[Noninvasive imaging techniques to study coronary artery aneurysms]. / Técnicas de imagen no invasivas para el estudio de los aneurismas coronarios.

Given the growing evidence about the use of membrane-covered stents to treat coronary artery aneurysms, it is fundamental to know the exact anatomy of the aneurysm to enable patients to be selected correctly. Invasive heart catheterization has limitations for diagnostic purposes and can underestimate the size of the aneurysm. In this article, we review the noninvasive diagnostic imaging techniques for the study of coronary artery aneurysms, illustrating the usefulness of each technique.

Soluble guanylate cyclase beta1-subunit expression is increased in mononuclear cells from patients with erectile dysfunction.

The aim was to determine in circulating mononuclear cells from patients with erectile dysfunction (ED), the level of expression of endothelial nitric oxide synthase (eNOS), soluble guanylate cyclase (sGC) beta1-subunit and phosphodiesterase type-V (PDE-V). Peripheral mononuclear cells from nine patients with ED of vascular origin and nine patients with ED of neurological origin were obtained. Fourteen age-matched volunteers with normal erectile function were used as control. Reduction in eNOS protein was observed in the mononuclear cells from patients with ED of vascular origin but not in those from neurological origin. Although sGC beta1-subunit expression was increased in mononuclear cells from patients with ED, the sGC activity was reduced. However, only the patients with ED of vascular origin showed an increased expression of PDE-V. This work shows for the first time that, independently of the aetiology of ED, the expression of sGC beta1-subunit was increased in circulating mononuclear cells; however, the expression of both eNOS and PDE-V was only modified in the circulating mononuclear cells from patients with ED of vascular origin.

WITHDRAWN: Effect of Intensive Diuretic Treatment over Right Ventricular Behaviour. Evidence Provided from Colour and Pulsed-wave Doppler Echocardiography.

The publisher regrets that this was an accidental duplication of an article that has already been published in Eur. J. Echocardiogr., 4 (2003) 226-228, . The duplicate article has therefore been withdrawn.

Occupational radiation doses in interventional cardiology: a 15-year follow-up.

This report describes occupational radiation doses of interventional cardiologists over 15 years and assesses action undertaken to optimize radiation protection. Personal dosimetry records of nine staff cardiologists and eight interventional cardiology fellows were recorded using personal dosemeters worn over and under their lead aprons. The hospital in which this study was conducted currently performs 5000 cardiology procedures per year. The hospital has improved its facilities since 1989, when it had two old-fashioned theatres, to include four rooms with more advanced and safer equipment. Intensive radiation protection training was also implemented since 1989. Initially, some individual dose values in the range of 100-300 mSv month(-1), which risked exceeding some regulatory dose limits, were measured over the lead apron. Several doses in the range of 5-11 mSv month(-1) were recorded under the apron (mean = 10.2 mSv year(-1)). During the last 5 years of the study, after the implementation of the radiation protection actions and a programme of patient-dose optimization, the mean dose under the apron was reduced to 1.2 mSv year(-1). Current mean occupational doses recorded under the lead apron are 14% of those recorded during 1989-1992 and those recorded over the apron are 14-fold less than those recorded during 1989-1992. The regulatory dose limits and the threshold for lens injuries might have been exceeded if radiation protection facilities had not been used systematically. The most effective actions involved in reducing the radiation risk were training in radiation protection, a programme of patient-dose reduction and the systematic use of radiation protection facilities, specifically ceiling-suspended protective screens.

Long-term clinical outcomes after unprotected left main trunk percutaneous revascularization in 279 patients.

BACKGROUND: Percutaneous coronary revascularization (PCI) has been increasingly applied to unprotected left main trunk (LMT) lesions, with varied long-term success. This study attempts to define the predictors of outcome in this population. METHODS AND RESULTS: Two hundred seventy-nine consecutive patients who had LMT PCI at 1 of 25 sites between 1993 and 1998 were studied. Forty-six percent of these patients were deemed inoperable or at high surgical risk. Thirty-eight patients (13.7%) died in hospital, and the rest were followed up for a mean of 19 months. The 1-year incidence was 24.2% for all-cause mortality, 20.2% for cardiac mortality, 9.8% for myocardial infarction, and 9.4% for CABG. Independent correlates of all-cause mortality were left ventricular ejection fraction /=2.0 mg/dL, and severe lesion calcification. For the 32% of patients <65 years old with left ventricular ejection fraction >30% and without shock, the prevalence of these adverse risk factors was low. No periprocedural deaths were observed in this low-risk subset, and the 1-year mortality was only 3.4%. CONCLUSIONS: Patients undergoing unprotected LMT PCI have frequent serious comorbidities and consequently have high event rates. PCI may be an alternative to CABG for a select proportion of elective patients and may also be appropriate for highly symptomatic inoperable patients. Meticulous follow-up of hospital survivors is required because of the rather high mortality during the first few months after treatment.

Randomized comparison of coronary stent implantation under ultrasound or angiographic guidance to reduce stent restenosis (OPTICUS Study).

BACKGROUND: Observational studies in selected patients have shown remarkably low restenosis rates after ultrasound-guided stent implantation. However, it is unknown whether this implantation strategy improves long-term angiographic and clinical outcome in routine clinical practice. Methods and Results-- A total of 550 patients with a symptomatic coronary lesion or silent ischemia were randomly assigned to either ultrasound-guided or angiography-guided implantation of

Incidence, predictors, and significance of abnormal cardiac enzyme rise in patients treated with bypass surgery in the arterial revascularization therapies study (ARTS).

BACKGROUND: Although it has been suggested that elevation of CK-MB after percutaneous coronary intervention is associated with adverse clinical outcomes, limited data are available in the setting of coronary bypass grafting. The aim of the present study was to determine the incidence, predictors, and prognostic significance of CK-MB elevation following multivessel coronary bypass grafting (CABG). METHODS AND RESULTS: The population comprises 496 patients with multivessel coronary disease assigned to CABG in the Arterial Revascularization Therapies Study (ARTS). CK-MB was prospectively measured at 6, 12, and 18 hours after the procedure. Thirty-day and 1-year clinical follow-up were performed. Abnormal CK-MB elevation occurred in 61.9% of the patients. Patients with increased cardiac-enzyme levels after CABG were at increased risk of both death and repeat myocardial infarction within the first 30 days (P=0.001). CK-MB elevation was also independently related to late adverse outcome (P=0.009, OR=0.64). CONCLUSIONS: Increased concentrations of CK-MB, which are often dismissed as inconsequential in the setting of multivessel CABG, appear to occur very frequently and are associated with a significant increase in both repeat myocardial infarction and death beyond the immediate perioperative period.

Early angiographic changes of side branches arising from a Palmaz-Schatz stented coronary segment: results and clinical implications.

OBJECTIVES: The purpose of this study was to assess the effects and clinical implications of Palmaz-Schatz stent implantation on coronary blood flow in side branches arising from a stented coronary artery segment. BACKGROUND: The occlusion of a side branch is a well defined risk after balloon angioplasty. However, the impact of stenting on the coronary flow in side branches arising within the stented segment is unknown. METHODS: Forty-six stented coronary artery segments with 79 side branches emerging from the stented segment were analyzed. Angiographic studies were performed before angioplasty, after balloon dilation, immediately after stenting and 24 h later. Side branches were classified as follows: type A (> or = 1 mm in diameter, with ostial narrowing), type B (> or = 1 mm in diameter, without ostial narrowing), type C (< 1 mm in diameter, with ostial narrowing) and type D (< 1 mm in diameter, without ostial narrowing). Quantitative angiography was used to assess the diameter of the side branches. RESULTS: Stents were implanted electively in lesions with restenosis (41 stents, 89%) or with a suboptimal result after angioplasty (5 stents, 11%). Nine side branches (11%) were type A, 25 (32%) type B, 7 (9%) type C and 38 (48%) type D. At baseline, 68 side branches had Thrombolysis in Myocardial Infarction (TIMI) trial flow grade 3; 10 had grade 2; and 1 had grade 1. Flow worsened (TIMI grade > or = 1) in six side branches (8%) after balloon dilation and in four side branches (5%) after stenting. One additional side branch (1%) was occluded at 24 h. Of the 34 side branches > or = 1 mm in diameter (mean diameter 1.5 +/- 0.3 mm), 2 (6%) had flow impairment after stenting. Three patients experienced transient angina, but no acute myocardial infarction occurred as a result of a side branch occlusion. CONCLUSIONS: Coronary artery stenting does not modify anterograde flow in 90% of side branches. Coronary flow is reduced after stenting in a few branches, but this does not appear to have major clinical relevance.

Midterm outcome of patients with asymptomatic restenosis after coronary balloon angioplasty.

Although many patients with restenosis after balloon coronary angioplasty have recurrence of angina, others remain asymptomatic. To assess the clinical implications of asymptomatic coronary restenosis, we analyzed clinical and angiographic characteristics of 277 consecutive patients with restenosis, 133 (48%) of whom were asymptomatic (group I) and 144 (52%) symptomatic (group II). Restenosis was documented 6 to 9 months after the index procedure, or earlier if angina recurred, and was defined as a greater than 50% lumen narrowing (visual estimation). Group I (asymptomatic group) included fewer female (9% vs. 18%, p less than 0.05) and hypertensive patients (38% vs. 56%, p less than 0.005) and more patients with a previous myocardial infarction (48% vs. 28%, p less than 0.05) and single-vessel disease (67% vs. 55%, p less than 0.05). Before angioplasty, symptoms had lasted for a shorter period (10 +/- 25 vs. 23 +/- 42 months, p less than 0.001), ischemia after a recent infarction was a more frequent indication (21% vs. 10%, p less than 0.05) and total revascularization more frequently obtained (74% vs. 63%, p less than 0.05) in group I than in group II patients. Only a normal blood pressure, previous myocardial infarction, single-vessel disease and a shorter duration of symptoms were independent correlates of asymptomatic restenosis. No differences were found in stenosis severity before angioplasty (90% in both groups) or after angioplasty (22% +/- 12% vs. 24% +/- 16%).(ABSTRACT TRUNCATED AT 250 WORDS)

Determinants of coronary compliance in patients with coronary artery disease: an intravascular ultrasound study.

OBJECTIVES: The aim of this study was to elucidate determinants of coronary compliance in patients with coronary artery disease. BACKGROUND: Intravascular ultrasound potentially enables in vivo evaluation of coronary artery compliance. METHODS: Twenty-seven patients (mean age [+/- SD] 57 +/- 11 years, three women) undergoing coronary angioplasty were studied with intravascular ultrasound imaging. A mechanical intravascular ultrasound system (4.8F, 20 MHz) was used. A total of 58 different coronary segments (proximal to the target angiographic lesion) were studied. Of these, 35 were located in the left anterior descending, 9 in the left main, 8 in the left circumflex and 6 in the right coronary arteries. During intravascular ultrasound imaging, 22 segments (38%) appeared normal, but 36 (62%) had plaque (24 fibrotic, 3 lipidic and 9 calcified). Systolic-diastolic changes in area (delta A) and pressure (delta P) with respect to vessel area (A) were used to study normalized compliance (Normalized compliance = [delta A/A]/delta P [mm Hg-1 x 10(3)]). RESULTS: Lumen area and plaque area were 12.6 +/- 5.7 and 3 +/- 3 min2, respectively. Plaque was concentric (more than two quadrants) at 10 sites, but the remaining 26 plaques were eccentric. Compliance was inversely related to age (r = -0.34, p < 0.05) but was not related to other clinical variables. Compliance was greater in the left main coronary artery (3.9 +/- 2.1 vs. 1.8 +/- 1.2 mm Hg-1, p < 0.05) and in coronary segments with normal findings on ultrasound imaging (2.9 +/- 1.9 vs. 1.6 +/- 1.1 mm Hg-1, p < 0.01). Moreover, at diseased coronary segments compliance was lower in calcified plaques than in other types of plaques (1.2 +/- 0.7 vs. 2.3 +/- 1.6 mm Hg-1, p < 0.01) but was similar in concentric and eccentric plaques (1.6 +/- 1.5 vs. 1.6 +/- 0.9 mm Hg-1). Plaque area (r = -0.38, p < 0.01) was inversely correlated with compliance. On multivariate analysis, only age and plaque area were independently related to compliance. CONCLUSIONS: Intravascular ultrasound may be used to evaluate compliance in patients with coronary artery disease. Compliance is reduced with increasing age and is mainly determined by the arterial site and by the presence, size and characteristics of plaque on intravascular ultrasound imaging.

Angioscopic findings during coronary angioplasty of coronary occlusions.

OBJECTIVES: This study sought to elucidate angioscopic findings in totally occluded vessels before and after intervention. BACKGROUND: Coronary angioscopy allows direct visualization of the lumen surface of the coronary arteries; however, the utility of coronary angioscopy during coronary angioplasty of vessels with a total occlusion is unknown. METHODS: Twenty-one consecutive patients (mean [+/- SD] 58 +/- 9 years, range 39 to 77; 3 women, 18 men) undergoing dilation of an occluded vessel were studied with coronary angioscopy. Occlusions were classified as functional in 8 patients (Thrombolysis in Myocardial Infarction [TIMI] flow grade 1) and anatomic in 13 (TIMI flow grade 0). Once the guide wire had crossed the occlusion, coronary angioscopy was attempted before and after angioplasty. RESULTS: In all patients, coronary angioscopy before dilation visualized protruding material occluding the coronary lumen where the guide wire was wedged. The occlusion consisted of red thrombus in 19 patients (90%) (2 with isolated occlusive thrombus, 17 with thrombus associated with atherosclerotic plaque) and protruding yellow plaque in 2 patients (10%). However, on angiography only 7 occlusions (33%) had data consistent with thrombus (p < 0.01 vs. coronary angioscopy). Successful dilation was obtained in 20 patients. After dilation, coronary angioscopy was repeated in 18 patients, revealing residual thrombus with plaque in 16 (89%) and a residual yellow plaque in 2. In addition, coronary angioscopy revealed coronary dissections in 13 patients (72%); however, angiography revealed dissections only in 10 patients (55%) and residual thrombus in 2 (10%) (p < 0.001). In one patient, coronary angioscopy visualized silent distal embolization of a red thrombus not previously recognized on angiography. CONCLUSIONS: Before intervention, coronary angioscopy provides unique insights into the pathologic substrate of occluded coronary vessels. An occlusive plaque with thrombus is the most common underlying substrate in these lesions. After successful dilation, angiographically silent mural thrombus is seen in most patients. This information could be used to assist in the selection of candidates and type of coronary interventions and could also prove to be of prognostic value in patients with occluded vessels.

Clinical and angiographic implications of coronary stenting in thrombus-containing lesions.

OBJECTIVES: This study sought to determine the results of coronary stenting in thrombus-laden lesions. BACKGROUND: The angiographic evidence of intracoronary thrombus has classically been considered a formal contraindication to stent implantation. However, with increasing use of stenting, the indications for this technique have widened to include treatment of patients who have an acute coronary syndrome or lesions with adverse anatomic features. METHODS: We studied 86 consecutive patients (mean age +/- SD 61 +/- 11 years, 14 women) undergoing coronary stenting of a thrombus-containing lesion; the procedure was performed electively in 39% and after angioplasty failure in 61%. Sixty-four patients (75%) were treated for unstable angina, and 19 (22%) underwent the procedure during an acute myocardial infarction. A specific protocol that included clinical and late angiographic follow-up was used. RESULTS: Angiographic success was obtained in 83 patients (96%). Five patients (6%) died during the hospital stay despite angiographic success; four of these had cardiogenic shock, and one (1%) had subacute stent thrombosis. Non-Q wave myocardial infarction developed in five additional patients (6%), and four of these five had data consistent with distal embolization. Of the 78 patients discharged with angiographic success, 67 (86%) were event-free and clinically improved at last follow-up visit (12 +/- 11 months). During the follow-up period, eight patients required repeat angioplasty, one patient required heart transplantation, and two patients died. Quantitative angiography demonstrated excellent angiographic results after stenting (minimal lumen diameter 0.31 +/- 0.4 vs. 2.77 +/- 0.6 mm). Late angiographic follow-up (5.5 +/- 1 months) was obtained in 50 patients with 54 lesions (93% of eligible), revealing a minimal lumen diameter of 2.0 +/- 1 mm and restenosis (lumen narrowing > 50%) in 18 lesions (33%). CONCLUSIONS: Coronary stenting constitutes an effective therapeutic strategy for patients with thrombus-containing lesions, either after failure of initial angioplasty or electively as the primary procedure. Coronary stenting in this adverse anatomic setting results in a high degree of angiographic success, a low incidence of subacute thrombosis and an acceptable restenosis rate.

Fate of stent-related side branches after coronary intervention in patients with in-stent restenosis.

OBJECTIVES: We sought to assess the fate of stent (ST)-related side branches (SB) after coronary intervention in patients with in-ST restenosis. BACKGROUND: In-ST restenosis constitutes a therapeutic challenge. Although the fate of lesion-related SB after conventional angioplasty or initial coronary stenting is well established, the outcome of ST-related SB in patients with in-ST restenosis undergoing repeat intervention is unknown. METHODS: One hundred consecutive patients (age 61 +/- 11 years, 22 women) undergoing repeat intervention for in-ST restenosis (101 ST) were prospectively studied. Two hundred and twenty-six SB spanned by the ST were identified. The SB size, type, ostium involvement, location within the ST and take-off angle were evaluated. The SB TIMI (Thrombolysis in Myocardial Infarction trial) flow grade was studied in detail before, during, immediately after the procedure, and at late angiography. RESULTS: Occlusion (TIMI flow grade = 0) was produced in 24 (10%) SB, whereas some degree of flow deterioration (> or = 1 TIMI flow grade) was observed in 57 SB (25%). The SB occlusion was associated with non-Q wave myocardial infarction in two patients (both had large and diseased SB). Side-branch occlusion at the time of initial stenting (RR [relative risk] 11.1, 95% CI [confidence interval] 3.5-35.5, p < 0.001), diabetes (RR 3.5, 95% CI 1.1-10.5, p = 0.02), SB ostium involvement (RR 5.0, 95% CI 1.4-17.2, p = 0.004), baseline SB TIMI flow grade <3 (RR 5.5, 95% CI 1.7-18.1, p = 0.005), and restenosis length (RR 1.05 95% CI 1.01-1.11, p = 0.03) were identified as independent predictors of SB occlusion. Late angiography in 19 initially occluded SB revealed that 17 (89%) were patent again. The long-term clinical event-free survival (81% vs. 82% at two years) in patients with and without initial SB occlusion was similar. CONCLUSIONS: Occlusion or flow deterioration of SB spanned by the ST is relatively common during repeat intervention for in-ST restenosis. Several factors (mainly anatomic features) are useful predictors of this event. However, most SB occlusions are clinically silent and frequently reappear at follow-up.

Coronary stenting for acute coronary dissection after coronary angioplasty: implications of residual dissection.

OBJECTIVES: The aim of this study was to assess the implications of residual coronary dissections after stenting. BACKGROUND: Coronary stenting is currently used in selected patients with coronary dissection after angioplasty. However, in some patients the total length of the dissection may not be completely covered with the device. METHODS: Forty-two consecutive patients (mean [+/- SD] age 58 +/- 11 years; 39 men, 3 women) undergoing stenting for a major coronary dissection after angioplasty were studied. RESULTS: Thirty (67%) coronary dissections were small (< or = 15 mm), and 29 (64%) were occlusive (Thrombolysis in Myocardial Infarction [TIMI] flow grade < or = 2). In 3 patients, coronary stenting was unable to open large occlusive dissections, but a good angiographic result was obtained in 39 patients (93%). After stenting, 22 of these patients (56%) had no visible residual dissections, and 13 (33%) had small and 4 (10%) had large residual dissections. These residual dissections were stable and did not compromise coronary flow. In a repeat angiogram (24 h later) the stent was patent in all 39 patients. However, two patients experienced a subacute stent occlusion. Of the remaining 37 patients, 36 (97%) had a late angiogram after stenting. Quantitative angiography revealed a reduction in minimal lumen diameter at the stent site (2.6 +/- 0.4 vs. 2 +/- 0.7 mm, p < 0.05) and a trend toward improvement in vessel diameter at the site of the previous residual dissection (1.7 +/- 0.6 vs. 1.9 +/- 0.5 mm, p < 0.1). The angiographic image of residual dissection disappeared in all patients. These factors provided a rather smooth angiographic appearance at follow-up. The four patients with large residual dissections after stenting did not have restenosis and were asymptomatic at last visit. CONCLUSIONS: Coronary stenting is effective in the management of acute coronary dissections after angioplasty. In this setting, small residual dissections are frequently seen but have a good outcome and disappear at follow-up. Large residual dissections may have a good outcome if coronary flow is not impaired and no residual stenosis is visualized.

Propensity and mechanisms of restenosis in different coronary stent designs: complementary value of the analysis of the luminal gain-loss relationship.

OBJECTIVES: This study sought to investigate the influence of stent design on the long-term angiographic outcome. BACKGROUND: The proportional relationship between vessel injury and late luminal loss in percutaneous revascularization should be best appreciated in coronary stenting, where recoil and shrinkage are theoretically minimal. It is unclear whether all stent designs can counterbalance this reactive loss by achieving a large initial luminal gain (bigger is better). METHODS: In 523 lesions successfully stented, the long-term angiographic results of slotted-tube (n = 331), coil (n = 85), multicellular (n = 70) and self-expandable mesh (n = 37) stent designs were compared using the angiographic gain-loss relationship (GLR). RESULTS: Restenosis rate was 10% for multicellular, 20% for slotted-tube, 46% for coil and 49% for self-expandable designs (p = 0.001). At a difference with other designs, no significant GLR was found in coil stents, suggesting additional mechanisms of luminal loss (i.e., plaque protrusion, stent compression) to neointimal proliferation. Significant differences in late loss between stents were found within each quartile of luminal gain, suggesting a specific role of design in luminal loss. Multivariate analysis identified use of coil and self-expandable stents, vessel size, minimal luminal diameter preintervention, luminal gain and stent length as variables with independent predictive value for several indices of angiographic long-term outcome. CONCLUSIONS: The analysis of GLR: 1) demonstrates that stent design influences late luminal loss; 2) challenges the applicability of the widely accepted "bigger is better" approach to all stent designs; and 3) appears as a valuable tool in assessing long-term stent performance.

First international new intravascular rigid-flex endovascular stent study (FINESS): clinical and angiographic results after elective and urgent stent implantation. The FINESS Trial Investigators.

OBJECTIVES: The purpose of this study was to determine the feasibility, safety and efficacy of elective and urgent deployment of the new intravascular rigid-flex (NIR) stent in patients with coronary artery disease. BACKGROUND: Stent implantation has been shown to be effective in the treatment of focal, new coronary stenoses and in restoring coronary flow after coronary dissection and abrupt vessel closure. However, currently available stents either lack flexibility, hindering navigation through tortuous arteries, or lack axial strength, resulting in suboptimal scaffolding of the vessel. The unique transforming multicellular design of the NIR stent appears to provide both longitudinal flexibility and radial strength. METHODS: NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter international registry from December 1995 through March 1996. Nine-, 16- and 32-mm long NIR stents were manually crimped onto coronary balloons and deployed in native coronary (94%) and saphenous vein graft (6%) lesions. Seventy-four percent of patients underwent elective stenting for primary or restenotic lesions, 21% for a suboptimal angioplasty result and 5% for threatened or abrupt vessel closure. Fifty-two percent of patients presented with unstable angina, 48% had a previous myocardial infarction, and 45% had multivessel disease. Coronary lesions were frequently complex, occurring in relatively small arteries (mean [+/-SD] reference diameter 2.8 +/- 0.6 mm). Patients were followed up for 6 months for the occurrence of major adverse cardiovascular events. RESULTS: Stent deployment was accomplished in 98% of lesions. Mean minimal lumen diameter increased by 1.51 +/- 0.51 mm (from 1.09 +/- 0.43 mm before to 2.60 +/- 0.50 mm after the procedure). Mean percent diameter stenosis decreased from 61 +/- 13% before to 17 +/- 7% after intervention. A successful interventional procedure with < 50% diameter stenosis of all treatment site lesions and no major adverse cardiac events within 30 days occurred in 95% of patients. Event-free survival at 6 months was 82%. Ninety-four percent of surviving patients were either asymptomatic or had mild stable angina at 6 month follow-up. CONCLUSIONS: Despite unfavorable clinical and angiographic characteristics of the majority of patients enrolled, the acute angiographic results and early clinical outcome after NIR stent deployment were very promising. A prospective, randomized trial comparing the NIR stent with other currently available stents appears warranted.

Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.

OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.

Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group.

OBJECTIVES: This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. BACKGROUND: The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. METHODS: To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. RESULTS: After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. CONCLUSIONS: These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.

Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial. The Laser Angioplasty of Restenosed Stents (LARS) Investigators.

OBJECTIVES: This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents. BACKGROUND: Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis. METHODS: A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters and adjunctive balloon angioplasty. RESULTS: Laser angioplasty success (< or =50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by < or =30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS: Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Lipid metabolism and occurrence of post-percutaneous transluminal coronary angioplasty restenosis: role of cholesteryl ester transfer protein and paraoxonase/arylesterase.

Plasma lipid metabolic and transfer processes have recently been suggested to play an important role in the development of early restenosis, a major complication of percutaneous transluminal coronary angioplasty (PTCA); in particular, the common variants of genes for cholesteryl ester transfer protein (CETP) and paraoxonase (PONA) have been implicated. We had the opportunity to investigate this question in a large, prospective cohort characterized by quantitative coronary angiography in all subjects. The CETP-TaqIB (intron 1), CETP-MspI (intron 8), and PONA-AlwI (exon 2) polymorphisms were characterized in a cohort of 779 patients of whom 342 ("cases") had developed restenosis (as defined by > 50% loss of lumen compared with immediate postprocedure results) at repeat angiography at 6 months post PTCA. Selected frequencies for CETP B1 and B2 alleles (absence/presence of TaqIB site) were 0.65 and 0.35 (cases) and 0.65 and 0.35 (controls), respectively; frequencies for CETP M1 and M2 alleles (absence/presence of MspI site) were 0.20 and 0.80 (cases), 0.21 and 0.79 (controls), respectively; frequencies for PONA A and B alleles (absence/presence of AlwI site) were 0.73 and 0.27 (cases), 0.72 and 0.28 (controls), respectively. All observed genotype frequencies were in Hardy-Weinberg equilibrium. There was no evidence for gene-gene interaction, or an association between genotype and restenosis or degree of lumen loss (adjusted for covariates). Our data, collected in the largest study of its kind so far, indicate that the common variants for CETP and PONA are not associated with incidence of restenosis after PTCA, and are therefore not useful markers for risk assessment.