Novoste Beta-Cath integrity test with the active source train

Intravascular brachytherapy (IVB) to prevent restenosis is currently being performed using several different commercial delivery devices. The Novoste Beta-Cath system uses a source train of 90Sr/90Y pure beta emitters and two gold radiopaque markers. A nonactive transfer device with dummy sources is also supplied to test the delivery catheter. We have developed an alternate procedure using an acrylic shield to test both the active transfer device and delivery catheter prior to patient treatment.     

Drug-eluting stents in the treatment of proximal vertebral artery stenosis

The objective of the study was to evaluate the efficacy of endovascular revascularization treatment using drug-eluting stents in patients with atherosclerotic proximal vertebral artery (VA) stenosis. Thirty-two patients (61 ± 10 years old) were implanted with 35 sirolimus and tacrolimus eluting stents (3 patients had them from two sides). 27 patients (84%) had vertebrobasilar symptoms at enrollment. All patients were pretreated with dual antiplatelet therapy. The intervention was technically successful in 89% cases. No stroke, myocardial infarction, or death occurred in perioperative period. On duplex scanning the stents remained completely functional. In the late postoperative period 29 (91%) patients, with 32 implanted stents were followed- up. The mean follow-up was 9.5 months. No stroke occurred in patients during this period. Recurrence of vertebrobasilar insufficiency symptoms was noted in 3 patients. VA renarrowing was detected in 16 (50%) arteries in 15 patients, and 12 (80%) of them were asymptomatic. Restenosis ≥50% (n = 13) and reocclusion (n = 3) were more frequent in those with implantation of tacrolimus eluting stents compared to those with sirolimus eluting stents: 10 (71%) of 14 observations to 6 (33%) of 18 cases (p = 0.1794), respectively. Stent fracture was observed in 2 cases (6%), followed by restenosis. Restenosis rate prevailed in men (p = 0.0173). Thus, stenting of VA extracranial portion is reasonably safe procedure with a good clinical effect. The use of drug-eluting stents looks promising but does not solve the problem of high restenosis rate in the late postoperative period.     

The Proliferation REduction with Vascular ENergy Trial (PREVENT)

PREVENT was the first prospective, randomized placebo-controlled study of intracoronary beta radiotherapy with ³²P. A total of 105 patients with de novo or restenotic lesions, treated by stenting or balloon angioplasty, received 0 (control), 16, 20, or 24 Gy to a depth of 1 mm beyond the lumen surface. Rates of restenosis (50% diameter stenosis or more) were significantly lower in radiotherapy patients at the target site (8% compared with 39%, P = 0.012) and at the target site plus adjacent segments (22% compared with 50%, P = 0.018). Stenosis adjacent to the target site and late thrombotic events reduced the overall clinical benefit of radiotherapy.     

Clinical and angiographic results with the NIR stent: First International NIR Endovascular Stent Study (FINESS-II)

BACKGROUND: Although safety and efficacy of the NIR trade mark stent have been reported, the long-term angiographic and clinical outcomes have yet to be investigated. The FINESS-II study (First International NIR Endovascular Stent Study) was designed to assess the procedural safety of single 9 and 16 mm NIR stent implantation, the six-month restenosis rate and finally the six- and 12-month clinical outcome of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >3 and <5 mm diameter were included in this multicentre, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary endpoint included major adverse cardiac events (death, myocardial infarction and target lesion revascularization) within 30 days after the procedure. Major bleeding complications and subacute stent thrombosis within the first 30 days were also reported as specific endpoints. Secondary endpoints were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. RESULTS: A total of 156 patients (81% male, mean age 60 +/- 10 years), with stable (54%), unstable (40%) angina pectoris or silent ischemia (6%) were enrolled. The target vessel diameter was 2.94 +/- 0.54 mm. The minimal lumen diameter pre, post and at follow-up was 1.04 +/- 0.32 mm, 2.64 +/- 0.42 mm and 1.88 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six month follow-up was 19% (26/136). At 12 months, the event-free survival rate was 83% (two deaths, one Q-wave and three non-Q-wave myocardial infarctions, four bypass surgery and 17 target lesion revascularizations), while 87% of the patients were free of angina pectoris. CONCLUSION: the outcome of the FINESS-II trial is comparable to those observed in previous stent trials (Benestent II), indicating that the coronary NIR stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.     

Head-to-Head Comparison of Sirolimus-Eluting Stents versus Paclitaxel-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of 76 Studies

Background

The relative short-, long- and overall-term efficacy and safety of sirolimus-eluting stents (SES, Cypher) compared with paclitaxel-eluting stents (PES, Taxus) in large head-to-head comparisons still remain to be defined.

Methods

We searched Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) for articles comparing outcomes of interest between SES and PES without language restriction. Short- (≤1 year), long- (>1 year), and overall-term (the longest follow-up of each study) outcomes were evaluated. The primary endpoint was target lesion revascularization (TLR). Other outcomes of interest were target vessel revascularization (TVR), myocardial infarction, all-cause death, cardiac death, stent thrombosis, major adverse cardiac events (MACEs), restenosis and late lumen loss.

Results

Seventy-six studies including more than 15000 patients in randomized controlled trials and over 70000 patients in adjusted observational studies were included. At overall-term follow-up, SES significantly reduced TLR (relative risk [RR]: 0.61; 95% confidence interval [CI]: 0.49–0.76), TVR (RR: 0.67; 95% CI: 0.54–0.83), MACE (RR: 0.79; 95% CI: 0.72–0.87), myocardial infarction (RR: 0.85; 95% CI: 0.73–0.99), in-segment restenosis (RR: 0.50; 95% CI: 0.38–0.65), and in-segment late lumen loss (weighted mean difference [WMD]: −0.19; 95% CI: −0.24–−0.14) in randomized controlled trials compared with PES. In addition, lower rates of death (RR: 0.91; 95% CI: 0.83–1.00), any stent thrombosis (RR: 0.62; 95% CI: 0.45–0.86), definite stent thrombosis (RR: 0.59; 95% CI: 0.45–0.77) were found in patients receiving SES in adjusted observational studies. Largely similar results were found at short- and long-term follow-up, and in patients with diabetes, acute myocardial infarction or long lesions.

Conclusions

SES significantly reduced the short-, long- and overall-term risk of TLR/TVR, MACE, and restenosis, and overall-term risk of myocardial infarction in randomized controlled trials, as compared with PES. Lower rates of death and stent thrombosis were also observed in observational studies in SES-treated patients.     

Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial

BACKGROUND: Although safety and efficacy of the beStent (Medtronic Inc., Santa Rosa, CA, USA) have been described, the long-term angiographic and clinical outcomes have yet to be investigated. The ROSE (Registry for Optimal beStent Evaluation) trial was designed to assess the procedural safety of single 15 mm beStent implantation, and the six-month angiographic and 12-month clinical outcomes of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >/=2.75 mm diameter were included in this multicenter, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary end-point included major adverse cardiac events (death, myocardial infarction and target lesion revascularization), major bleeding complications, and thrombotic occlusions at one-month follow-up. Secondary end-points were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. A total of 120 patients (80% male, mean age 58.6 +/- 10.6 years) with stable (48%) or unstable (44%) angina pectoris were allocated. The target vessel reference diameter pre-procedure was 2.85 +/- 0.52 mm. RESULTS: Minimal lumen diameter pre/post and at follow-up was 0.97 +/- 0.28 mm, 2.53 +/- 0.40 mm and 1.86 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six-month follow-up was 21.5%. At 12 months, the event-free survival rate was 75% (no deaths, two Q-wave and seven non-Q-wave infarctions, five bypass surgery interventions and 16 target lesion revascularizations), whilst 87% of the patients were free of angina pectoris. CONCLUSION: Despite the relatively high percentage of small vessels, the outcome of the ROSE trial is comparable to those observed in previous stent trials, indicating that the coronary beStent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.     

Measured TG-60 dosimetric parameters of the Novoste Beta-Cath 90Sr/Y source trains for intravascular brachytherapy

Measurements were performed on the 30, 40 and 60-mm 90Sr/Y beta-emitter source trains used in the Novoste Beta-Cath system to determine the dosimetric characteristics of the sources at millimeter distances and provide the necessary TG-60 dosimetry parameters for mapping the dose distributions. These measurements were carried out in a Solid Water phantom where MD-55-2 Gafchromic films were placed in direct contact with a 5 French (F) catheter used for the 30 and 60-mm source trains and a 3.5 F catheter used for a thinner 40-mm source train. The dosimetric analysis was performed according to the AAPM TG-60 formalism. For the 30-mm source train, data were collected with the source axis at distances of 0.41 and 1.19 mm from the film surface, respectively, in order to investigate possible dosimetric effects due to the intrinsic off centering of the source train lumen within the 5 F catheter. Absolute dose rates at 2 mm were determined by calibrating the radiochromic film in a high energy electron beam from a radiotherapy accelerator. The dose rates at a radial distance of 2 mm were found to be within 10% of the values provided by Novoste. Radial dose functions from this study were in good agreement (< or = 10%) with a 30-mm, 90Sr/Y source train dose data generated from C. G. Soares et al. 90Sr/Y single seed data. However, larger differences were observed at distances shorter than 1 mm when compared to radial dose functions from the Novoste Monte Carlo data.     

Evaluation of cellular phenotypes implicated in immunopathogenesis and monitoring immune reconstitution inflammatory syndrome in HIV/leprosy cases

Background

It is now evident that HAART-associated immunological improvement often leads to a variety of new clinical manifestations, collectively termed immune reconstitution inflammatory syndrome, or IRIS. This phenomenon has already been described in cases of HIV coinfection with Mycobacterium leprae, most of them belonging to the tuberculoid spectrum of leprosy disease, as observed in leprosy reversal reaction (RR). However, the events related to the pathogenesis of this association need to be clarified. This study investigated the immunological profile of HIV/leprosy patients, with special attention to the cellular activation status, to better understand the mechanisms related to IRIS/RR immunopathogenesis, identifying any potential biomarkers for IRIS/RR intercurrence.

Methods/Principal Findings

Eighty-five individuals were assessed in this study: HIV/leprosy and HIV-monoinfected patients, grouped according to HIV-viral load levels, leprosy patients without HIV coinfection, and healthy controls. Phenotypes were evaluated by flow cytometry for T cell subsets and immune differentiation/activation markers. As expected, absolute counts of the CD4+ and CD8+ T cells from the HIV-infected individuals changed in relation to those of the leprosy patients and controls. However, there were no significant differences among the groups, whether in the expression of cellular differentiation phenotypes or cellular activation, as reflected by the expression of CD38 and HLA-DR. Six HIV/leprosy patients identified as IRIS/RR were analyzed during IRIS/RR episodes and after prednisone treatment. These patients presented high cellular activation levels regarding the expression of CD38 in CD8+ cells T during IRIS/RR (median: 77,15%), dropping significantly (p<0,05) during post-IRIS/RR moments (median: 29,7%). Furthermore, an increase of cellular activation seems to occur prior to IRIS/RR.

Conclusion/Significance

These data suggest CD38 expression in CD8+ T cells interesting tool identifying HIV/leprosy individuals at risk for IRIS/RR. So, a comparative investigation to leprosy patients at RR should be conducted.     

In-stent restenosis after revascularization of myocardium with drug-eluting stents is accompanied by elevated level of blood plasma eosinophil cationic protein

The aim of this study was to assess the involvement of eosinophil cationic protein, a marker of eosinophil activation, in the development of in-stent restenosis after drug-eluting stent implantation. Follow-up angiography at 6 to 12?months was performed in 32 patients who were treated with percutaneous coronary intervention and implantation of sirolimus-eluting stents. Blood plasma levels of eosinophil cationic protein (ECP) and total immunoglobulin E (IgE) were measured by enzyme-linked immunosorbent assay and the level of C-reactive protein (hs-CRP) by high-sensitivity nephelometry. According to angiography data, in-stent restenosis occurred in 13 patients, while 19 patients did not develop it. There were no differences between the hs-CRP and IgE levels in patients with or without restenosis. In contrast, ECP level was higher in patients with restenosis compared with that in patients without restenosis [17.7?ng/mL (11.2-24.0) vs. 9.0?ng/mL (6.4-12.9), p?= 0.017]. The incidence of in-stent restenoses was 63% in patients with ECP level higher than or equal to 11?ng/mL, and 19% in patients with an ECP level lower than 11?ng/mL (p?= 0.019). These findings suggest that elevated eosinophil activation may play an important role in the pathogenesis of in-stent restenosis after implantation of drug-eluting stents.     

Economic evaluation of sirolimus-eluting stents

Background

Sirolimus-eluting stents have recently been shown to reduce the risk of restenosis among patients who undergo percutaneous coronary intervention (PCI). Given that sirolimus-eluting stents cost about 4 times as much as conventional stents, and considering the volume of PCI procedures, the decision to use sirolimus-eluting stents has large economic implications.

Methods

We performed an economic evaluation comparing treatment with sirolimus-eluting and conventional stents in patients undergoing PCI and in subgroups based on age and diabetes mellitus status. The probabilities of transition between clinical states and estimates of resource use and health-related quality of life were derived from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) database. Information on effectiveness was based on a meta-analysis of randomized controlled clinical trials (RCTs) comparing sirolimus-eluting and conventional stents.

Results

Cost per quality-adjusted life year (QALY) gained in the baseline analysis was Can$58 721. Sirolimus-eluting stents were more cost-effective in patients with diabetes and in those over 75 years of age, the costs per QALY gained being $44 135 and $40 129, respectively. The results were sensitive to plausible variations in the cost of stents, the estimate of the effectiveness of sirolimus-eluting stents and the assumption that sirolimus-eluting stents would prevent the need for cardiac catheterizations in the subsequent year when no revascularization procedure was performed to treat restenosis.

Interpretation

The use of sirolimus-eluting stents is associated with a cost per QALY that is similar to or higher than that of other accepted medical forms of therapy and is associated with a significant incremental cost. Sirolimus-eluting stents are more economically attractive for patients who are at higher risk of restenosis or at a high risk of death if a second revascularization procedure were to be required.Restenosis is a major limitation to the long-term success of percutaneous coronary intervention (PCI). It is estimated that 14% of patients who undergo PCI with stent implantation require a second intervention within a year to manage restenosis.¹ A second coronary procedure carries a significant risk of death or impairment in health-related quality of life (HRQOL).² Moreover, given that approximately 21 200 PCIs with stenting were performed in Canada in 1999, restenosis has major economic implications.³Drug-eluting stents are the most recent technologic advance in restenosis prevention. To date, 4 randomized controlled clinical trials (RCTs) have compared the efficacy of sirolimus-eluting stents (the first available drug-eluting stent) and standard uncoated stents in the treatment of de novo native coronary artery disease and published their findings: RAVEL⁴ (RAndomized study with the sirolimus-eluting VELocity balloon-expandable stent), SIRIUS⁵ (study of the SIRolImUS-eluting stent), and C-SIRIUS⁶ and E-SIRIUS,⁷ the Canadian and European arms of SIRIUS. These trials all found notable reductions in the incidence of radiographic evidence of restenosis and symptomatic restenosis with the use of sirolimus-eluting stents. However, the overall survival rate was not affected. Currently, the cost of sirolimus-eluting stents (about Can$2900 per stent) is nearly 4 times that of conventional stents.⁸ Given the volume of PCIs performed annually, decision-makers must determine their optimal use.Using a subset of the cohort in the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH),⁹ we estimated clinical event rates, HRQOL and health care costs for patients undergoing PCI with implantation of a conventional stent. Combining this information with data from the 4 RCTs, we estimated the cost per quality-adjusted life-year (QALY) gained by using sirolimus-eluting stents rather than conventional stents for such patients.     

Effects of Probucol on Restenosis after Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Background

Restenosis after percutaneous coronary intervention (PCI) is a remained clinical problem which limits long-term success of PCI. Although there was recognition that probucol in treating restenosis after percutaneous transluminal coronary angioplasty, the efficacy of probucol on restenosis after stent-implantation is controversial. So this meta-analysis was conducted to investigate the association between probucol and late restenosis.

Methods

Articles were assessed by four trained investigators, with divergences resolved by consensus. PubMed, EMBASE, ScienceDirect and the Cochrane Central Register of clinical trials were searched for pertinent studies. Inclusion criteria were random allocated to treatment and a comparison of probucol-treated patients and control patients (not treated with lipid-lowering drug) undergoing PCI.

Results

Fifteen studies with 859 subjects were analyzed. Major outcome, binary angiographic restenosis defined as >50% stenosis upon follow-up angiography, was significantly decreased with probucol treatment (RR = 0.59 [0.43, 0.80] among vessels, P = 0.0007; and RR = 0.52 [0.40, 0.68] among patients, P<0.00001). Probucol also increased the minimal luminal diameter (SMD = 0.45 [0.30, 0.61], P<0.00001) and decreased late loss upon follow-up after 6 months (SMD = -0.41 [-0.60, -0.22], P<0.0001). Moreover, there was a significantly lower incidence of major adverse cardiac events (MACE) in the probucol group than control group (RR = 0.69 [0.51, 0.93], P = 0.01).

Conclusion

Probucol is more than a lipid-lowering drug. It is also effective in reducing the risk of restenosis and incidence of MACE after PCI.     

Clinical and quantitative angiographic outcomes following elective implantation of the self-expanding Wallstent for longer coronary artery lesions--final results of the Wellstent native study

BACKGROUND: Implantation of short balloon-expandable stents provides superior clinical and angiographic outcome compared with balloon angioplasty in selected patients. The purpose of the Wellstent study was to evaluate the safety and efficacy of the self-expanding Wallstent combined with aspirin and ticlopidine in patients with stable or unstable angina related to a native coronary lesion up to 45 mm in length. METHODS: 105 patients (111 lesions) with stable (57%) or unstable (43%) angina were included in this prospective multicentre evaluation. Angiography before and after Wallstent implantation and at 6-month follow-up was analysed at the core lab using the CAAS 2 system. The primary end-point was incidence of major adverse cardiac events (MACE) at 30 days. Secondary end-points were angiographic outcome at 6 months and MACE at 6 months and 1 year. RESULTS: Acute procedural success (successful stent implantation with residual stenosis <20%) was achieved in 99%. Mean reference diameter was 3.18 +/- 0.66 mm, minimal luminal diameter was 1.00 +/- 0.50 mm pre- and 2.84 +/- 0.47 mm poststent (diameter stenosis 16 +/- 6%). The mean hospital stay was 2.2 days. At 30 days, 95% of patients were free of MACE. At 6 month and 1 year clinical follow-up, 75% and 71% of patients, respectively, remained free of MACE, the majority of which (19 of 30) were re-interventions at re-angiography. In 90% of eligible patients, MLD at follow-up was 1.65 +/- 0.75 mm (late loss 1.20 +/- 0.66 mm, loss index 0.66), diameter stenosis 42 +/- 15%, with a restenosis rate of 32%. Longer stents were associated with greater luminal loss (P = 0.001) and less-favourable clinical outcome. CONCLUSIONS: Wallstent implantation, combined with aspirin and ticlopidine, achieved excellent acute and 30 day clinical results in a heterogenous high-risk patient group. Clinical outcome at 6 months and 1 year remained good, and most adverse events were re-PTCA during follow-up angiography. The loss index of 0.66 and restenosis rate of 32%, related in part to the use of longer stents, emphasizes the continuing need for effective anti-proliferative therapy.     

Pharmacologic prevention of both restenosis and atherosclerosis progression: AGI-1067, probucol, statins, folic acid and other therapies

PURPOSE OF REVIEW: In this article, the authors intend to provide an update on clinical trials of pharmacologic prevention of restenosis after percutaneous coronary interventions, placed in the perspective of the use of orally administered therapy for the prevention of atherosclerosis progression and clinical events. RECENT FINDINGS: AGI-1067, the mono-succinic acid ester of probucol, is a phenolic antioxidant member of a novel class of agents termed v-protectants. It has strong antioxidant properties equipotent to those of probucol and antiinflammatory properties. It inhibits gene expression of VCAM-1 and MCP-1 and has been effective at preventing atherosclerosis in all tested animal models including the non-human primate. In the Canadian Antioxidant Restenosis Trial (CART) 1, AGI-1067 and probucol improved lumen dimensions at the site of percutaneous coronary intervention. AGI-1067 also improved luminal dimensions of non-intervened coronary reference segments in the Canadian Antioxidant Restenosis Trial, which suggests a direct antiatherosclerosis effect. Probucol reduced post-percutaneous coronary intervention restenosis and progression of carotid atherosclerosis in other clinical trials. Although statins reduce atherosclerotic events, they do not appear to have a significant effect on restenosis. The failure of folate therapy to protect against restenosis in the Folate After Coronary Intervention Trial (FACIT) occurred despite significant reductions in homocysteine levels. SUMMARY: Prevention of both post-percutaneous coronary intervention restenosis and atherosclerosis progression with a pharmacologic agent such as AGI-1067 may be an attractive treatment paradigm. Two important trials that test the antioxidant/antiinflammatory hypothesis are ongoing with AGI-1067: the Canadian Atherosclerosis and Restenosis Trial 2, which assesses its value for the reduction of both atherosclerosis progression and post-percutaneous coronary interventions restenosis, and the Aggressive Reduction of Inflammation Stops Events (ARISE) trial which is evaluating its effects on cardiovascular events.     

Long-term clinical efficiency of endovascular treatment using Cypher rapamycin-eluting stents in patients with coronary heart disease

The study was undertaken to analyze the long-term results in patients with coronary heart disease (CHD) one year or more after Cypher stent implantation. It covered 1221 patients. One-, two-, and three- vessel lesions were observed in 693 (56.8%), 344 (28.2%), and 184 (15%) patients, respectively. A total of 1967 Cypher stents were implanted. The results of treatment were analyzed 1 and 2 years after intervention. The efficiency of a procedure was evaluated by the following parameters: the presence or absence of anginal symptoms, the presence and absence of complications (fatal outcome, myocardial infarction). The following morphological parameters: the rate of restenosis and that of late stent thrombosis were also assessed. The results of one- and two-year follow-ups were used to make a multivariate analysis of the clinical and morphological predictors of coronary complications (fatal outcome, myocardial infarction, recurrent angina pectoris) in the late period, as well as the predictors of restenosis and late stent thrombosis. Restenosis following 1 year of Cypher stent implantation is 3.1%. The factors that significantly increase the risk of this complication within the first year are diabetes mellitus and revascularization in the patients operated on. The one-year rate of Cypher stent thromboses is 1.6%. Patients' discontinuation of antiaggregant therapy is the sole factor that significantly increases the rate of their late thromboses in this period. Within the second year of a follow-up, the rate of late Cypher stent thromboses is 1.8%. The risk of this complication is significantly increased by factors, such as a lengthy (more than 3 mm) stented portion, renal failure, and less than 40% left ventricular ejection fraction.     

Combining short stent implantation and drug-eluting stenting for routine use yields a low restenosis rate

Background

Stent length serves as a predictor of restenosis in use of bare metal stents (BMS). This has been demonstrated in a feasibility study that used a single short BMS implant (<9 mm) in a high proportion of lesions; the study observed a low rate of restenosis.

Methods

We performed a pilot prospective study to investigate in a series of consecutive patients the immediate and long-term effects of implantation of either 1) a single short BMS for all lesions with low probability of restenosis or 2) a drug-eluting stent (DES) for all other lesions.

Results

The 200 patients studied had 236 coronary artery lesions that were treated with short BMS in 168/236 patients (71.2%) and with DES in 68/236 patients (28.8%). Angiographic success was achieved in 230/236 lesions (97.5%) and procedural success in 194/200 patients (97.0%). Restenosis occurred in 15/153 lesions (9.8%) after short BMS, in 3/62 lesions (4.8%) after DES, and in 18/215 of all lesions (8.4%) angiographically controlled after six to eight months. Target vessel revascularization was performed in 16/218 lesion (7.4%).

Conclusion

Most of the coronary artery lesions in this small group of consecutive patients were treated sufficiently with a single BMS implant. This differential approach of treating suitable lesions in medium- to large-sized vessels with a single short BMS device and treating all other lesions with a DES implant resulted in a low incidence of restenosis.     

Fluvastatin in the therapy of acute coronary syndrome: Rationale and design of a multicenter, randomized, double-blind, placebo-controlled trial (The FACS Trial)[ISRCTN81331696]

Background

Stent length serves as a predictor of restenosis in use of bare metal stents (BMS). This has been demonstrated in a feasibility study that used a single short BMS implant (<9 mm) in a high proportion of lesions; the study observed a low rate of restenosis.

Methods

We performed a pilot prospective study to investigate in a series of consecutive patients the immediate and long-term effects of implantation of either 1) a single short BMS for all lesions with low probability of restenosis or 2) a drug-eluting stent (DES) for all other lesions.

Results

The 200 patients studied had 236 coronary artery lesions that were treated with short BMS in 168/236 patients (71.2%) and with DES in 68/236 patients (28.8%). Angiographic success was achieved in 230/236 lesions (97.5%) and procedural success in 194/200 patients (97.0%). Restenosis occurred in 15/153 lesions (9.8%) after short BMS, in 3/62 lesions (4.8%) after DES, and in 18/215 of all lesions (8.4%) angiographically controlled after six to eight months. Target vessel revascularization was performed in 16/218 lesion (7.4%).

Conclusion

Most of the coronary artery lesions in this small group of consecutive patients were treated sufficiently with a single BMS implant. This differential approach of treating suitable lesions in medium- to large-sized vessels with a single short BMS device and treating all other lesions with a DES implant resulted in a low incidence of restenosis.     

Efficiency of endovascular re-interventions for evolving restenosis of different types of stents

The paper compares the results of different treatment options (balloon angioplasty and restenting) for in-stent restenosis in case of evolving restenosis of drug- and nondrug eluting stents. The investigation enrolled 496 coronary heart disease patients with clinical presentation of angina pectoris and/or signs of myocardial ischemia, as well as hemodynamic restenosis of a previously implanted stent. Of them, 216 and 280 patients had restenosis of previously implanted drug- and nondrug-eluting stents, respectively. In the patients with non-drug-eluting stent restenosis, recurrent angina pectoris and the frequency of repeated restenosis were significantly more frequently observed after balloon dilatation than after drug-eluting stent implantation (28.4 and 10.2%; p < 0.05; 19.9 and 8.7%; p < 0.05). In those with drug-eluting stent restenosis, recurrent angina pectoris and the frequency of repeated restenosis did not differ significantly between balloon dilatation of restenosis and implantation of a second drug-eluting stent.     

The potential role of homocysteine in percutaneous coronary interventions (PCI): review of current evidence and plausibility of action.

Several millions of patients with coronary heart disease worldwide are treated by means ofpercutaneous interventions each year. Above all conventional balloon dilation and implantation of uncoated stents are, however, only of limited success as reflected by 6-month restenosis rates of 50% (balloon dilation) and 25-35% (bare-metal stent). It is therefore of utmost importance to identify high-risk groups and explore further secondary-prophylactic measures for the prevention of restenosis. A large body of evidence suggests that elevated homocysteine and/or folate and B-vitamin deficiencies are relevant risk factors for restenoses due to their proatherothrombotic potential. Hyperhomocysteinemia is an ideal target as this parameter can be lowered easily, safely and at a low cost by means of folate and B-vitamin supplementation. The results of published studies exploring a potential correlation between homocysteine levels and the risk of restenosis and those of interventional studies for the reduction of the risk of restenosis have not yet lead to consistent conclusions. However, a critical assessment can by no means exclude the plausibility of postinterventional lowering of homocysteine levels. This review aims at providing insight into the current evidence and biological plausibility of homocysteine-lowering therapy in regard to PCI-related vascular damage. Currently available clinical observational and interventional studies are reviewed in detail.