Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.     

Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)

OBJECTIVES: A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate. METHODS: The study was designed to be multicentred, prospective, and observational. RESULTS: One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8.3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 97%. CONCLUSIONS: These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intravascular ultrasound coupled with the Palmaz-Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months.     

Stenting after optimal lesion debulking (sold) registry. Angiographic and clinical outcome

BACKGROUND: Coronary stenting has reduced restenosis in focal de novo lesions, but its impact has been less pronounced in complex lesion subsets. Preliminary data suggest a role for plaque burden in promoting intimal hyperplasia after stent implantation. The aim of this study was to test the hypothesis that plaque removal with directional atherectomy before stent implantation may lower the intensity of late neointimal hyperplasia, reducing the incidence of in-stent restenosis. METHODS AND RESULTS: Seventy-one patients with 90 lesions underwent directional atherectomy before coronary stenting. Intravascular ultrasound-guided stenting was performed in 73 lesions (81%). Clinical success was achieved in 96% of patients. Procedural complications were as follows: emergency bypass surgery in 1 patient (1.4%), who died 2 weeks later; Q-wave myocardial infarction in 2 patients (2.8%); and non-Q-wave myocardial infarction in 8 patients (11.3%). None of the patients had stent thrombosis at follow-up. Angiographic follow-up was performed in 89% of eligible patients at 5.7+/-1.7 months. Loss index was 0.33 (95% CI, 0.26 to 0.40), and angiographic restenosis was 11% (95% CI, 5% to 20%). Clinical follow-up was performed in all patients at 18+/-3 months. Target lesion revascularization was 7% (95% CI, 3% to 14%). CONCLUSIONS: Directional atherectomy followed by coronary stenting could be performed with good clinical success rate. Also, these data point to a possible reduction in angiographic restenosis and a significant reduction in the need for repeated coronary interventions. Therefore, a randomized clinical trial seems appropriate to test the validity of this approach.     

Reduction of in-hospital complications after elective percutaneous transluminal coronary angioplasty using a combined pretreatment with ticlopidine and aspirin

OBJECTIVES: In a retrospective study the effect of a combined pretreatment using ticlopidine and aspirin (ASA) in patients undergoing elective PTCA procedures was investigated with respect to in-hospital complications of PTCA and with respect to the efficacy in avoiding a subacute stent thrombosis in case of stent implantation. The systematically performed pretreatment with ticlopidine and ASA takes the delayed begin of full antiplatelet effect of ticlopidine into account. METHODS: 1108 consecutive patients (group 1) underwent elective PTCA without pretreatment with ticlopidine. In case of stent implantation oral anticoagulation was initiated in this group. In 758 consecutive patients (group 2) with elective PTCA, a combined regimen with ticlopidine and ASA was initiated at least 24 h prior to PTCA and was continued in case of stent implantation. The rate of procedural success, necessary reinterventions, cardiac events (myocardial infarction, death) and complications as well as the rate of subacute stent thrombosis in the subgroups with stent implantation were evaluated. RESULTS: The number of patients without in-hospital cardiac complications (myocardial infarction, coronary artery bypass surgery, death) and without re-PTCA interventions was 92.8% in group 1 and 96.3% in group 2 (p < 0.005). Especially the rate of necessary reinterventions was significantly reduced in group 2 compared with group 1 (5.3% vs. 2.4%, p < 0.001). Cardiac events were reduced in group 2 (myocardial infarction: 2.0% vs. 1.1%, coronary artery bypass graft: 0.8% vs. 0.5%, exitus: 0.5% vs. 0%), the incidence of bleeding complications was similar in both groups (2.5% vs. 2.4%). The combined pretreatment with ticlopidine and ASA with a stent implantation rate of 16.4% in group 2 was effective to avoid a subacute stent thrombosis (1.6%, independent of the indication to stent implantation). One patient of 758 in group 2 had allergic reactions to ticlopidine. CONCLUSIONS: The "prophylactic" pretreatment with ticlopidine and ASA in combination with a higher rate of stent implantation reduces necessary reinterventions and cardiac events after PTCA and is effective to avoid subacute stent thrombosis without increase of complications, especially bleeding complications. Thus, this pretreatment can be proposed even in patients scheduled for elective PTCA without planned stent implantation to reduce the interval between a necessary unforeseen stent implantation and the full treatment effects of ticlopidine.     

Intestinal epithelial cell regulation of macrophage and lymphocyte interleukin 10 expression

Patients with recurrent angina after coronary artery bypass graft surgery pose a problem. Stent implantation has been advocated in an effort to avoid repeat operation and to address the limitations of balloon angioplasty. Aim of the present study was to determine the in-hospital and long-term results of stent deployment in focal, de novo lesions of vein grafts. Thirty-five focal, de novo lesions of vein grafts in 31 patients were treated with stent deployment. Twenty-four patients (77%) had three vessels, 6 (20%) two vessels and 1 (3%) single vessel disease. Saphenous vein grafts aged 9.7 +/- 4.2 years (range 1-19 years). Twenty-two lesions (63%) were located within the body of the saphenous graft, 8 (23%) at the graft/coronary artery anastomosis and 5 (14%) at the aorta/graft anastomosis. The indications for stent deployment included: suboptimal result from balloon angioplasty (defined as > or = 50% post-angioplasty residual stenosis) in 29/35 lesions (83%); post-angioplasty coronary dissection with threatening occlusion in 4/35 (11%); abrupt closure in 2/35 (6%). Patients were screened for death, myocardial infarction, bypass surgery and repeat angioplasty during in-hospital stay and after a follow-up of 12 +/- 8 months. Even-free survival curve was constructed by the Kaplan-Meier method. Stent deployment was successful in all patients. One stent was deployed in 24/35 lesions (69%), half Palmaz-Schatz stent in 6/35 (17%) and 2 or more stents in 5/35 (14%). The balloon/vessel ratio resulted of 1.0 +/- 0.1 Minimal lumen diameter increased from 0.8 +/- 0.4 to 3.8 +/- 0.6 mm, with a mean gain of 1.8 +/- 0.6 mm (range 1.8-4.0 mm). During the in-hospital period 1 patient (3.2%) died and 1 (3.2%) had a non Q wave myocardial infarction. Therefore, the clinical success rate, was 94%. During the follow-up period, 2 patients died (6.9%), 2 (6.9%) developed a non Q wave myocardial infarction, 1 (3.4%) underwent bypass surgery and 3 (10.3%) underwent repeat angioplasty. The estimated 2-year event-free survival rate (free from myocardial infarction, repeat surgery and repeat angioplasty) was 62%. In conclusion, Palmaz-Schatz stent deployment in focal, de novo vein grafts presents a high rate of procedural success, a low rate of acute complications and good long-term results.     

Cytochrome P450 2E1 mRNA in the rat prostate: detection and quantitation by competitive reverse transcription and polymerase chain reaction

Conventional balloon angioplasty treatment of aorto-ostial stenoses in native coronary arteries and saphenous vein grafts is associated with a low primary success rate, a high complication rate and a high incidence of restenosis. The short-term outcome of Palmaz-Schatz stent implantation in aorto-ostial lesions was compared with that of balloon angioplasty. Thirteen patients underwent stent implantation for 13 de novo lesions (four in the left main coronary trunk, two in the right coronary artery, seven in the vein graft) between January 1994 and December 1995. Fourteen patients underwent balloon angioplasty for 14 de novo lesions (five in the left main coronary trunk, four in the right coronary artery, five in the vein graft between January 1986 and April 1992. Both groups had similar clinical characteristics. Initial success was obtained in all patients in the stent group, compared with 71% of the balloon angioplasty group. Insufficient dilation was the main cause for such failure in the balloon angioplasty group. Baseline reference diameters were similar (3.40 +/- 0.65 mm in the stent group vs 3.36 +/- 0.42 mm in the balloon angioplasty group) and there was no difference in baseline minimal luminal diameter (1.41 +/- 0.74 vs 1.08 +/- 0.56 mm). Minimal luminal diameter was significantly greater in the stent group than in the balloon angioplasty group at both post-procedure and follow-up examinations (post: 3.36 +/- 0.58 vs 2.69 +/- 0.45 mm, p < 0.01; follow-up: 2.33 +/- 0.96 vs 1.52 +/- 0.68 mm, p < 0.05). There was no subacute occlusion in either group. The overall angiographic restenosis rate (> 50% stenosis) was lower in the stent group (17%) than in the balloon angioplasty group: the restenosis rates of native lesions were 0% in the stent group and 40% in the balloon angioplasty group; those of saphenous vein graft lesions were 33% in the stent group and 50% in the balloon angioplasty group. Although the number of patients was limited, these results suggest that Palmaz-Schatz stent implantation may be a safe and effective strategy for treating aorto-ostial lesions in both native coronary arteries and saphenous vein grafts.     

In-laboratory removal of femoral sheath following protamine administration in patients having intracoronary stent implantation

Two hundred twenty-eight patients with successful coronary stent implantation were randomized either to protamine administration and femoral sheath removal (group I, n = 117) or no heparin neutralization and delayed sheath removal (group II, n = 111). The hospital stay after treatment was shorter in patients receiving protamine; therefore, protamine use for neutralizing circulating heparin may be safely administered immediately after stent implantation.     

Use of heparin-coated "Jo Stent M" in patients with ischemic heart disease: first results

The aim of the present study was to make a clinical and angiographic assessment of early outcomes of the use of heparin-coated new "Jo Stents M". The Study comprised 41 patients who were implanted a heparin-coated new "Jo Stent M". There was an immediate success in 45 (97.6%) of 46 cases, the optimal angiographic and suboptimal (the maximum residual stenosis (13%)) results being achieved in 43 (93.4%) and 2 (4.4%) cases, respectively. The first success of the procedure was 97.8%. Due to acute stent thrombosis, acute occlusion with evolving myocardial infarction occurred in 1 (2.4%) patient. Following the procedure, the mean proportion of the stenotic diameter was (-5.8 +/- 6)%. After the procedure, the minimum stenotic diameter with the mean due diameter of 2.9 +/- 0.5 mm was 3.0 +/- 0.2 mm. The procedure-induced diameter increase was 2.1 +/- 0.5 mm. The total number of lateral branches involved in the stenting area was 11 (100%), 2 (18.2) of them closed after stent implantation. Two branches came into the stenting area in 1 (2.4%) case. At discharge, angina pectoris was absent in 30 (74%) patients. The heparin-coated "Jo Stent M" are effective and safe in treating patients with various clinical and angiographic manifestations of coronary atherosclerotic lesions.     

Antithrombotic therapy after coronary stent placement

Subacute stent thrombosis and hemorrhagic complications due to intensive anticoagulant therapy limit the clinical benefit of coronary stenting. Antithrombotic therapy after coronary stent placement has not been standardized yet. From January 1994 to December 1995 a total of 338 Palmaz-Schatz stents were implanted in 285 patients. Procedural success rate was 98.8%. In the initial period, after stent placement, patients were treated with acetylsalicylic acid (ASA) and warfarin (135 patients, Group A), while subsequently, according to the results of other studies, patients were treated with ASA plus ticlopidine (146 patients, Group B). Two hours after sheath removal, Group A patients were treated with intravenous heparin until therapeutic INR (2.5-3.5) was reached; warfarin was stopped 3 months later. In Group B patients 2 hours after sheath removal a treatment with subcutaneous heparin 25,000 IU/die plus ticlopidine 500 mg/die was started. Subcutaneous heparin was maintained until hospital discharge, ticlopidine was stopped after 1 month and ASA was maintained indefinitely. There were no significant differences in baseline characteristics between the two groups. Most patients had unstable angina and in the majority of cases the stent was implanted due to intimal dissection after balloon dilation. Eleven patients had subacute thrombosis of the stent (3.9%): 9 patients were in Group A (6%) and 2 patients were in Group B (1.3%; p = 0.04). Seven patients (6 in Group A, 1 in Group B) were treated with emergency coronary angioplasty and 3 (2 in Group A, 1 in Group B) with coronary bypass; nevertheless 7 patients (6 in Group A, 1 in Group B) had an acute myocardial infarction. Eight patients (6 in Group A, 2 in Group B) had major bleeding due to a large groin hematoma requiring blood transfusion or vascular surgery. In conclusion, after coronary stenting antithrombotic therapy with ASA plus ticlopidine, as compared with anticoagulant therapy, reduces the incidence of both cardiac events and hemorrhagic complications.     

Immobilization of domestic goats (Capra hircus) using orally administered carfentanil citrate and detomidine hydrochloride

A total of 147 stents were implanted (in overlapping manner in 76% of vessels) in a single coronary artery in 59 patients (60 vessels, 97 lesions, 2.45 stents/vessel) over a period of 18 mo using high pressure stent deployment without ultrasound guidance. The indications for stenting were suboptimal percutaneous transluminal coronary angioplasty (PTCA) result (45%), primary prevention of restenosis (44%), acute closure (10%), and restenosis after plain balloon angioplasty (1%). One patient required emergency coronary artery bypass grafting (CABG) (extensive dissection), and one required early intervention with plain balloon angioplasty and intracoronary urokinase for stent thrombosis. There were no deaths. Thirteen patients had recurrence of angina within 6 mo and angiograms were performed in all. These showed intrastent restenosis in nine (all had successful repeat plain balloon angioplasty), development of new disease in other vessels along with restenosis close to the stent in the target vessel in one (underwent elective CABG) and normal angiograms with widely patent stents in three. Forty-five patients (77%) remained free of recurrent angina and 25 of these had follow-up angiograms (56%) at a mean of 172 days, two showing restenosis. Thus, the restenosis rate per patient in the symptomatic group (angiographic follow-up in 100%) was 77% and in the asymptomatic group (angiographic follow-up in 56%) was 8%. The restenosis rate in the subgroup with bailout stenting (n = 6) was 20% (angiographic follow-up in 83%). The overall restenosis rate per patient was 32% (overall angiographic follow-up in 66%). During the 6-mo follow-up period, one patient underwent elective CABG (1.7%), one sustained a non-Q myocardial infarction (1.7%), nine had repeat PTCA to the target vessel (15.5%), and there were no deaths. The event-free survival rate was 77%. Multiple stent implantation aided by high pressure stent deployment without ultrasound guidance and with adjunctive optimal antiplatelet therapy without oral anticoagulation seems to be a useful and effective revascularisation strategy to deal with long lesions and acute dissections with a high procedural success rate. The restenosis rate is acceptable and is not appreciably high as reported in previous studies from the "warfarin era."     

Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results

BACKGROUND: Treatment of calcified (in contrast to simple) lesions with PTCA has been associated with a lower success rate and more procedural complications. Rotablation can improve acute results, but the high restenosis rate remains a problem. The purpose of this study was to evaluate the clinical and angiographic outcome of patients with complex and calcified lesions treated with a combination of rotablation and stenting. METHODS AND RESULTS: Seventy-five consecutive patients with 106 lesions had rotablation prior to coronary stenting. Intravascular ultrasound-guided stenting was used without subsequent anticoagulation in 93% of patients. Procedural success was achieved in 93.4% of lesions. Acute stent thrombosis occurred in two lesions (1.9%), and subacute stent thrombosis in one lesion (0.9%). Angiographic follow-up was performed in 82.5% of lesions at 4.6 +/- 1.9 months with an angiographic restenosis rate of 22.5%. Clinical follow-up was performed in all patients at 6.4 +/- 3 months; target lesion revascularization was needed in 18% of lesions; Q-wave myocardial infarction occurred in 1.3%, coronary bypass surgery in 4.0%, and death in 1.3%. CONCLUSIONS: Optimal coronary stenting after rotablation in calcified and complex lesions can be performed with a high success rate, an acceptable rate of procedural complications, and a low rate of stent thrombosis. This approach was associated with a low incidence of angiographic restenosis compared with results usually obtained with other interventional strategies in calcified and complex lesion subsets.     

Glucosamine

We have taken a stepwise approach to improving the dosing of continuous intravenous heparin in patients with acute coronary syndromes. Our primary objective was to use computer modeling to develop a nomogram for managing heparin therapy and to put in place a continuous quality monitoring system to evaluate the nomogram's effectiveness. We prospectively collected data on 41 patients with unstable angina or myocardial infarction who were treated with heparin. Their response to heparin was computer modeled and the dose to achieve an activated partial thromboplastin time (aPTT) ratio of 2.0 was established. This dose was regressed against all demographic characteristics to establish predictors of heparin dose (phase I). The regression formula was used prospectively in 110 patients to initiate the infusion rate of heparin and a bolus dose to achieve an aPTT ratio of 2.5. Subsequent dosage adjustments were achieved by computer modeling the patient's aPTT response (phase II). A nomogram was developed that simulated the decisions achieved using computer-assisted methods. This was retrospectively tested and then prospectively tested in 50 patients using nursing staff (phase IV). The nomogram was then made generally available (phase IV) and has been tested in an additional 310 patients. Phase I: Of the original 41 patients, 32% of the aPTT ratios were in the therapeutic range, 36% were supratherapeutic, and 32% were subtherapeutic after the first 24 hours. Phases II and III resulted in 85% of the aPTT ratios between 1.5 and 2.5 at 24 hours. Phase 4 had similar results in 310 patients. The use of computer-assisted or a computer-generated nomogram to adjust heparin therapy results in better control of heparin therapy than using standard methods.     

Direct coronary stenting without predilatation: a new therapeutic approach with a special balloon catheter design

Coronary stenting is the primary therapeutic option for many coronary lesions, after the risk of subacute stent thrombosis and bleeding complications has been reduced by antithrombotic regimens and improved stent expansion. It would be desirable to shorten the procedure and the duration of ischemia, and to reduce the risk of ischemic complications during balloon inflation by implanting the stent without previous dilatation of the lesion. This is not possible with the presently available stent delivery systems. This new therapeutic concept was tested with a specially designed balloon catheter, on which slotted-tube stents can be fixed between two conical radiopaque markers. Sixty-one patients eligible for angioplasty underwent direct stent implantation without predilatation. Four procedures were performed for acute myocardial infarction, and two as high-risk PTCA. Single slotted-tube stents (Palmaz-Schatz, NIR, or JOStent) of 14-16-mm length were mounted between the conical radiopaque markers of a special balloon which provided a fixation for the crimped stent. The direct implantation was successful in 80% of all patients, while in 10% the stent could be deployed after predilatation of the lesion. In 10% of lesions a stent could not be implanted with this and any other delivery system. When patients with successful direct stenting were compared with those with indirect (after predilatation) or unsuccessful stent deployment, the presence of angiographically visible calcification was higher in the unsuccessful cases (75% vs. 19%; P < 0.01), and the patients were older (72+/-8 vs. 61+/-12 years; P < 0.01). Radiation exposure time was only 8.7+/-5.1 min as compared with 12.6+/-7.6 min in conventional stent procedures with predilatation (P < 0.05). The number of balloons used per lesion was also lower than with conventional stenting. Stent dislocation was observed in 5%, and no embolization occurred. The new therapeutic approach of direct stenting without predilatation proved to be a safe and successful procedure in this initial series of coronary angioplasties. When calcified coronary lesions are avoided, it provides a way to rationalize stent implantation with shorter radiation exposure times, fewer balloons, and the potential advantage of fewer ischemic complications as no balloon predilatation is required.     

Influence of various antithrombotic therapy methods on the incidence of subacute coronary stent occlusions, hemorrhagic complications and length of hospitalization

BACKGROUND: The clinical benefit of coronary stenting is reduced by the risk of thrombotic stent occlusion as well as hemorrhagic complications of intensive antithrombotic therapy. We compared the influence of different antithrombotic therapies on the incidence of post-interventional complications and in-hospital stay duration. METHODS: After successful placement of a coronary stent, 334 consecutive patients were given different antithrombotic treatments in addition to aspirin 100 mg/d indefinitely: (1) phenprocoumon for 3 months (n = 47), (2) low molecular weight heparin 2 x 100 U/kg/d s.c. for 4 weeks (n = 90), (3) ticlopidine 2 x 250 mg/d and low molecular weight heparin 2 x 100 U/kg/d s.c. for 4 weeks (n = 72) and (4) ticlopidine 2 x 250 mg/d for 4 weeks (n = 125). RESULTS: Major events were subacute stent thrombosis in 17 patients (5%), and severe hemorrhagic complication in 20 patients (5.9%). The incidence of subacute stent thrombosis in groups 1 to 4 was 10.6%, 11%, 1.4% and 0.8% respectively. The use of ticlopidine was associated with a significant lowering of stent occlusions in univariate and multivariate analysis (p = 0.0013). Additional uni- and multivariate predictors were stent placement as a "bail-out" procedure (p = 0.033) and in patients with acute coronary syndrome (p = 0.049). Anticoagulant therapy was associated with a higher incidence of severe hemorrhagic complications (p < 0.01) and a prolonged in-hospital stay (p = 0.01). CONCLUSIONS: These results confirm that anti-thrombotic therapy with aspirin and ticlopidine combines low rates of subacute stent occlusion and hemorrhagic complications. Treatment with phenprocoumon and low molecular weight heparin does not improve the rate of subacute stent occlusion but increases hemorrhagic complications. Very low rates of stent occlusion permit short in-hospital stays with concomitant reduction in cost.     

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

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

Direct stent implantation without predilatation using the MultiLink stent

The standard coronary stent implantation technique requires routine predilatation of the target lesion with a balloon catheter. In this study, we prospectively studied the feasibility and efficiency of elective coronary stent implantation without predilatation. In 94 patients who presented with various ischemic syndromes, direct implantation of 100 balloon expandable ACS MultiLink stents (7 over-the-wire, 93 rapid exchange) was attempted in 100 coronary lesions selected to have favorable characteristics. The stent crossed the lesion without predilatation in 97 cases (97%) and was successfully deployed in 93 (95.8%). In 4 patients, adjunctive high-pressure postdilatation was necessary to achieve optimal stent expansion. Reference vessel diameter was 3.12+/-0.77 mm and lesion length 8.8+/-2.7 mm. Minimal luminal diameter increased from 0.95+/-0.38 mm to 2.98+/-0.28 mm and diameter stenosis decreased from 71+/-11% to 8+/-11% after stenting. One occlusive dissection was treated by a second stent. There were no major in-hospital complications. At 1 month follow-up, 1 subacute thrombotic occlusion occurred. These results indicate that in a carefully selected coronary lesion subset, elective stent implantation without predilatation can be safely and effectively performed. The long-term results of this approach and possible advantages over the conventional implantation techniques remain unclear and need to be evaluated in further clinical studies.     

Long-term (4- to 6-year) outcome of Palmaz-Schatz stenting: paucity of late clinical stent-related problems

OBJECTIVES: The purpose of this prospective single-center study was to evaluate the longer-term outcome of Palmaz-Schatz stenting in the treatment of native coronary and saphenous vein bypass graft disease. BACKGROUND: The STRESS (Stent Restenosis Study) and BENESTENT (Belgian Netherlands Stent) trials have demonstrated a decrease in both angiographic restenosis and the need for repeat revascularization in the 1st year for vessels treated by stenting rather than balloon angioplasty. Longer-term (1 to 5 years) clinical results of Palmaz-Schatz stenting are not yet well established. Late migration of the stent, metal fatigue, endarteritis and late restenosis have all been proposed as potential late clinical complications of coronary stent implantation. METHODS: The study cohort consisted of 175 consecutive patients who underwent elective placement of 194 Palmaz-Schatz stents in 185 vessels. Clinical events (death, myocardial infarction, recurrent angina or any revascularization) were assessed at 6 weeks, 2, 4 and 6 months, 1 year and yearly thereafter. Clinical follow-up was available on all patients at a mean +/- SD of 54 +/- 17 months. RESULTS: Angiographic success was achieved in 173 patients (98.9%); angiographic restenosis was observed at 6 months in 26.1% of target sites. The survival rate was 86.7% at 5 years, with a 5-year event-free survival rate decreasing progressively to 50.7%, reflecting primarily repeat revascularization procedures (41.2% at 5 years). However, the rate of repeat revascularization of the treatment site (target site revascularization [TSR]) was 14.4%, 17.7% and 19.8% at 1, 3 and 5 years, respectively, with late (> 1 year) TSR driven by in-stent restenosis in only 3 patients (1.7%). Rates of both 5-year survival (70.5% vs. 93.4%) and event-free survival (21.1% vs. 63.3%) were lower for patients who underwent saphenous vein graft (SVG) stenting than for those with native coronary artery stenting. However, 5-year TSR rates were similar for SVGs (21.9%) and native vessels (19.2%), indicating that the higher incidence of repeat revascularization for SVGs was due to an increase in non-TSR, driven by progressive disease at other sites. CONCLUSIONS: The long-term outcome of stenting shows stability of the treated lesion, with only a slight increase in TSR between 2 and 5 years (17.1% to 19.8%). The progressive increase in repeat revascularization over that period (24% to 41%) and most ongoing late events can be attributed to the progression of coronary disease at other sites, rather than to late deterioration of the stent result itself. Such non-TSR events account for the majority of clinical events in the patients who underwent SVG stenting.     

Effect of growth hormone therapy in children with achondroplasia: growth pattern, hypothalamic-pituitary function, and genotype

PURPOSE: To evaluate the success rates of the implantation of stent grafts in the treatment of peripheral aneurysms. MATERIALS AND METHODS: In 13 patients with 15 aneurysms at the common iliac artery (n = 6), external iliac artery (n = 1), hypogastric artery (n = 2), femoral artery (n = 2) or popliteal artery (n = 4), implantation of dacron-covered nitinol stents was performed. The patients were followed up for three to 20 months (mean, 8.8 months) with intravenous digital subtraction angiography, CT or colour-coded Doppler sonography. RESULTS: In all cases, the aneurysm was successfully occluded after stent implantation. In one case with a popliteal aneurysm, kinking of the vessel caused thrombosis of the stent. The stent was successfully reopened. The aneurysm however, had to be surgically treated 9 months later. The primary and secondary patency rates at 6 months were 93% and 100%, respectively. CONCLUSION: The method described might be an alternative therapy to surgery. There are some limitations in respect of treatment of popliteal aneurysms.     

The relation between multiple sleep latency test findings and the frequency of apneic events in REM and non-REM sleep

OBJECTIVES: The purpose of this prospective study was to evaluate the immediate results and the 6-month angiographic recurrent restenosis rate after balloon angioplasty for in-stent restenosis. BACKGROUND: Despite excellent immediate and mid-term results, 20% to 30% of patients with coronary stent implantation will present an angiographic restenosis and may require additional treatment. The optimal treatment for in-stent restenosis is still unclear. METHODS: Quantitative coronary angiography (QCA) analyses were performed before and after stent implantation, before and after balloon angioplasty for in-stent restenosis and on a 6-month systematic coronary angiogram to assess the recurrent angiographic restenosis rate. RESULTS: Balloon angioplasty was performed in 52 patients presenting in-stent restenosis. In-stent restenosis was either diffuse (> or =10 mm) inside the stent (71%) or focal (29%). Mean stent length was 16+/-7 mm. Balloon diameter of 2.98+/-0.37 mm and maximal inflation pressure of 10+/-3 atm were used for balloon angioplasty. Angiographic success rate was 100% without any complication. Acute gain was lower after balloon angioplasty for in-stent restenosis than after stent implantation: 1.19+/-0.60 mm vs. 1.75+/-0.68 mm (p=0.0002). At 6-month follow-up, 60% of patients were asymptomatic and no patient died. Eighteen patients (35%) had repeat target vessel revascularization. Angiographic restenosis rate was 54%. Recurrent restenosis rate was higher when in-stent restenosis was diffuse: 63% vs. 31% when focal, p=0.046. CONCLUSIONS: Although balloon angioplasty for in-stent restenosis can be safely and successfully performed, it leads to less immediate stenosis improvement than at time of stent implantation and carries a high recurrent angiographic restenosis rate at 6 months, in particular in diffuse in-stent restenosis lesions.     

Restenosis rate after intravascular ultrasound-guided coronary stent implantation

This study was designed to test the hypothesis that patients fulfilling intravascular ultrasound (IVUS) criteria for optimal coronary stent implantation show a reduction in the restenosis rate at 6 months. IVUS guidance for stent dilation may be associated with facilitated stent implantation and an increased acute luminal gain, but it has not yet been determined, whether and to what extent this procedure is associated with a reduction in the restenosis rate. IVUS-guided optimization of Palmaz-Schatz stent placement was performed in 125 consecutive patients, 64 of whom fulfilled IVUS-criteria for optimal stent placement. Another 125 patients served as the non-IVUS control group. In 107 patients (86%) of the non-IVUS control group and 105 patients (84%) of the IVUS group, angiographic follow-up was performed. The IVUS group of patients revealed a significantly lower restenosis rate of 20.9% as compared with 29.9% in the control group (P = 0.033). Patients that met IVUS criteria for optimal stent placement had a larger minimal lumen diameter immediately after stent implantation (3.13 +/- 0.44 vs. 2.95 +/- 0.47 mm; P = 0.045) and at 6-month follow-up (2.23 +/- 0.78 vs. 1.87 +/- 0.76 mm; P = 0.019) as well as a significantly lower restenosis rate (13.5% vs. 28.3%; P = 0.038) as compared with patients that did not fulfil these criteria. Our data suggest that patients fulfilling IVUS criteria for optimal stent placement demonstrate a reduced risk for the development of restenosis. Thus, IVUS investigation identifies factors predictive of restenosis after coronary stent placement.