Effects of stent design on side branch occlusion after coronary stent placement.

This study was performed to assess the immediate and long-term patency of stent-associated side branches (SB) according to the types of stent. A total of 314 patients with 332 lesions (CrossFlex stent 86, NIR 100, GFX 146) had 365 SB (>1 mm) covered by coronary stents. Side branch occlusion (SBO) occurred in 7.7% of CrossFlex stent, in 10.5% of NIR stent and in 8.8% of GFX stent (P = NS). SBO primarily occurred in SB with ostial disease, and the presence of SB ostial disease was the only independent predictors of SBO after stenting (OR 22.1, 95% CI 9.47-51.49, P < 0.001). At 6 months follow-up, 11 of 31 SBO regained the patency, but the remaining SB had persistent SBO. Delayed SBO occurred in 8 SB, being associated with the presence of SB ostial disease and in-stent restenosis. In conclusions, SBO was not associated with the types of stent design, but with the SB lesion morphology.     

Predictors and implications of residual plaque burden after coronary stenting: an intravascular ultrasound study

Background Residual plaque burden after coronary stenting may be visualized by use of intravascular ultrasound. Determinants and implications of residual atherosclerotic plaque burden after coronary stenting are not well established. In particular, the implications of residual plaque burden, after adjusting for confounding factors, are still unknown. Methods Sixty-two consecutive patients (age 56 ± 9 years) undergoing coronary stenting under intravascular ultrasound imaging guidance were prospectively studied. A total of 616 slices were analyzed (every 2 mm of stent length) from motorized pull-back recordings. Residual plaque burden was calculated as residual plaque/vessel area × 100. Results In 565 slices (89%), both residual plaque area and stent area could be measured. Mean residual plaque burden was 46.5% ± 6%. By use of multiple regression analysis, lesion plaque area and reference segment plaque burden were identified as independent predictors of residual plaque burden after stenting. In addition, a significant correlation was found between residual plaque burden and most relevant angiographic parameters at follow-up (including minimal lumen diameter, percent diameter stenosis, and loss index), which persisted after adjustment. Furthermore, stents with a residual plaque burden ≥46% had higher a restenosis rate (relative risk [RR] 4.4, 95% CI 1.09-18.2, P = .03). On logistic regression analysis, residual plaque burden (RR 4.8, 95% CI 4.1-5.6, P = .01) and diabetes (RR 4.3, 95% CI 3.6-5.1, P = .03) emerged as the only independent predictors of restenosis. Conclusions The amount of residual plaque burden after coronary stenting plays an independent role on the late angiographic outcome of these patients. (Am Heart J 2003;145:254-61.)     

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

Objectives : To compare the long‐term risks of coronary bifurcation lesions treated with side‐branch stenting using drug‐eluting versus bare‐metal stents. Background : Side‐branch stenting is an off‐label practice, but when needed, the incidence of late adverse events may differ between drug‐eluting and bare‐metal stents. Methods : We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta‐analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random‐effects models and meta‐regression in 6,825 subjects from 42 studies. Results : Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side‐branch stenting, and length of follow‐up. Compared with drug‐eluting stents without side‐branch stenting, drug‐eluting stents with side‐branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare‐metal stenting without side‐branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare‐metal side‐branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Conclusions : Side‐branch stenting has a much smaller impact on long‐term MACE with drug‐eluting stents compared with bare‐metal stents. Although this study does not support routine side‐branch stenting, when side‐branch stenting is required, drug‐eluting stents are associated with less adverse outcomes.© 2011 Wiley‐Liss, Inc.     

Enoxaparin in acute coronary syndromes: evidence for superiority over placebo or untreated control

Background Heparins, both standard unfractionated heparin (SUFH) and low-molecular weight heparin, play a prominent role in the treatment of acute coronary syndromes. Enoxaparin has been shown in 2 trials to be superior to heparin but has not been compared with placebo or untreated control. Methods A putative enoxaparin versus placebo/control odds ratio (OR) was computed with a recently described statistical technique with the logarithm of the ORs of the pooled results of both the enoxaparin-SUFH trials and SUFH-placebo or controlled trials. Results The combined heparin versus control results show a 33% reduction in the risk of death or acute myocardial infarction (AMI), with an OR of 0.67 (95% confidence interval [CI], 0.45 to 0.99). At up to 12 weeks (data from only 4 trials), the combined results show a 21% reduction (OR, 0.79; 95% CI, 0.54 to 1.15; P = .23). The 2 enoxaparin trials show a nonsignificant 20% reduction in the risk of death or AMI during treatment (OR, 0.80; 95% CI, 0.68 to 1.16; P = .24) and a significant reduction at 43 days (OR, 0.82; 95% CI, 0.69 to 0.97; P = .022). With these pooled data, the putative OR for enoxaparin versus placebo/untreated control during treatment is 0.53 (95% CI, 0.31 to 0.92; P = .023). The data are consistent with a 47% reduction in the risk of death or AMI. The difference persists on longer term follow-up period (OR, 0.65; 95% CI, 0.43 to 0.98; P = .04). The risk of bleeding is nonsignificantly increased (OR, 2.32; 95% CI, 0.8 to 7.85; P = .51). Conclusion On the basis of this methodology, enoxaparin would appear to be more effective than placebo when added to aspirin in acute coronary syndromes. Moreover, the effect of enoxaparin is similar to the results of a metaanalysis of trials of other low-molecular weight heparins versus placebo/control. (Am Heart J 2002;143:748-52.)     

The relative importance of left atrial function versus dimension in predicting atrial fibrillation after coronary artery bypass graft surgery

Background Atrial fibrillation (AF) is a common complication after coronary artery bypass graft (CABG) surgery. The purpose of this study was to determine whether pre-existing left atrial dysfunction is a predictor of postoperative AF compared with other clinical predictors. Methods Ninety-three patients undergoing CABG were prospectively studied. Intraoperatively, transesophageal echocardiography was performed to measure left atrial size, transmitral flow velocity, and other routine parameters. Left atrial function was estimated by the following formula: Atrial index = Transmitral VTI total × LAEF/Left atrial maximal area (where VTI = velocity time integral of E and A waves, LAEF = left atrial ejection fraction). The association of potential clinical predictors with the occurrence of postoperative AF was evaluated by χ² or Fisher exact tests, followed by stepwise multivariate logistic regression model. P values and odds ratios (OR) with 95% CIs were reported. Significance was set at P < .05. Results Postoperative AF occurred in 28 of 93 patients (30.1%). Patients with postoperative AF were older (67.0 ± 8.3 vs 61.5 ± 9.6 years, P = .0075), had larger left atrial maximal area (14.3 ± 4.6 cm² vs 10.9 ± 4.3 cm², P < .001), lower atrial index (0.54 ± 0.56 vs 0.82 ± 0.64, P = .008), larger body surface area (BSA) (OR 57, 95% CI 3.97-827), longer aortic cross-clamp time (OR 1.03, 95% CI 1.00-1.05), and more likely to have a postoperative myocardial infarction (OR 3.28, 95% CI 0.99-10.87) compared with those without AF. By multivariate analysis, only age (OR 1.11, 95% CI 1.04-1.19, P = .002) and atrial dimension (OR 1.75, 95% CI 1.03-2.96, P = .038) were significant independent predictors of postoperative AF. Body surface area also increased the odds of postoperative AF, but the CI was wide (OR 114, 95% CI 4.65-2810, P = .004). Conclusions Our results demonstrate that age and atrial enlargement, rather than atrial function, were independent predictors of postoperative AF. (Am Heart J 2002;143:181-6.)     

Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome.

OBJECTIVES: The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting. BACKGROUND: The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes. METHODS: We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001). CONCLUSIONS: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.     

Coronary stent implantation in patients older than 75 years of age: clinical profile and initial and long-term (3 years) outcome

Objective The objective of this study was to compare the initial and long-term outcome of elderly and younger patients after coronary stent implantation. Methods The evolutions of 76 patients aged >75 years and of 860 patients aged ≤75 years who underwent consecutive stenting (from June 1991 to June 1997) were compared in a cohort study. Results The elderly patients had lower left ventricular ejection fractions (0.58 ± 0.14 vs 0.61 ± 0.13; P = .03) and more frequently had unstable angina (78.9% vs 55.3%; P <.0001), previous heart failure (10.5% vs 4.9%; P = .03), and multivessel disease (68.4% vs 58.3%; P = .08). After the procedure, the elderly patients showed a higher inhospital mortality rate (6.6% vs 2.4%; P = .03) and myocardial infarction rate (5.3% vs 1.7%; P = .04). The long-term follow-up period (mean, 3.2 ± 1.4 years; median, 3.0 years) showed in the elderly a higher mortality rate (15.4% vs 5.8%; P = .006), a lower rate of repeat revascularization (9.2% vs 19.7%; P = .04), and a similar incidence rate of major adverse cardiac events (27.7% vs 28.2%; P = .93). Multivariate analysis of the elderly group identified female gender (hazard ratio, 2.19; 95% CI, 1.18 to 4.06; P = .012) and presence of multivessel disease (hazard ratio, 2.35; 95% CI, 1.05 to 5.26; P = .037) as independent predictors of further events. Conclusion Patients aged >75 years have a less favorable baseline profile and higher inhospital and 3-year mortality rates. However, the incidence rate of major adverse cardiac events in the long term is acceptable and similar to that of younger patients. (Am Heart J 2002;143:620-6.)     

Clinical and economic outcomes of multivessel coronary stenting compared with bypass surgery: a single-center US experience

Background Randomized trials comparing multivessel stenting with coronary artery bypass surgery (CABG) have demonstrated similar rates of death and myocardial infarction but higher rates of repeat revascularization after stenting. The impact of these alternative strategies on overall medical care costs is uncertain, particularly within the US health care system. Methods We performed a retrospective, matched cohort study to compare the clinical and economic outcomes of multivessel stenting and bypass surgery. The stent group consisted of 100 consecutive patients who underwent stenting of ≥2 major native coronary arteries at our institution. The CABG group consisted of 200 patients who underwent nonemergent isolated bypass surgery during the same time frame, matched (2:1) for age, sex, ejection fraction, diabetes mellitus, and extent of coronary disease. Detailed clinical follow-up and resource utilization data were collected for a minimum of 2 years. Total costs were calculated by use of year 2000 unit prices. Results Over a median follow up period of 2.8 years, there were no significant differences in all-cause mortality rates (3.0% vs 3.0%), Q-wave myocardial infarction (5.1% vs 4.0%), or the composite of death or myocardial infarction (7.1% vs 7.0%) between the stent and CABG groups (P = not significant for all comparisons). However, at 2-year follow up, patients with stents were more likely to require ≥1 repeat revascularization procedure (32.0% vs 4.5%, P < .001). The initial cost of multivessel stenting was 43% less than the cost of CABG ($11,810 vs $20,574, P < .001) and remained 27% less ($17,634 vs $24,288, P = .005) at 2 years. Conclusions Multivessel stenting and CABG result in comparable risks of death and myocardial infarction. Despite a higher rate of repeat revascularization, multivessel stenting was significantly less costly than CABG through the first 2 years of follow-up. (Am Heart J 2003;145:334-42.)     

Elective versus provisional intra-aortic balloon pumping in high-risk percutaneous transluminal coronary angioplasty

Background Elective intra-aortic balloon pump (IABP) support may reduce acute complications occurring during percutaneous coronary interventions (PCI) in patients with severe depression of the left ventricular ejection fraction (EF ≤ 30%). Methods Since February 1998, 133 consecutive patients with EF ≤30% underwent elective PCI in our institution; 61 had elective preprocedural IABP support (group A) and 72 patients had conventional PCI (group B). Jeopardy score was calculated in each patient from the coronary angiograms to quantify the myocardium at risk. Results EF was similar in the 2 groups. Jeopardy score was higher in group A (8.0 ± 2.8 vs 6.7 ± 2.4, P = .008). The other principal clinical and angiographic characteristics were similar in the 2 groups. Severe hypotension and/or shock occurred in 11 patients, all in group B (P = .001). All required urgent IABP support, and 3 eventually died. Intraprocedural major adverse cardiac and cerebral events (eg, myocardial infarction, severe hypotension and/or shock, urgent bypass surgery, stroke, and death) were higher in group B (17% vs 0%, P = .001). By stepwise logistic regression analysis, elective IABP support (odds ration [OR] 0.11 [95% CI 0.21-0.60], P = .011), jeopardy score (OR 5.37 [95% CI 1.10-8.70], P = .040), and female sex (OR 2.72 [95% CI 1.85-3.10], P = .015), were the correlates of intraprocedural events. Conclusions This study supports the potential usefulness of elective versus provisional IABP to prevent intraprocedural major adverse cardiac and cerebral events in high-risk PCI. (Am Heart J 2003;145:700-7.)     

Relationship between coronary angioplasty laboratory volume and outcomes after hospital discharge

Background Although an inverse association has been established between short-term complications of percutaneous coronary interventions (PCIs) and the volume of angioplasty procedures performed by catheterization laboratories, no data are available on the association between laboratory volume and long-term outcomes. Methods A cohort study of 25,222 patients undergoing PCI in 43 laboratories in Pennsylvania from October 1994 to December 1995 was performed by use of the Pennsylvania Health Care Cost Containment Council database. The association of laboratory volume with inhospital, 1-month, and 6-month events was estimated by use of multivariable analyses adjusting for patient and procedural characteristics. Results Although a higher volume of procedures was associated with reduced inhospital coronary bypass ([CABG] 0.6 odds ratio [OR] for ≥400 vs <400 PCIs/year; 95% CI 0.4, 0.8), it was not associated with CABG occurring within 1 month after discharge (P = .71; OR 1.0, 95% CI 0.6, 1.7). Laboratory volume was also not significantly associated with postdischarge revascularization (PCI or CABG) at 1 month (P = .58; OR 1.1, 95% CI 0.8, 1.4) or 6 months (P = .47; OR 1.04, 95% CI 0.91, 1.19). In addition, laboratory volume was not associated with rates of myocardial infarction (P = .14), death (P = .28), or the combined outcome of PCI, CABG, myocardial infarction, or death (P = .90) at 1 month after hospital discharge. Conclusions Although our study confirmed the volume/complication relationship for inhospital CABG, it did not reveal an association between volume and postdischarge events. These results suggest that inhospital complications will remain the standard for assessing laboratory volume and that selective use of higher-volume laboratories may not improve long-term outcomes. (Am Heart J 2002;143:833-40.)     

Meta-analysis of sero-epidemiologic studies of the relation between Chlamydia pneumoniae and atherosclerosis: does study design influence results?

Background The results of sero-epidemiologic studies of the relation between Chlamydia pneumoniae and atherogenesis vary considerably. A meta-analysis was performed to calculate the overall odds ratio (OR) and to identify potential sources of variability. Methods The MEDLINE database was searched from January 1997 to December 2000 for studies describing the seroprevalence of IgG antibodies to C pneumoniae in relation to clinically manifest atherosclerosis. Data extracted included 1) the study design used, 2) the number of included patients, 3) the type of disease (or end point), 4) the number of control subjects, 5) the type of control subjects, 6) the follow-up duration, 7) the crude and adjusted ORs (and 95% CI), and 8) the extent of adjustment for potential confounders. Results Thirty-eight studies were included in the meta-analysis. The overall OR was 1.6 (95% CI 1.3-2.0). The overall OR of cross-sectional case-control studies (2.0, 95% CI 1.5-2.6) was higher than that of prospective (nested) case-control studies (1.1, 95% CI 0.8-1.4). Moreover, the duration of follow-up in prospective studies was inversely related to the strength of the relation (β = −0.04, 95% CI −0.08, −0.01). Adjustment of risk estimates for potentially confounding factors did not influence the strength of the relation. Conclusions The relation between C pneumoniae and clinically manifest atherosclerosis is not durable. This probably is due to a lack of causality, although results may have been influenced by the design of the component studies. (Am Heart J 2003;145:409-17.)     

Clinical and angiographic outcome after implantation of drug-eluting stents in bifurcation lesions with the crush stent technique: importance of final kissing balloon post-dilation

OBJECTIVES: The purpose of this research was to evaluate the long-term outcomes after implantation of drug-eluting stents (DES) in bifurcation lesions with the "crush" technique. BACKGROUND: The long-term outcome of "crush" stenting technique has yet to be determined. METHODS: We identified 181 consecutive patients who were treated with DES with the "crush" stent technique from April 2002 to April 2004. Based on the usage of final kissing balloon post-dilation (FKB), the patients were divided into an FKB group (n = 116) and a non-FKB group (n = 65). RESULTS: Clinical follow-up at nine months was available in all patients, and angiographic follow-up in 80% of patients. Three cases (1.7%) of intraprocedural stent thrombosis and five (2.8%) cases of postprocedural stent thrombosis occurred. Restenosis rate of the main branch in the entire cohort lesions was 11.5%. Restenosis rate of the side branch was lower in the FKB group than that in the non-FKB group (11.1% vs. 37.9%, p < 0.001). The target lesion revascularization (TLR) rate for all patients was 14.9%. The lack of FKB was a predictor for TLR (hazard ratio [HR] 4.17; 95% confidence interval [CI] 1.30 to 14.3, p = 0.02). Diabetes was also a predictor for TLR (HR 1.79; 95% CI 1.14 to 2.80, p = 0.01). Premature discontinuation of dual antiplatelet therapy (odds ratio [OR] 16.8; 95% CI 1.31 to 159.5, p = 0.03) and age (OR 1.10; 95% CI 1.00 to 1.21, p = 0.048) was associated with the occurrence of postprocedural stent thrombosis. CONCLUSIONS: Compared to the absence of FKB, the "crush" stenting technique with FKB appears to be associated with more favorable long-term outcomes. When utilizing the "crush" stenting technique, FKB is mandatory.     

Drug-Eluting Stents Versus Bare-Metal Stents in Patients With End-Stage Renal Disease

Background

The clinical outcomes of drug-eluting stents versus bare-metal stents in end-stage renal disease patients remains controversial.

Inhospital outcome of acute myocardial infarction in patients with prior coronary artery bypass surgery

Objectives Our goals were to compare the characteristics of patients with and without prior coronary artery bypass graft (CABG) presenting with acute myocardial infarction (MI) with or without ST elevation/left bundle branch block (LBBB), and to evaluate the effect of ST shift on inhospital mortality. Methods and Results Using the National Registry of Myocardial Infarction-3 Registry, we identified 112,697 patients with acute MI without exclusion criteria. Of these, 15,936 (14.1%) had prior CABG. Patients with prior CABG had more adverse characteristics and were less likely to have ST elevation/LBBB than patients without prior CABG. The unadjusted mortality for ST elevation/LBBB patients was higher in patients with prior CABG versus without (16.2% vs 14.1%, P = .0001), whereas in patients without ST elevation/LBBB, prior CABG conferred a lower unadjusted mortality versus without (10.1% vs 12.4%, P = .0001). Adjusting for baseline differences, prior CABG was weakly associated with inhospital mortality in ST elevation/LBBB patients (odds ratio [OR], 1.11, 95% CI 1.00-1.23), but not in patients without ST elevation/LBBB (OR 0.99, 95% CI 0.92-1.07). Conclusion Acute MI patients with prior CABG are more likely to present without ST elevation/LBBB than patients without prior CABG. Prior CABG was weakly associated with inhospital mortality in patients with ST elevation/LBBB, but not in patients without these electrocardiographic findings. This suggests the differences in absolute mortality rates between patients presenting with MI with and without a history of prior CABG are largely caused by differences in baseline characteristics and presentation. (Am Heart J 2002;144:463-9.)     

Randomized comparison of cilostazol versus ticlopidine hydrochloride for antiplatelet therapy after coronary stent implantation for prevention of late restenosis

Background Cilostazol is a newly developed antiplatelet drug that has been widely applied for clinical use. Its antiplatelet action appears to be mainly related to inhibition of intracellular phosphodiesterase activity. Recently, cilostazol has been used for antiplatelet therapy after coronary stent implantation. However, its evaluation has not been established yet. Methods This prospective randomized trial was designed to investigate the efficacy of cilostazol for the prevention of late restenosis and acute or subacute stent thrombosis in comparison with ticlopidine hydrochloride. One hundred thirty consecutive patients, scheduled for elective coronary stenting, were randomly assigned to receive oral aspirin (81 mg/day) plus ticlopidine hydrochloride therapy (200 mg/day; group I) or aspirin plus cilostazol therapy (200 mg/day; group II). These medications were started at least 2 days before coronary intervention and continued until follow-up coronary angiography was performed 6 months later. Results Subacute stent thrombosis was observed in 2 patients of group I but in no patients of group II. Major cardiac events were similarly present in both groups. Elevated transaminase levels were observed more frequently in group I than in group II (P < .05). Each of the quantitative coronary angiography variables before and immediately after coronary stenting were similar in both groups. At follow-up angiography, however, late lumen loss (0.69 ± 0.79 mm vs 0.28 ± 0.40 mm; P < .01) and loss index (0.42 ± 0.56 vs 0.16 ± 0.27; P < .01) were smaller in group II than in group I. Restenosis rate (13% vs 31%; P < .05) and target lesion revascularization rate (7% vs 21%; P < .05) were both lower in group II than in group I. Conclusion Aspirin plus cilostazol therapy may be an effective regimen for prevention of not only stent thrombosis but also restenosis. (Am Heart J 2002;144:303-8.)     

Randomized comparison of mounted versus unmounted stents: the multicenter COMUS trial

Background Although the use of premounted stents on a delivery balloon has almost completely eliminated the initially used hand-crimping procedure, no data are available that prove the superiority of one or the other approach on a randomized basis. Therefore, this study was designed to examine whether the use of premounted stents is comparable with the hand-crimping procedure. Methods A total of 123 patients (64 treated with unmounted stents, 59 treated with premounted stents) were examined in a multicenter, randomized, prospective study. There were no significant differences in patient characteristics between groups. Results Primary end points (acute, postinterventional [within 72 hours], and late complications related to the stenting procedure) were reached in 1 patient treated with an unmounted stent versus 2 patients with mounted stents (P = not significant). In patients with angiographic follow up (n = 84, mean follow-up period 6 ± 1 months), the total rate of restenosis was 27% (unmounted 12, mounted 11, P = not significant). Secondary end points were procedural success of stenting and maximal balloon inflation pressure needed for optimal stenting results by use of angiography. There were no differences in secondary end points for both techniques. The mean balloon pressure was 12.56 ± 2.1 atmospheres (unmounted) and 12.12 ± 1.92 atmospheres (mounted, P = not significant). Conclusion Stenting with premounted devices was demonstrated to have a similar clinical and angiographic outcome as the hand-crimping approach for maximal inflation pressure, procedural success, major cardiac events, and rate of restenosis after 6 months of follow up. Thus, the more convenient use of a premounted stent provides procedural safety and efficacy comparable with a hand-crimped system. (Am Heart J 2003;145:e4.)     

Drug‐eluting stents in bifurcation lesions: To stent one branch or both?

OBJECTIVES: The objective of this study was to compare two techniques to treat bifurcation lesions: a single drug-eluting stent (DES) implanted in the main branch combined with balloon dilatation for the side branch vs. stenting of both branches (double stent). BACKGROUND: Percutaneous coronary intervention in coronary bifurcation lesions remains challenging. Although DES reduce restenosis in lesions, the double stent procedure has not shown clear advantages over a single stent with balloon dilation. METHODS: Fifty-three symptomatic patients with true bifurcation lesions were treated using either the double stent technique (n = 25) or one stent in the parent vessel plus balloon angioplasty of the side branch (n = 28). Procedural results and major adverse cardiac event rates (MACE: cardiac death, myocardial infarction, target vessel revascularization (TVR)) were compared. RESULTS: Angiographic procedural success (residual stenosis <30% in both branches) was 75% in the single stent group and 100% in the double stent group (P = 0.01). All differences were due to residual stenosis of the side branch. Clinical follow-up (6-18 months) was available for all patients; 90.5% of patients had a coronary angiography or nuclear stress test. Three patients (11%) in the single stent group and two (8%) in the double stent group had ischemia-driven TVR (P = NS). Asymptomatic angiographic restenosis (>50% diameter stenosis) in the ostium of the side branch was seen in two patients in the double-stent group. At 6 months, MACE-free was comparable between groups (89.3% vs. 88%, P = 0.7). CONCLUSIONS: When treating bifurcation lesions with sirolimus-eluting stents, restenosis following a single stent procedure is comparable to stenting both parent and side branch vessels. Thus, stenting the main-branch lesion, coupled with balloon angioplasty in the side branch, produces a high success rate and good clinical outcomes at 6 months.     

Abciximab therapy improves 1-month survival rate in unselected patients with acute myocardial infarction undergoing routine infarct artery stent implantation

Background The impact of abciximab therapy on mortality in unselected patients with acute myocardial infarction (AMI) undergoing routine primary infarct-related artery (IRA) stent implantation is not yet defined, and previous randomized studies have produced conflicting results. Methods A strategy of IRA stenting alone as opposed to IRA stenting plus abciximab was compared in a series of 561 consecutive unselected patients with AMI. Abciximab tretament was strongly encouraged for all patients. The contraindication for abciximab therapy was a high risk of major bleeding as assessed by the operator before mechanical intervention. Results Of 561 patients, 348 patients underwent abciximab therapy and 213 underwent primary IRA stenting alone. The 1-month overall mortality rate was 2.9% in the abciximab group and 10.8% in the stent alone group (P < .001). The relative reduction in mortality rate was 73% for patients overall, 77% in the subset of patients aged ≤70 years (mortality rate, 1.2% vs 5.2%, P = .020), 57% in patients aged >70 years (7.7% vs 18%, P = .043), 63% in patients with cardiogenic shock (17% vs 46%, P = .022), and 77% in patients without cardiogenic shock (1.3% vs 5.6%, P = .002). Multivariate analyses on the basis of all patients, and on the subset of patients aged ≤70 years, showed that abciximab therapy was independently related to the risk of death at 1 month. No differences were seen between groups in the procedural success rate (99.1% vs 98.1%) or in the incidence rates of nonfatal reinfarction (0.3% vs 1.9%) or repeat target vessel revascularization (1.7% vs 1.9%). Conclusion The results of this study strongly support the use of abciximab therapy in nonselected patients with AMI undergoing routine IRA stent implantation. The mechanism of the clinical benefit of abciximab was not related to the patency of the IRA. (Am Heart J 2002;144:315-22.)     

Antithrombotic Regimens for Patients Taking Oral Anticoagulation After Coronary Intervention: A Meta‐analysis of 16 Clinical Trials and 9185 Patients

The optimal antithrombotic regimen remains controversial in patients taking oral anticoagulation (OAC) undergoing coronary stenting. This study sought to compare efficacy and safety outcomes of triple therapy (OAC, aspirin, and clopidogrel) vs dual therapy (clopidogrel with aspirin or OAC) in these patients. We hypothesize OAC plus clopidogrel could be the optimal regimen for patients with indications for OAC receiving stent implantation. Medline, the Cochrane Library, and other Internet sources were searched for clinical trials comparing the efficacy and safety of triple vs dual therapy for patients taking OAC after coronary stenting. Sixteen eligible trials including 9185 patients were identified. The risks of major adverse cardiac events (odds ratio [OR]: 1.06, 95% confidence interval [CI]: 0.82‐1.39, P = 0.65), all‐cause mortality (OR: 0.98, 95% CI: 0.76‐1.27, P = 0.89), myocardial infarction (OR: 1.01, 95% CI: 0.77‐1.31, P = 0.97), and stent thrombosis (OR: 0.91, 95% CI: 0.49‐1.69, P = 0.75) were similar between triple and dual therapy. Compared with dual therapy, triple therapy was associated with a reduced risk of ischemic stroke (OR: 0.57, 95% CI: 0.35‐0.94, P = 0.03) but with higher major bleeding (OR: 1.52, 95% CI: 1.11‐2.10, P = 0.01) and minor bleeding (OR: 1.59, 95% CI: 1.05‐2.42, P = 0.03). Subgroup analysis indicated there were similar ischemic stroke and major bleeding outcomes between triple therapy and therapy with OAC plus clopidogrel. Treatment with OAC and clopidogrel was associated with similar efficacy and safety outcomes compared with triple therapy. Triple therapy could be replaced by OAC plus clopidogrel without any concern about additional risk of thrombotic events.     

Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study

Objectives Recently, direct stenting has been shown in retrospective and randomized studies to be feasible and safe in highly selected patients, with a potential interest to reduce the cost of the procedure and the rate of no-reflow. This randomized pilot study was designed to compare the incidence of no-reflow after direct stenting or conventional stenting after balloon predilation in acute coronary syndrome-related lesions. Methods and Results Between December 1998 and October 1999, 130 patients in our center with acute coronary syndromes were included in this study and randomized in 2 groups. In group A (n = 65), direct stent implantation was performed without balloon predilation. In group B (n = 65), conventional balloon predilation was carried out before stent implantation. Baseline clinical and angiographic characteristics before the procedure were similar in the 2 groups of patients. No-reflow was observed in 7.7% after direct stenting and in 6.1% after conventional stent implantation (P = not significant). The immediate clinical success rate was similar in the 2 groups. Among the procedural data, only duration of the procedure (shorter in the direct stenting group), the number of balloons used, and the quantity of contrast agent (lower in the direct stenting group) were significantly different between the 2 groups (P < .05). The 6-month clinical outcome was similar in the 2 groups. Conclusion This randomized study confirms the promising results of previous studies that show the feasibility and the safety of direct coronary stenting in highly selected acute coronary syndrome-related lesions. The major impact of this strategy is the improvement of the cost-benefit ratio, with no major influence on the acute complications and especially on the occurrence of no-reflow in this high-risk population. (Am Heart J 2002;143:1027-32.)