Procedural results and late clinical outcomes after placement of three or more stents in single coronary lesions

BACKGROUND: Previous reports have suggested higher procedural and long-term complications among patients treated with multiple stents for diffuse lesions and/or long dissections. METHODS AND RESULTS: To evaluate procedural success, major complications, and clinical outcomes (> or = 1 year) in a consecutive series of patients treated with multiple (> or = 3) contiguous stents in single lesions, we evaluated in-hospital and long-term (1-year) clinical outcomes in 117 consecutive patients treated with > or = 3 coronary stents compared with a concurrent series of patients treated with 1 or 2 stents (n=1673) between January 1, 1994, and December 31, 1995. Multiple stents were implanted more often in larger vessels, in the right coronary artery or saphenous vein grafts, and for unfavorable lesion characteristics, including long (>20 mm), calcified, ulcerated, thrombotic, and/or flow-obstructing lesions. Overall procedural success was obtained in 97.4% of patients and was similar whether 1 or 2 versus > or = 3 stents were used. Non-Q-wave MI (CK-MB > or = 5 times normal) was more frequent after > or = 3 stents (22.8% versus 13.4%, P=.005). Target lesion revascularization (TLR) was 14.6% for 1 or 2 stents and 13.3% for > or = 3 stents (P=.70). There was no difference in death (2.2% versus 0.9%, P=.34) or Q-wave MI (1.4% versus 0.9%, P=.64) between the two groups (1 or 2 stents versus > or = 3 stents, respectively), and overall cardiac event-free survival was similar during follow-up (P=.70). CONCLUSIONS: Patients treated with multiple (> or = 3) contiguous stents compared with 1 or 2 stents have (1) similar in-hospital procedural success and major complications despite having more unfavorable lesion characteristics, (2) a higher rate of procedural non-Q-wave MI, and (3) similar TLR and overall major cardiac event rates during 1 year of follow-up.     

Long-term angiographic and clinical outcome of patients undergoing multivessel coronary stenting

BACKGROUND: Randomized clinical trials have shown that multivessel coronary angioplasty is feasible and provides similar long-term survival as bypass surgery in selected patients. However, the higher need for repeat intervention, in particular, coronary artery bypass graft surgery, remains a problem. The objective of this study was to test the hypothesis that multivessel stenting is safe and effective in reducing the need for repeat interventions, in particular, the need for bypass surgery. METHODS AND RESULTS: Between March 1993 and June 1995, 100 consecutive patients (243 lesions) had multivessel coronary stenting. High-pressure stent optimization was used in all patients. Procedural success was achieved in 97% of lesions; 2 patients (2%) required emergency bypass surgery. Angiographic follow-up was obtained in 89% of patients at 5.2+/-2.5 months. Angiographic restenosis occurred in 22% of the lesions, but 37% of patients had > or = 1 lesion with restenosis. Clinical follow-up was obtained in all patients at 21 +/- 10 months: target lesion revascularization was needed in 30 patients (30%), repeat angioplasty in 28 patients (28%) and coronary bypass surgery in 2 patients (2%); the overall survival rate was 96% (2% noncardiac death). CONCLUSIONS: Multivessel coronary stenting can be performed with high success rate and low need for emergency bypass surgery. Compared with historical results with multivessel percutaneous transluminal coronary angioplasty, patients who undergo multivessel stenting need less repeat interventions, in particular, less coronary bypass surgery and have similar long-term survival.     

Comparison of primary coronary stenting to primary balloon angioplasty with stent bailout for the treatment of patients with acute myocardial infarction

This study compares the immediate and long-term outcomes of a primary coronary stenting strategy with primary balloon angioplasty with stent bailout in the treatment of patients with acute myocardial infarction (AMI). One hundred forty-seven consecutive patients who underwent primary balloon angioplasty with stent bailout (n = 94) or primary stenting (n = 53) for AMI were clinically followed for 8.1 +/- 5.7 and 8.5 +/- 4.5 months, respectively. Immediate results, as well as in-hospital and long-term ischemic events (death, reinfarction, and repeat revascularization) were compared between both groups. Angiographic success was 91.5% in the balloon angioplasty group and 94% in the stent group. In-hospital and late follow-up combined ischemic events were 22 of 94 (23%) versus 0 of 53 (0%); p < 0.001 and 33 of 78 (42%) versus 13 of 53 (25%), p = 0.04 for the balloon angioplasty and stent groups, respectively. At 6 months, the cumulative probability of repeat target lesion revascularization was higher in the balloon angioplasty group (47% vs 18%, p = 0.0006) as was the probability of late target revascularization (36% vs 18%, p = 0.046); the cumulative event-free survival after 6 months was significantly lower in the balloon angioplasty group (44% vs 80%, p = 0.0001). This study demonstrates that a primary stent placement strategy in patients with AMI is safe, feasible, and superior to primary balloon angioplasty with stent bailout. Primary stenting results in a larger postprocedural minimal luminal diameter, a lower early and late recurrent ischemic event rate, and a lower incidence of target lesion revascularization at follow-up.     

Late results of percutaneous transluminal coronary angioplasty of two or more major native coronary arteries

Of 613 consecutive patients with multivessel coronary artery disease (CAD) undergoing revascularization, 521 patients (85%) underwent primary management with percutaneous transluminal coronary angioplasty (PTCA). To examine long-term outcome in a series of patients often referred for coronary artery bypass graft (CABG) surgery, all patients undergoing multivessel dilations were identified for late follow-up analysis (n = 161). Mean age was 65 years; 54 patients (34%) were women. Four hundred fifty-five of 502 lesions (90.6%) were successfully dilated. Major in-hospital procedural complications occurred in 6 patients (3.7%), including death in 3 (1.9%), nonfatal Q-wave myocardial infarction in 2 (1.2%), and CABG in 1 (0.6%). Final follow-up data were available in 159 patients (99%) at a mean of 39 +/- 18 months. Including in-hospital events, actuarial 3-year survival was 93%, and 3-year infarct-free survival was 90%. At final follow-up, 143 of 146 patients alive (98%) were angina free. Crossover to CABG was required in 25 patients (16%). Repeat PTCA was performed in 67 patients (42%) (mean 1.7 PTCAs/patient, range 1 to 7). PTCA is an effective therapeutic alternative in the management of most patients with multivessel CAD requiring revascularization. A strategy using multiple repeated PTCA procedures when necessary results in prolonged infarct-free survival, with long-term freedom from angina and limited crossover to CABG.     

Percutaneous transluminal coronary angioplasty versus medical therapy for stable angina pectoris: outcomes for patients with double-vessel versus single-vessel coronary artery disease in a Veterans Affairs Cooperative randomized trial. Veterans Affairs ACME InvestigatorS

OBJECTIVES: This study sought to assess outcomes of men with double-vessel coronary artery disease randomly assigned to treatment by percutaneous transluminal coronary angioplasty (PTCA) or medical therapy, compared with previously reported outcomes for men with single-vessel disease. BACKGROUND: We previously reported that PTCA provides better symptom relief and treadmill performance than medical therapy for men with stable angina pectoris due to single-vessel disease. Whether this advantage applies to patients with double-vessel disease is unknown. METHODS: Male patients (n = 328) with stable angina pectoris and ischemia on treadmill testing were randomly assigned to PTCA or medical therapy; 101 patients had double-vessel disease, and 227 had single-vessel disease. Symptoms, treadmill performance, quality of life score, coronary stenosis and myocardial perfusion were compared at baseline and at 6 months. Patients were followed up for up to 6 years and underwent additional treadmill testing 2 to 3 years after randomization. RESULTS: PTCA-treated and medically treated patients with double-vessel disease experienced comparable improvement in exercise duration (+1.2 vs. +1.3 min, respectively, p = 0.89), freedom from angina (53% and 36%, respectively, p = 0.09) and improvement of overall quality of life score (+1.3 vs. +4.4, respectively, p = 0.32) at 6 months compared with baseline. This contrasts with greater advantages favoring PTCA by these criteria in patients with single-vessel disease (p = 0.0001 to 0.02). Trends present at 6 months persisted at late follow-up. Patients undergoing double-vessel dilation had less complete initial revascularization (45% vs. 83%) and greater average stenosis of worst lesions at 6 months (74% vs. 56%). Likewise, patients with double-vessel disease showed less improved myocardial perfusion imaging (59% vs. 75%). CONCLUSIONS: PTCA is beneficial in male patients with double-vessel disease; however, we cannot demonstrate the same advantage over medical therapy seen in similar patients with single-vessel disease. Less complete revascularization and greater restenosis for patients having multiple dilations would account for these findings. Alternatively, a type 2 error might be operative. Technical advances since completion of this trial might improve these outcomes. These findings warrant further investigation in a larger trial.     

Directional coronary atherectomy for the treatment of Palmaz-Schatz in-stent restenosis

Management of in-stent restenosis has become a significant challenge in interventional cardiology. The results of balloon angioplasty have been disappointing due to the high recurrence of restenosis at follow-up. Debulking of the restenotic tissue within the stents using directional coronary atherectomy (DCA) may offer a therapeutic advantage. We report the immediate clinical and angiographic outcomes and long-term clinical follow-up results of 45 patients (46 lesions), mean age 63+/-12 years, 73% men, with a mean reference diameter of 2.9+/-0.6 mm, treated with DCA for symptomatic Palmaz-Schatz in-stent restenosis. DCA was performed successfully in all 46 lesions and resulted in a postprocedural minimal luminal diameter of 2.7+/-0.7 mm and a residual diameter stenosis of 17+/-10%. There were no in-hospital deaths, Q-wave myocardial infarctions, or emergency coronary artery bypass surgeries. Four patients (9%) suffered a non-Q-wave myocardial infarction. Target lesion revascularization was 28.3% at a mean follow-up of 10+/-4.6 months. Kaplan-Meier event-free survival (freedom from death, myocardial infarction, and repeat target lesion revascularization) was 71.2% and 64.7% at 6 and 12 months after DCA, respectively. Thus, DCA is safe and efficacious for the treatment of Palmaz-Schatz in-stent restenosis. It results in a large postprocedural minimal luminal diameter and a low rate of both target lesion revascularization and combined major clinical events at follow-up.     

Predictors of major in-hospital ischemic complications and length of hospital stay after coronary stenting

Although recent data show that coronary stenting reduces procedural complications and late restenosis, major concern has been expressed about the greater hospital cost associated with the use of this device as compared to conventional coronary angioplasty. Since length of hospital stay after surgical procedures is a major determinant of resource use, the identification of variables associated with an excessively long hospital stay after intracoronary stent placement may have important practical consequences. The purpose of this study was to assess factors responsible for the occurrence of in-hospital complications and prolonged hospital stay after coronary stenting in 939 consecutive patients enrolled in the Registro Impianto Stent Endocoronarico (RISE Study Group). Consecutive patients undergoing coronary stent implantation at 16 medical centers in Italy were prospectively enrolled in the Registry. Clinical data, qualitative and quantitative angiographic findings were obtained from data collected in case report forms at each investigator site. Major ischemic complications were considered death, Q-wave myocardial infarction, emergency bypass surgery and emergency repeat angioplasty. The study group consisted of 939 patients (781 men, 158 women with a mean age of 59 years) in whom 1392 stents were implanted in 1006 lesions and expanded at a maximal inflation pressure of 14.7 +/- 3 atmospheres. The great majority of patients (92%) received only antiplatelet drugs after coronary stenting. During hospitalization, there were 45 major ischemic complications in 39 patients (4.2%): 13 events were related to acute or subacute thrombosis (1.4%). On multivariate logistic regression analysis, the following factors were predictive of in-hospital complications: increasing age (OR 2.19, 95% CI 1.18-4.07), unplanned stenting (OR 3.46, 95% CI 1.65-7.23) and maximal inflation pressure (OR 0.83, 95% CI 0.75-0.93). Mean hospital stay after stent implantation was 4.1 +/- 4.4 days and was related, by multivariate regression analysis, to female sex (p = 0.0001), prior bypass surgery (p = 0.03), non-elective stenting (p = 0.0001), use of anticoagulation (p = 0.0001) and development of major ischemic complications (p = 0.0001). This Registry shows that in an unselected population of patients undergoing coronary stenting, major ischemic complications occur at a relatively low rate (4.2%) and thrombotic events can be kept at 1.4%, despite the omission of anticoagulation in the great majority of patients. Length of hospital stay was affected by the occurrence of major ischemic complications, unplanned stenting, use of anticoagulation, female sex and prior bypass surgery. Accumulating experience, further reduction in complications and complete omission of anticoagulation may decrease length of hospital stay, thus reducing the use of resources after coronary stenting.     

Are directional coronary atherectomy and Palmaz-Schatz stent more efficacious than conventional balloon angioplasty for treating de novo coronary artery lesions?

It is unclear whether new devices such as directional coronary atherectomy (DCA) or Palmaz-Schatz stent implantation improve long-term outcomes compared with conventional balloon angioplasty in patients with stable angina and de novo coronary artery lesions of type A or type B except for complete occlusive lesions investigated by the American College of Cardiology/American Heart Association task force on percutaneous transluminal coronary angioplasty. A total of 146 patients with stable angina and simple lesions were assigned to either conventional balloon angioplasty (62 patients), DCA (50 patients), or Palmaz-Schatz implantation (34 patients). The acute results and late outcomes were assessed by coronary angiography. The results of the three procedures were similar with respect to procedural success and complications. Patients who underwent stenting or DCA had a larger immediate increase in the diameter of the lumen and a larger luminal diameter immediately after the procedure than those who underwent balloon angioplasty. At six months follow-up, the patients treated by stenting continued to have a larger luminal diameter and a lower rate of restenosis than those treated with balloon angioplasty (2.30 +/- 0.66 vs 1.85 +/- 0.83 mm, p < 0.005; 5.9% vs 29%, p < 0.05) and DCA (2.30 +/- 0.66 vs 1.90 +/- 0.96 mm, p < 0.05; 5.9% vs 24%, NS). The patients treated with balloon angioplasty had a smaller late loss than those treated with DCA or Palmaz-Schatz stent. The patients treated with DCA had a larger loss index than those treated with balloon angioplasty or Palmaz-Schatz stent. Stenting was a significant factor in decreasing the rate of restenosis by logistic regression analysis, compared with balloon angioplasty. The angiographic outcomes were better in patients who received a stent than in those who received other treatments. This study suggests that even lesions stable for treatment by balloon angioplasty and DCA can also be treated with Palmaz-Schatz stents.     

Coronary stenting in cardiac allograft vasculopathy

OBJECTIVE: The purpose of this study was to evaluate acute angiographic success, in-hospital complications and long-term outcome after intracoronary stenting in patients with cardiac allograft vasculopathy. BACKGROUND: The application of conventional interventional modalities to treat discrete lesions in patients with cardiac allograft vasculopathy is associated with higher procedural morbidity, mortality and higher restenosis compared to atherosclerotic coronary artery disease. Elective coronary stenting has been shown to lower restenosis rates and improve long-term outcome in selected patients with native coronary artery disease; however, its safety and efficacy in reducing restenosis in patients with cardiac allograft vasculopathy is unknown. METHODS: Ten patients with 19 discrete lesions in a major coronary artery without diffuse distal disease underwent intracoronary stenting using Palmaz-Schatz stents. The average stent size was 3.4 mm, and the stent/artery ratio was 0.99+/-0.07. Eight of ten (80%) patients received antiplatelet therapy (aspirin plus ticlopidine) only. RESULTS: Procedural success was 100% with no in-hospital stent thrombosis, Q-wave myocardial infarction or death. Minimal luminal diameter increased from 0.83+/-0.38 mm to 3.23+/-0.49 mm after stenting. Diameter stenosis decreased from 74.91+/-11.52% to 5.90+/-4.09% after stenting. Follow-up angiography was performed in 8 of 10 (80%) patients and 16 of 19 (84%) lesions. Target lesion revascularization was required in 2 of 10 (20%) patients and 3 of 16 (19%) lesions. Allograft survival was 7 of 10 (70%) at the end of 22+/-11 months follow-up. CONCLUSIONS: Intracoronary stenting can be performed safely with excellent angiographic success in selected patients with cardiac allograft vasculopathy. The restenosis rate appears to be low despite the aggressive nature of the disease. A multicenter study with a larger number of patients is required to assess its efficacy in reducing restenosis and improving allograft survival.     

Comparison of six-month outcome of coronary artery stenting in patients <65, 65-75, and >75 years of age

We studied 1,238 patients receiving 1,880 coronary stents. In-hospital outcomes were divided by age into <65 years (n = 747, group 1), 65 to 75 years (n = 326, group 2), and >75 years (n = 165, group 3). Procedural success was 97.2%, 95.1%, and 98.8% in groups 1, 2, and 3, respectively (p = NS). There was 1 death (group 1). Myocardial infarction occurred in 1.2%, 2.8%, and 1.8%, bypass surgery occurred in 0.9%, 1.8%, and 1.2%, and repeat balloon angioplasty in 0.3%, 0.6%, and 0% of patients in groups 1, 2, and 3, respectively (p = NS for all comparisons). Vascular complications occurred in 2.8%, 4.9%, and 6.1% in groups 1, 2, and 3, respectively (p <0.05). Six-month follow-up of patients was divided by age: <65 years (n = 564, group 1); 65 to 75 years (n = 221, group 2); and >75 years (n = 122, group 3). Event-free survival was 94.5%, 90.5%, and 89.3% for groups 1, 2, and 3, respectively (p = NS). Death occurred in 0.4%, 0.5%, and 1.6%; myocardial infarction occurred in 1.2%, 2.3%, and 1.6%, and target vessel revascularization in 4.3%, 8.6%, and 7.4% for groups 1, 2, and 3, respectively (p = NS for all comparisons). Thus, coronary stenting produced favorable in-hospital and 6-month outcomes in all 3 age groups. Age itself should not preclude patients from undergoing coronary stenting.     

Anterior knee pain syndrome: a historical review]

The aim of this study was to determine whether advances in angioplasty techniques have improved results in multiple vessel coronary disease and to compare present results with those reported in randomised trials comparing angioplasty and surgery. The hospital results of two cohorts of multivessel coronary patients treated by angioplasty during two different periods were compared (group 1: 1990-1991. group 2: 1994-1995). The first period corresponded to the inclusion period of randomised trials comparing surgery and angioplasty. The patients in group 2 (n = 449) were older than those in group 1 (n = 424), had more triple vessel disease, more severe angina and more previous angioplasty attempts. Moreover, there were more cases of unfavourable lesions. Nevertheless, the clinical success rate was high in group 2 (92% vs 84%; p < 0.001) and the major complication rate (death, myocardial infarction or emergency bypass surgery) was lower (2.9% vs 6.1%; p = 0.02). The main technical difference between the two periods concerned the use of coronary stents (12% vs 8%; p < 0.001). The fact of being in group 2 was identified by multivariate analysis as an independent predictor for clinical success and a lower major complication rate. The authors conclude that, since the publication of randomised trials comparing angioplasty with coronary surgery, the hospital results of angioplasty have significantly improved. This should be taken into account in considering the clinical applications of the results of these trials.     

Prognostic value of intracoronary flow velocity and diameter stenosis in assessing the short- and long-term outcomes of coronary balloon angioplasty: the DEBATE Study (Doppler Endpoints Balloon Angioplasty Trial Europe)

BACKGROUND: The aim of this prospective, multicenter study was the identification of Doppler flow velocity measurements predictive of clinical outcome of patients undergoing single-vessel balloon angioplasty with no previous Q-wave myocardial infarction. METHODS AND RESULTS: In 297 patients, a Doppler guidewire was used to measure basal and maximal hyperemic flow velocities proximal and distal to the stenosis before and after angioplasty. In 225 patients with an angiographically successful percutaneous transluminal coronary angioplasty (PTCA), postprocedural distal coronary flow reserve (CFR) and percent diameter stenosis (DS%) were correlated with symptoms and/or ischemia at 1 and 6 months, with the need for target lesion revascularization, and with angiographic restenosis (defined as DS > or = 50% at follow-up). Logistic regression and receiver operator characteristic curve analyses were applied to determine the prognostic cutoff value of CFR and DS separately and in combination. Optimal cutoff criteria for predictors of these clinical events were DS, 35%; CFR, 2.5. A distal CFR after angioplasty > 2.5 with a residual DS < or = 35% identified lesions with a low incidence of recurrence of symptoms at 1 month (10% versus 19%, P=.149) and at 6 months (23% versus 47%, P=.005), a low need for reintervention (16% versus 34%, P=.024), and a low restenosis rate (16% versus 41%, P=.002) compared with patients who did not meet these criteria. CONCLUSIONS: Measurements of distal CFR after PTCA, in combination with DS%, have a predictive value, albeit modest for the short- and long-term outcomes after PTCA, and thus may be used to identify patients who will or will not benefit from additional therapy such as stent implantation.     

Relationship between glomerular epithelial cell injury and proteinuria in IgA nephropathy

The cost of in-hospital percutaneous transluminal coronary angioplasty (PTCA) has risen since the introduction of the coronary stent. Increased attention is now being given to the PTCA charges in Japan and a multicenter study is necessary with regard to in-hospital charges. To clarify the differences in in-hospital charges for PTCA with and without coronary stent [Stent Group and plain old balloon angioplasty (POBA) Group, respectively], we studied the PTCA charges of 352 patients in 6 hospitals. Age, male gender and extent of coronary artery disease were not different. The ratio of acute myocardial infarction ranged from 16% to 64% and that of coronary stenting ranged from 24% to 65% (p < 0.001). In-hospital charge ranged from 1.4 +/- 0.8 to 2.2 +/- 1.0 million yen (p < 0.0001). The procedural charge accounted for 53% to 75% of the in-hospital charge (p < 0.01). The in-hospital charge ranged from 1.6 +/- 0.7 to 3.3 +/- 1.6 million yen in the Stent Group, higher than the charge of 1.1 +/- 0.8 to 1.9 +/- 0.7 million yen in the POBA Group (p < 0.0001). There was a statistical difference in the number of balloon catheters used (1.1 +/- 0.4 to 2.1 +/- 0.9, p < 0.005) but not in the mean number of stents used (1.1 +/- 0.3 to 1.4 +/- 0.7). The procedural charge of the institutes with higher stenting rate (> 45%) seemed to be lower than that of the institutes with lower stenting rate (p < 0.02). In conclusion, there are large variation between institutions in PTCA charges, and in-hospital charges increased with the use of stents on introduction of the Diagnosis Related Group used in the United States. We should charge separately for coronary stenting and POBA. Despite any initial increase in the in-hospital charge for coronary stenting compared to POBA, successful stent implantation will result in a superior saving in procedural charges.     

Evaluating the potential cost-effectiveness of stenting as a treatment for symptomatic single-vessel coronary disease. Use of a decision-analytic model

BACKGROUND: Coronary stenting appears to provide more predictable immediate results and lower rates of restenosis than conventional balloon angioplasty for selected lesion types, but its hospital costs are significantly higher. This study was designed to evaluate the potential cost-effectiveness of Palmaz-Schatz coronary stenting relative to conventional balloon angioplasty for the treatment of patients with symptomatic, single-vessel coronary disease. METHODS AND RESULTS: We developed a decision-analytic model to predict quality-adjusted life expectancy and lifetime treatment costs for patients with symptomatic, single-vessel coronary disease treated by either Palmaz-Schatz stenting (PSS) or conventional angioplasty (PTCA). Estimates of the probabilities of overall procedural success (PTCA, 97%; PSS, 98%), abrupt closure requiring emergency bypass surgery (PTCA, 1.0%; PSS, 0.6%), and angiographic restenosis (PTCA, 37%; PSS, 20%) were derived from review of the literature published as of September 1993. Procedural costs were based on the true economic (ie, variable) costs of each procedure at Boston's Beth Israel Hospital. On the basis of these data, coronary stenting was estimated to result in a higher quality-adjusted life expectancy than conventional angioplasty but to incur additional costs as well. Compared with conventional angioplasty, stenting had an estimated incremental cost-effectiveness ratio of $23,600 per quality-adjusted life year gained. Although the cost-effectiveness ratio for stenting changed with variations in assumptions about the relative costs and restenosis rates, it remained less than $40,000 per quality-adjusted year of life gained--and thus was similar to many other accepted medical treatments--unless the stent angiographic restenosis rate was > 23%, the angioplasty restenosis rate was < 34%, or the cost of stenting (including vascular complications) exceeded that of conventional angioplasty by more than $3000. The alternative strategy of secondary stenting (initial angioplasty followed by stenting only for symptomatic restenosis) was estimated to be both less effective and less cost-effective than primary stenting over a wide range of plausible assumptions and thus does not appear to be cost-effective when primary stenting is also an option. CONCLUSIONS: Decision-analytic modeling can be used to evaluate the potential cost-effectiveness of new coronary interventions. Our analysis suggests that despite its higher cost, elective coronary stenting may be a reasonably cost-effective treatment for selected patients with single-vessel coronary disease. Primary stenting is unlikely to be cost-effective for lesions with a low probability of restenosis (eg, < 30%) or for patients for whom the cost of stenting is expected to be much higher than usual (eg, because of a high risk of vascular complications). Given the sensitivity of the cost-effectiveness ratios to even modest variations in the relative restenosis rates and cost estimates, future studies will be necessary to determine more precisely the cost-effectiveness of coronary stenting for specific patient and lesion subsets.     

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.     

Long-term results of RITA-1 trial: clinical and cost comparisons of coronary angioplasty and coronary-artery bypass grafting. Randomised Intervention Treatment of Angina

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA) and coronary-artery bypass grafting (CABG) are both effective intervention strategies for patients with coronary heart disease. We report comparative long-term clinical and health-service cost findings for these interventions in the first Randomised Intervention Treatment of Angina (RITA-1) trial. METHODS: 1011 patients with coronary heart disease (45% single-vessel, 55% multivessel) were randomly assigned initial treatment strategies of PTCA or CABG. Information on clinical events, subsequent intervention, symptomatic status, exercise testing, and use of health-care resources is available for a median 6.5 years of follow-up. Analyses were by intention to treat. FINDINGS: The predefined primary endpoint of death or nonfatal myocardial infarction occurred in 87 (17%) PTCA-group patients and 80 (16%) CABG-group patients (p=0.64). Similarly, there was no significant treatment difference in deaths alone (39 PTCA, 45 CABG), of which 46% were cardiac related. In both groups, the risk of cardiac death or myocardial infarction was more than five times higher in the first year than in subsequent years of follow-up. 26% of patients assigned PTCA subsequently also had CABG, and a further 19% required additional nonrandomised PTCA. Most of these reinterventions occurred within a year of randomisation, and from 3 years onwards the reintervention rate averaged 4% per year. In the CABG group the reintervention rate averaged 2% per year. The prevalence of angina was consistently higher in the PTCA group, with an absolute average 10% excess compared with the CABG group (p<0.001). Total health-service costs over 5 years showed no significant difference between initial strategies of PTCA and CABG (mean difference pounds sterling 426 [95% Cl -pounds sterling 383 to pounds sterling 1235]; p=0.30). The clinical and cost comparisons showed similar patterns for patients with single-vessel and multivessel disease. INTERPRETATION: Initial strategies of PTCA and CABG led to similar long-term results in terms of survival and avoidance of myocardial infarction and to similar long-term health-care costs. Choice of approach, therefore, rests on weighing the more invasive nature of CABG against the greater risk of recurrent angina and reintervention over many years after PTCA.     

Myocardial infarction as a complication of new interventional devices

Percutaneous transluminal coronary balloon angioplasty has been associated with acute myocardial infarction (MI) as a complication of the procedure. Abrupt closure, distal coronary embolization, intimal dissection, coronary spasm, and acute thrombosis are the principal etiologies. New interventional devices (stent, laser, and atherectomy catheters) have been introduced as alternatives or adjuncts to balloon angioplasty. With use of the New Approaches to Coronary Intervention Registry, the incidence, predictors, and outcome of MI as a complication of using these devices as the primary mode of intervention were studied. There were 3,265 patients from 39 participating centers in the cohort treated with new devices. MI was reported as an in-hospital complication of using new devices in 154 patients (4.7%), including Q-wave MI in 36 patients (1.1%), and non-Q-wave MI in 119 patients (3.6%). MI rates were not significantly different among all patients with devices in the cohort treated with atherectomy (directional, extractional, rotational), laser (AIS, Spectranetics) or the Palmaz-Schatz stent. Multivariate logistic regression showed that post-procedure MI was associated with multivessel disease, high surgical risk, postinfarction angina, and presence of a thrombus prior to the procedure. Prior percutaneous transluminal coronary angioplasty was inversely related to the incidence of MI. When a specific cause of MI could be detected, the main etiologies were: coronary embolus 16.9%, and abrupt closure 27.3%. Other major in-hospital complications were higher in the MI group than the non-MI group: death 7.8% versus 0.8% (p <0.001), and bypass surgery 13.6% versus 1.7% (p <0.001). At 1 year, mortality rates remain higher at 12.9% in the MI group versus 4.9% in the non-MI group (p <0.01). Despite different indications for the use of new devices, they were not predictors for MI with the exception of the rotablator. The incidence of MI (1.1% Q-wave, 3.6% non-Q-wave) was comparable to previously reported rates for balloon angioplasty. The occurrence of MI is associated with an increase in other in-hospital complications and a doubling of 1-year mortality.     

Impact of diabetes mellitus on percutaneous revascularization (CAVEAT-I). CAVEAT-I Investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial

We examined the relation between diabetes mellitus and outcomes in patients undergoing percutaneous coronary revascularization in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), a randomized trial comparing treatment with either percutaneous transluminal coronary angioplasty or directional atherectomy for de novo lesions in native coronary arteries. Acute success and complication rates, 6-month angiographic restenosis rates, and 1-year clinical outcomes were compared between diabetic and nondiabetic patients undergoing each procedure. Acute success rates between diabetic (n = 191) and nondiabetic (n = 821) patients were similar for both revascularization techniques. Except for the need for dialysis, complication rates were also similar. Six months after atherectomy, diabetic patients had significantly more angiographic restenosis than nondiabetics (59.7% vs 47.4%) and significantly smaller minimum luminal diameters (1.20 vs 1.40 mm). Diabetics undergoing atherectomy required more frequent bypass surgery (12.8% vs 8.5%) and more repeat percutaneous revascularizations (36.5% vs 28.1%) than nondiabetics undergoing atherectomy. Restenosis rates, minimum luminal diameters and repeat revascularizations between diabetics and nondiabetics undergoing angioplasty were similar. The higher restenosis and repeat revascularization rates and the smaller minimum luminal diameter at follow-up in diabetic patients suggest that atherectomy may provide only modest benefit for these patients. The increased restenosis rate in diabetics undergoing atherectomy (but not angioplasty) requires further evaluation.     

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results

OBJECTIVE: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography. BACKGROUND: Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate. METHODS: To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). RESULTS: Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). CONCLUSIONS: The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.     

K-ras mutations in nonmucinous ovarian epithelial tumors: a molecular analysis and clinicopathologic study of 144 patients

BACKGROUND: Coronary stent deployment failure may be more common in clinical practice than generally appreciated. The incidence of failed deployment in routine clinical practice and the clinical sequelae have not been described. This study sought to determine the incidence and consequences of failed coronary stent deployment and to identify clinical and angiographic characteristics associated with deployment failure. METHODS AND RESULTS: A series of 1303 consecutive procedures involving attempted coronary stenting were reviewed retrospectively. Failed stent deployment was defined as failure of the stent to be either delivered to or adequately deployed at the target lesion site. Clinical records and angiograms were reviewed and qualitative coronary angiography was performed for all cases of failed deployment. Deployment was unsuccessful in 108 (8.3%) cases involving 134 stents. Stenting was attempted as a primary procedure in 40%, as bailout in 18%, and for suboptimal angioplasty in 43% of cases. In 87% of cases, attempts were made to withdraw the stent from the coronary artery. Stent retrieval was successful in 45%, peripheral embolization occurred in 38% of patients, and in 4% the stent dislodged in the left main artery. In 35% of cases, additional stent(s) were successfully deployed. Deployment failure was associated with an overall in-hospital adverse outcome in 19% of patients, including 16% urgent coronary artery bypass grafting, 5% nonfatal myocardial infarction, and 3 in-hospital deaths. At 6-month follow-up, 39% of patients had had at least 1 adverse clinical outcome of death, myocardial infarction, or repeat target lesion revascularization. CONCLUSIONS: Failure to deploy stents is a serious and relatively common problem that is associated with significant morbidity and mortality rates. Improved deployment strategies, including new stent designs, are required to improve procedural outcomes.