Target Lesion Stenosis Research Articles

Intracoronary Brachytherapy for Recurrent DES Restenosis

<h3>Purpose/Objective(s)</h3> This study aims to report outcomes of intracoronary brachytherapy (ICBT) in treating drug-eluting stent (DES) in-stent restenosis (ISR) and to identify correlated, patient and treatment factors. <h3>Materials/Methods</h3> Patients undergoing ICBT for recurrent DES ISR from 2010 to 2021 were included in this single-institution retrospective PCI registry. Most lesions had ≥2 layers of pre-existing DES and were treated with balloon angioplasty, excimer laser coronary atherectomy (ELCA), or rotablator followed by ICBT at a dose of 18.4 Gy (vessel diameter ≤ 3.35mm) or 23 Gy (vessel diameter >3.35mm) delivered 2 mm from source center at the site of ISR. After March 2015, the standard dose was changed to 23 Gy or 25 Gy. All patients had operator-determined final target lesion stenosis <50%, and there were no in-hospital deaths. The primary outcome was 3-year target lesion failure rate (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Secondary endpoints where target lesion failure (TLF) rate at one year, any cause mortality, and cardiac mortality. Cox regression analyses were used to determine covariates, correlated with TLF rate, with p<0.05 considered significant and 0.05<p<0.10 considered a trend. The covariates were pre-specified based on previous studies and limited in number to avoid over-modelling. Analysis was performed using IBM statistical software and SYSTAT version 13. <h3>Results</h3> There was a total of 330 patients with 345 treated lesions. The mean age was 66 years, and 70.3% were men. At 3 years, all-cause mortality was 22.6% and cardiac mortality was 13.5%. The mean time to ISR from last failed DES implantation was 284 days. 255 of the 285 patients with known number of stent layers had at least 2 stents at the target lesion. Most of the patients had advanced coronary disease; 62% had prior bypass surgery. Rate of TLF was 18% at 1 year and 46% at 3 years. More stent layers were found to be correlated with 3-yr TLF (p=0.045). Lower radiation dose was negatively correlated with 1-yr TLF (p=0.039) but not at 3 years. TLF was trended higher if the target lesion was a vein graft (p=0.097). Final diameter of stenosis of the target lesion was not correlated with TLF at 1 year or at 3 years. <h3>Conclusion</h3> ICBT for recurrent DES-ISR provided low recurrence rates at 1 year, which increased substantially by 3 years. Outcomes were significantly better with lower numbers of stent layers at the target lesion but not with greater final diameter of target lesion stenosis.

Efficacy and safety of drug-coated balloons in the treatment of de novo coronary lesions in very small vessels: a prospective, multicenter, single-arm trial.

BackgroundEvidence of the use of drug-coated balloons (DCB) in de novo large or small coronary lesions and in-stent restenosis has accumulated over the past years. Due to their anatomical peculiarity, the treatment of very small vessels (VSV) (lumen diameter <2 mm) is still a controversial issue. Studies that examine the use of DCB in VSV are limited. We investigated the efficacy and safety of using DCBs for the de novo coronary lesions in VSV undergoing percutaneous coronary intervention (PCI).MethodsIn this prospective, single-arm study, we enrolled adult patients with coronary artery disease from six centers in China. A total of 29 patients had VSV with a target lesion stenosis ≥70% were included. All patients were treated with DCB. The primary endpoint was late lumen loss (LLL) at 9 months of follow-up. The secondary endpoints were major adverse cardiac events including target lesion revascularization, death, or myocardial infarction at 9 months of follow-up.ResultsTwenty-nine eligible patients with VSV were enrolled between November 2019 to May 2020. Angiographic and clinical follow-up were completed at 9 months in 18 (56.25%) patients (7 patients refused to final angiography; 2 failed to finish DCB angioplasty; 1 patient request; 1 other causes of death). The mean diameter of the reference vessel of the target lesion was 1.71±0.27 mm, the minimum lumen diameter (MLD) of the target lesion before operation was 0.31±0.24 mm, the average LLL of the target lesion was 0.13±0.28 mm, and the MLD of the target vessel immediately after operation was (1.19±0.20 mm) and at the 9-month follow-up (1.06±0.31 mm) were significantly higher than those before operation (P=0.043). One patient (5.56%) underwent revascularization. No myocardial infarction or death occurred during follow-up after treatment with DCBs.ConclusionsDCB can be a safe and effective alternative in the treatment of de novo coronary lesions in VSV.

Intravascular Lithotripsy During Transcarotid Artery Revascularization: A Novel Approach to Highly Calcified Lesions in High-Risk Patients

Introduced in 2009, transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk surgical patients. In comparing in-hospital outcomes, TCAR had stroke/death/myocardial infarction rates similar to those of open CEA despite older and substantially higher risk patients (Schermerhorn et al, 2020). Compared with transfemoral stenting, TCAR had significantly lower in-hospital TIA/stroke/death rates despite a population with significantly more comorbidities (Malas et al, 2019). A relative contraindication to use of TCAR and carotid stenting in general is heavily calcified target lesions and lesions with circumferential calcification. Intravascular lithotripsy (IVL) has been introduced and approved for use in coronary artery and lower extremity arterial disease for endovascular treatment of heavily calcified lesions. IVL generates a sonic pressure wave that interacts with calcium, creating sheer stress that fractures the calcium. The objective of the study was to apply IVL to heavily calcified carotid lesions undergoing treatment with TCAR in high-risk surgery patients. This study represents a multicenter case series of seven patients undergoing TCAR with circumferential calcification of the target lesion. Treatment included off-label/off-instructions for use predilation or postdilation using IVL. Patients treated were considered high risk for carotid endarterectomy secondary to medical comorbidities in all cases. The primary end point was procedural success plus the absence of stroke in the immediate and 30-day postoperative period. The secondary end point was an improvement in the target lesion stenosis by North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria and nonsignificant (<50%) residual stenosis on follow-up imaging. Technical success was achieved in all cases. No patient suffered a stroke in the immediate or 30-day postoperative period. No cranial nerve abnormality, hematoma, wound infection, or other procedural complications was reported in the immediate postoperative period or at the first follow-up visit. By NASCET criteria, all patients had improvement in the target lesion stenosis, with all having nonsignificant stenosis on follow-up imaging. Dilation with IVL during TCAR is shown herein to be applicable safely without neurologic consequence in seven patients and has proved to be a technically feasible option in patients with extensive calcification of the target lesion. A larger study is needed to confirm the safety of applying IVL in the carotid vasculature in conjunction with TCAR. and longer follow-up data are needed to confirm the durability of these early results. The addition of IVL appears to increase the applicability of TCAR to highly calcified lesions and may offer expansion of indications for carotid stenting.

A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.

Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions. Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses. At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group. In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis. ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.

Outcomes of directional atherectomy for common femoral artery disease.

Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard. The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions. A retrospective analysis of patients who underwent DA of the CFA between March 2009 and June 2017 was performed. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdTLR). Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (ABI), and Rutherford-Becker class (RBC) during follow-up. This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR. The use of DA for the treatment of CFA lesions leads to promising midterm results with an acceptable complication rate.

Characteristics of acute myocardial infarction caused by spontaneous coronary artery dissection in young female patients

Objective: To investigate the characteristics of acute myocardial infarction caused by spontaneous coronary artery dissection(SCAD) in young female patients. Methods: In this casecontrolstudy,127 young(≤55 years) female patients with acute myocardial infarction onset within 1 week in Nanjing first hospital, Xuzhou central hospital, affiliated hospital of Xuzhou medical university, and Lianyungang first people's hospital were enrolled between January 2013 and February 2017,and the clinical data were retrospectively analyzed. According to their clinical manifestations and coronary angiography(CAG) results,the patients were divided into coronary atherosclerosis disease(CAD) group(CAG evidenced atherosclerosis, n=83) and SCAD group(CAG detected coronary artery dissection,n=44).The SCAD patients were subdivided into definite group (the results affirmed from intravenous ultrasound or optical coherence tomography, n=21) and probable group (the CAG results highly confirmed to characteristics of SCAD,but no intravenous ultrasound or optical coherence tomography image affirmation,n=23). Then, according to the different treatment strategies, the SCAD patients were subdivided into conservative treatment group(treated with drugs,n=19) and interventional therapy group(treated with percutaneous coronary intervention,n=25). Results: (1)Compared to CAD group, patients in the SCAD group had less risk factors, such as hypertension history (25.0% (11/44) vs. 45.8% (38/83) , P=0.022) and diabetes history (6.8% (3/44) vs. 21.7% (18/83) , P=0.043),and had lower levels of fasting blood glucose (5.34(4.59,5.87) mmol/L vs. 7.12(5.18,8.60)mmol/L, P=0.001),total cholesterol((3.94±1.14) mmol/L vs. (4.91±1.50) mmol/L, P=0.001),triglyceride(1.42 (0.91,1.64) mmol/L vs. 1.89 (1.23,2.45) mmol/L, P=0.005),and low density lipoprotein cholesterol ((2.24±0.91) mmol/L vs. (2.94±1.16) mmol/L, P=0.001),CAG results showed that patients in the SCAD group had more single vessel lesion (88.6% (39/44) vs. 39.8% (33/83) , P=0.001), and their target lesion stenosis was less severe ( (79.2±22.4) % vs. (91.5±12.1) %, P=0.001). (2) The clinical risk factors such as hypertension history, diabetes history, smoking history, family history of cardiology disease, fasting blood glucose,total cholesterol,triglyceride and low density lipoprotein cholesterol were similar between definite group and probable group (all P>0.05). CAG results showed that prevalence of single vessel lesion (100% (21/21) vs. 78.3% (18/23) , P=0.050) and percent of target lesion stenosis ( (76.9±20.6) % vs. (81.2±24.1) %, P=0.529) were similar between definite group and probable group.(3)There were no significant difference in single vessel(84.0% (21/25) vs. 94.7% (18/19) , P=0.370), target lesion stenosis(85.0(70.0,100.0)% vs. 75.0(50.0,90.0)%, P=0.186),and survival rates in hospital(96.0% (24/25) vs. 100% (19/19) , P=1.000) between interventional therapy group and conservative treatment group. Conclusions: Prevalence of SCAD is highin young female patients with acute myocardial infarction. Acute myocardial infarction patients with less risk factors of CAD and with CAG showing smooth lesion of narrowing segment and normal finding in the other vessels, are more likely to be diagnosed with SCAD.Acute myocardial infarction patients caused by SCAD have high survival rate either receiving percutaneous coronary intervention or drug treatment.

Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions

Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1-5 years were similar in Firehawk stent group and Xience V stent group (5.7% and 6.6% respectively, HR=0.88, 95%CI 0.42-1.84, P=0.72). Land-Mark analysis showed that TLF rates bewteen 1-5 years were similar in Firehawk stent group and Xience V stent group (3.6% and 4.4% respectively, HR=0.83, 95%CI 0.34-2.00, P=0.67). Kaplan-Meier analysis showed that PoCE rates between 1-5 years were also similar in Firehawk stent group and Xience V stent group (11.4% and 17.3% respectively, HR=0.64, 95%CI 0.39-1.04, P=0.07). Land-Mark analysis showed that PoCE rates after 5 years were similar in Firehawk stent group and Xience V stent group (8.4% and 10.0% respectively, HR=0.66, 95%CI 0.40-1.10, P=0.11). (5) No stent thrombosis was documented in Firehawk stent group during the 5 years follow-up period, and there was 1 case of stent thrombosis in Xience V stent group after 3 years of stent implantation. Conclusion: TARGETⅠ trial results of 5 years follow up indicate the novel Firehawk stent have a durable safety and efficacy profile which is comparable to the Xience V stent in treating patients with single de novo coronary lesion. Clinical Trial Registration North American Clinical Trial Registration Center, NCT01196819.

HDL-Bound Sphingosine 1-Phosphate (S1P) Predicts the Severity of Coronary Artery Atherosclerosis

Background: We have recently demonstrated a reduction in HDL-bound sphingosine 1-phosphate (S1P) in patients with stable coronary artery disease (CAD). In the current study, we tested whether HDL-associated S1P is predictive for the degree of coronary stenosis, restenosis and overall CAD severity on follow up in patients undergoing elective percutaneous coronary intervention (PCI). Methods: Coronary angiography of patients with CAD (n=59) undergoing elective PCI and presenting for a follow up after 6 months (n=48) was graded for disease severity defined clinically as 1- or multi-vessel disease. Target lesion stenosis was quantified by quantitative coronary angiography (QCA). S1P in plasma and isolated HDL were measured by mass spectrometry in the initial samples and in 32 available follow up samples. Results: HDL-bound S1P levels remained stable over time and correlated closely at first visit and follow up. While not associated with the extent of target lesion stenosis or restenosis, HDL-bound S1P correlated negatively with the overall severity of CAD and discriminated 1-vessel-disease from multi-vessel disease. Furthermore, low HDL-bound S1P was predictive for CAD extent. Conclusion: In stable CAD, HDL-bound S1P does not predict the degree of stenosis or restenosis of the target lesion but constitutes a marker of clinically defined disease burden.

Relationship of interleukin-6-572C/G promoter polymorphism and serum levels to post-percutaneous coronary intervention restenosis

Background It has been recently reported that inflammatory mechanisms play an important role in in-stent restenosis (ISR) processes. Inflammatory factors after percutaneous coronary intervention (PCI) for dynamic monitoring can probably predict ISR. Functional polymorphisms in the promoter region of genes coding for inflammatory factors might be important for determining the magnitude of the inflammatory response. Thus, in the present study, we aimed to investigate the serial changes in serum interleukin-6 (IL-6) levels before and after PCI and the relationship between the -572C/G polymorphism in the promoter region of the IL-6 gene and ISR. We also discussed genetic polymorphisms in the inflammatory response to PCI. Methods A total of 437 patients who successfully underwent bare metal stent (BMS) implantation with a follow-up angiography were divided into an ISR group (n=166) and a non-ISR (NISR) group (n=271). The IL-6 gene promoter polymorphism at position -572 was determined by restricted fragment length polymorphism using the polymerase chain reaction (PCR-RFLP) method. The serum IL-6 levels before and one day, five days and 180 days after PCI were determined by the radioimmunoassay method. Results ISR patients showed higher IL-6 serum levels than NISR patients before PCI ((324.42±28.14) ng/L vs. (283.22±47.30) ng/L, P &lt;0.001), and one day post-PCI IL-6 serum levels in the ISR group also showed a significantly higher level than in the NISR group (P &lt;0.001). Increased IL-6 after PCI persisted at a statistically significant level throughout the study in ISR patients, whereas IL-6 levels had normalized five days after the procedure in NISR patients. One day post-PCI serum IL-6 level was the most accurate marker for diagnosis of ISR, the area under the ROC curve being 0.927 (95% CI 0.878-0.977). The cut-off value for IL-6 to predict ISR was over 355.50 ng/L, with a sensitivity of 0.968 and a specificity of 0.865. There were no significant differences in frequencies of -572 genotype and allele between the two groups (P &gt;0.05). One day post-PCI IL-6 serum levels in patients with the G allele was significantly higher than in patients without the G allele ((366.99±49.37) ng/L vs. (347.20±55.30) ng/L, P &lt;0.05). In the ISR group, one day post-PCI serum levels of IL-6 in patients with the G allele was also significantly higher than that in patients without the G allele ((405.67±26.56) ng/L vs. (375.69±38.81) ng/L, P &lt;0.05). Multivariate Logistic regression analysis revealed positive correlations between male gender, one day post-PCI serum levels of IL-6, the pre-PCI degree of stenosis, the length of the target lesion stenosis, and restenosis; and there were negative correlations between the stent diameter, the diameter of the reference vessel before stent implantation and restenosis. Conclusions IL-6 is an early post-PCI inflammatory cytokine, and one day post-PCI serum IL-6 level is an independent risk factor for restenosis. The frequencies of IL-6 gene -572 genotype and allele are not different between patients with and without ISR in a Chinese Tianjin Han population, but carrying the IL-6 -572G allele is likely to increase an individual's susceptibility to ISR by promoting serum IL-6 levels.

Clinical comparative study on efficacy and safety for treatment of coronary heart disease with cobalt-base alloy bio absorbable polymer sirolimus-eluting stent and PARTNER stent

ObjectiveTo evaluate the efficacy and safety for treatment of coronary heart disease with cobalt-base alloy bio absorbable polymer sirolimus-eluting stent.MethodsA total of 228 patients with up to two de novo...

Primary Cryoplasty Therapy Provides Durable Support for Limb Salvage in Critical Limb Ischemia Patients With Infrapopliteal Lesions:12-month Follow-up Results From the BTK Chill Trial

To report the 12-month follow-up data from the prospective 16-center Below-the-Knee (BTK) Chill Trial, which examined the use of primary cryoplasty for BTK occlusive disease in patients with critical limb ischemia (CLI). The trial included 108 patients (77 men; mean age 73 +/- 11 years, range 41-101) with CLI (Rutherford categories 4-6) involving 111 limbs with 115 target infrapopliteal lesions. Angiographic inclusion criteria were reference vessel diameter > or = 2.5 mm and < or = 5.0 mm and target lesion stenosis > or = 50%. The primary study endpoints were acute technical success (the ability to achieve < or = 50% residual stenosis and continuous inline flow to the foot) and absence of major amputation of the target limb at 6 months. Secondary endpoints were serious adverse events specifically related to use of primary cryoplasty and absence of major amputation of the target limb at 1, 3, and 12 months. Acute technical success was achieved in 108 (97.3%) of treated limbs, with only 1 clinically significant dissection (> or = type C) and 2 residual stenoses >50%; stent placement was required following cryoplasty in only 3 (2.7%) procedures. At 6 months and 1 year, major amputation was avoided in 93.4% (85/91) and 85.2% (69/81) of patients, respectively. Through 1 year, 21% (17/81) of patients underwent target limb revascularization. Rates of major amputation and death at 1 year were 0% for limbs of patients with initial Rutherford category 4; 11.4% and 0%, respectively, for initial category 5; and 40.0% and 31.8% for initial category 6. One-year rates of major amputation and death were 20.4% and 8.8%, respectively, for diabetics, versus 4.0% and 10.7% for non-diabetics. At 1 year, major amputation occurred in 16.7% (2/12) of limbs that were expected to be amputated at the time of treatment. Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent results and a high rate of limb salvage in patients with CLI. Study outcomes through 1 year support the use of cryoplasty as a primary treatment option for patients with CLI secondary to BTK occlusive disease.

Angiographic and Clinical Outcome Following Sirolimus-Eluting Stent (Cypher) Implantation A Single Center Experience

To investigate the late outcomes of sirolimus-eluting stent implantation in patients with coronary artery disease. Drug-eluting stents reduce intimal hyperplasia, which is the main cause of in-stent restenosis. Sirolimus-eluting stents significantly reduce clinical and angiographic restenosis and improve event-free survival. The study population consisted of 207 patients (273 stents) who had undergone coronary Cypher stent implantation. Patients were eligible for enrollment if there was symptomatic coronary artery disease or positive exercise testing, and angiographic evidence of single or multivessel disease with a target lesion stenosis of > or = 70% in a > or = 2.25 mm vessel. Follow-up coronary angiography was performed 18 months after stent deployment. Patients were followed-up for a mean of 24.7 +/- 7.4 months. All patients survived after stent implantation, but 5 (2.4%) patients experienced acute ST elevation myocardial infarction and 4 (1.9%) patients developed non-Q wave myocardial infarction following angioplasty. Recurrent angina pectoris was observed in 16 (7.7%) patients (11 stable angina pectoris and 5 unstable angina pectoris). Angiographic evidence of restenosis was observed in these 20 (9.66%) patients. The 5 other patients had noncritical angiographic restenosis. Eleven (5.3%) patients underwent angioplasty because of restenosis, and coronary artery bypass grafting was conducted in the other 9 (4.3%) patients. The results of the present study indicate that Cypher stents could be implanted with a very high success rate and have encouraging long-term angiographic and clinical results.

&lt;b&gt;Angiographic and Clinical Outcome Following Paclitaxel-Eluting Stent (Taxus) Implantation&lt;/b&gt;

Coronary stents dramatically improve acute outcomes of percutaneous coronary interventions but also induce abundant intraluminal neointimal growth. Drug-eluting stents reduce intimal hyperplasia, the main cause of in-stent restenosis. The safety and beneficial effects of paclitaxel-eluting stents (Taxus) in patients treated in daily practice remains to be defined. The aim of this study was to report the late outcomes of Taxus implantation in patients with coronary artery disease. The study population consisted of 151 patients (202 stents) who had undergone coronary Taxus stent implantation between March 2003 and May 2005. Patients were eligible for enrollment if there was symptomatic coronary artery disease or positive functional testing, and angiographic evidence of single or multivessel disease with a target lesion stenosis of 70% in a 2.0 mm vessel. The control coronary angiographies were performed after stent deployment at 12 +/- 2.8 months, and approximately 2 years of follow-up was completed. The polymer-based paclitaxel-eluting stent has been shown to be effective in reducing restenosis. Patients were followed-up for 16.7 +/- 7.4 months. All patients survived after stent implantation, but 2 (1.3%) patients experienced acute myocardial infarction after 3 and 9 months following angioplasty. Recurrent angina pectoris was observed in 3 patients. Angiographic evidence of restenosis was observed in these 5 patients. Three patients underwent angioplasty because of re- stenosis, and coronary artery bypass grafting was conducted in the other 2 patients. The results indicate that Taxus stents can be implanted with a very high success rate and have encouraging long-term angiographic and clinical results.

Clinical experience in coronary stenting with the Vivant® Z Stent

This single centre study was designed to demonstrate feasibility, safety and efficacy of the Vivant Z stent (PFM AG, Cologne, Germany). Patients with de novo lesion were recruited. Coronary angioplasty was performed with either direct stenting or after balloon predilatation. Repeated angiogram was performed 6 months later or earlier if clinically indicated. Between January to June 2003, a total of 50 patients were recruited (mean age 55.8 +/- 9 years). A total of 52 lesions were stented successfully. Mean reference diameter was 2.77 mm (+/-0.59 SD, range 2.05-4.39 mm) with mean target lesion stenosis of 65.5% (+/-11.6 SD, range 50.1-93.3%). Forty-six lesions (88.5%) were American College of Cardiologist/American Heart Association class B/C types. Direct stenting was performed in 18 (34.6%) lesions. Mean stent diameter was 3.18 mm (+/-0.41 SD, range 2.5-4 mm), and mean stent length was 14.86 mm (+/-2.72 SD, range 9-18 mm). The procedure was complicated in only one case which involved the loss of side branch with no clinical sequelae. All treated lesions achieved Thrombolysis In Myocardial Infarction 3 flow. Mean residual diameter stenosis was 12.2% (+/-7.55 SD, range 0-22.6%) with acute gain of 1.72 mm (+/-0.50 SD, range 0.5-2.8). At 6 months, there was no major adverse cardiovascular event. Repeated angiography after 6 months showed a restenosis rate of 17% (defined as >50% diameter restenosis). Mean late loss was 0.96 mm (+/-0.48 SD) with loss index of 0.61 (+/-0.38 SD). The restenosis rate of those lesions less than 3.0 mm in diameter was 22.2% compared with 6.25% in those lesions more than 3.0 mm in diameter. The Vivant Z stent was shown to be safe and efficacious with low restenosis rate in de novo coronary artery lesion.

Coronary revascularization in heart transplant recipients by excimer laser angioplasty

Background and Objective Aggressive development of allograft coronary artery disease is a major cause of death in heart transplant recipients. Percutaneous balloon angioplasty is considered suboptimal for complex lesions in native coronary vessels and heart transplant recipients, alike. Excimer laser energy (308-nm wavelength) can successfully remove and vaporize atherosclerotic plaques in native coronary vessels; however, its application in heart transplant recipients has not been studied clinically yet. Study Design/Materials and Methods Six heart transplant recipients underwent percutaneous excimer laser (CVX-300, Spectranetics, Colorado Springs, CO) coronary angioplasty for treatment of a total of 10 discrete, obstructive coronary artery lesions. By using concentric or eccentric multifiber laser catheters, energy parameters were set at a fluence of 45 mJ/mm2 or 60 mJ/mm2 with a frequency of 25 Hz and 40 Hz, respectively, with a pulse duration of 135 ns and output of 200 mJ/pulse. The “saline flush” and “pulse and retreat” lasing techniques were used. In each case, adjunct balloon angioplasty was performed; in five lesions, an intracoronary stent was implanted. Angiographic evaluation was performed by visual assessment. Results Each procedure was successful as defined by laser recanalization of the target lesion (reduction of target lesion stenosis in more than 20%) and subsequent adequate final luminal patency (reduction of target lesion stenosis to less than 50%) and absence of any major in-cardiac catheterization complication (such as perforation, acute closure, dissection, emergency coronary artery bypass surgery), or in-hospital complications (such as death, myocardial infarction, cardiac enzyme elevation, major bleeding), or need for surgical revascularization. A 92 ± 5% preprocedural percent diameter stenosis was reduced by laser to 35 ± 16% and by adjunct balloon angioplasty in all lesions and stenting in five lesions, to final residual stenosis of 2 ± 6%. Angiographic follow-up between 2 and 6 months after the procedure demonstrated a target lesion restenosis rate of 22%. Conclusion Percutaneous excimer laser is safe and efficacious in the treatment of focal obstructive lesions caused by allograft coronary artery disease. These data represent an early clinical experience; thus, the long-term outcome of this revascularization method in recipients of heart transplantation will have to be determined by a large scale prospective, randomized, multicenter clinical study. Lasers Surg. Med. 26:425–431, 2000. © 2000 Wiley-Liss, Inc.

Lesion-directed administration of alteplase with intracoronary heparin in patients with unstable angina and coronary thrombus undergoing angioplasty.

Percutaneous coronary revascularization in patients with unstable angina and coronary thrombus carries a high complication rate. A new strategy to reduce thrombus burden before revascularization was tested in a multicenter prospective trial. Patients with unstable angina and coronary thrombus (n = 45) received alteplase through an infusion catheter at the proximal aspect of the target lesion and concomitant intracoronary heparin via a standard guiding catheter. Angiography was performed before and alter lesion-directed therapy and post-intervention. Systemic fibrinogen depletion and thrombin activation were not observed, while fibrinolysis was evident for > or = 4 hr after treatment. Target lesion stenosis did not change significantly after lesion-directed therapy, but thrombus score was reduced, particularly among patients who had large thrombi (mean 2.2 vs. 1.6, P = 0.02). Revascularization was successful in 89% of patients. Median final stenosis was 30% and mean final thrombus score was 0.4. Complications included recurrent ischemia (11%), MI (7%), abrupt closure (7%), severe bleeding (4%), and repeat emergency angioplasty (2%). Patients with overt thrombus appeared to derive the most angiographic benefit from lesion-directed alteplase plus intracoronary heparin. Later revascularization was highly successful. This strategy may be a useful adjunct to percutaneous revascularization for patients with unstable angina and frank intracoronary thrombus.