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Biomedical subjects

Pim de Feyter

Publications and source records attributed to Pim de Feyter.

At least 37 records · Page 2Linked to original sources
PubMed2004

Restenosis rates following bifurcation stenting with sirolimus-eluting stents for de novo narrowings.

The percutaneous treatment of coronary bifurcation stenoses is hampered by an increased rate of subsequent restenosis. The present study reports on the outcomes of a consecutive series of 58 patients with 65 de novo bifurcation stenoses treated with sirolimus-eluting stent implantation in both the main vessel and side branch. At 6 months, the incidence of major adverse cardiac events was 10.3% (1 death and 5 target lesion revascularizations) with no episodes of acute myocardial infarction or stent thrombosis.

Angioplasty, Balloon, Coronary↗
PubMed2004

Incidence of thrombotic stent occlusion during the first three months after sirolimus-eluting stent implantation in 500 consecutive patients.

Sirolimus-eluting stents have been used in our institution for all percutaneous interventions, without clinical or anatomic exclusion criteria, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry. We analyzed the incidence of (sub)acute stent thrombosis after sirolimus-eluting stent implantation in an unselected population of 510 consecutive patients. At 3-month follow-up, (sub)acute stent thrombosis was diagnosed in 2 patients (0.4%) 6 hours and 11 days after the procedure, respectively. These cases occurred in diabetic women with complex coronary lesions. Intravascular ultrasound examination showed inadequate stent expansion and uncovered distal dissection as possible mechanical explanations for the thrombosis.

Angioplasty, Balloon, Coronary↗
PubMed2004

Treatment of very small vessels with 2.25-mm diameter sirolimus-eluting stents (from the RESEARCH registry).

A total of 91 patients with 112 lesions received 2.25-mm sirolimus-eluting stents (SESs), and these lesions were compared with those treated with SESs of > or =2.5-mm diameter in the same procedure (n = 109). The reference diameters were 1.88 +/- 0.34 and 2.52 +/- 0.57 mm, respectively (p <0.01). At follow-up, the late lumen loss was 0.07 +/- 0.48 mm for the 2.25-mm SES versus 0.03 +/- 0.38 mm for the larger SES (p = 0.5), and the binary restenosis rate was 10.7% versus 3.9%, respectively (p = 0.1). The 12-month target lesion revascularization rate was 5.5%. In conclusion, 2.25-mm SESs were associated with low rates of clinical and angiographic late complications.

Aged↗
PubMed2004

Short- and long-term clinical benefit of sirolimus-eluting stents compared to conventional bare stents for patients with acute myocardial infarction.

OBJECTIVES: This study investigated the clinical outcomes of patients with ST-segment elevation myocardial infarction (MI) treated with sirolimus-eluting stents (SESs) or with conventional bare stents. BACKGROUND: The clinical impact of SES implantation for patients with ST-segment elevation MI is currently unknown. METHODS: Primary angioplasty was performed with SESs in 186 consecutive patients with acute MI who were compared with 183 patients treated with bare stents. The incidence of death, reinfarction, and repeat revascularization was assessed at 30 and 300 days. RESULTS: Postprocedure vessel patency, enzymatic release, and the incidence of short-term adverse events were similar in both the sirolimus and the bare stents (30-day rate of death, reinfarction, or repeat revascularization: 7.5% vs. 10.4%, respectively; p = 0.4). Stent thrombosis was not diagnosed in any patient in the sirolimus group and occurred in 1.6% of patients treated with bare stents (p = 0.1). At 300 days, treatment with SESs significantly reduced the incidence of combined adverse events (9.4% vs. 17%; hazard ratio [HR] 0.52 [95% confidence interval (CI) 0.30 to 0.92]; p = 0.02), mainly due to a marked reduction in the risk of repeat intervention (1.1% vs. 8.2%; HR 0.21 [95% CI 0.06 to 0.74]; p = 0.01). CONCLUSIONS: Compared to conventional bare stents, the SESs were not associated with an increased risk of stent thrombosis and were effective in reducing the incidence of adverse events at 300 days in unselected patients with ST-segment elevation acute MI referred for primary angioplasty.

Angioplasty, Balloon, Coronary↗
PubMed2004

Effect of fluvastatin on long-term outcome after coronary revascularization with stent implantation.

We assessed the impact of long-term fluvastatin treatment on adverse atherosclerotic cardiac events (cardiac death, myocardial infarction, and revascularization excluding repeat interventions due to restenosis in the first 6 months) in 847 patients (fluvastatin [n = 417] or placebo [n = 430]) with average cholesterol levels treated with stents in the Lescol Intervention Prevention Study (LIPS). During the 4-year follow-up period, fluvastatin significantly decreased total cholesterol and low-density lipoprotein cholesterol levels and decreased the risk of first adverse atherosclerotic cardiac events by 30% compared with placebo (95% confidence interval -49 to -3.4, p = 0.03).

Adolescent↗
PubMed2004

Elective sirolimus-eluting stent implantation for left main coronary artery disease: six-month angiographic follow-up and 1-year clinical outcome.

The effectiveness of sirolimus-eluting stent (SES) implantation in patients treated electively for left main (LM) stenoses has not been yet ascertained. The present study reports on the clinical and angiographic outcome of 16 consecutive patients treated electively for de novo stenoses in the LM. The impact of SES implantation on major adverse cardiac events was evaluated. Mean age was 65 +/- 11 years. Unprotected LM was present in nine (56%), and eight patients (50%) received stents extending into both the left anterior descending and circumflex arteries for stenoses of the distal left main bifurcation. In-house mortality and reintervention rate was zero. One patient developed a non-Q-wave myocardial infarction related to the index procedure. At 1-year clinical follow-up, there were no deaths or further myocardial infarctions; one (6%) patient required target lesion revascularization. A total of 12 patients (75%) underwent 6-month angiographic follow-up with a late lumen loss of 0.04 +/- 0.65 mm and one focal restenosis (8% of patients). Elective SES implantation for LM disease was associated with zero mortality and a very low incidence of additional major adverse events at 1 year.

Aged↗
PubMed2004

Elective sirolimus-eluting stent implantation for multivessel disease involving significant LAD stenosis: one-year clinical outcomes of 99 consecutive patients--the Rotterdam experience.

The aim of this study was to evaluate the effectiveness of sirolimus-eluting stent (SES) implantation for patients with multivessel disease, which included left anterior descending artery (LAD) treatment. Since April 2002, SES has been utilized as the device of choice for all interventions in our institution as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Hospital (RESEARCH) registry. In the first 6 months of enrollment, 99 consecutive patients (17.6% of the total population) were treated for multivessel disease involving the LAD. The impact of SES implantation on major adverse cardiac events (MACE) was evaluated. All the patients received SES in the LAD. Additional stent implantation in the right coronary artery, the left circumflex, or in all three major vessels was attempted successfully in 32 (32%), 51 (52%), and 16 (16%) of the treated patients respectively. During a mean follow-up of 360 +/- 59 days (range, 297-472 days), we had one death, one non-Q-wave myocardial infarction, and eight patients required subsequent intervention. The event-free survival of MACE at 1 year was 85.6%. SES implantation for multivessel disease in a consecutive series of patients is associated with low incidence of adverse events. The reported results are related predominantly to the reduction in repeat revascularization.

Aged↗
PubMed2004

Effectiveness of the sirolimus-eluting stent in the treatment of patients with a prior history of coronary artery bypass graft surgery.

OBJECTIVE: Percutaneous coronary intervention in patients with a history of previous coronary artery bypass grafting (CABG) is associated with an increased rate of subsequent adverse events compared to those without prior CABG. We evaluated the impact of utilizing the sirolimus-eluting stent (SES) in this high-risk population. METHODS: Since April 2002, SES implantation was utilized as the default strategy for all percutaneous procedures in our hospital. Consecutive patients with a history of previous CABG and de novo lesions (n=47) treated exclusively with SES, were compared to 66 patients who received bare stents in the 6-month period just before SES introduction. RESULTS: There were no significant differences between the groups (SES and bare stent) with respect to baseline clinical or lesion characteristics. The only difference between the groups related to the nominal diameter of stent utilized, which was smaller in the SES group than the bare stent group. (The maximum diameter of SES available was 3.0 mm). At 1 year, the cumulative incidence of major adverse events (defined as death, myocardial infarction, or target vessel revascularization) was significantly lower in the SES group than the bare stent group [8.5 versus 30.3%, hazard ratio 0.37 (95% confidence interval 0.15-0.91); P=0.03]. CONCLUSIONS: The utilization of the sirolimus-eluting stent for percutaneous intervention in a high-risk population with a history of previous CABG surgery is associated with a significant reduction in the rate of major adverse cardiac events at 1 year.

Aged↗
PubMed2004

Long-term outcome of percutaneous coronary interventions following failed beta-brachytherapy.

BACKGROUND: Recurrent restenosis following vascular brachytherapy (VBT) has been reported in up to one-third of the patients enrolled in clinical trials. The long-term outcome of repeat percutaneous intervention (PCI) after failed beta-brachytherapy is currently unknown. METHODS: We retrospectively analyzed 97 consecutive patients undergoing percutaneous coronary reintervention after failed beta-brachytherapy at our institution (80.8% of all brachytherapy failures). Long-term incidence of major adverse cardiac events (MACE, death, myocardial infarction, target lesion revascularization) was assessed. RESULTS: The procedure was successful in 90 patients (92.8%). A new stent was implanted in 72% of the procedures (sirolimus-eluting stent in 16.5%). After 3 years, survival was 94.3%, survival-free from myocardial infarction was 86.7% and MACE-free survival was 66.1%. No difference was observed in MACE-free survival between patients originally treated with brachytherapy for recurrent in-stent restenosis and patients receiving irradiation for de novo lesions (68.2% de novo group versus 61.2% ISR group; p=0.6 by log rank test). Overall, a second target lesion revascularization was performed in 27 patients (27.8%) after an average of 11.2 11.2 months; 21 patients (21.6%) had restenosis, and 6 (6.2%) developed late total vessel occlusion (related to acute myocardial infarction in 2 cases). CONCLUSION: Repeat PCI is the most common choice after failed brachytherapy. This strategy appears to be a reasonable therapeutic option for this complex iterative pathology.

Aged↗
PubMed2004

Effectiveness of the sirolimus-eluting stent in the treatment of saphenous vein graft disease.

The use of bare stents for the percutaneous intervention of saphenous vein bypass grafts (SVGs) is associated with a high subsequent rate of restenosis. To assess the impact of the sirolimus-eluting stent (SES), we studied 19 consecutive patients who underwent de novo SVG intervention treated solely with SES. Mean graft age was 10 years. Clinical presentation was an acute coronary syndrome in 68%. In total, twenty-two de novo lesions were treated with 35 SESs (mean=1.6 stents per lesion). Use of glycoprotein IIb/IIIa inhibitor therapy and distal embolization protection device were at operator discretion and were 42% and 32%, respectively. The rate of in-hospital major adverse cardiac events (MACE) was 11%, related to 2 patients with a creatine kinase rise consistent with peri-procedural acute myocardial infarction (AMI); a distal protection device was not utilized in either. Over a mean 12.5+/-2.6 month follow-up, one patient died from a non-cardiac cause, and there were no further AMIs. Target lesion revascularization was undertaken in 1 patient (5%); survival free of MACE was 84%. In conclusion, utilizing SESs for percutaneous intervention of degenerate SVGs is associated with a low rate of target vessel revascularization. Increased utilization of distal protection devices might reduce the peri-procedural rate of AMI.

Acute Disease↗
PubMed2004

Predictors of survival after contemporary percutaneous coronary revascularization for acute myocardial infarction in the real world.

Management strategies for ST-elevation myocardial infarction (STEMI) have undergone great evolution over the past decade. The objectives of this study were to evaluate the in-hospital and long-term clinical outcomes, as well as predictors of survival, among patients who received the most contemporary percutaneous coronary revascularization strategies for STEMI in real clinical practice. During the period from October 1, 2000 to April 30, 2002, 316 patients have undergone primary percutaneous coronary intervention (PCI) in a tertiary University hospital, the in-hospital (11.1%), 30-day (13.9%) and long-term (21.8%) mortality rates were higher than that reported in randomized studies. This is likely to be due to the higher prevalence of adverse clinical profiles. Multivariable analysis show that age >65, cardiogenic shock, resuscitated cardiac arrest and intubation independently predicted in-hospital and long-term mortality, while multi-vessel disease predicted major adverse cardiac event (MACE). Among patients with cardiogenic shock, similar mortality was observed in patients with anterior myocardial infarction (MI) or inferior MI with/without right ventricle involvement.

Age Factors↗
PubMed2003

Coronary restenosis after sirolimus-eluting stent implantation: morphological description and mechanistic analysis from a consecutive series of cases.

BACKGROUND: We describe the clinical and morphological patterns of restenosis after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: From 121 patients with coronary angiography obtained >30 days after SES implantation, restenosis (diameter stenosis >50%) was identified in 19 patients and 20 lesions (located at the proximal 5-mm segment in 30% or within the stent in 70%). Residual dissection after the procedure or balloon trauma outside the stent was identified in 83% of the proximal edge lesions. Lesions within the stent were focal, and stent discontinuity was identified in some lesions evaluated by intravascular ultrasound. CONCLUSIONS: Sirolimus-eluting stent edge restenosis is frequently associated with local trauma outside the stent. In-stent restenosis occurs as a localized lesion, commonly associated with a discontinuity in stent coverage. Local conditions instead of intrinsic drug-resistance to sirolimus are likely to play a major role in post-SES restenosis.

Adult↗
PubMed2003

Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes: insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.

OBJECTIVES: This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES). BACKGROUND: The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown. METHODS: Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention). RESULTS: Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97). CONCLUSIONS: Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.

Acute Disease↗
PubMed2003

Evaluation of coronary remodeling after sirolimus-eluting stent implantation by serial three-dimensional intravascular ultrasound.

This study evaluates the response of the coronary vessel wall to implantation of the sirolimus-eluting stent (SES), Bx-VELOCITY, by using serial intravascular ultrasound. SESs have a major impact on the inhibition of in-stent neointimal hyperplasia. However, changes in the vessel wall and behind stent struts in animal models and humans have not been evaluated after SES implantation. Thirty-four patients who received a SES (n = 24) or a Bx-VELOCITY bare stent (BS) (n = 10) for single de novo coronary lesions and had serial motorized pullback 3-dimensional intravascular ultrasound were included. Stent, lumen, and vessel volumes were similar in the 2 groups at baseline. At follow-up, significantly larger lumen and lower neointimal hyperplasia volumes (0.7 vs 33 mm(3), p = 0.001) were seen in the SES group compared with the BS group. There was no significant difference between SES and BS in either the vessel volume (+2.4% vs +0.7%, p = NS) or the plaque behind stent volume change (+3.4% vs +2.5%, p = NS) from after the procedure to late follow-up. The stent edges also showed no significant difference between postprocedural and follow-up measurements, either in patients receiving SESs or BSs. No stented or edge segment required redilatation in the SES group, whereas 2 patients underwent repeat percutaneous coronary angioplasty in the BS group. In the SES group, 1 patient (4%) showed late acquired incomplete stent apposition. Thus, the SES is effective in inhibiting neointimal hyperplasia without affecting vessel volume and plaque behind the stent.

Angioplasty, Balloon, Coronary↗
PubMed2003

TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation.

BACKGROUND: The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR). METHODS AND RESULTS: The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length < or =30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm. They were treated with one or more TAXUS NIRx paclitaxel-eluting stents. Twenty-five patients completed the angiographic follow-up at 6 months, and 17 of these underwent intravascular ultrasound (IVUS) examination. No subacute stent thrombosis occurred up to 12 months, but there was one late chronic total occlusion, and additional 3 patients showed angiographic restenosis. The mean late loss was 0.54 mm, with neointimal hyperplasia volume of 20.3 mm3. The major adverse cardiac event rate was 29% (8 patients; 1 non-Q-wave myocardial infarction, 1 coronary artery bypass grafting, and 6 target lesion revascularization [TLR]). Of the patients with TLR, 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents. Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up (1 incomplete apposition and 1 insufficient expansion of the stent). CONCLUSIONS: Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.

Antineoplastic Agents, Phytogenic↗