First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.

BACKGROUND: The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes. AIMS: We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions. METHODS: The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months. RESULTS: A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%. CONCLUSIONS: In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.

Diagnostic Performance of CT FFR With a New Parameter Optimized Computational Fluid Dynamics Algorithm From the CT-FFR-CHINA Trial: Characteristic Analysis of Gray Zone Lesions and Misdiagnosed Lesions.

To assess the diagnostic performance of fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) (CT-FFR) obtained by a new computational fluid dynamics (CFD) algorithm to detect ischemia, using FFR as a reference, and analyze the characteristics of "gray zone" and misdiagnosed lesions. This prospective multicenter clinical trial (NCT03692936, https://clinicaltrials.gov/) analyzed 317 patients with coronary stenosis between 30 and 90% in 366 vessels from five centers undergoing CTA and FFR between November 2018 and March 2020. CT-FFR were obtained from a CFD algorithm (Heartcentury Co., Ltd., Beijing, China). Diagnostic performance of CT-FFR and CTA in detecting ischemia was assessed. Coronary atherosclerosis characteristics of gray zone and misdiagnosed lesions were analyzed. Per-vessel sensitivity, specificity and accuracy for CT-FFR and CTA were 89.9, 87.8, 88.8% and 89.3, 35.5, 60.4%, respectively. Accuracy of CT-FFR was 80.0% in gray zone lesions. In gray zone lesions, lumen area and diameter were significantly larger than lesions with FFR < 0.76 (both p < 0.001), lesion length, non-calcified and calcified plaque volume were all significantly higher than non-ischemic lesions (all p < 0.05). In gray zone lesions, Agatston score (OR = 1.009, p = 0.044) was the risk factor of false negative results of CT-FFR. In non-ischemia lesions, coronary stenosis >50% (OR = 2.684, p = 0.03) was the risk factor of false positive results. Lumen area (OR = 0.567, p = 0.02) and diameter (OR = 0.296, p = 0.03) had a significant negative effect on the risk of false positive results of CT-FFR. In conclusion, CT-FFR based on the new parameter-optimized CFD model provides better diagnostic performance for lesion-specific ischemia than CTA. For gray zone lesions, stenosis degree was less than those with FFR < 0.76, and plaque load was heavier than non-ischemic lesions.

Diastolic versus systolic coronary computed tomography angiography derived fractional flow reserve for the identification of lesion-specific ischemia.

OBJECTIVES: To investigate the measurement discrepancy of coronary computed tomography angiography (CTA)-derived fractional flow reserve (FFR) between diastolic (CT-FFR-D) and systolic (CT-FFR-S) phases using FFR as the reference standard. METHODS: Participants, suspected of coronary artery disease and indicated for invasive coronary angiography (ICA) and FFR and coronary CTA and CT-FFR, were enrolled in this study (Clinicaltrials.gov:NCT03692936) from September 2018 to October 2019. For every participant, coronary CTA of both systolic and diastolic phases was postprocessed to calculate CT-FFR-S and CT-FFR-D, respectively. Diagnostic sensitivity, specificity, accuracy, and the area under the receiver operating characteristic (ROC) curve were compared. RESULTS: A total of 181 lesions from 151 participants (mean age 54.5 ± 7.8 years, 113 males) were analyzed. Of these, 129 lesions from 110 participants were successfully measured both in diastolic and systolic phases. Sensitivity, specificity, and accuracy of CT-FFR-D and CT-FFR-S on per-patient level were 88.9%, 91.3%, 90.1% and 66.7%, 87.7%, 76.7%, on per-vessel level were 89.5%, 91.5%, 90.6% and 66.7%, 87.0%, 77.9%, respectively. The ROC curve of CT-FFR-D was significantly higher than that of CT-FFR-S on both per-patient and per-vessel levels (0.938 vs. 0.771, 0.935 vs. 0.772, both p < 0.0001). In severe hemodynamic lesions (FFR ≤ 0.7), the absolute difference between CT-FFR-S and FFR was significantly higher than that between CT-FFR-D and FFR [0.1636, inter-quartile range (IQR): 0.0662-0.2586 vs. 0.0953, IQR: 0.0496-0.1702, p = 0.035]. CONCLUSION: CT-FFR derived in diastole was superior to that derived in systole in detecting coronary ischemic lesions. For lesions with FFR < 0.7, CT-FFR measured in the diastolic phase was noted to be more closely approximated to FFR.

Long-term clinical outcomes in transradial versus transfemoral access for left main percutaneous coronary intervention.

OBJECTIVE: The present study compared 10-year clinical outcomes between transradial access (TRA) and transfemoral access (TFA) for left main (LM) percutaneous coronary intervention (PCI). BACKGROUND: There are limited data regarding the long-term safety and efficacy of TRA for LM PCI. METHODS: This retrospective study evaluated consecutive patients who underwent unprotected LM PCI between January 2004 and December 2008 at Fu Wai Hospital. The exclusion criteria were age of less than 18 years and presentation with acute myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), which was defined as a composite of all-cause death, myocardial infarction, stroke, and any revascularization at the 10-year follow-up. RESULTS: Among 913 eligible patients, TRA was used for 417 patients (45.7%) and TFA was used for 496 patients (54.3%). The 30-day clinical outcomes were similar between the two groups. Results from the 10-year follow-up revealed that MACCE occurred in 180 patients (46.7%) from the TRA group and in 239 patients (51.2%) from the TFA group (log-rank p = .3). The TRA and TFA groups also had low and comparable cumulative rates of all-cause death (14.6% vs. 17.3%, log-rank p = .56) and cardiac death (7.9% vs. 9.1%, log-rank p = .7). CONCLUSION: The present study revealed no significant differences in long-term clinical outcomes when TRA or TFA were used for LM PCI.

Long-Term Clinical Outcomes of Unprotected Left Main Percutaneous Coronary Intervention: A Large Single-Centre Experience.

AIMS: This study sought to report the 10-year clinical outcomes of patients who underwent unprotected left main (LM) percutaneous coronary intervention (PCI) in a large centre. METHODS AND RESULTS: A total of 913 consecutive patients who underwent unprotected LM PCI from January 2004 to December 2008 at Fu Wai Hospital were retrospectively analysed; the mean age was 60.0 ± 10.9 years, females accounted for 22% of patients, diabetes was present in 27.7% of patients, and an LM bifurcation lesion occurred in 82.9% of patients. During the median follow-up of 9.7 years, major adverse cardiac or cerebrovascular events (MACCEs) occurred in 25.6% (234) of patients, and the rates of all-cause death, myocardial infarction, and stroke were 14.9%, 11.0%, and 7.1%, respectively. Cardiac death occurred in only 7.9% of patients. The estimated event rate was 41.9% for death/myocardial infarction/any revascularization and 45.9% for death/MI/stroke/any revascularization. Definite/probable stent thrombosis occurred in 4.3% (39) of patients. According to the subgroup analysis, IVUS-guided PCI was associated with less long-term MACCEs. Further multivariate analysis identified that age and LVEF<40% were the only independent predictors for 10-year death. Age, LVEF<40%, creatinine clearance, and incomplete revascularization were independent predictors for death/MI, while a two-stent strategy, diabetes, a transradial approach, and the use of bare metal stents (BMSs) or first-generation drug-eluting stents (DESs) were not. CONCLUSIONS: Unprotected LM PCI in a large cohort of consecutive patients in a single large centre demonstrated favourable long-term outcomes up to 10 years even with the use of BMSs and first-generation of DESs.

First-in-man study of a thinner-strut sirolimus-eluting bioresorbable scaffold (FUTURE-I): Three-year clinical and imaging outcomes.

OBJECTIVES: The FUTURE-I study aimed to assess preliminary safety and effectiveness with the long-term clinical and imaging follow-up for the Firesorb (MicroPort, Shanghai, China), a thinner-strut sirolimus-eluting bioresorbable scaffold (BRS). BACKGROUND: First-generation BRS has been associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS: In this prospective, open-label, first-in-man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 (n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 (n = 15) at 12 and 36 months. All patients underwent clinical follow-up at 1, 6, and 12 months and annually up to 5 years. RESULTS: Between January and March 2016, 45 patients were enrolled. At 3-year follow-up, one patient had experienced target lesion failure and none scaffold thrombosis. In-scaffold minimal lumen diameter decreased significantly from 6-month to 2-year (2.53 ± 0.24 mm vs. 2.27 ± 0.37 mm, p = .0003), and only numerically from 1-year to 3-year follow-up (2.48 ± 0.28 mm vs. 2.22 ± 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3-year follow-up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts. CONCLUSIONS: At 3-year follow-up of the FUTURE-I study, implantation of the thinner-strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.

Feasibility and safety of robotic PCI in China: first in man experience in Asia.

OBJECTIVES: To evaluate the feasibility and safety of a second generation robotic percutaneous coronary intervention (R-PCI) system in China. BACKGROUND: Robotic PCI has been shown to be an effective method for conducting coronary interventions. It has further benefits of more accurate lesion measurement, improved stent deployment, reduced incidence of geographic miss and reduction of operator radiation exposure. METHODS: This single center evaluation enrolled 10 consecutive patients who had been selected for PCI. Clinical success was defined as residual stenosis < 30% and no in-hospital major adverse cardiovascular events. Learning curve effect was assessed by comparing efficiency metrics of early vs. later cases. RESULTS: Eleven lesions were treated all successfully without manual interruption or MACE events. Most lesions (63%) were ACC/AHA class B2 and C. Mean procedure time was 57.7 ± 26.4 min, however two procedures were part of live demonstrations. Excluding the two live cases, the mean procedure time was 51.8 ± 23.7 min. Procedural efficiency tended to improve from early cases to later cases based on PCI time (48.3 ± 32.9 vs. 25.5 ± 13.0 min, P = 0.27), fluoroscopy time (20.3 ± 8.2 vs. 12.5 ± 4.6 min, P = 0.16), contrast volume (145.0 ± 28.9 vs. 102.5 ± 17.1 mL, P = 0.05) and Air Kerma dose (1932 ± 978 vs. 1007 ± 70 mGy, P = 0.31). CONCLUSIONS: Second generation robotic PCI was safe, effective and there were trends toward improvements in procedural efficiency during this early experience in China.

Outcomes of percutaneous coronary intervention and coronary artery bypass grafting in patients with Takayasu arteritis.

BACKGROUND: Coronary artery involvement is not a rare presentation of Takayasu arteritis (TA) and the treatment is challenging. The optimal methods of revascularization, and prognosis of treatment have not been established. OBJECTIVES: To assess the long-term outcomes of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in TA patients. METHODS: Patients with coronary artery involved in TA who underwent either PCI or CABG were identified between February 2003 and December 2015. The primary outcome was long-term all-cause mortality. Secondary outcomes were myocardial infarction (MI), stroke, and repeat revascularization. RESULTS: Thirty-one patients were enrolled (PCI=19 vs. CABG=12). Most of them were female (25, 80.6%) and the mean age was 42.6±13.8years (16-64years). Angina pectoris was the most common initial symptom (26 cases, 83.9%) and concomitant aortic regurgitation was present in 8 (25.8%) patients. Both groups had a low rate of corticosteroids use [4/19 (21.1%) vs. 2/12 (16.7%)]. During the median follow-up of 101months (10-384months), PCI group had a significantly higher incidence of restenosis [12/19(63.2%) vs. 3/12(25%)]. Two patients with severe aortic regurgitation in PCI group suffered from cardiac death during follow-up. CONCLUSIONS: Coronary artery involvement should be suspected in TA patients with angina pectoris, especially young women. PCI had a very high rate of in-stent restenosis in patients without corticosteroids and CABG may be a preferred treatment option.

Improvement of Image Quality and Diagnostic Performance by an Innovative Motion-Correction Algorithm for Prospectively ECG Triggered Coronary CT Angiography.

OBJECTIVE: To investigate the effect of a novel motion-correction algorithm (Snap-short Freeze, SSF) on image quality and diagnostic accuracy in patients undergoing prospectively ECG-triggered CCTA without administering rate-lowering medications. MATERIALS AND METHODS: Forty-six consecutive patients suspected of CAD prospectively underwent CCTA using prospective ECG-triggering without rate control and invasive coronary angiography (ICA). Image quality, interpretability, and diagnostic performance of SSF were compared with conventional multisegment reconstruction without SSF, using ICA as the reference standard. RESULTS: All subjects (35 men, 57.6 ± 8.9 years) successfully underwent ICA and CCTA. Mean heart rate was 68.8±8.4 (range: 50-88 beats/min) beats/min without rate controlling medications during CT scanning. Overall median image quality score (graded 1-4) was significantly increased from 3.0 to 4.0 by the new algorithm in comparison to conventional reconstruction. Overall interpretability was significantly improved, with a significant reduction in the number of non-diagnostic segments (690 of 694, 99.4% vs 659 of 694, 94.9%; P<0.001). However, only the right coronary artery (RCA) showed a statistically significant difference (45 of 46, 97.8% vs 35 of 46, 76.1%; P = 0.004) on a per-vessel basis in this regard. Diagnostic accuracy for detecting ≥50% stenosis was improved using the motion-correction algorithm on per-vessel [96.2% (177/184) vs 87.0% (160/184); P = 0.002] and per-segment [96.1% (667/694) vs 86.6% (601/694); P <0.001] levels, but there was not a statistically significant improvement on a per-patient level [97.8 (45/46) vs 89.1 (41/46); P = 0.203]. By artery analysis, diagnostic accuracy was improved only for the RCA [97.8% (45/46) vs 78.3% (36/46); P = 0.007]. CONCLUSION: The intracycle motion correction algorithm significantly improved image quality and diagnostic interpretability in patients undergoing CCTA with prospective ECG triggering and no rate control.

[Clinical outcome of patients undergoing emergent coronary artery bypass grafting following failed percutaneous coronary intervention in stent era].

OBJECTIVE: To explore clinical outcomes of patients undergoing emergent coronary artery bypass grafting (CABG) following failed percutaneous coronary intervention (PCI) in the stent era. METHODS: Eleven patients who underwent emergent CABG following failed PCI from January, 2002 to December 2010 were enrolled. The in-hospital follow-up included cardiac deaths, Q-wave myocardial infarction, kidney failure, and cerebrovascular events. The clinical end-point of out-hospital follow-up was the major adverse cardiac events including death, myocardial infarction, and target lesion revascularization. RESULTS: The patients were (61 ± 5) years old. Coronary angiography showed 5 patients had triple vessel lesions. There were 9 target lesions on left anterior descending artery. There were 3 (27.3%) severe calcified, 4 (36.4%) chronic total occlusion, and 4 (36.4%) diffused long lesions. Reasons for emergent CABG were dissection (n = 5, 45.5%), perforation (n = 3, 27.3%), failure to sufficient predilation (n = 1, 9.1%), acute closure (n = 1, 9.1%) and stent loss (n = 1, 9.1%). The average duration of follow-up was (47 ± 33) months. During in-hospital follow-up, there were 1 (9.1%) cardiac death and 2 (18.2%) Q wave myocardial infarction. During follow-up after hospital discharge, 1 patient (9.1%) died of kidney failure, and there was no rehospitalization due to cardiac events. CONCLUSIONS: Emergent CABG after failed PCI often happened in patients with complex coronary lesions. The long term outcome of patients requiring emergent CABG after failed PCI was favorable in this cohort.

[The in-hospital outcome and predictors of major adverse cardiac events after transradial intervention in patients with coronary artery disease].

OBJECTIVE: The purpose of this study is to evaluate the in-hospital clinical outcome of patients with coronary artery disease who underwent transradial intervention (TRI) and analyze the predictors of clinical outcome. METHODS: From May 2004 to May 2009, there were 16 281 patients who underwent transradial intervention, as well as 5388 patients who underwent transfemoral intervention (TFI) at our institution. The clinical characteristics, procedural characteristics, and in-hospital clinical adverse events were compared between TRI and TFI groups. Multivariable logistic regression analysis was performed to determine predictors of in-hospital major adverse cardiac events (composite of death, myocardial infarction, or target lesion revascularization) of TRI. RESULTS: The annulations time was significantly longer for TRI than TFI (P < 0.01), fluoroscopy time, amount of contrast agent and procedural success rate (95.5% for TRI and 96.2% for TFI) were similar between the two groups. However, the rates of vascular complications (0.1% for TRI group and 1.3% for TFI group, P < 0.01), incidence of in-hospital major adverse cardiac events (1.6% vs. 3.8%, P < 0.01) and in-hospital death (0.2% vs. 0.4%, P < 0.01) were all significantly lower in TRI group compared with TFI group. The following characteristics were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI: age ≥ 65 (OR: 1.98, 95%CI: 1.50 - 2.61, P < 0.01), prior myocardial infarction (OR: 2.14, 95%CI: 1.63 - 2.82, P < 0.01), use of drug-eluting stent (DES) (OR: 0.68, 95%CI: 0.47 - 0.98, P = 0.04), dissection during procedure (OR: 4.08, 95%CI: 2.28 - 7.33, P < 0.01), left main lesion (OR: 2.12, 95%CI: 1.09 - 4.13, P = 0.03), number of implanted stents (OR: 1.25, 95%CI: 1.09 - 1.43, P < 0.01), and total stented length (OR: 1.01, 95%CI: 1.00 - 1.02, P = 0.03). CONCLUSIONS: In this large single-centre patient cohort, the transradial intervention is superior to transfemoral intervention in terms of in-hospital safety and efficacy. Age ≥ 65, prior myocardial infarction, use of DES, dissection during procedure, left main lesion, number of implanted stents and total stented length were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI.

[Comparison of outcomes after transradial intervention in patients of different age groups].

OBJECTIVE: To compare the in-hospital clinical outcome of patients with coronary artery disease in different age groups [< 65 years (younger), 60 to 79 years (older), and ≥ 80 years (octogenarians)] underwent transradial intervention (TRI) so asto analyze the predictors of adverse events. METHOD: From May 2004 to May 2009, a total of 16 293 patients underwent transradial intervention at our institution. The in-hospital outcome for patients in different age groups after TRI was investigated. Multivariable logistic regression analysis was performed to determinate the predictors of in-hospital major adverse cardiac events (MACE) (composed of death, myocardial infarction or target vessel revascularization). RESULTS: Angiographic success rates were not different (97.5%, 97.4%, 98.1%, P > 0.05) between 3 groups. However, the rates of procedural complications became progressively higher with age group (0.8%, 1.2%, 4.0%, P < 0.01). In-hospital MACE (1.3% vs 2.2% vs 7.5%, P < 0.01) and mortality (0.1% vs 0.3% vs 2.9%, P < 0.01) increased incrementally with age group. Aad it was associated with a significant decrement of DES (92.0%, 89.6%, 57.3%, P < 0.01). The following characteristics were identified as independent multivariate predictors of in-hospital major adverse cardiac events: age ≥ 80 (OR 6.26, 95%CI: 3.33 to 11.74; P < 0.01), prior myocardial infarction (OR 2.19, 95%CI: 1.66 to 2.88; P < 0.01), left main lesion (OR 2.02, 95%CI: 1.04 to 3.91; P = 0.04), age of 65 to 79 (OR 1.83, 95%CI: 1.37 to 2.43; P < 0.01), number of implanted stents (OR 1.31, 95%CI: 1.15 to 1.50; P < 0.01), total stented length (OR 1.01, 95%CI: 1.01 to 1.02; P = 0.03), and use of DES (OR 0.59, 95%CI: 0.39 to 0.89; P = 0.01). CONCLUSIONS: The younger and older patients undergoing TRI have a more favorable in-hospital outcome. However the octogenarians has a substantially higher risk of in-hospital MACE.

Profound thrombocytopenia induced by clopidogrel with a prior history of long-term safe administration.

Clopidogrel has shown an excellent safety, tolerability and efficacy ever since its marketing. However, here we report a rare case with profound thrombocytopenia following clopidogrel administration previously safely exposed to this same drug. This reminds us that thrombocytopenia might be induced by clopidogrel even with a prior, safe history of long-term administration.

Coronary intervention in patients>or=75 years old with ST-elevation myocardial infarction: in-hospital and 6-month clinical outcomes.

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) in elderly patients presents specific clinical characteristics. The study on percutaneous coronary intervention (PCI) in elderly patients (>or=75 years) with STEMI, however, has less been performed. METHODS: In the present study, 522 consecutive STEMI patients undergoing PCI within 12 hours from symptom onset were investigated, and clinical characteristics and in-hospital and 6-month outcomes of 66 elderly patients (>or=75 years, group A) were compared to those of 456 younger patients (<75 years, group B). RESULTS: Compared to younger patients, elderly ones had more females (42.4% vs. 17.8%, P<0.005), a history of cerebral vascular events (7.6% vs. 0.9%, P<0.05), higher serum creatinine level ((96.48+/-31.65) mmol/L vs. (84.87+/-19.81) mmol/L, P<0.005) and fewer smokers (28.8% vs. 45.4%, P<0.05). The elderly ones had worse Killip class (Killip I class: 69.7% vs. 85.7%, P<0.05), less drug-eluting stent implantation and lower rates of TIMI flow 3 following PCI (33.3% vs. 47.1%, and 84.8% vs. 94.7%, P<0.05 respectively). Additionally, both in-hospital mortality and myocardial infarction rate were found to be higher in elderly patients (16.7% vs. 1.5%, and 7.6% vs. 2.6%, P<0.05 respectively), which were also observed until 6-month follow-up (9.1% vs. 0, and 6.1% vs. 0, P<0.05 respectively). In multivariable Cox regression analysis, serum creatinine level, history of hypertension, left anterior descending coronary artery as infarct-related artery and Killip class were independent predictors of 6-month overall death in elderly patients. CONCLUSIONS: The clinical characteristics of elderly patients with STEMI after PCI are different from those of younger patients. Although PCI in this population is with a low rate of PCI failure, it is still associated with a worse outcome.

[Clinical and angiographic outcome in coronary artery disease patients with type-II diabetes mellitus undergoing elective bare-metal stenting or drug-eluting stenting].

OBJECTIVE: To compare the clinical and angiographic outcome in patients with type-II diabetes mellitus undergoing drug-eluting stent (DES) or bare-metal stent (BMS). METHODS: A total of 139 consecutive diabetic patients (114 males) with coronary disease who underwent successful elective percutaneous coronary intervention with DES (n = 83 with 151 lesions) or BMS (n = 56 with 70 lesions) on native coronary arteries from April 2004 to August 2005 at our institution were included in this study. All patients were treated according to guidelines and coronary angiography was repeated at 6 months post procedure in all patients. Aspirin (300 mg/d) and clopidogrel (75 mg/d) were administered till 6 months after the procedure. RESULTS: There were 42.5% C type by ACC/AHA and 19.0% total occlusion lesions. The average stent length of each lesion was 26.53 +/- 14.72 mm, and mean reference diameter was 2.80 +/- 0.43 mm. Baseline characteristics were similar between DES and BMS groups except lower mean reference vessel diameter in DES than that of BMS group (2.71 +/- 0.41 mm vs. 2.98 +/- 0.53 mm, P < 0.001). The in stent restenosis rate at 6 months (10.6% vs. 38.6%, P < 0.001) and in-segment late loss (0.24 +/- 0.56 mm vs. 0.91 +/- 0.77 mm, P < 0.001) were significantly lower in DES group than those of BMS group. The target lesion revascularization (TLR) incidence was also significantly lower in DES group compared to BMS group (8.6% vs. 30.0%, P < 0.001). However, 4 late in-stent thrombosis were seen in DES group and none in BMS group of DES (P = 0.148). CONCLUSION: DES implantation in patients with diabetes mellitus is associated with lower in-stent restenosis and TLR rates compared to BMS implantation 6 months after procedure and attention should be paid on late in-stent thrombosis after DES implantation.

Coronary restenotic reduction of drug-eluting stenting may be due to its anti-inflammatory effects.

The development of coronary stent has revolutionized the field of interventional cardiology by reducing the incidence of restenosis after balloon angioplasty. However, the stent has still associated with a serious complication, namely, in-stent restenosis. Although, restenosis following coronary stenting has long been attributed to neointimal proliferation, thrombosis, and negative remodeling, the inflammation may be a trigger for those vascular reactions following coronary stenting. Both experimental and clinical studies have demonstrated a marked activation of local and systemic inflammatory response following stent implantation, suggesting that inflammation may play an important role in determining in-stent restenosis via neointimal proliferation. The key role of inflammation in vascular healing and in-stent retsenosis has also been increasingly well understood. Recently, drug-eluting stents (DESs) have been shown to decrease in-stent restenosis in a large number of clinical studies. In addition to their anti-proliferative activity, DESs have been considered to possess an anti-inflammatory property, especially for sirolimus-eluting stent compared with bare metal stent. Moreover, the benefit of the anti-inflammatory therapy during the peri-procedural period and long-term follow-up by means of drug administration is also dependent on the inflammatory status during percutaneous coronary intervention. Measurement of cytokine and acute phase proteins, such as C-reactive protein, therefore, may be important to identify high-risk subjects and develop specific treatment tailored to the individual patients with stent restenosis. Thus, therapeutic approach should be further directed toward increasing local resistance to proliferative inflammatory stimuli by means of anti-proliferative, locally delivered drugs and reducing the magnitude and persistence of systemic inflammation.

[Compare drug-eluting stent to bare-metal stent in prognosis on treating diffuse coronary lesions].

OBJECTIVE: Compare drug-eluting stent (DES) to bare-metal stent (BMS) in prognosis on treating diffuse coronary lesions and analysis risk factor of treating complex and diffuse lesions in PCI. METHODS: 205 consecutive patients with complex and diffuse coronary lesions enrolled our hospital, who were treated with more than 25 mm long DES or BMS. We exclude unsuccessful operation and location. All patients received medical treatment by guideline, and aspirin 300 mg and clopidogrel 75 mg once daily were continued at 6 months after the procedure. The patients were followed up after 6 months. RESULTS: The study population were consisted of 205 patients that there were 181 man, and 24 women, who got 382 stents for 227 target lesions in coronary. There were 93.8% C and 6.2% B2 ACC/AHA type lesion. There were 86.8% patients with binary or above vessel treated. The average reference vessel diameter was 2.88 +/- 0.43 mm. The average stent length of per lesion was 40.09 +/- 12.94 mm. There were 54.2% lesions treated with overlapping stent. There were not different between DES and BMS in patients baseline characteristics, but RVD of group DES less than of group BMS (2.80 +/- 0.37 mm, 3.10 +/- 0.48 mm, P = 0.005) in lesion baseline characteristics. After 6 months, restenosis rate in group DES was less than in group BMS (15.4%, 48.4%, P < 0.001). There were obvious superiority TVR of DES than of BMS (11.6%, 38.5%, P < 0.001). The rate of local restenosis in group of DES was higher than that in group of BMS (33.3%, 18.2%, P = 0.029). We analyzed the risk factors for diffuse lesion by a logistic regression model, the significant univariate clinical and angiographic predictors of restenosis were treating with overlapping stent (OR = 2.82, P = 0.017) and drug-eluting stent (OR = 5.71, P < 0.001). CONCLUSIONS: We find that implantation of DES in patients with diffuse lesions in coronary is relatively more safe and associated with more good clinical outcomes, than of BMS.

[Clinical and angiographic outcome in patients undergoing elective bare- metal stenting or drug-eluting stenting for total occlusion lesion].

OBJECTIVE: To compare the clinical and angiographic outcome in patients with total occlusion lesion treated with drug-eluting stent (DES) or bare-metal stent (BMS). METHODS: A total of 155 (138 males) consecutive patients with total occlusion lesion underwent successful revascularization with DES (n = 74) or BMS (n = 81) in our hospital were included in this study. All patients received aspirin 300 mg and clopidogrel 75 mg once daily for at least 3 months after the procedure. Clinical and angiographic follow-up were completed in all patients at 6 months post stenting. RESULTS: Demographic data between the two groups were similar except there was more diabetic patients in DES group (33.8% vs. 18.5%, P < 0.05). A total of 232 stents for 159 target lesions (77 treated with DES, 82 treated with BMS) were implanted. There were 85.4% C ACC/AHA type lesions and 17.0% lesions were treated with overlapping stents. Six months post stenting, the incidence of restenosis (15.6% vs. 41.5%, P < 0.001), the cumulative rate of major adverse cardiac events (MACE) (1.4% vs. 11.1%, P = 0.032) and TLR (5.8% vs. 19.9%, P = 0.001) were significantly lower in DES group than that of BMS group. The incidence of local restenosis in DES group is higher in DES group than that in BMS group (58.3%, 17.6%, P < 0.001). Two DES treated patients developed late in-stent thrombosis. CONCLUSION: For patients with total occlusion lesion, the clinical and angiographic outcome 6 months post DES stenting is clearly superior to that of BMS stenting.