Ong, A.T.L.

Two-year outcome of the use of paclitaxel-eluting stents in aorto-ostial lesions (Article)

2008-10-13T00:00:00Z

Background: Percutaneous treatment of stenoses involving aorto-ostial lesions is technically demanding and has been associated with lower procedural success and poorer clinical and angiographic outcomes when compared with non-ostial lesions. This study evaluated the immediate and long-term (2-year) outcome of aorto-ostial stenoses treated with paclitaxel-eluting stents (PES). Methods: From February 2003 to December 2004, a total of 76 consecutive patients with 76 lesions underwent percutaneous intervention with PES for aorto-ostial lesions (right coronary artery, 37; left main, 26; saphenous vein graft, 13). All patients were clinically followed for the occurrence of major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR). Results: All stents (1.7/lesion) were successfully deployed. Three lesions (3.9%) were pre-treated with debulking devices. Thirty-seven lesions (48.7%) were post-dilated with non-compliant balloons (balloon/artery ratio, 1.2). Stents were positioned protruding into the aortic lumen in 29 lesions (38.2%). Cumulative 2-year event-free survival was 68.4%. There was one angiographically-proven stent thrombosis occurring 427 days after TLR for restenosis after the index procedure. The restenosis rate at 7 months (median) was 20.0% and in-stent late lumen loss was 0.48 mm in 40 patients with angiographic follow-up. Conclusions: Utilization of PES in this complex lesion subset is feasible and associated with favorable angiographic results at 7 months. However, the gradual increase in later events up to 2 years suggests that aorto-ostial disease remains problematic even in the era of drug-eluting stents.

The Unrestricted Use of Paclitaxel-Eluting Stents and Sirolimus-Eluting Stents in the Rotterdam T-SEARCH and RESEARCH Registries: Studies on Efficacy, Safety, Stent Thrombosis, Cost Effectiveness and the Future (Doctoral Thesis)

2007-09-07T00:00:00Z

This year, 2007, marks the 30th anniversary of the first percutaneous coronary intervention, in the form of a percutaneous transluminal coronary angioplasty (PTCA) or balloon angioplasty, by Andreas Gruentzig.
1 It is also the 20th anniversary of the first report of the use of a stent to maintain vessel patency following balloon angioplasty.
2 Up until recently, the major limitation to stent implantation was restenosis, or renarrowing, at the site of stent implantation, leading to recurrence of angina. Th s occurred in between 10 to 50% of patients. In 2000, the first reports of a revolutionary new stent, the drug-eluting stent began to emerge, with early promises of zero restenosis.
3 In 2003, the fi rst drug-eluting stent was commercialised, coated with the immunosuppressive agent sirolimus, leading to the sirolimus-eluting stent, and followed in 2004 by the paclitaxel-eluting stent. The trials performed that led to the commercialisation of drug-eluting stents were in simple lesions, to reduce the number of confounding factors.
4 The patients studied in these trials make up only 25% of the typical patient population seen in a cardiac catheterisation laboratory. For the remaining 75%, it was extrapolated that these drug-eluting stents would be safe and efficacious, but that assumption required proving.

Adverse clinical events in patients treated with sirolimus-eluting stents: The impact of Type D personality (Article)

2007-02-01T00:00:00Z

BACKGROUND: Little is known about the impact of psychological risk factors on cardiac prognosis in the drug-eluting stent era. We examined whether the distressed personality (Type D) moderates the effect of percutaneous coronary intervention with sirolimus-eluting stent implantation on adverse clinical events at 2-year follow-up. Type D is an emerging risk factor in patients with cardiovascular disease. DESIGN: Prospective follow-up study. METHODS: Three hundred and fifty-eight patients with ischemic heart disease, who consecutively underwent percutaneous coronary intervention with sirolimus-eluting stent as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry, completed the Type D Scale (DS14) post-percutaneous coronary intervention (PCI). The end-point was a composite of death and non-fatal myocardial infarction 2 years after PCI. RESULTS: At follow-up, there were 22 events (12 deaths and 11 myocardial infarctions). Type D patients had a greater than two-fold risk of an event at follow-up compared with non-Type D patients (10.4 vs. 4.4%, P=0.031). In multivariable analysis, Type D remained an independent predictor of adverse outcome (hazard ratio: 2.61; 95% confidence interval: 1.12-6.09; P=0.027) adjusting for sex, age, and history of coronary artery disease, multivessel disease, diabetes, hypercholesterolemia, hypertension, renal impairment and smoking. Previous cardiac history was also an independent predictor of death or myocardial infarction (hazard ratio: 2.83; 95% confidence interval: 1.00-7.96; P=0.049). CONCLUSIONS: Type D personality moderated the effect of percutaneous coronary intervention on hard clinical events despite treatment with the latest innovation in interventional cardiology. The inclusion of psychological risk factors in general and personality factors in particular may optimize risk stratification in the drug-eluting stent era.

Impaired health status in Type D patients following PCI in the drug-eluting stent era (Article)

2007-01-18T00:00:00Z

Background: Drug-eluting stenting reduces restenosis post-percutaneous coronary intervention (PCI), but subgroups of patients may not benefit optimally from this procedure. We examined the impact of Type D personality on health status over time and the clinical relevance of Type D as a predictor of impaired health status at 12 months in unselected post-PCI patients. Methods: Consecutive patients (n = 692) participating in the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry completed the Type D Scale at 6 months and the Short Form Health Survey 36 (SF-36) at 6 and 12 months post-PCI. Results: Although there was a significant improvement in health status over time (p < 0.001), Type D patients reported a substantially lower score on all health status domains of the SF-36 compared with non-Type D patients (p < 0.001). Type D personality was an independent predictor of impaired health status on all SF-36 sub domains at 12 months except for physical functioning, adjusting for baseline demographic and clinical variables and health status at 6 months. In these adjusted analyses, Type D personality increased the likelihood of impaired health status at 12 months post-PCI from 60% (OR: 1.60; 95% CI: 1.04-2.46) to almost 300% (OR: 3.99; 95% CI: 2.52-6.32), varying among the parameters analyzed. Conclusions: Type D personality was associated with impaired health status in post-PCI patients treated in the drug-eluting stent era. The role of personality factors as determinants of clinical outcome and health status should not be overlooked as these factors may have much explanatory power.

Five year clinical effect of coronary stenting and coronary artery bypass grafting in renal insufficient patients with multivessel coronary artery disease: insights from ARTS trial. (Article)

2005-08-01T00:00:00Z

AIMS: To compare coronary stent implantation and bypass surgery for multivessel coronary disease in patients with renal insufficiency. METHODS AND RESULTS: In the ARTS trial, 142 moderate renal insufficient patients (Ccr<60 mL/min) with multivessel coronary disease were randomly assigned to stent implantation (n=69) or CABG (n=73). At 5 years, there was no significant difference between the two groups in terms of mortality (14.5% in the stent group vs. 12.3% in the CABG group, P=0.81), or combined endpoint of death, cerebrovascular accident (CVA), or myocardial infarction (MI) (30.4% in the stent group vs. 23.3% in the CABG group, P=0.35). Among patients who survived without CVA or MI, 18.8% in the stent group underwent a second revascularization procedure when compared with 8.2% in the surgery group (P=0.08). The event-free survival at 5 years was 50.7% in the stent group and 68.5% in the surgery group (P=0.04). CONCLUSION: At 5 years, the differences in mortality and combined incidence of death, CVA, and MI between coronary stenting and surgery did not reach statistically significant level. However, the occurrence of MACCE in the stent group was higher than in the CABG group, mainly driven by the higher incidence of repeat revascularization in the stent group.

Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). (Article)

2005-03-22T00:00:00Z

BACKGROUND: The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown. METHODS AND RESULTS: From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P=0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P=0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P=0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events. CONCLUSIONS: When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy.

Drug-eluting stents: current issues (Article)

2005-01-01T00:00:00Z

Early stent thrombosis occurs in about 1% to 1.5% of patients with drug-eluting stents, very similar to the rate with bare-metal stents. Late stent thrombosis is more of a concern with drug-eluting stents, with an incidence of at least 0.35%. I would urge caution if you feel you have to stop antiplatelet therapy in patients with drug-eluting stents. While neointima formation peaks at 6 months and then may actually regress with bare-metal stents, it continues to grow with drug-eluting stents--although this process appears to plateau by 4 years with sirolimus. With the others, we have to wait and see. We still don't know the best drug-eluting stent. Trials are under way to compare stents with surgery, and the future brings the arrival of a number of exciting new devices and approaches that are now entering clinical trials.

One year clinical follow up of paclitaxel eluting stents for acute myocardial infarction compared with sirolimus eluting stents (Article)

2005-01-01T00:00:00Z

OBJECTIVE: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction. DESIGN AND PATIENTS: The first 136 consecutive patients treated exclusively with PES in the setting of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period. SETTING: Academic tertiary referral centre. RESULTS: At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16). CONCLUSIONS: No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis.

Comparison of three-year outcomes after coronary stenting versus coronary artery bypass grafting in patients with multivessel coronary disease; including involvement of the left anterior descending coronary artery proximally (a subanalysis of the arterial revascularization therapies study trial). (Article)

2004-09-01T00:00:00Z

The long-term effect of stents in patients with multivessel disease involving the proximal left anterior descending artery was investigated. At 3 years, there was no difference in the combined incidence of death, stroke, and myocardial infarction in either group, but the need for repeat revascularization was more frequent in the group with stenting than in the group with coronary artery bypass grafting.

Post-sirolimus-eluting stent restenosis treated with repeat percutaneous intervention: late angiographic and clinical outcomes. (Article)

2004-06-01T00:00:00Z

BACKGROUND: We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention. METHODS AND RESULTS: A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis needing early (<6 months) treatment, and post-SES restenosis treated with balloon dilatation. The recurrent restenosis rate of originally de novo lesions re-treated with drug-eluting stents was 18.2%. CONCLUSIONS: Even though de novo lesions treated with SES at baseline and re-treated with drug-eluting stents had reasonably better outcomes than other lesion types and strategies, our study shows that the treatment of post-SES restenosis is currently suboptimal and warrants further investigation.

Classification and current treatment options of in-stent restenosis. Present status and future perspectives. (Article)

2004-01-01T00:00:00Z