Chi-Hang Lee

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.

Long-Term Follow-Up of Incomplete Stent Apposition in Patients Who Received Sirolimus-Eluting Stent for De Novo Coronary Lesions An Intravascular Ultrasound Analysis

Background—Incomplete stent apposition (ISA) has been previously documented after sirolimus-eluting stent (SES) implantation. The aim of this study was to investigate the long-term intravascular ultrasound (IVUS) findings of ISA in patients who received SES. Methods and Results—A total of 13 patients who received SES and showed ISA at follow-up IVUS (follow-up I) were investigated. IVUS was performed on all of these patients 12 months later (follow-up II). Quantitative ISA area measurement was also performed at follow-up I and II. No vascular remodeling was observed in the vessel segment with ISA; external elastic membrane area was 19.4±6.6 versus 19.5±6.4 mm2 at follow-up I and II, respectively. There was also no significant change in external elastic membrane area between vessel segment with ISA and without ISA (+1.5% versus −3.0%, respectively; P =0.27) at late follow-up. The ISA area, either including (2.5±1.7 versus 3.8±6.3 mm2; P =NS) or excluding (2.5±1.8 versus 2.4±1.7 mm2; P =NS) a single patient with aneurysm formation, was not significantly different between follow-up I and II. One patient manifested a coronary aneurysm in the stented segment at late follow-up that was probably present at the initial follow-up but masked by thrombus. It was successfully treated with a covered stent. All patients were asymptomatic, and no patient experienced late thrombotic occlusion. Conclusions—Vessel dimensions and area of ISA did not change over time, except for 1 coronary aneurysm that became apparent. ISA after implantation of a SES was not associated with adverse events at late follow-up.

Sirolimus-Eluting Stent Implantation in ST-Elevation Acute Myocardial Infarction A Clinical and Angiographic Study

Background—Sirolimus-eluting stents (SES) have recently been proven to reduce restenosis and reintervention compared with bare stents. Safety and effectiveness of SES in acute myocardial infarction remain unknown. Methods and Results—Since April 16, 2002, a policy of routine SES implantation has been instituted in our hospital, with no clinical or anatomic restrictions, as part of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) registry. During 6 months of enrollment, 96 patients with ST-elevation acute myocardial infarction underwent percutaneous recanalization and SES implantation; these patients comprise the study population. The incidence of major adverse cardiac events (death, nonfatal myocardial infarction, reintervention) was evaluated. Six-month angiographic follow-up was scheduled per protocol. At baseline, diabetes mellitus was present in 12.5% and multivessel disease in 46.9%. Primary angioplasty was performed in 89 patients (92.7%). Infarct location was anterior in 41 (42.7%) of the cases, and 12 patients (12.5%) had cardiogenic shock. Postprocedural TIMI-3 flow was achieved in 93.3% of the cases. In-hospital mortality was 6.2%. One patient (1.1%) had reinfarction and target lesion reintervention the first day as a result of distal dissection and acute vessel occlusion. During follow-up (mean follow-up of 218±75 days), 1 patient died (1.1%), no patient had recurrent myocardial infarction, and there were no additional reinterventions. No early or late stent thromboses were documented. At angiographic follow-up (70%), late loss was −0.04±0.25, and no patient presented angiographic restenosis. Conclusions—In this study, sirolimus-eluting stent implantation for patients with ST-elevation acute myocardial infarction was safe without documented angiographic restenosis at 6 months.

Effectiveness of sirolimus-eluting stent for treatment of left main coronary artery disease.

The present study reports on the clinical outcome of 31 consecutive patients with left main coronary artery disease treated with a sirolimus-eluting stent. The implantation of this stent was associated with abolition of post-discharge fatal events and percutaneous reintervention.

Effectiveness of sirolimus-eluting stent implantation for recurrent in-stent restenosis after brachytherapy

C vascular brachytherapy is, to date, the only effective treatment available for complex instent restenosis (ISR).1 However, its efficacy is hampered by late restenosis,2 late thrombosis,3,4 edge effect,5 geographic miss,6 and delayed healing.3 Moreover, the fate of the patients after “failed” brachytherapy is uncertain, as well as the result of the various percutaneous treatments employed thereafter. Sirolimus is a macrolide antibiotic produced by Streptomyces hygroscopicus with immunosuppressive effects; it is approved for the prevention of renal transplant rejection.7 The main effect of sirolimus is the interruption of G1 to S cell cycle progression mediated by its binding to a cytosolic receptor (FK506 protein binding protein 12) and a cascade of subsequent actions. Importantly, sirolimus inhibits proliferation and migration of vascular smooth muscle cells, a key element in the development of restenosis after percutaneous coronary interventions (PCIs). Recently, stent-based local sirolimus delivery has been shown to strongly suppress neointimal hyperplasia and prevent restenosis in de novo lesions followed up for 2 years.8,9 The revolutionary results obtained with drugeluting stents have encouraged the assessment of their efficacy in more complex clinical and morphologic subsets. The first human experience evaluating the sirolimus-eluting stent (SES) for the treatment of ISR has been recently reported; it showed this strategy to be highly effective.10 We describe here the first series of patients treated with SESs for recurrent ISR after brachytherapy. • • • The patients described in this report consist of 2 cohorts treated during separate time periods. The first cohort was treated between March 2001 and June 2001, as part of a pilot study on SESs for treatment of ISR. Since April 2002, shortly after European Community market approval, SES implantation has been adopted as the default strategy in all patients treated with PCI at our institution, irrespective of clinical presentation and coronary morphology. These latter patients have been included in the RESEARCH Registry (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospitals) and will be followed up for 1 year.11 The only exclusion criteria were unavailability of an adequately sized SES at the time of the procedure and enrollment in another revascularization protocol (SESs were available in diameters from 2.25 to 3.0 mm and lengths of 8, 18, and 33 mm). All patients treated with SES after “failed” brachytherapy were scheduled for 6-month angiography. ISR was defined as 50% diameter stenosis by quantitative coronary angiography within a previously stented vessel segment and classified as proposed by Mehran et al.12 Treatment strategy and device utilization other than stenting was left to the physician’s discretion. The procedure was considered successful when residual stenosis 30% by quantitative coronary angiography was achieved together with Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 to 3. The study stent utilized was the sirolimus-eluting Cypher (Cordis Europa NV, Johnson & Johnson, Roden, The Netherlands), which contains a 140 g sirolimus/cm metal surface area in a slow release formulation ( 28 days). Pretreatment with clopidogrel for 48 hours or a 300-mg loading dose was required. During the procedure, intravenous heparin was given to maintain an activated clotting time 300 seconds. After the procedure, all patients received aspirin indefinitely ( 75 mg/day) and clopidogrel (75 mg/day) for at least 2 months. Clinical status information was collected at follow-up visits or by telephone contact with the patient or referring physician. Data are presented as number and relative percentage or mean SD. Median and range have been reported when deemed necessary for a better description. From the beginning of the study until August 15, 2002, 12 consecutive patients (both cohorts) underwent PCI with SES implantation for recurrent ISR after local radiation therapy. All of them presented with angina pectoris and/or myocardial ischemia as documented by stress test or thallium scan. Coronary brachytherapy had been previously performed in 11 patients with catheter-based local irradiation (10 beta, 1 gamma) and in 1 patient with phosphorus-32 radioactive stent implantation. Baseline clinical and angiographic characteristics are listed in Tables 1 and 2, respectively. Nine patients (75%) had had more than 1 previous episode of restenosis. Average time from the preceding percutaneous reintervention was 24 months (range 111 to 1,678 days, median 719). Remarkably, 9 patients (75%) presented with a From Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands. Dr. Serruys’ address is: Erasmus MC, Thoraxcenter, Bd404, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail: p.w.j. c.serruys@erasmusmc.nl. Manuscript received January 16, 2003; revised manuscript received and accepted April 14, 2003.

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.

Beneficial effects of fluvastatin following percutaneous coronary intervention in patients with unstable and stable angina: results from the Lescol intervention prevention study (LIPS)

Aims: To investigate the effect on risk of major adverse cardiac events (MACE) of lipid lowering treatment with fluvastatin 80 mg/day after a first percutaneous coronary intervention in patients with stable and unstable angina. Method and results: This prespecified subgroup analysis of the LIPS (Lescol intervention prevention study) analysed 1658 patients with documented diagnosis; 824 had unstable angina (417 randomly assigned to fluvastatin, 407 to placebo) and 834 had stable angina (including silent ischaemia; fluvastatin, 418; placebo, 416). Median follow up was 3.9 years. There was no significant effect of anginal status on long term risk of MACE. Fluvastatin treatment reduced the risk of MACE by 28% compared with placebo (p  =  0.03) among patients with unstable angina, with no difference between patients with stable and patients with unstable angina (relative risk 1.07, 95% confidence interval 0.87 to 1.30, p  =  0.53). Fluvastatin reduced coronary atherosclerotic events (MACE excluding restenosis) by 36% (p  =  0.006) among patients with unstable angina and 31% (p  =  0.02) among patients with stable angina. Fluvastatin caused similar reductions in total cholesterol and low density lipoprotein cholesterol concentrations in both patient groups. Conclusion: Treatment with fluvastatin 80 mg/day produced significant reductions in MACE and coronary atherosclerotic events after percutaneous coronary intervention in patients with average cholesterol concentrations. The beneficial effects of fluvastatin are observed in patients with unstable or stable angina alike.

Impact of Different Anatomical Patterns of Left Main Coronary Stenting on Long-Term Survival

There are no significant differences in long-term and event-free survival in patients who undergo stent implantation in different anatomic locations of the left main coronary artery. Predictors of long-term survival are age <65 years, normal left ventricular ejection fraction, and absence of an intra-aortic balloon pump.

Acquired coronary artery fistula leading to acute myocardial infarction after endomyocardial biopsy.

A55 year old man with type A aortic dissection underwent an emergency Bentall operation in 1995. Intraoperatively, he developed myocardial infarction. This resulted in progressive heart failure, eventually requiring heart transplantation in January 2002. The transplantation was successful and uncomplicated. He was admitted for routine endomyocardial biopsy on 11 March 2002. A total …

Sirolimus eluting stent aborted recurrent distal left main in-stent restenosis involving bifurcation

Left main coronary artery stenosis is associated with dismal prognosis when untreated. Coronary artery bypass grafting (CABG) is the standard treatment. Although stent implantation is increasingly performed for de novo left main lesion, CABG is inevitable if in-stent restenosis (ISR) occurs. Recently, use of sirolimus eluting stents has proved effective in reducing restenosis in …