Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study

PURPOSE: Outcome with selective or systematic stenting with the Palmaz vascular stent was compared in patients with limb-threatening ischemia or persistent disabling claudication despite medical therapy, with less than 7 cm stenosis or occlusion of the superficial femoral artery. METHODS: This was a multicenter prospective randomized trial with centralized allocation of treatment and independent review of vascular events. The primary end point was presence of more than 50% stenosis at 1-year angiographic follow-up. Secondary end points were survival; occurrence of vascular events in the treated leg; and number of failed procedures, defined as more than 50% stenosis or death at 1 year. RESULTS: Two hundred twenty-seven patients were enrolled in the study, 112 in the selective stent group, and 115 in the systematic stent group. Seventeen patients (15%) in the selective stent group received a stent after suboptimal results of percutaneous transluminal angioplasty. Angiograms for 140 patients were available at 1-year follow-up and demonstrated no statistical difference between the two groups; more than 50% stenosis of the dilated site was noted in 21 of 65 patients (32,3%) in the selective stent group and 26 of 75 patients (34.7%) in the systematic stent group (P =.85, Fisher exact test). Survival in the percutaneous transluminal angioplasty and stent groups was, respectively, 92% and 96% at 1 year, 89% and 93% at 2 years, and 82% and 80% at 4 years (P =.40, log-rank test). Survival free of new vascular events in the treated limb was 77% and 65% at 1 year, 70% and 53% at 2 years, and 57% and 44% at 4 years (P =.017, log-rank test). Number of failed procedures at 1 year was 29 of 86 (33%) and 30 of 89 (34%) (P = 0.9). CONCLUSION: Systematic stenting of short stenosis or occlusion of the superficial femoral artery is not justified. Palmaz vascular stent placement should be reserved for use in patients with suboptimal results of balloon angioplasty.     

Iliac artery stenting versus surgical reconstruction for TASC (TransAtlantic Inter-Society Consensus) type B and type C iliac lesions

OBJECTIVE: The TransAtlantic Inter-Society Consensus (TASC) document did not define the best treatment for moderately severe iliac artery lesions, ie, TASC type B and type C iliac lesions, because of insufficient solid evidence to make firm recommendations. The purpose of this study was to evaluate the influence of risk factors on outcome of iliac stenting and operative procedures used to treat TASC type B and type C lesions. METHODS: Over the 5 years from 1996 to 2001, 188 endovascular and direct aortoiliac surgical reconstruction procedures were performed in 87 women and 101 men with TASC type B and type C iliac lesions and chronic limb ischemia. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery (SVS/ISCVS) were followed to define variables. Both univariate analysis (Kaplan-Meier method) and multivariate analysis (Cox proportional hazards model) were used to determine the association between variables, cumulative patency rate, limb salvage, and survival. RESULTS: Indications for revascularization were disabling claudication (73%), limb salvage (25%), and blue toe syndrome (2%). Patients in the surgery group (n = 52) had significantly higher primary patency rates compared with patients in the stent group (n = 136) at univariate analysis (Kaplan-Meier method, log-rank test; P =.015). Primary patency rates at 1, 3, and 5 years were 85%, 72%, and 64% after iliac stenting, and 89%, 86%, and 86% after surgical reconstruction, respectively. Univariate and multivariate Cox regression analysis enabled identification of poor runoff (ie, runoff score >5 for unilateral procedures or >2.5 for bilateral outflow procedures; relative risk, 2.5; 95% confidence interval [CI], 1.4-4.2; P =.001) as the only independent predictor of decreased primary patency in all patients. However, stratified analysis including only patients with poor runoff revealed that patients undergoing iliac stenting had significantly lower primary patency rates compared with those undergoing surgical reconstruction (Kaplan-Meier method, log-rank test; P =.05). External iliac artery disease and female gender were also identified as independent predictors of decreased primary stent patency. CONCLUSIONS: Poor infrainguinal runoff is the main risk factor for decreased primary patency after surgical reconstruction and iliac stenting to treat TASC type B and type C iliac lesions. However, primary patency is less affected by poor runoff in patients undergoing surgical procedures. The presence of poor runoff, external iliac artery disease, and female gender are independent predictors of poor outcome after iliac stenting, and therefore these risk factors should determine the need for surgical reconstruction.     

Predictors for adverse outcome after iliac angioplasty and stenting for limb-threatening ischemia

OBJECTIVE: The role of iliac artery angioplasty and stenting (IAS) for the treatment of limb-threatening ischemia is not defined. IAS has been used primarily for patients with disabling claudication. Because poorer results have been shown in patients with critical ischemia after iliac artery angioplasty, the purpose of this study was to estimate the influence of risk factors on the outcome of iliac angioplasty and stent placement in patients with limb-threatening ischemia. METHODS: During a 5-year period (from 1996 to 2001), 85 iliac angioplasty and stent placement procedures (107 stents) were performed in 31 women and 43 men with limb-threatening ischemia. Patients with claudication were specifically excluded. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery) were followed to define the variables. The TransAtlantic InterSociety Consensus classification was used to characterize the type of iliac lesions. Both univariate (Kaplan-Meier [KM]) and multivariate analyses (Cox proportional hazards model) were used to determine the association between variables, cumulative patency, limb salvage, and survival. RESULTS: Indications for iliac angioplasty with stenting were ischemic rest pain (56%) and tissue loss (44%). Primary stenting was performed in 36 patients (42%). Stents were placed selectively after iliac angioplasty mainly for residual stenosis or pressure gradient (43%). Overall, primary stent patency rate was 90% at 1 year, 74% at 3 years, and 69% at 5 years. Primary stent patency rate was significantly reduced in women compared with men (KM, log-rank test, P <.001). Primary patency rates at 1, 3, and 5 years were 79%, 57%, and 38% for women and 92%, 88%, and 88% for men. Primary stent patency rate also was significantly reduced in patients with renal insufficiency (creatinine level, >1.6 mg/dL; KM, log-rank test, P <.001). Cox regression analysis identified female gender (relative risk, 5.1; 95% CI, 1.8 to 7.9; P =.002) and renal insufficiency (relative risk, 6.6; 95% CI, 1.6 to 14.2; P =.01) as independent predictors of decreased primary stent patency. No independent predictors for limb salvage and survival were identified. CONCLUSION: Women undergoing iliac angioplasty and stenting for limb-threatening ischemia have significantly reduced primary stent patency rates and may need additional procedures to obtain satisfactory clinical improvement and limb salvage. Patients with renal insufficiency and critical ischemia also have reduced primary stent patency rates after IAS. Limb salvage, as shown in this study, is not affected by previous iliac stent failure.     

Chronic mesenteric ischemia: open surgery versus percutaneous angioplasty and stenting

OBJECTIVE: The aim of the study was to evaluate the safety and efficacy of percutaneous angioplasty and stenting (PAS) in comparison with traditional open surgical (OS) revascularization for the treatment of chronic mesenteric ischemia. METHODS: Over a 3.5-year period, 28 patients (32 vessels) underwent PAS (balloon angioplasty alone, 5 [18%] of 28; angioplasty and stenting, 23 [82%] of 28) for symptoms of chronic mesenteric ischemia. These patients were compared with a previously published series of 85 patients (130 vessels) treated with OS (bypass grafting, 60 [71%] of 85; transaortic endarterectomy, 19 [22%] of 85; or patch angioplasty, 6 [7%] of 85). RESULTS: The PAS and OS groups were similar with respect to baseline comorbidities, duration of symptoms (median: 6.7 vs 10.5 months, P =.52), and the number of vessels involved, but the patients differed in their age at presentation (median: 72 vs 65 years, P =.005). Fewer vessels were revascularized per patient in the PAS group (1.1 +/- 0.4) compared with the OS group (1.5 +/- 0.6, P =.001). Overall, 85.7% (24/28) had one vessel and 14.3% (4/28) had two vessels revascularized in the PAS group versus 48.2% (41/85) with one-vessel and 47.1% (40/85) with two-vessel revascularization in the OS group. No difference was noted in the early in-hospital complications (median: 17.9% [PAS] vs 32.9% [OS], P =.12) or mortality rate (10.7% [PAS] vs 8.2% [OS], P =.71). A reduced length of hospital stay in the PAS patients did not attain statistical significance (median: 5 days [PAS] vs 13 days [OS], P =.08). Although the 3-year cumulative recurrent stenosis (P =.62) and mortality rate (P =.99) did not differ, the PAS treatment group had a higher incidence of recurrent symptoms (P =.001). CONCLUSION: Although the results of PAS and OS were similar with respect to morbidity, death, and recurrent stenosis, PAS was associated with a significantly higher incidence of recurrent symptoms. These findings suggest that OS should be preferentially offered to patients deemed fit for open revascularization.     

Isolated high-grade lesion of the proximal LAD: a stent or off-pump LIMA?

OBJECTIVES: The objective of this study was to compare the long-term outcome of patients with an isolated high-grade stenosis of the left anterior descending (LAD) coronary artery randomized to percutaneous transluminal coronary angioplasty with stenting (PCI, stenting) or to off-pump coronary artery bypass grafting (surgery). METHODS: Patients with an isolated high-grade stenosis (American College of Cardiology/American Heart Association classification type B2/C) of the proximal LAD were randomly assigned to stenting (n=51) or to surgery (n=51) and were followed for 3-5 years (mean 4 years). Primary composite endpoint was freedom from major adverse cardiac and cerebrovascular events (MACCEs), including cardiac death, myocardial infarction, stroke and repeat target vessel revascularization. Secondary endpoints were angina pectoris status and need for anti-anginal medication at follow-up. Analysis was by intention to treat. RESULTS: MACCEs occurred in 27.5% after stenting and 9.8% after surgery (P=0.02; absolute risk reduction 17.7%). Freedom from angina pectoris was 67% after stenting and 85% after surgery (P=0.036). Need for anti-anginal medication was significantly lower after surgery compared to stenting (P=0.002). CONCLUSION: Patients with an isolated high-grade lesion of the proximal LAD have a significantly better 4-year clinical outcome after off-pump coronary bypass grafting than after PCI.     

Indications of coronary angioplasty and stenting in 2003: what is left to surgery?

For many years, coronary artery by-pass graft (CABG) remained the only effective treatment of multivessel disease compared to medical treatment. The first technical revolution was in 1977 when Gruentzig introduced balloon percutaneous transluminal coronary angioplasty (PTCA), the 2nd in the 90's with the developments of stents and antiaggregant protocols. The equipment for PTCA became more and more sophisticated, and the skill of cardiologists greater. In the 90's, interventional cardiology played a predominant role in revascularization as the number of CABG decreased at the same time, and emergency CABG for bail out almost disappeared (0% to 0.5%). Systematic stenting decreased the need for repeat revascularization to about 18-20% nowadays in the majority of centers, except in diabetic patients. Despite this fact restenosis remains the pitfall of angioplasty, mostly in diabetic patients presenting multivessel disease in which surgery with "all arterial grafts" gives good long term RESULTS: The first studies comparing PTCA and CABG are favourable to surgery (BARI), then late ones using stents (ARTS, ERACI 2) showed that stenting was at least equivalent to CABG, in terms of mortality or serious complications (major acute coronary events, MACE), despite a higher target vessel revascularisation (TVR) mainly due to restenosis in the angioplasty cohort. The same results are observed by stenting a high risk lesion as the unprotected left main stenosis can be, until then treated surgically. However, high volume centers studies treating by PTCA+stent the unprotected left main artery (LMA) shows that the 1 year survival rate is similar to surgery, but always related to a restenosis rate of 20% at 6 months in the stent group, which represents the only significant difference in terms of MACE; the new drug eluting stents lead us to expect, according to SIRIUS and TAXUS II studies, to reduce the restenosis rate, and by the way, the MACE could be dramatically lowered from 50% to 60%. Randomised studies would be necessary, but the extrapolation of the actual data, more particularly results of subgroups with a high risk of restenosis, diabetic patients and small vessels, lead us to think that stenting could come in first intention before surgery if TVR is significantly reduced. A complex anatomy, failed attempted chronic occlusion, several lesions on tortuous vessels, would remain the last surgical indication if CABG provides a more complete revascularization. The impact of these new drugs seems promising. However, we should await early results of studies in diabetic patients and bifurcations. But in high volume experienced centers, CABG indications would be reduced in the future to the technical pitfalls of stenting (complex or tortuous anatomy, chronic occlusions) or to the adverse additional cost of this device, unless reduction of restenosis or TVR could also cancel this extra cost. We expect randomised studies CABG versus stented angioplasty using drug eluting stents to confirm these preliminary data.     

External iliac and common iliac artery angioplasty and stenting in men and women

OBJECTIVE: The effect of anatomic location of stent placement on the outcome of iliac artery angioplasty and stenting is not defined. Analyses of patency rates of external iliac artery (EIA) and common iliac artery (CIA) stents have provided conflicting results and have not considered men and women independently. The purpose of this study was to estimate the influence of the anatomic location of stenting on the outcome of iliac angioplasty and stent placement in both men and women. METHODS: From 1995 to 1999, 247 iliac angioplasty and stent placement procedures (303 stents) were performed in 67 women and 122 men, and all were included in a retrospective cohort study. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery) were followed. The TransAtlantic Inter-Society Consensus classification was used to characterize the type of iliac lesions. Both univariate (Kaplan-Meier [KM]) and multivariate analyses (Cox proportional hazards model) were used to determine the association among the variables, cumulative patency, limb salvage, and survival. RESULTS: Indications for iliac angioplasty with stenting were disabling claudication (65%), limb salvage (33%), and blue toe syndrome (2%). Primary stenting was performed in 103 procedures (42%). Stents were placed selectively after iliac angioplasty mainly for residual stenosis or pressure gradient (43%). Patients with EIA stents, as compared with those who had CIA stents, had more extensive lesions (TransAtlantic Inter-Society Consensus type C lesions), poorer runoff, smaller vessel size, and less frequency of hyperlipidemia (P <.05). Primary patency rates at 1, 3, and 5 years were 76%, 56%, and 56%, respectively, for patients with EIA stents and 92%, 85%, and 76%, respectively, for those with CIA stents. Although overall primary patency rates were significantly decreased in patients with EIA lesions (KM, log-rank test, P =.001), stratified analyses revealed that women with EIA stents had the poorest outcome, with 61%, 47%, and 23% primary patency rates at 1, 3, and 5 years, respectively, (KM, log-rank test, P <.001). Cox regression analysis identified EIA stenting (relative risk, 4.3; 95% CI, 2.3-7.9; P <.001) as an independent predictor of decreased primary patency in women but not in men. CONCLUSIONS: Women undergoing EIA angioplasty with stent placement have significantly reduced primary patency rates. Despite initial technical success, these patients are at increased risk of long-term failure and might require subsequent procedures to obtain clinical success. Conversely, men undergoing EIA stenting have a more favorable outcome than women.     

Independent predictors of restenosis after percutaneous coronary revascularization in haemodialysis patients.

BACKGROUND: Percutaneous balloon angioplasty has become a well-established and routine procedure for coronary revascularization of haemodialysis patients with coronary artery disease. However, the incidence of restenosis after balloon angioplasty is significantly higher in haemodialysis patients than in the general population. We performed a retrospective study comparing balloon angioplasty with coronary stenting in haemodialysis patients. We evaluated the long-term clinical and angiographic outcome after successful percutaneous coronary revascularization in haemodialysis patients. METHODS: A total of 103 consecutive haemodialysis patients (123 lesions) underwent procedurally and clinically successful percutaneous revascularization. Patients were treated with three different strategies: (i) balloon angioplasty in 55 patients (69 lesions); (ii) coronary stenting with balloon angioplasty in 23 patients (25 lesions); and (iii) coronary stenting with rotational atherectomy in 25 patients (29 lesions) who had severely calcified stenotic coronaries. RESULTS: The rates of in-hospital mortality were similar in the three groups. The 1-year incidence of overall events and major adverse cardiac events (MACE) were significantly higher in the balloon group than in the stent with/without rotational atherectomy groups (75% vs 36 and 28%, P<0.01; 71% vs 32 and 28%, P<0.01). Use of coronary stenting (relative risk=0.006, P<0.001) and the presence of calcified coronary lesion (relative risk=68.2, P<0.001) were independent predictors of the 1-year MACE-free survival after percutaneous revascularization. The 3-year MACE-free survival rate was significantly lower in the balloon group than in the stent with/without rotational atherectomy groups (11% vs 33 and 47%, P<0.005 and P<0.001). CONCLUSIONS: This study shows that coronary stenting reduces the incidence of MACE in haemodialysis patients with/without calcified coronary lesions. Moreover, coronary stenting reduces the restenosis rate of both complex and restenotic lesions, and rotational atherectomy prior to coronary stenting reduces the restenosis rate of the severely calcified coronary lesions. These results suggest that coronary stenting with/without rotational atherectomy has led to an improved long-term outcome in the haemodialysis patients with coronary artery disease.     

Limitations in the cardiac risk reduction provided by coronary revascularization prior to elective vascular surgery

OBJECTIVE: The objective of this study was to evaluate the proposed cardiac protective effect of previous coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) before elective major arterial surgery. METHOD: Preoperative cardiac risk stratification using American College of Cardiology/American Heart Association (ACC/AHA) guidelines was done on 425 consecutive patients undergoing 481 elective major vascular operations at an academic VA Medical Center. The algorithm assumed asymptomatic patients with prior coronary revascularization (CABG, <5 year; PTCA, <2 year) were low cardiac risk. Coronary angiography was done for recurrent symptoms with secondary intervention when appropriate. Outcomes (myocardial infarction, unstable angina, congestive heart failure, ventricular arrhythmia, cardiac death, and mortality) within 30 days of vascular surgery were compared between patients with and without previous CABG or PTCA by contingency table and logistic regression analyses. RESULTS: Coronary revascularization was classified as recent (CABG, <1 year; PTCA, <6 months) in 35 cases (7%), prior (1 year < or = CABG < 5 year, 6 months < or = PTCA < 2 year) in 45 cases (9%), and remote (CABG, > or = 5 year; PTCA, > or = 2 year) in 48 cases (10%). A larger fraction of patients with previous revascularization possessed pathologic cardiac risk variables and were stratified as high-risk preoperatively than their nonrevascularized counterparts. Outcomes in patients with previous PTCA were similar to those after CABG (P =.7). Significant differences in adverse cardiac events (P =.01) and mortality (P =.05) were found between patients with CABG done within 5 years or PTCA within 2 years (6.3%, 1.3%, respectively), individuals with remote revascularization (10.4%, 6.3%), and nonrevascularized patients stratified at high risk (13.3%, 3.3%) or intermediate/low (2.8%, 0.9%) risk. De novo or recurrent 3-vessel coronary disease by angiography, but not the presence or timing of previous revascularization, was an independent predictor of cardiac events after vascular operations, whereas remote revascularization was associated with fatal outcomes by multivariate analysis. CONCLUSIONS: Previous coronary revascularization (CABG, <5 years; PTCA, <2 years) may provide only modest protection against adverse cardiac events and mortality following major arterial reconstruction.     

Surgical revascularization versus endovascular therapy for chronic mesenteric ischemia: a comparative experience

INTRODUCTION: Endovascular therapy (percutaneous transluminal angioplasty [PTA] with stenting) has been increasingly applied in patients with chronic mesenteric ischemia (CMI) to avoid morbidities associated with open repair (OR). The purpose of this study was to compare outcomes of PTA/Stent vs OR in patients with symptomatic CMI. METHODS: During the interval of January 1991 to December 2005, 80 consecutive patients presenting with symptomatic CMI underwent elective revascularization. Patients with acute mesenteric ischemia or those with mesenteric revascularization performed as part of complex aneurysm repair were excluded. PTA/Stent (with stenting in 87%) was the initial procedure in 31 patients (42 vessels). OR was performed in 49 patients (88 vessels) and consisted of bypass grafting in 31 (63%), transaortic endarterectomy in 7 (14%), patch angioplasty in 4 (8%), or combined in 7 (15%). Mean follow-up was 15 months in the PTA/Stent group and 42 months in the OR cohort. Study end points included perioperative morbidity, mortality, late survival (Kaplan-Meier), and symptomatic and radiographic recurrence. RESULTS: Baseline comorbidities, with the exception of heart disease (P=.025) and serum albumin<3.5 g/dL (P=.025), were similar between PTA/Stent and OR patients. The PTA/Stent group had fewer vessels revascularized (1.5 vs 1.8 vessels, P=.001). Hospital length of stay was less for the PTA/Stent group (5.6 vs 16.7 days, P=.001). No difference was noted in in-hospital major morbidity (4/31 vs 2/49, P=.23) or mortality (1/31 vs 1/49, P=.74). Actuarial survival at 2 years was similar between the groups (88% PTA/Stent vs 74% OR, P=.28). There was no difference in the incidence of symptomatic (7/31 [23%] vs 11/49 [22%], P=.98) or radiographic recurrence (10/31 [32%] vs 18/49 [37%], P=.40) between the two groups. Radiographic primary patency (58% vs 90%, P=.001) and primary assisted patency (65% vs 96%, P<.001) at 1 year were lower in the PTA/Stent group compared with OR. Five (16%) of 31 PTA/Stent patients compared with 11 (22%) of 49 OR patients required a second intervention on at least one index vessel at any time (P=.49). CONCLUSIONS: Symptomatic recurrence requiring reintervention is common (overall 16/80 [20%]) after open and endovascular treatment for CMI. PTA/Stent was associated with decreased primary patency, primary assisted patency, and the need for earlier reintervention. In-hospital mortality or major morbidity were similar in patients undergoing PTA/Stent and OR. These findings suggest that OR and PTA/Stent should be applied selectively in CMI patients in accordance with individual patient anatomic and comorbidity considerations.     

Mesenteric stenting for chronic mesenteric ischemia

BACKGROUND: Mesenteric stenting has not been widely adopted for the treatment of chronic mesenteric ischemia (CMI). The recent availability of embolic protection and low-profile devices with the theoretical ability to decrease perioperative bowel necrosis, led us to begin using mesenteric stenting for patients with CMI. We review our initial experience to examine short-term outcomes. METHODS: We performed a retrospective analysis of all patients who were treated by vascular surgeons with mesenteric stenting for CMI. Patients with acute mesenteric ischemia were excluded. We evaluated perioperative morbidity and mortality, restenosis, recurrent symptoms, and reintervention. Kaplan-Meier methods were used to assess events during follow-up. We also compared these outcomes with a historical control group of patients treated with open surgical revascularization. RESULTS: Fourteen patients underwent mesenteric stenting over the past 3 years. Mean age was 73, and 64% were women. There was no perioperative or 30-day mortality or major morbidity. Early restenosis and recurrent symptoms occurred in 10% and 9% of patients at 6 months. At a mean follow-up of 13 months, 53% of patients underwent reintervention. However, 93% were symptom-free at their last follow-up. Compared with open surgery, stent patients had lower perioperative major morbidity (30% vs 0%, P < .01) and shorter hospital and intensive care unit length of stay (median 10 days vs 2 days, and 3 days vs 0 days, respectively, P < .01 for both). However, stent patients were seven times as likely to develop restenosis (P < .01), four times more likely to develop recurrent symptoms (P < .01), and 15 times more likely to undergo reintervention (P < .01). There was one death 13 months after stenting due to mesenteric infarction in a patient lost to follow-up. One patient was successfully converted to open surgery after a second restenosis. He had regained 20 pounds and was determined to be a better operative candidate than at his initial presentation. There was no perioperative or 30-day mortality or major morbidity with reintervention after mesenteric stenting. CONCLUSION: Mesenteric stenting for CMI can be performed with low perioperative risk. However, stenting is associated with early restenosis and recurrent symptoms requiring secondary procedures. Patients with severe nutritional depletion or high surgical risk may benefit from mesenteric stenting for CMI, but close follow-up is required. Later open surgery can be performed for restenosis if nutritional status and surgical risk are improved, or repeat angioplasty and stenting can be effectively performed if operative risk remains high.     

Correlation between prior coronary revascularization and perioperative cardiac events in patients for noncardiac surgery

We evaluated the influence of interval between prior coronary revascularization and subsequent noncardiac surgery on perioperative cardiac events. We retrospectively identified 162 consecutive patients with previous revascularization procedures who had undergone noncardiac surgery. Postoperative cardiac complications occurred in 10 (6.2%) patients, cardiac death in 1 patient, and significant arrhythmia in 3 patients. These patients had higher rates of unstable angina, myocardial infarction within 3 months, cerebrovascular disease, peripheral vascular disease, renal dysfunction (Cr > or = 1.9 mg.dl-1) and higher preoperative risk scores as described by the Cleveland Clinic (P < 0.05). Also, the incidence of cardiac complications increased when noncardiac surgery was performed within 1 week of previous percutaneous transluminal coronary angioplasty (PTCA) and in more than 5 years after coronary artery bypass grafting or PTCA (P < 0.05). Although PTCA is widely accepted, especially in Japan, early lesion progression was observed during the first several days and atherosclerotic progression was apparent in more than 5 years after the procedure. Therefore, the time between coronary revascularization and noncardiac surgery, as well as atherosclerotic risk factors, is important in evaluating patients with history of previous revascularization procedures.     

Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery: Moses JW,Leon NB,Pomma JJ,et al. N Engl J Med 2003;349:1315-23

ConclusionSirolimus-eluting stents in patients with complex coronary artery disease reduced the rate of recurrent stenosis and related clinical events in all subjects analyzed, including patients with diabetes, patients with longer coronary lesions, and patients with small coronary arteries.SummarySirolimus (Rapamycin) is a cytostatic lactone with antiproliferative and anti-inflammatory properties. When delivered via a polymer-encapsulated stent it reduces risk for restenosis in patients undergoing coronary artery stenting who are at low risk for restenosis. In this study the authors investigated the utility of Sirolimus-eluding stents in patients with more complex coronary lesions at greater risk for restenosis.This was a randomized double-blind clinical trial comparing Sirolimus-eluting stents with standard stents in 1058 patients. Fifty-three centers in the United States were used. All patients had a newly diagnosed lesion in a native coronary artery. Twenty-six percent of the patients included in this study had diabetes, many had longer coronary artery lesions (mean, 14.4 mm), and many had small vessels (mean, 2.8 mm). The primary end point was failure of the target vessel within 270 days after stent implantation. Failure was defined as death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel with either open coronary surgery or repeat coronary angioplasty.Target vessel failure was reduced from 21% with the standard stent to 8.6% with Sirolimus-eluting stents P < .001). This end point was driven largely by the decreased frequency of target vessel revascularization in patients with the drug-eluting stents (16.6% in the standard stent group vs 4.1% in the Sirolimus stent group; P < .001). Results in favor of the Sirolimus-eluting stent held for all subgroups, including the patients with diabetes, those with smaller vessels, and those with more complex coronary lesions. Three-hundred fifty patients in the Sirolimus stent group and 353 in the standard stent group had angiographic follow up. The frequency of in-stent restenosis of at least 50% lumen diameter was 35.4% in the standard stent group and 3.2% in the Sirolimus stent group P < .001).CommentThe study indicates a consistent and powerful treatment effect of Sirolimus-eluting stents in patients with complex coronary lesions out to 270 days. Longer follow-up is clearly required. Short-term benefits do not always translate into long-term benefits.     

Intravascular ultrasound scanning improves long-term patency of iliac lesions treated with balloon angioplasty and primary stenting

PURPOSE: Underdeployment of an intravascular stent has been identified as a cause of restenosis or occlusion of a treated arterial lesion. Intravascular ultrasound (IVUS) has been shown to initially improve the anatomic and clinical stenting. The purpose of this study was to determine whether the use of IVUS increased long-term patency of this intervention. METHODS: Between March 1992 and October 1995, 71 limbs (52 patients) with symptomatic aortoiliac occlusive disease underwent balloon angioplasty with primary stenting. IVUS and arteriography were used in 49 limbs (36 patients) to evaluate stent deployment. Arteriography alone was used in 22 limbs (16 patients) to evaluate stent deployment. Patients were captured prospectively in a vascular registry and retrospectively reviewed. RESULTS: Mean age of patients treated with IVUS was 61.1 plus minus 9.0 years (range, 38-85) versus 70.0 plus minus 10.1 years (range, 57-87) in patients treated without IVUS (P <.01). There was no difference between the groups with respect to preoperative comorbidities, ankle-brachial indices, or number of stents per limb. Mean follow-up for IVUS patients was 62.1 plus minus 7.3 months (range, 15-81) and 57.9 plus minus 8.7 months (range, 8-80) for patients treated without IVUS (P = not significant). In 40% (20/49) of limbs, IVUS demonstrated inadequate stent deployment at the time of the original procedure. Kaplan-Meier 3- and 6-year primary patency estimates were 100% and 100% in the IVUS group and 82% and 69%, respectively, in limbs treated without IVUS (P <.001). There have been no secondary procedures performed in limbs treated with IVUS and a 23% (5/22) secondary intervention rate in the non-IVUS group (P <.05). Overall Kaplan-Meier survival estimates at 3 and 6 years for all patients were 84% and 67%, respectively. CONCLUSION: Balloon angioplasty and primary stenting of symptomatic aortoiliac occlusive lesions is a durable treatment option. Long-term follow-up of treated patients shows outcomes that are comparable with direct surgical intervention. IVUS significantly improved the long-term patency of iliac arterial lesions treated with balloon angioplasty and stenting by defining the appropriate angioplasty diameter endpoint and adequacy of stent deployment.     

Iliac artery stenting in patients with poor distal runoff: Influence of concomitant infrainguinal arterial reconstruction

OBJECTIVE: Inadequate infrainguinal runoff is considered an important risk factor for iliac stent failure. However, the influence of concomitant infrainguinal arterial reconstruction (CIAR) on iliac stent patency is unknown. This study evaluated the influence of CIAR on outcome of iliac angioplasty and stenting (IAS) in patients with poor distal runoff. METHODS: Over 5 years (1996 to 2001), 68 IAS procedures (78 stents) were performed in 62 patients with poor distal runoff (angiographic runoff score >or=5). The SVS/AAVS reporting standards were followed to define outcome variables and risk factors. Data were analyzed with both univariate analysis (Kaplan-Meier method [K-M]) and regression analysis (Cox proportional hazards model). RESULTS: Indications for iliac artery stenting were disabling claudication (59%) and limb salvage (41%). Of the 68 procedures, IAS with CIAR was performed in 31 patients (46%), and IAS alone was performed in 37 patients (54%). Patients undergoing IAS with CIAR were older (P =.03) and had more extensive and multifocal iliac artery occlusive disease, with more TASC (TransAtlantic Inter-Society Consensus) type C lesions (P =.03), compared with patients undergoing IAS alone. No other significant differences in risk factors were noted. Runoff scores between patients undergoing IAS with CIAR and those undergoing IAS alone were not significantly different (median runoff scores, 6 [range, 5-8] and 7 [range, 5-9], respectively; P =.77). Primary stent patency rate at 1, 3, and 5 years was 87%, 54%, and 42%, respectively, for patients undergoing IAS with CIAR, and was 76%, 66%, and 55%, respectively, for patients undergoing IAS. Univariate analysis revealed that primary stent patency rate was not significantly different between the 2 groups (K-M, log-rank test, P =.81). Primary graft patency rate for CIAR was 81%, 52%, and 46% at 1, 3, and 5 years, respectively. Performing CIAR did not affect primary iliac stent patency (relative risk, 1.1; 95% confidence interval, 0.49-2.47; P =.81). Overall, there was a trend toward improved limb salvage in patients undergoing IAS with CIAR, compared with those undergoing IAS alone (K-M, log rank test, P =.07). CONCLUSION: In patients undergoing IAS with poor distal runoff, CIAR does not improve iliac artery stent patency. Infrainguinal bypass procedures should therefore be reserved for patients who do not demonstrate clinical improvement and possibly for those with limb-threatening ischemia.     

Minimally invasive coronary artery bypass grafting versus percutaneous transluminal coronary angioplasty with stenting in isolated high-grade stenosis of the proximal left anterior descending coronary artery: six months' angiographic and clinical follow-up of a prospective randomized study

OBJECTIVE: We sought to compare minimally invasive coronary artery bypass grafting (surgical intervention) with percutaneous transluminal coronary angioplasty with primary stenting (stenting) in patients having an isolated high-grade stenosis (American College of Cardiology/American Heart Association classification type B2 or C) of the proximal left anterior descending coronary artery. At 6 months, both procedures were compared on the basis of quantitative angiography and clinical outcome. METHODS: Both treatments were compared in a single-center, prospective, randomized study. The primary end point of this study was quantitative angiographic outcome at 6 months. The secondary end point was 6-month clinical outcome. Statistical analysis was performed in accordance with the intention-to-treat principle. RESULTS: From March 1997 to September 1999, patients with angina pectoris caused by an isolated high-grade stenosis of the proximal left anterior descending coronary artery were randomly assigned to surgical intervention (n = 51) or stenting (n = 51). At 6 months, quantitative coronary angiography showed an anastomotic stenosis rate of 4% after surgical intervention and a restenosis rate of 29% after stenting (P <.001). Periprocedural events did not significantly differ between surgical intervention and stenting. After surgical intervention, 2 patients died; no patients died after stenting. After 6 months, no significant difference was found for major adverse cardiac or cerebral events and need for repeat target vessel revascularization. After 6 months, return of angina pectoris, physical work capacity, and use of antianginal drugs did not significantly differ between treatments. CONCLUSIONS: After 6 months, surgical intervention had a significantly better angiographic outcome than stenting in patients with an isolated high-grade stenosis of the proximal left anterior descending coronary artery. Clinical outcome did not significantly differ between treatments.     

High-risk carotid endarterectomy: challenges for carotid stent protocols.

BACKGROUND: Carotid angioplasty and stenting is under investigation in clinical trials as an alternative to endarterectomy. Some clinicians have hypothesized that stenting would be applicable for patients at high risk who need carotid revascularization. To further test this hypothesis, we stratified our carotid endarterectomy procedures according to current carotid stent protocols. METHODS: We reviewed our computerized registry and the clinical charts of patients who underwent carotid endarterectomy. Each procedure was categorized as high risk or low risk, according to the following six separate high-risk factors: 1, severe cardiac dysfunction; 2, the requirement for combined coronary and carotid vascularization; 3, severe pulmonary dysfunction; 4, contralateral internal carotid artery occlusion; 5, previous ipsilateral carotid endarterectomy; and 6, anatomically limited access for carotid endarterectomy. Rates of stroke at 30 days, cardiac complications, and death were tabulated. RESULTS: Between January 1, 1998, and December 31, 2000, 415 carotid endarterectomies were performed on 389 patients. Ninety-eight procedures (23.6%) were classified as high risk on the basis of the following factors: 1, severe cardiac dysfunction (n = 30); 2, requirement for combined coronary and carotid revascularization (n = 14); 3, severe pulmonary dysfunction (n = 8); 4, contralateral carotid occlusion (n = 31); 5, previous ipsilateral carotid endarterectomy (n = 25); and 6, anatomically limited access (n = 4). Seven patients had ipsilateral postoperative strokes (1.7%), with two additional patients having contralateral hemispheric strokes. One patient died from exacerbation of congestive heart failure 9 days after undergoing a second carotid endarterectomy. The total stroke and death rate was 2.6% for all the patients. Two of the 98 procedures in the high-risk group were complicated with ipsilateral stroke (2.0%) as compared with six of the 317 low-risk procedures (1.9%; P = 1). Six procedures were complicated with cardiac dysfunction after surgery, including myocardial infarction, congestive heart failure, or the new onset of atrial fibrillation. Three cardiac complications occurred in the low-risk group (1%), and three occurred in the high-risk group (3.1%; P =.15). CONCLUSION: This series shows that patients at high risk can undergo carotid endarterectomy with stroke rates equivalent to the rates of patients at low risk. The cardiac morbidity rate may be increased in the high-risk group. Carotid stenting is unlikely to offer any improvement in stroke risk as compared with carotid endarterectomy, but stenting may reduce non-stroke morbidity rates associated with some high-risk cases.     

A reassessment of carotid endarterectomy in the face of contralateral carotid occlusion: surgical results in symptomatic and asymptomatic patients

OBJECTIVE: Total occlusion of the contralateral internal carotid artery has often been considered to be a predictor of poor outcome after carotid endarterectomy (CEA) of ipsilateral carotid stenosis. Data from both the North American Symptomatic Carotid Endarterectomy Trial and the Asymptomatic Carotid Atherosclerosis Study have suggested this to be true. However, each of these trials had relatively few patients with contralateral occlusion in the surgical arms of the studies. Recently, advocates of carotid angioplasty and stenting have suggested that this technique may be preferable in patients with a contralateral occlusion because of the perceived poor outcome with surgery. The purpose of this study was to review a large series of CEAs performed in patients with contralateral occlusion to see whether results differed from patients with patent contralateral arteries and to determine whether the presence of preoperative symptoms was an important factor in outcome in these cases. PATIENTS AND METHODS: A review was conducted of a prospectively compiled database of all primary CEAs performed at our institution from 1985 to 1999. Surgery was performed on 2420 patients, of whom 338 (14.0%) had contralateral total occlusion. RESULTS: Patients with contralateral total occlusion were more likely to be symptomatic (65.7% versus 60.1%; P =.1), male (70.9% versus 58%; P <.001), and hypertensive (63.9% versus 58.4%; P =.07) with a positive smoking history (42.6% versus 31.4%; P <.001) than patients with patent contralateral carotid artery. No significant difference was seen in the rates of perioperative neurologic events between patients with contralateral occlusion (3.0%) and those without (2.1%; P =.34). Among the total of 913 asymptomatic patients, of whom 115 had contralateral occlusion, no difference was seen in the rate of perioperative neurologic events (1.8% for contralateral occlusion cases; 1.9% for cases without contralateral occlusion). Among the total of 1507 symptomatic patients, of whom 223 had contralateral occlusion, no significant difference was seen in the rate of perioperative neurologic events (3.7% for contralateral occlusion cases; 2.2% for cases without contralateral occlusion; P =.2). CONCLUSION: The presence of contralateral occlusion does not appear to increase the perioperative risk of CEA. Although the risk of CEA in symptomatic patients with contralateral occlusion may be slightly increased, this must be weighed against the risk with medical treatment alone. CEA can be performed safely in patients with contralateral occlusion, which should not necessarily be considered a high-risk condition for surgery in favor of angioplasty and stenting.     

Primary stenting versus MIDCAB: preliminary report-comparision of two methods of revascularization in single left anterior descending coronary artery stenosis

BACKGROUND: Percutaneous revascularization is a well-accepted method of treatment for a single left anterior descending coronary artery (LAD) stenosis. With the introduction of primary stenting, it has become the treatment of choice for a LAD lesion. In the last few years however, the introduction of minimally invasive cardiac surgery, video-assisted left internal thoracic artery (LITA) harvesting, and robotic surgery have raised the question as to whether minimally invasive surgical revascularization would be competitive with percutaneous coronary interventions in cases of single-vessel stenoses. METHODS: A group of 100 patients with Canadian Cardiovascular Society class II to IV, and angiographically confirmed single critical stenosis of the LAD (type A or B), were treated with direct primary stenting (group 1, n = 50), or with endoscopic atraumatic coronary artery bypass grafting (group 2, n =50). RESULTS: All patients in a group 1, obtained a very good angiographic and clinical effect. No acute postoperative complications were noted at 1 month of follow-up. However, at 1 month of follow-up, 3 patients (6%) developed restenosis of the LAD, and at 6 months follow-up, 6 patients (12%), developed restenosis of the LAD. In these cases, repeated percutaneous coronary interventions of the target vessel were successfully performed. In group 2, very good operative results were observed. In 1 and 6 months of follow-up, all patients remained asymptomatic. Critical stenosis of the left internal thoracic artery-LAD anastomosis was angiographically documented in 1 case (2%). This patient was successfully treated with balloon angioplasty. CONCLUSIONS: The study results document the superiority of endoscopic atraumatic coronary artery bypass grafting over direct primary stenting in LAD revascularization, along with the slightly higher costs of the surgical procedure.     

Reinterventions for recurrent ischemic heart disease following a successful first re-do myocardial revascularization: predictors, indications and results.

Predictors for a reintervention following a successful first re-do surgical revascularization (CABG) were examined. Success and limitations of the reintervention procedures were evaluated. Between 3/88 and 3/95, 16.81% (302/1796) patients who had undergone a first re-do CABG surgery in the authors' center, required a reintervention. Graft angioplasty was performed in 158 (52.32%) patients and a second re-do CABG in 47.68% (n = 144). Graft angioplasty was preferred over surgery in patients aged 70 years or older (43% versus 24.3%, P<0.001) and in patients with unstable angina (55.6% versus 33.3%, NS) or a Left Ventricular Ejection Fraction (LVEF) <30% (34.8% versus 20%, P<0.05). Re-do CABG was preferred over graft angioplasty for multivessel revascularization (3+/-0.3 versus 1+/-0.6, P<0.001), proximal occlusive disease (P<0.001) and for graft disease of a longer duration (7.18+/-1.7 years versus 3+/-0.6 years, P<0.01). The independent predictors of a reintervention were (i) lack of arterial revascularization and (ii) inability to achieve a complete revascularization in a previous operation. The predictors of a failed graft angioplasty were diameter stenosis >70%, long occlusive lesions (multivariate), angulation, calcification and asymmetrical lesions (univariate). Failed graft angioplasty required a re-do CABG (n = 48: early 21, late 27), repeat graft angioplasty (n = 34: early 8, late 26) or transplant (n = 1). Recurrent symptoms following a second re-do CABG required a graft angioplasty (n = 6: early 2, late 4), a subsequent re-do CABG (n = 32) or a transplant (n = 4). Cumulative incidence of cardiac events at 1 month, and 1 and 8 years were: 20, 40.45 and 66.44% following graft angioplasty and 5.5, 10 and 56.55% following a second re-do CABG, respectively (P<0.05). Actuarial survival at 1 month and 6 years following graft angioplasty were 97.15 and 77.22%, and 94.7 and 83.26% after a second re-do CABG, respectively (NS). Re-do CABG was more effective and durable. Graft angioplasty provided a good palliation in suitable cases and also postponed the need for a high-risk surgical intervention for more favorable conditions.