death/MI/target-stented site revascularization, and freedom from death/MI/any coronary revascularization) was (mean ± SE) 0.86 ± 0.01, 0.62 ± 0.03, and 0.47 ± 0.02, respectively. Unstable angina, lower left ventricular ejection fraction, and saphenous vein graft stenting were found to be independent predictors of death during follow-up. Hypertension, unstable angina, multivessel disease, and multiple stent implantation were found to be independent predictors of the composite of death/MI/any coronary revascularization during follow-up. This study provided a useful assessment of very long-term outcome in survival, event-free survival, and predictors of major cardiac events 8 to 10 years after Palmaz-Schatz stent implantation.

Influence of diabetes mellitus on early and late clinical outcomes in saphenous vein graft stenting. ahmed jm, hong mk, mehran r, et al. j am coll cardiol 2000;36:1186–93

Influence of diabetes mellitus on early and late clinical outcomes in saphenous vein graft stenting. ahmed jm, hong mk, mehran r, et al. j am coll cardiol 2000;36:1186–93

Influence of gender on early and one-year clinical outcomes after saphenous vein graft stenting

Compared with men, women may have a worse prognosis after native coronary revascularization. However, the influence of gender on clinical outcomes after saphenous vein graft (SVG) stenting is unknown. The purpose of this study was to compare early and 1-year clinical outcomes between men and women after stent implantation in SVG. A total of 1,199 consecutive patients with 1,858 SVG lesions were studied. Procedural success, in-hospital events, and late clinical outcomes were compared between men (n = 951) and women (n = 248). Overall procedural success was similar between men and women (97% vs 96%, p = NS). However, in-hospital (3.2% vs 1.6%, p = 0.07) and 30-day cumulative (4.4% vs 1.9%, p = 0.02) mortality rates were higher in women than in men. In addition, women had a higher incidence of vascular complications (12% vs 7.3%, p = 0.006) and postprocedural acute renal failure (8.1% vs 4%, p = 0.02). At 1-year follow-up, mortality was 13% in women and 11% in men (p = NS) and target lesion revascularization was 18% versus 23%, respectively (p = NS). By multivariate regression analysis, independent correlates of in-hospital mortality were female gender (odds ratio [OR] 3.6, confidence interval [CI] 1.0 to 12.5, p = 0.05) and left ventricular ejection fraction (OR 0.9, CI 0.9 to1.0, p = 0.01). Female gender was found to predict 30-day mortality (OR 2.5, CI 1.1 to 5.5, p = 0.02). The sole predictor of 1-year mortality was diabetes mellitus (OR 1.6, CI 1.1 to 2.3, p = 0.01). This study shows that women compared with men treated with stent implantation in SVG lesions have (1) a trend toward higher in-hospital mortality, (2) higher risk of 30-day mortality, (3) increased incidence of vascular complications and postprocedure acute renal failure, and (4) similar 1-year clinical outcome.

Influence of diabetes mellitus on early and late clinical outcomes in saphenous vein graft stenting

OBJECTIVESThe purpose of this study was to compare early and late clinical outcomes in diabetic and nondiabetic patients after stent implantation in saphenous vein grafts (SVG).BACKGROUNDPatients with diabetes mellitus have less favorable acute and long-term outcomes after stent implantation in native coronary arteries. The impact of diabetes on SVG stenting, however, is not known.METHODSWe studied 908 consecutive patients (1,366 SVG lesions) treated with Palmaz-Schatz stents. In-hospital and late clinical outcomes (death, Q-wave myocardial infarction and repeat revascularization rates at one year) were compared between diabetic (n = 290) and nondiabetic (n = 618) patients.RESULTSIn-hospital mortality was significantly higher in diabetic as compared with nondiabetic patients (2.2% vs. 0.3%, p = 0.003). At one-year follow-up, target lesion revascularization (TLR) was 16.6% in diabetic and 12.3% in nondiabetic patients (p = 0.03). Overall cardiac event-free survival (freedom from death, Q-wave myocardial infarction and any coronary revascularization procedure) at one year was significantly lower in the diabetic (68%) compared with the nondiabetic patients (79%, p = 0.0003). By Cox regression analysis, diabetes mellitus was an independent predictor of both TLR (relative risk: 1.23; confidence interval: 0.96 to 1.58; p = 0.004) and late cardiac events (relative risk: 1.40; confidence interval: 1.05 to 1.86; p = 0.02).CONCLUSIONSPatients with diabetes undergoing stent implantation in SVG have: 1) higher in-hospital and late mortality, 2) higher one-year TLR rates, and 3) significantly lower one-year cardiac event-free survival. Thus, diabetic patients have less favorable acute and late clinical outcomes after stent implantation in SVG lesions.

Procedural results and intermediate clinical outcomes after multiple saphenous vein graft stenting

OBJECTIVESWe evaluated the early and mid-term (18-month) clinical events in a consecutive series of patients undergoing a nonstaged multiple saphenous vein grafting (SVG) intervention with stents as compared with a single SVG stent procedure.BACKGROUNDSaphenous vein graft angioplasty has been limited by high rates of distal embolization, myocardial infarction, restenosis and late mortality. It is unknown whether stenting of multiple, different SVGs at the same setting is associated with higher risk.METHODSWe evaluated in-hospital and mid-term clinical outcomes (death, Q wave myocardial infarction [MI] and repeat revascularization rates up to 18 months) in 70 consecutive patients treated with coronary stents in 2 (93% of patients) or 3 SVGs, as compared with 649 patients undergoing stenting of a single SVG between January 1, 1994 and December 31, 1997.RESULTSOverall procedural success was obtained in 97% of patients with 2 or 3 SVGs and 97% of patients with a single SVG (p = 0.94). Procedural complications were also similar (2.8% for multiple SVGs vs. 2.7% for a single SVG, p = 0.94). There was a higher prevalence of periprocedural non–Q wave MI (28% vs. 16%, p = 0.009) in the multiple SVG group. During follow-up (18 months), target lesion revascularization was 11% in multiple SVG and 15% in single SVG interventions (p = 0.19), and repeat revascularization (calculated per treated patient) was also similar for both groups (19% vs. 18%, p = 0.94). There was no difference in death (5.6% vs. 5.3%, p = 0.92) and Q wave MI rate (4.3% vs. 2.9%, p = 0.55) after the multiple SVG intervention. Overall cardiac event-free survival was similar for both groups (62% vs. 60%, p = 0.75). The study was powered to detect a clinically meaningful difference of 10% in mortality; smaller differences could not be evaluated on the basis of this sample size.CONCLUSIONSSimultaneous stenting of multiple SVGs in carefully selected patients has similar in-hospital procedural success and major complications rates, as well as mid-term (18-month) clinical outcomes, as compared with single SVG stenting. Thus, multiple SVG interventions using stents may be a viable revascularization strategy for carefully selected patients and suitable lesions in multiple SVG disease.

Novel distal occluder washout method for prevention of no-reflow during stenting of saphenous vein grafts.

This study assessed safety of the distal occlusion washout (DOW) method for prevention of no-reflow during stenting of degenerated saphenous vein grafts (SVGs). The DOW method involves protection of distal native coronary circulation with an occlusive balloon during the pretreatment and washout steps prior to stenting. Outcomes of stenting of 23 grafts in 21 patients after pretreatment with the DOW method were evaluated. The mean graft age was 7.4 +/- 4.3 years. The mean treated lesion length was 53 +/- 28 mm. Total occlusions were treated in 6 grafts and thrombotic lesions in 10 nontotally occluded grafts. One non-Q-wave MI and one acute stent thrombosis were observed. No deaths, Q-wave MIs, or subacute thromboses occurred. Follow-up in 18/21 (85.7%) patients at 28 +/- 8 weeks demonstrated target graft revascularization in 1 (5%) patient. The DOW method prevented clinically significant no-reflow in all 23 degenerated SVGs stented.

Novel distal occluder washout method for prevention of no‐reflow during stenting of saphenous vein grafts

This study assessed safety of the distal occlusion washout (DOW) method for prevention of no-reflow during stenting of degenerated saphenous vein grafts (SVGs). The DOW method involves protection of distal native coronary circulation with an occlusive balloon during the pretreatment and washout steps prior to stenting. Outcomes of stenting of 23 grafts in 21 patients after pretreatment with the DOW method were evaluated. The mean graft age was 7.4 ± 4.3 years. The mean treated lesion length was 53 ± 28 mm. Total occlusions were treated in 6 grafts and thrombotic lesions in 10 nontotally occluded grafts. One non–Q-wave MI and one acute stent thrombosis were observed. No deaths, Q-wave MIs, or subacute thromboses occurred. Follow-up in 18/21 (85.7%) patients at 28 ± 8 weeks demonstrated target graft revascularization in 1 (5%) patient. The DOW method prevented clinically significant no-reflow in all 23 degenerated SVGs stented. Cathet. Cardiovasc. Intervent. 47:397–403, 1999. © 1999 Wiley-Liss, Inc.

Retrieval and analysis of particulate debris after saphenous vein graft intervention

OBJECTIVESThis study was designed to evaluate the composition and quantity of particulate debris resulting from vein graft intervention.BACKGROUNDDistal embolization and “no reflow” are frequent and important complications resulting from angioplasty of diseased saphenous vein grafts. Little is known about the composition and quantity of embolic particulate debris associated with vein graft intervention, and no intervention has been shown to protect against its clinical consequences.METHODSA catheter system, designed to contain, retrieve and protect against distal embolization of this material, was evaluated during 27 percutaneous interventional saphenous vein graft procedures. Clinical, angiographic and pathologic analyses were performed.RESULTSThe duration of distal graft occlusion required to allow intervention and subsequent debris removal was 150 ± 54 s, decreasing as experience was gained. Thrombolysis in Myocardial Infarction trial (TIMI) flow grade increased from 2.6 ± 0.8 to 3.0 ± 0.0. Creatine kinase (CK) rose above normal in three patients (11.1%) exceeding 3× normal in one (3.7%) resulting in the diagnosis of non-Q-myocardial infarction. Particulate material was identified following 21 of 23 procedures suitable for analysis. Particle size was 204 ± 57 μm in the major axis and 83 ± 22 μm in the minor axis. Particles consisted predominantly of soft acellular atheromatous material, such as that typically found under a fibrous cap. Semiquantitative analysis suggested that the quantity of particulate material was less following stenting than following balloon dilation.CONCLUSIONSParticulate matter is commonly present following routine angioplasty and stenting of saphenous vein grafts. Containment, retrieval and analysis of this particulate debris are all feasible. Comparison to prior clinical experience is limited by small sample size. However, to the extent that these particles may contribute to distal embolization, no-reflow and infarction, such a system may contribute to the reduction of complications following vein graft intervention.

Coronary stent deployment without predilation: prevention of complications of venous graft angioplasty.

Saphenous vein graft stenting without predilation may potentially decrease procedural complications such as distal embolization and no-reflow phenomenon. In this report the authors describe the deployment of stents (three Wallstents, one Palmaz-Schatz, one Multilink, and one NIR) without predilation in five patients with unstable angina pectoris due to high-grade stenosis in old saphenous vein grafts. Stent deployment was successful in all patients without procedure-related complications. Stenting without predilation appears to be feasible in old bypass grafts with significant stenosis. The potential of this new stenting technique to reduce the risk of stenting complications should be tested by a randomized trial.

Acute and Long-Term Outcome After Palmaz-Schatz Stenting: Analysis From the New Approaches To Coronary Intervention (NACI) Registry

The randomized Stent Restenosis Study (STRESS) and Belgium Netherlands Stent (Benestent) trials established that elective use of Palmaz-Schatz stents (PSSs) in native coronary arteries with de novo lesions is associated with increased procedural success and reduced restenosis. However there are other clinical indications for which stents are commonly used (unplanned use, vein grafts, restenosis lesions) that are not addressed in these studies. From 1990–1992, 688 lesions in 628 patients were treated with PSSs in the New Approaches to Coronary Intervention (NACI) registry. Angiographic core laboratory readings were available for 543 patients (595 lesions, of which 106 were stented for unplanned indications, 239 were in saphenous vein bypass grafts, and 296 were previously treated). The cohort of patients in whom stents were placed for unplanned indications had more women, current smokers, and had a higher incidence of recent myocardial infarction (MI). Patients who underwent stenting of saphenous vein grafts were older, had a higher incidence of diabetes mellitus, unstable angina, prior MI, and congestive heart failure. Lesion success was similar in all cohorts (98%), but procedural success was significantly higher for planned stenting (96% vs 87%; p <0.01). Predictors of adverse events in-hospital were presence of a significant left main stenosis and stenting for unplanned indication. The incidence of target lesion revascularization by 30 days was significantly higher for patients undergoing unplanned stenting due to a higher risk for stent thrombosis. Recent MI, stenting in native lesion, and small postprocedural minimum lumen diameter independently predicted target lesion revascularization at 30 days. Independent predictors of death, Q-wave myocardial infarction, or target lesion revascularization at 1 year included severe concomitant disease, high risk for surgery, left main disease, stenting in the left main coronary artery, and low postprocedure minimum lumen diameter.

Long-Term Follow-Up of a High Risk Cohort After Stent Implantation in Saphenous Vein Grafts

Objectives. We sought to provide short- and long-term clinical outcomes of a high risk cohort treated with stents in saphenous vein grafts (SVGs).Background. Data on the long-term outcome of SVG stenting in high risk patients are limited.Methods. Johnson & Johnson stents were implanted in the SVGs of 186 patients (302 stents, 244 lesions). Ninety percent of patients presented with myocardial infarction (MI) or unstable angina (mean ±SD ejection fraction [EF] 44 ± 11%, patient age 71 ± 9 years, graft age 9.4 ± 5 years). Using a risk score classification, 155 patients (83%) were defined as high risk for repeat surgical repair or angioplasty.Results. The procedural success rate was 97.3%, with 2.7% major complications (death, Q wave MI, coronary artery bypass graft surgery [CABG]). Clinical follow-up was obtained in 177 patients (mean 19.1 ± 13.5 months, range 7 to 59). Event rates were 10% for death; 9% for MI; 11% for repeat CABG; and 15% for repeat angioplasty (total events 45%). Kaplan-Meier estimated survival and event-free survival at 4 years were 0.79 ± 0.06 and 0.29 ± 0.07, respectively. Predictors of death were congestive heart failure (p < 0.01) and EF <44% (p < 0.05). Predictors of combined events of death, MI and CABG were low EF (p < 0.01) and high SVG age (>10 years, p < 0.01). There were 66 revascularization procedures (35% of patients), 24% of which were in nontarget lesions. Fifty-three percent of the cardiac events occurred during the first year of follow-up. Of the 160 survivors, 36% were free of angina, 49% were in Canadian Cardiovascular Society functional class I or II, and 15% were in class III or IV. Sixty-nine percent of patients were in class I or II according to the Specific Activity Scale, and 31% of patients were in class III or IV.Conclusions. Balloon-expandable stent implantation in the SVGs of high risk patients is associated with a low early complication rate. Expected survival rates are good, as are the anginal and functional classifications, but there is a high rate of recurrent events and need for repeat revascularization. Vein graft stenting is an acceptable palliative option in many high risk patients.

Long-Term (4- to 6-Year) Outcome of Palmaz-Schatz Stenting: Paucity of Late Clinical Stent-Related Problems

Objectives. The purpose of this prospective single-center study was to evaluate the longer-term outcome of Palmaz-Schatz stenting in the treatment of native coronary and saphenous vein bypass graft disease.Background. The STRESS (Stent Restenosis Study) and BENESTENT (Belgian Netherlands Stent) trials have demonstrated a decrease in both angiographic restenosis and the need for repeat revascularization in the 1st year for vessels treated by stenting rather than balloon angioplasty. Longer-term (1 to 5 years) clinical results of Palmaz-Schatz stenting are not yet well established. Late migration of the stent, metal fatigue, endarteritis and late restenosis have all been proposed as potential late clinical complications of coronary stent implantation.Methods. The study cohort consisted of 175 consecutive patients who underwent elective placement of 194 Palmaz-Schatz stents in 185 vessels. Clinical events (death, myocardial infarction, recurrent angina or any revascularization) were assessed at 6 weeks, 2, 4 and 6 months, 1 year and yearly thereafter. Clinical follow-up was available on all patients at a mean ± SD of 54 ± 17 months.Results. Angiographic success was achieved in 173 patients (98.9%); angiographic restenosis was observed at 6 months in 26.1% of target sites. The survival rate was 86.7% at 5 years, with a 5-year event-free survival rate decreasing progressively to 50.7%, reflecting primarily repeat revascularization procedures (41.2% at 5 years). However, the rate of repeat revascularization of the treatment site (target site revascularization [TSR]) was 14.4%, 17.7% and 19.8% at 1, 3 and 5 years, respectively, with late (> 1 year) TSR driven by in-stent restenosis in only 3 patients (1.7%). Rates of both 5-year survival (70.5% vs. 93.4%) and event-free survival (21.1% vs. 63.3%) were lower for patients who underwent saphenous vein graft (SVG) stenting than for those with native coronary artery stenting. However, 5-year TSR rates were similar for SVGs (21.9%) and native vessels (19.2%), indicating that the higher incidence of repeat revascularization for SVGs was due to an increase in non-TSR, driven by progressive disease at other sites.Conclusions. The long-term outcome of stenting shows stability of the treated lesion, with only a slight increase in TSR between 2 and 5 years (17.1% to 19.8%). The progressive increase in repeat revascularization over that period (24% to 41%) and most ongoing late events can be attributed to the progression of coronary disease at other sites, rather than to late deterioration of the stent result itself. Such non-TSR events account for the majority of clinical events in the patients who underwent SVG stenting.

A novel approach to the placement of Palmaz-Schatz biliary stents in saphenous vein grafts.

The placement of Palmaz-Schatz biliary stents has become a successful method to treat stenoses in large saphenous vein grafts. Unlike coronary stents, the biliary stents are not routinely delivered with a selective delivery sheath and may be more difficult to deliver and prone to detachment from the balloon and even embolization during delivery. In order to enhance the ability to deliver these stents, a guide-within-a-guide system was developed. A 7F guiding catheter was used as a selective delivery sheath within a standard guiding catheter. Nineteen biliary stents were successfully placed in vein grafts in 15 patients using this system. One procedure was complicated by an embolic event documented angiographically following intragraft delivery of urokinase but prior to stent implantation.

792-5.Three Year Follow-up After Intracoronary Stent Implantation

To identify predictors of long-term success following intracoronary stenting, we analyzed clinical outcome in 65 consecutive patients who electively received Palmaz-Schatz stents at least 3 years prior to analysis. 83 stents were successfully inserted in 63 of 65 patients (97%), of whom 49 (75%) were men and 16 (25%) were women, with a mean age (±SD) of 59 ± 9 years, 18 patients (28%) were diabetic. 16 patients (24%) required more than one stent. Indications for stenting included restenosis following prior PTCA (52%) and lesion complexity (43%). 10 patients (15%) received stents in saphenous vein grafts. Demographic, clinical, and procedural predictors of survival and event-free survival at a mean follow-up of 39 ± 17 months were analyzed. Event-free survival was defined as survival without MI, CABG, PTCA at the stent site, or recurrent target vessel ischemia. Survival and event-free survival at 3 years were 86% and 54%, respectively. Predictors of decreased long term survival (p &lt; 0.05) included diabetes, and a high angina score (Canadian Heart Class 3–4) at 6 and 12 months following stenting. Predictors of decreased event-free survival (p &lt; 0.05) included smaller balloon size at implantation, greater number of stents at the primary lesion, and high angina score at each follow-up interval. Freedom from adverse events by 6 months following stenting correlated with long term success. 35 of 44 patients (80%) with event-free survival at 6 months remained event-free at follow-up. During follow-up, 17 patients (27%) developed symptomatic stent restenosis, requiring primarily early revascularization; 18 patients (28%) developed symptomatic stenoses in other vessels, requiring primarily late revascularization. (1) long term survival after stenting is excellent; (2) the need for late revascularization is dictated primarily by disease progression in non-stented vessels; and (3) long-term success of stenting is predicted by freedom from adverse events at 6 months.

710-5 Progressive Deterioration in Late (2-Year) Clinical Outcomes After Stent Implantation in Saphenous Vein Grafts: The Multicenter JJIS Experience

Late clinical follow-up (after I-year) in patients treated with native coronary stents demonstrates no further clinical events (death or MI) and rare delayed target lesion revascularization (TLR = repeat PTCA or CABG). To examine the long-term effects of stent placement in saphenous vein grafts (SVG), we evaluated all follow-up clinical data in 661 consecutive patients (775 SVG lesions) from the JJIS multicenter registry (17 sites). Baseline demographics were pertinent for a high incidence of unstable angina (72%), heart failure (22%), and high surgical risk status (49%). The mean SVG age was 9 ± 4 years, and the mean ejection fraction was 49 ± 14%. Overall procedure success (&lt;50% residual stenosis without in-hospital death. MI, or CABG) was 92%, and subacute thrombosis was documented in 9 patients (14%). Actuarial follow-up event rates:Events6-months12-months24-months– Death (%)5814– MI(%)788– CABG (%)7912– PTCA(%)6812– Event-free survival (%)756755Event-free survival = freedom from death, MI. CABG or PTCA Event-free survival = freedom from death, MI. CABG or PTCA Similar to PTCA in SVG lesions and in contrast to stents in native coronaries, patients with stents in SVG's exhibit a disappointing attrition in late clinical outcomes beyond one year, Both increasing mortality and repeat revascularization procedures contribute to the 2-year 55% event-free survival. We surmise that further deterioration at the stent site (i.e. “late” restenosis), increasing non-TLR events, and less favorable baseline characteristics are responsible for these findings.

951-75 Comparative Analysis of Long Term Clinical Outcomes After Native Coronary versus Saphenous Vein Graft Stent Implantation

To assess the late (3 years) clinical outcomes of JJIS stent (S) placement in the treatment of native coronary(NC) and saphenous vein graft (SVG) lesions, we compared baseline factors, procedural results and late clinical events in 112 pts (122 lesions) with native and 118 pts (153 lesions) with SVG lesions treated with S at the Washington Hospital Center. Pts with SVG lesions were older, had more frequent multivessel disease, history of prior MI, ostial and denovo lesions and lower ejection fractions (all p &lt; 0.005). The initial and final % stenosis, procedural success and major complications (death, Q wave MI, CABG) were similar between the 2 groups. Clinical events Native 1/3 yr SVG 1/3 yr P value (log-rank) Death (%) 0/1.5 8/22 0.0003 Q-wave MI (%) 1/1 5/8 0.06 TLR(%) 26/29 28/49 0.08 Non-TLR (%) 0/9 10/17 0.02 TLR = target lesion revascularization (repeat PTCA or CABG) and EFS = event free survival (freedom from death, Q-wave MI, and TLR). During the first year after S placement, SVG lesions (compared with NC) had higher mortality and Q-wave MI. similar TLR and greater non-TLR events. Between 1 and 3 years, in SVG pts there was a further dramatic increase in mortality and TLR resulting in a 3-year actuarial EFS of only 37% (see figure). In contrast, NC behavior was stable between 1 and 3 years with no further mortality, Q-wave MI, or TLR, but a 10% incidence of non-TLR events. In conclusion: Despite similar procedural results, SVG vs native pts treated with S manifested disparate late clinical responses. Disturbingly, in SVG pts there was progressive mortality(in part due to increased pt morbidity) and additional TLR events after the first year of S implantation (ie. “late” restenosis) causing a striking attrition in 3 year EFS.

Long-term angiographic and clinical outcome after implantation of balloon-expandable stents in aortocoronary saphenous vein grafts

Balloon angioplasty of aortocoronary saphenous vein graft lesions is associated with high restenosis and clinical event rates. The goal of this multicenter study was to assess long-term angiographic and clinical outcome of patients electively treated with single Palmaz-Schatz stents in aortocoronary saphenous vein grafts. In 198 patients (209 lesions), elective placement of single Palmaz-Schatz stents was attempted. Angiography was performed at baseline, immediately after stent placement, and at 6-month follow-up. Stent placement was successful in 98.5% of patients. One patient (0.5%) had stent thrombosis. Restenosis occurred in 34% (45 of 133) of the restudied lesions. Restenosis was lower in de novo lesions than in restenotic lesions (22% vs 51%, p < 0.001). Ostial lesions had a higher restenosis rate than nonostial lesions (61% vs 28%, p = 0.003). Freedom from death, myocardial infarction, coronary artery bypass surgery, and repeat angioplasty was present in 70% of patients. Eighty-two percent of patients with de novo lesions remained event-free at 1 year, whereas only 55% of patients with prior angioplasty were event-free at 1 year (p < 0.001). The use of the Palmaz-Schatz stent for the treatment of focal, de novo, aortocoronary saphenous vein graft lesions is associated with a high procedural success rate, a low angiographic restenosis rate, and low clinical event rates, including the need for repeat revascularization. The results of this study need validation by a prospective randomized trial comparing stent implantation with angioplasty.