Safety of sirolimus-eluting stenting and its effect on restenosis in patients with unstable angina pectoris (a SIRIUS substudy)

The SIRIUS study was a double-blinded, randomized trial of the sirolimus-eluting stent (SES) to evaluate its effect on the rate of restenosis. The present report is a retrospective analysis of short- and long-term outcomes of SESs compared with bare metal stents (BMSs) in a subgroup of patients with unstable angina enrolled in the trial. Of 1,058 patients randomized in SIRIUS, 533 (50.4%) had unstable angina pectoris and 490 had stable angina. In the unstable angina group, patients treated with SESs and BMSs had similar clinical and angiographic characteristics. The stenting procedure was highly successful in the 2 groups (95.9% and 97.4%, respectively) with similar immediate angiographic results and short-term (in-hospital) clinical event rates. At 1-year follow-up, compared with BMSs, patients with unstable angina treated with SESs had significantly lower rates of target lesion revascularization (5.5% vs 22.3%, p <0.0001), target vessel failure (10.9% vs 26.3%, p <0.0001), and major adverse cardiac events (8.4% vs 24.8%, p <0.0001). Stent thrombosis was a rare event, with only 1 patient (0.4%) in each group during the first 30 days. Late thrombosis occurred in 2 patients (0.7%) in the BMS group but in none of the SES group. In conclusion, in the higher risk subgroup of patients with unstable angina, SESs are as safe as BMSs in decreasing restenosis and the need for repeat revascularization. This is reflected by a significant decrease in major adverse cardiac events and target vessel failure. Patients with unstable angina undergoing percutaneous coronary intervention who meet the entry criteria of the SIRIUS study should be preferentially treated with SESs.     

Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials

OBJECTIVES: We sought to evaluate clinical restenosis in a large population of patients who had undergone coronary stent placement. BACKGROUND: One-year success after coronary stenting is limited mainly by restenosis of and requirement for repeat revascularization of the treated lesion.We studied 6,186 patients (6,219 lesions) pooled from several recently completed coronary stent trials. Clinical restenosis was defined using three different definitions: target lesion revascularization (TLR) beyond 30 days, target vessel revascularization (TVR) beyond 30 days, and target vessel failure (TVF), defined as TVR, any death, or myocardial infarction (MI) of the target vessel territory after hospital discharge. RESULTS: By one year, 638 (12.2%) patients had TLR, 748 (14.3%) had TVR, and 848 (16.0%) had TVF, more than two-thirds higher than the rate of these end points at six months. The severity of angiographic restenosis (> or =50% follow-up diameter stenosis [DS]) in 419 of 1,437 (29%) patients undergoing routine angiographic follow-up correlated directly with the likelihood of TLR (73% vs. 26% for >70% DS compared with <60% DS). Smaller pretreatment minimum lumen diameter (MLD), smaller final MLD, longer stent length, diabetes mellitus, unstable angina, and hypertension were independent predictors of TLR. Prior MI and current smoking were negative predictors. CONCLUSIONS: At one year after stenting, most clinical restenosis reflected TLR, which was predicted by the same variables previously associated with an increased risk of angiographic restenosis. The lower absolute rate of clinical restenosis relative to angiographic restenosis was due to infrequent TLR in lesions with less severe (<60% DS) angiographic renarrowing.     

Impact of in-stent restenosis on death and myocardial infarction

Although drug-eluting stents reduce restenosis and target lesion revascularization compared with bare metal stents (BMSs), the specter of late stent thrombosis has curbed enthusiasm for the widespread use of drug-eluting stents. Alternatively, increasing BMS use would increase restenosis and potentially increase adverse events. The presentation and outcomes of BMS restenosis are controversial. We evaluated 2,539 patients with BMS restenosis referred for repeat revascularization. Major adverse cardiac events, including mortality and myocardial infarction (MI), were assessed at clinical presentation, 30 days, and 6 months. Patients with acute presentation (i.e., unstable angina requiring hospitalization or MI) were compared with patients with stable presentation. At presentation, 19.2% of patients were asymptomatic, 27.5% had exertional angina, 46.6% had unstable angina, and 6.7% had MI. Mortality and MI rates were 1.1% and 1.4%, respectively, at 30 days and 3.3% and 4.5%, respectively, at 6 months. Patients with acute coronary syndrome (ACS) and those without ACS had similarly low mortality rates at 30 days (1.2% ACS vs 1.0% non-ACS, p = 0.65) and 6 months (3.4% ACS vs 3.3% non-ACS, p = 0.93) and MI rates at 30 days (1.3% ACS vs 1.4% non-ACS, p = 0.87) and 6 months (4.7% ACS vs 4.3% non-ACS, p = 0.65). Combined major adverse cardiac events were similar at 30 days (2.5% vs 2.1%, p = 0.53) and 6 months (7.4% ACS vs 6.9%, non-ACS, p = 0.65). In conclusion, although BMS restenosis often manifests as an ACS, it is associated with a low incidence of 6-month major adverse cardiac events and does not predict a negative outcome.     

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

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

Impact of diabetes mellitus on the late clinical outcome of coronary revascularization with stents

INTRODUCTION: The Influence of diabetes mellitus in the late outcome of coronary stenting remains controversial. AIM: The aim of this study was to determine the late clinical outcome of diabetics in comparison with non diabetics and to establish whether there are subgroups of diabetic patients with a greater need for target lesion revascularization. METHODS: Two hundred sixteen consecutive patients (74 diabetics; 95 stents in 90 lesions and 142 non diabetics) who had successfully undergone coronary stenting were included in the study and followed over 17.6 +/- 10 months. The clinical events evaluated were target lesion revascularization, death and acute myocardial infarction. Independent predictive variables of target lesion revascularization were studied in both groups of patients. RESULTS: The diabetic patients presented greater cardiovascular mortality (6.7% vs 1.4%; p=0.02) but the incidence of infarction was similar in the two groups (2.7% vs. 3.5%; p=0.6). The accumulated rate of target lesion revascularization at two years was 18.2% in diabetics vs 13.3% in non diabetics (p=0.09), respectively. The presence of three vessel disease (p=0.014), history of arterial hypertension ([=0.011) and residual stenosis > 0% (p=0.005) were specific predictive factors of target lesion revascularization for diabetic patients and together with vessel diameter < 3mm (p<0.001) subgroups of diabetics were independently selected with a significantly greater incidence of target lesion revascularization than the non diabetic patients. CONCLUSIONS: Following coronary stenting, diabetic patients show a greater cardiovascular mortality than non diabetics, but only some subgroups of diabetics (small vessels extensive coronary disease, associated arterial hypertension, residual stenosis) show a significantly greater risk of target lesion revascularization.     

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.     

Predictive factors of cardiac events after implantation of sirolimus-eluting stents for treatment of in-stent restenosis

BACKGROUND: The factors associated with recurrent restenosis after SES implantation for in-stent restenosis are unknown. This study aimed to assess the clinical outcome and to analyse predictive factors of cardiac events in patients with in-stent restenosis treated with Sirolimus-eluting stent (SES). METHODS: In 3 centers, consecutive patients (n = 100) with elective indication to percutaneous coronary intervention (PCI) for in-stent restenosis (n = 110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 showed total occlusion. RESULTS: SES implantation was successful in all patients, without complication during the first hospital stay. The mean follow-up was 15 (10-24) months. A cardiac event related to the target vessel occurred in 24 (24%) patients, and was associated with dialysis status (p < 0.05), lower ejection fraction (p < 0.05) and revascularization without SES in another site (p < 0.0001). A cardiac event related to the SES occurred in 11 (11%) patients, secondary to an acute or sub-acute thrombosis of the SES (2%), to a late occlusion of the target vessel (4%) or to a non-occlusive restenosis of the SES (5%), and was associated with unstable angina (p < 0.01), multivessel disease (p < 0.03) and revascularization without SES in another site (p < 0.03). No cardiac event related to the SES occurred in patients with direct stenting. Target lesion revascularization for in-SES restenosis or occlusion of the target vessel was performed in 7 (7%) patients, and was associated with unstable angina (p < 0.01) and revascularization without SES in another site (p < 0.01). Target vessel revascularization was needed in 20 patients (20%), related to dialysis status (p < 0.01) and a revascularization without SES in another site (p < .0001). CONCLUSIONS: SESs are effective in the treatment of high risk patients with complex in-stent restenosis. Most of cardiac events during follow-up are related to a revascularization without SES in another site.     

Three-year follow-up after intravascular gamma-radiation for in-stent restenosis in saphenous vein grafts.

The Washington Radiation for In-Stent Restenosis Trial in Saphenous Vein Grafts (SVG WRIST) demonstrated safety and efficacy of intravascular radiation therapy (IRT) for the treatment of in-stent restenosis (ISR) in SVG at 12 months. In this study, we aimed to examine whether the safety and efficacy of IRT is durable up to 36 months. One hundred twenty patients with diffuse ISR in SVG underwent balloon angioplasty, laser or atherectomy ablation, and/or additional stenting. After successful intervention, patients were randomly assigned in a double-blind fashion to intravascular treatment with a ribbon containing either iridium (Ir)-192 (n = 60) or nonradioactive seeds (n = 60). The prescribed dose at 2 mm from the source was either 14 or 15 Gy in vessels 2.5-4.0 mm or 18 Gy in vessels > 4.0 mm in diameter. At 36 months, target lesion revascularization (TLR; 43% vs. 66%; P = 0.02) and target lesion revascularization-major adverse cardiac event (TLR-MACE; 49% vs. 71%; P = 0.02) rates continued to be lower in the IRT group, but both target vessel revascularization (TVR; 59% vs. 71%; P = 0.17) and TVR-MACE (63% vs. 77%; P = 0.11) rates were not. In SVG WRIST, patients with ISR treated with IRT had a marked reduction in the need for repeat TLR at 36 months, with sustained clinical benefit at 3 years despite late recurrences, which were more pronounced in the radiation group.     

Two-year outcome of patients treated with sirolimus- versus paclitaxel-eluting stents in an unselected population with coronary artery disease (from the REWARDS Registry)

Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.     

Long-term prognosis in patients with single-vessel or double-vessel coronary artery disease: does successful revascularization achieved by coronary angioplasty improve late outcome?

OBJECTIVES: It is not clear whether revascularization by coronary angioplasty improves long-term prognosis in patients with stable angina, single- or double-vessel coronary artery disease. This study investigated the extent of late revascularization achieved by percutaneous transluminal coronary angioplasty(PTCA) and evaluated the long-term effect of revascularization in patients with coronary artery disease. METHODS: This study reviewed 178 patients with single-vessel or double-vessel disease and significant coronary diameter stenosis(American Heart Association classification, 75% or more stenosis), but excluded 35 patients with failed revascularization of the target vessels because of initial failed angioplasty(n = 14) or restenosis(n = 21). The remaining 143 patients were available for assessment. Revascularization was successful at follow-up angiography after the last angioplasty in 105 patients(Group A). The remaining 38 patients received conservative medical therapy(Group B). Kaplan-Meier survival curves were used to examine absolute survival difference. RESULTS: One hundred forty-three patients(mean age 64 +/- 9 years) were followed-up for 3.8 +/- 1 years. The patients were 70.6% male, 59.4% had myocardial infarction and 76.9% had single-vessel disease. Anatomical complete revascularization in the chronic phase was accomplished in 80 patients with single-vessel disease(97.6%) and 11 patients with double-vessel disease(47.8%). The event-free survival rate was not significantly different between Group A and Group B(88.6% vs 84.2%, p = NS). Cardiac survival rate decreased significantly in Group B compared to Group A(89.5% vs 99.0%, p < 0.01). This difference in survival rate was due to sudden cardiac death in Group B(7.9% vs 0%, p < 0.05). Non-fatal myocardial infarctions occurred in seven patients(6.7%) with revascularization and in one patient(2.6%) with conservative medical therapy, but with no significant difference. Late successful revascularization improved cardiac survival rate in patients with proximal left anterior descending coronary artery involvement or single-vessel disease. CONCLUSIONS: Cardiac events decreased and long-term prognosis appeared to be a good possibility in patients with single- or double-vessel coronary artery disease if late successful revascularization of target vessel was accomplished.     

Long-term outcome in patients treated by intracoronary stenting with ticlopidine and aspirin, and deleterious prognostic role of unstable angina pectoris

Compared with stable clinical conditions, unstable angina carries an increased risk of immediate and delayed cardiac adverse events after balloon coronary angioplasty. The influence of stent use in reducing these differences remains unknown. We analyzed the early (30 days) and late outcome of a cohort of 459 consecutive patients who underwent stent placement with ticlopidine and aspirin as antithrombotic regimen according to the presence (group 1, n = 151) or absence (group 2, n = 308) of unstable angina at rest (Braunwald classes II and III). Group 1 patients were older and more likely to be current or former smokers. In group 2, prior myocardial infarction was more frequent. Procedural, in-hospital results, and early outcome were similar in the 2 groups. However, over the long term, the incidence of myocardial infarction (11% vs 6%, p <0.04), target lesion revascularization (19% vs 13%, p <0.04), or any revascularization (30% vs 20%, p <0.01) was significantly higher in group 1. Kaplan-Meier probabilities of survival without myocardial infarction (85% vs 91%, p <0.05), survival without revascularization of the target lesion (73% vs 83%, p <0.01), survival without any revascularization (65% vs 77%, p <0.006), and survival without any events (61% vs 73%, p <0.009) were significantly worse in group 1. In addition, Cox multivariate analysis showed that unstable angina at rest was an independent predictor of target lesion revascularization, of survival without any revascularization, and without any events. Thus, unstable angina at rest remains an adverse prognostic indicator in patients treated with intracoronary stents, particularly with regard to subsequent requirement of revascularization procedures and event-free survival.     

The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with chronic renal failure

OBJECTIVES: This study was designed to analyze the in-hospital and six-month clinical and angiographic outcomes of patients with chronic renal failure (CRF) treated with intracoronary radiation for the prevention of recurrence of in-stent restenosis. BACKGROUND: Patients with CRF are at a higher risk than the general population for accelerated atherosclerotic cardiovascular disease and for restenosis after percutaneous coronary intervention. Previous studies have shown the effectiveness of both beta and gamma radiation in preventing recurrent restenosis in patients with in-stent restenosis. METHODS: We studied the in-hospital and six-month clinical and angiographic outcomes of 118 patients with CRF and 481 consecutive patients without CRF who were treated with intracoronary radiation for the prevention of recurrence of in-stent restenosis in native coronaries and saphenous vein grafts. RESULTS: Patients with CRF were usually older, women, hypertensive and diabetic, with multivessel disease and with reduced left ventricular function. In-hospital outcome for patients with CRF was marred by a higher incidence of death, non-Q-wave myocardial infarction and major vascular and bleeding complications. At six-month follow-up, the mortality rate was higher in patients with CRF, 7.6% compared with 1.9% in non-CRF patients (p = 0.003). Restenosis, target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were similar in the two groups. In patients with CRF, radiation therapy compared to placebo reduced restenosis (53.8% vs. 22.6%, p = 0.04), TLR (71.4% vs. 15.3%, p < 0.0001) and TVR (78.6% vs. 23.7%, p = 0.0002). CONCLUSIONS: Intracoronary radiation for the prevention of recurrence of in-stent restenosis achieved similar rates of restenosis and revascularization procedures in patients with and without CRF. Despite this benefit, patients with renal dysfunction continued to have significantly higher in-hospital and six-month adverse outcomes.     

Does abciximab improve the prognosis of diabetics after percutaneous coronary intervention?

INTRODUCTION AND OBJECTIVES: It is known that the outcome of percutaneous coronary intervention is worse in diabetics than in non-diabetics. The aim of our study was to determine whether abciximab therapy could improve clinical outcome in an unselected diabetic population that underwent percutaneous coronary interventions. MATERIAL AND METHODS: We analyzed retrospectively 198 diabetic patients who underwent PTCA from January 1997 to January 2000. Seventy-three patients (36.7%) were treated with abciximab and the remaining 125 patients (63.3%) did not receive abciximab. The mean follow-up was 12.6 months. The events considered were death, non-fatal myocardial infarction, any revascularization procedure (including the target vessel), and hospital admission for unstable angina. RESULTS: Patients who received abciximab had more frequent previous myocardial infarction (67.1 vs. 52.8%; p = 0.04), worse left ventricular function (0.53 vs. 0.59%; p = 0.02), more frequent angiographic thrombus (67.1 vs. 36.8%; p < 0.001), more complex lesions (B2/C) (76.4 vs. 55.8%; p = 0.004), and less frequent location in left anterior descending artery (34.2 vs. 60.8%; p = 0.002). The indication for PTCA in patients who received abciximab was most often related to myocardial infarction. There were no differences between the groups in sex, age and distribution of diabetes treatment. Events were more frequent in diabetics not treated with abciximab than in those who were treated with abciximab (38 vs. 22%; p < 0.037). The patients not treated with abciximab suffered more frequently target vessel revascularization (22.7 vs. 7.2%; p < 0.007). There were no significant differences in the frequency of death or non-fatal myocardial infarction, but hospital readmissions for unstable angina were significantly more frequent in diabetics not treated with abciximab (29.1 vs. 15.9%; p = 0.045). Multivariate analysis identified abciximab as a predictor of the absence of complications during follow-up (OR: 0.45; p = 0.03). CONCLUSION: Abciximab treatment seems to reduce events in unselected diabetic patients undergoing percutaneous coronary intervention, particularly target vessel revascularization.     

Outcome in high risk patients with unprotected left main coronary artery stenosis treated with percutaneous coronary intervention

Objective : We examined mortality, risk of myocardial infarction (MI), and target lesion revascularization (TLR) in high‐risk patients with unprotected left main (LM) percutaneous coronary intervention (PCI) in Western Denmark. Background : PCI of left main coronary artery lesions may be an alternative to coronary artery bypass grafting in high‐risk surgical patients. Methods : From January 2005 to May 2007, all patients who had unprotected LM PCI with stent implantation were identified in the Western Denmark Heart Registry. The indications for PCI were: (1) ST segment elevation MI (STEMI), (2) non‐STEMI (NSTEMI) or unstable angina, and (3) stable angina. All patients were followed up for 18 months. Results : A total of 344 patients were treated with LM PCI (STEMI: 71, NSTEMI/unstable angina: 157, and stable angina: 116). In STEMI patients, the median logistic EuroSCORE was 22.5 (interquartile range 12.5–39.5), in non‐STEMI (NSTEMI)/unstable angina patients 13.8 (4.8–23.9), and in stable angina patients 4.8 (2.2–10.4). Mortality after 18 months 38.0, 18.5, and 11.2% (P < 0.001) in patients with STEMI, NSTEMI/unstable angina, and stable angina, respectively. MI after 18 months was 9.9, 6.4, and 6.0% (P = ns), respectively. Four subacute and one late definite stent thrombosis were seen. TLR occurred in 5.6, 4.5, and 6.9% (P = ns) of patients, respectively. Conclusion : After PCI, patients with STEMI and LM culprit lesion have a high‐mortality risk, whereas long‐term outcome for patients with NSTEMI and stable angina pectoris is comparable with other high surgical risk patients with unprotected left main lesion. Further, TLR rates and risk of stent thrombosis were low. © 2009 Wiley‐Liss, Inc.     

In-stent restenosis: long-term outcome and predictors of subsequent target lesion revascularization after repeat balloon angioplasty

OBJECTIVES: We sought to evaluate the long-term clinical outcome of patients undergoing successful balloon angioplasty for in-stent restenosis, and to determine correlates of the need for subsequent target lesion revascularization (TLR). BACKGROUND: In-stent restenosis can be safely treated by repeat percutaneous intervention. Reported subsequent TLR rates have varied from 20% to 80% and seem related to the type of restenotic lesion. METHODS: The study population comprised 234 patients with follow-up data who were successfully treated with repeat balloon angioplasty for in-stent restenosis in 257 lesions between May 1995 and January 1998 at our institution. RESULTS: Clinical follow-up was available at 459 (286 to 693) days after the repeat procedure. Event-free survival was 78.5% and 74.6% at 12 and 24 months, respectively. Recurrent events occurred in 58 patients (24.8%), including 6 deaths (2.6%), 4 myocardial infarction (1.7%) and repeat target vessel revascularization in 50 patients (21.4%). Independent predictors of repeat TLR were time to in-stent restenosis <90 days (Hazard ratio 4.67, p < 0.001), minimal luminal diameter after repeat procedure (Hazard ratio 0.38, p = 0.034) and the angiographic pattern of in-stent restenosis (Hazard ratio 1.65, p = 0.036). CONCLUSIONS: Balloon angioplasty is an effective means of treating in-stent restenosis. The long-term results are acceptable particularly for focal restenotic lesions. Further restenosis is more common in patients with early initial recurrence, more proliferative lesions and a poorer angiographic result from repeat angioplasty.     

Angiographic findings,time course of regional and global left ventricular function,and clinical outcome in diabetic patients with acute myocardial infarction treated with primary percutaneous transluminal coronary angioplasty

There is scarce information available about the outcome of diabetic patients with acute myocardial infarction (AMI) treated with percutaneous transluminal coronary angioplasty (PTCA). We sought to compare left ventricular (LV) function, and angiographic and clinical outcomes in diabetics versus nondiabetics with AMI treated with primary PTCA. This study examined 720 consecutive patients with AMI treated with primary PTCA, 102 of whom had diabetes. Six-month follow-up coronary angiography was obtained in 560 patients (88% of eligible patients). In a subgroup of 284 patients, LV function was serially determined by 2-dimensional echocardiography. During 6-month follow-up no significant differences were observed between diabetics and nondiabetics with regard to restenosis rates (31.6% vs 28.2%, p = 0.6), recovery of LV function (6-month wall motion score index: 1.8 +/- 0.7 vs 1.8 +/- 0.7, p = 0.88; 6-month LV ejection fraction: 48.5 +/- 12% vs 51.2 +/- 13%, p = 0.173), nonfatal re-AMI rates (2.9% vs 1.3%, p = 0.2), and target vessel revascularization rates (21.6% vs 16.8%, p = 0.2). Early and late mortality were higher in diabetics than in nondiabetic patients (8.8% vs 4.2%, p = 0.045 and 11.7% vs 5.5%, p = 0.016, respectively). By Cox analysis, diabetes was an independent predictor of both early (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1 to 5.3, p = 0.03) and late mortality (OR 2.37, 95% CI 1.16 to 4.84, p = 0.017) as well as 6-month major adverse cardiac events (MACEs): death, re-AMI, target vessel revascularization (OR 1.51, 95% CI 1.04 to 2.18, p = 0.03). Thus, diabetes is an independent predictor of clinical outcome even if PTCA is used as the primary reperfusion strategy.     

The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with diabetes mellitus

OBJECTIVES: The purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabetic patients with in-stent restenosis (ISR). BACKGROUND: Diabetic patients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR. METHODS: The study group consisted of 749 consecutive patients with ISR who were treated with either IRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51 placebo) were compared with nondiabetic patients (371 radiation and 75 placebo). RESULTS: In-hospital outcomes were similar between diabetic and nondiabetic patients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabetic patients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabetic patients. In contrast, diabetic and nondiabetic patients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates. CONCLUSIONS: In diabetic patients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabetic patients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabetic patients with ISR.     

Comparative early and late outcomes after primary percutaneous coronary intervention in ST-segment elevation and non-ST-segment elevation acute myocardial infarction (from the CADILLAC trial)

We determined the outcomes of patients with acute ST-segment elevation (STE) myocardial infarction (STEMI) and non-STEMI (NSTEMI) after primary percutaneous coronary intervention (PCI). The prognosis after primary PCI in STEMI has been extensively studied and defined. Outcomes of patients who undergo primary PCI for NSTEMI are less well established. In total, 2,082 patients with ongoing chest pain for > 30 minutes consistent with acute MI were randomized to balloon angioplasty versus stenting, each with/without abciximab. Of 1,964 patients, STEMI was present in 1,725 (87.8%) and NSTEMI in 239 (12.2%). Compared with STEMI, those with NSTEMI were more likely to have delayed time-to-hospital arrival (2.4 vs 1.8 hours, p = 0.0002) and increased door-to-balloon time (3.2 vs 1.9 hours, p < 0.0001). Patients with NSTEMI were more likely to have Thrombolysis In Myocardial Infarction grade 3 flow at baseline (37.3% vs 19.4%, p < 0.0001) and higher ejection fraction (58.7% vs 55.8%, p = 0.001), but similar rates of postprocedural Thrombolysis In Myocardial Infarction grade 3 flow. At 1 year, patients with NTEMI had similar mortality (3.4% vs 4.4%, p = 0.40) but higher rates of major adverse cardiac events (24.0% vs 16.6%, p = 0.007) that was driven by more frequent ischemic target vessel revascularization (21.8% vs 11.9%, p <0.0001). In conclusion, patients with acute MI without STE who are treated with primary PCI have marked delays to treatment, similar late mortality, and increased rates of ischemic target vessel revascularization compared with patients with STEMI, despite more favorable angiographic features at presentation and similar reperfusion success. The adverse prognosis of patients with NSTEMI should be recognized and efforts made to decrease reperfusion times.     

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial

OBJECTIVES: We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). BACKGROUND: Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown. METHODS: In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome. RESULTS: Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04). CONCLUSIONS: The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.     

Comparable clinical outcomes with paclitaxel- and sirolimus-eluting stents in unrestricted contemporary practice.

OBJECTIVES: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. BACKGROUND: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. METHODS: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. RESULTS: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). CONCLUSIONS: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.