Efficacy and safety of alirocumab versus ezetimibe in high cardiovascular risk Chinese patients with hyperlipidemia: ODYSSEY EAST Study-Chinese sub-population analysis / 中华心血管病杂志

Objective: To compare the efficacy and safety profile of alirocumab (PCSK9 inhibitor) versus ezetimibe on top of maximally tolerated statin dose in high cardiovascular risk Chinese patients with hyperlipidemia. Methods: The ODYSSEY EAST study was a randomized, double-blinded, double dummy, active-control, parallel group, multi-centers clinical trial, the Chinese sub-population included 456 patients with hyperlipidemia and high cardiovascular risk on maximally tolerated statin dose. Patients were randomized (2∶1) to receive the subcutaneous injection of alirocumab (75 mg Q2W; with dose up titration to 150 mg Q2W at week 12 if low-density lipoprotein cholesterol (LDL-C) was ≥1.81 mmol/L at week 8) or the oral administration of ezetimibe (10 mg daily) for 24 weeks. The primary endpoint was percentage change in calculated LDL-C from baseline to week 24. Key secondary efficacy endpoints included percentage change from baseline to week 12 or 24 in LDL-C (week 12) and other lipid parameters, including apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (non-HDL-C), TC, lipoprotein(a) (Lp(a)), HDL-C, fasting triglycerides (TG), and Apo A1, and the proportion of patients reaching LDL-C<1.81 mmol/L at week 24. Safety profile of therapeutic drugs was also assessed during the treatment period. Results: The mean age of 456 Chinese patients was (59.5±10.9) years, 341(74.8%) patients were male, 303 patients (66.4%) in alirocumab group and 153 patients (33.5%) in ezetimibe group. Demographic characteristics, disease characteristics, and lipid parameters at baseline were similar between the two groups. LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both P<0.001). At 12 weeks, alirocumab had significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-40.3±2.8)%, (-27.7±1.8)%, (-19.6±1.5)% and (-27.7±1.9)%, respectively (all P<0.001). At 24 weeks, the percent of patients who reached LDL-C<1.81 mmol/L and LDL-C<1.42 mmol/L was significantly higher in alirocumab group (85.3% and 70.5%) than in ezetimibe group (42.2% and 17.0%, both P<0.001), and alirocumab use was also associated with significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-37.2±2.8)%, (-29.1±2.0)%, (-21.6±1.6)% and (-29.6±2.2)%, respectively (all P<0.001). The incidence of treatment related adverse events was similar between the two treatment groups (223/302 patients (73.8%) in alirocumab group and 109/153 patients (71.2%) in ezetimibe group). Respiratory infection, urinary infection, dizziness and local injection-site reactions were the most frequently reported adverse events. Conclusions: In high cardiovascular risk patients with hyperlipidemia from China on maximally tolerated statin dose, the reduction of LDL-C induced by alirocumab is more significant than that induced by ezetimibe. Both treatments were generally safe during the observation period of study.

The clinical, angiographic and percutaneous coronary intervention characteristics in young patients with chronic total occlusion / 中国介入心脏病学杂志

Objective To investigate the characteristics in clinical, angiographic and percutaneous intervention (PCI) aspects of patients with chronic total occlusion (CTO) across different age groups, especially in young patients. Methods This study retrospectively analyzed 195 cases of CTO lesions admitted to the Department of Cardiology, General Hospital of Northern Theater Command from 2009 to 2014. These 1951 patients with CTO had undergone PCI and were divided into the young CTO group (≤44 years), the middle-aged CTO group (45-59 years) and the senior CTO group (≥60 years) according to their age. All patients had objective evidence of angina pectoris or myocardial ischemia before PCI. All the clinical features, coronary angiographic results, PCI related data and hospitalization outcome were all derived from our hospital PCI archives. Results There were significant differences in male ratio, body mass index, smoking and, drinking habit, creatinine clearance, triglyceride and LDL levels across the three groups (all P<0.05), and the highest values were found in the young patient group. The prevalence of unstable angina pectoris, hypertension and stroke were lowest in the young patient group (all P<0.05). The number of stenotic vessels and CTO occlusion time were less in young patients (all P <0.05). There was no significant difference among the three groups in CTO vascular distribution, coronary collateral Rentrop degree, CTO lesion length, CTO lesion diameter and CTO lesion characteristics (blunt CTO, CTO with bridging collateral and proximal branch of CTO lesion). There were no significant differences among the three groups in the volume of contrast agent used, CTO operation time, average stent number and average stent length (P>0.05). The procedural success rate of target vessels, races complete revascularization and mean stent diameter were highest in the young patient group (P<0.001).Conclusions Young CTO patients had typical risk factors of coronary heart disease with higher PCI success rate to target vessels and complete revascularization rate, which may be related to the short history of CTO.

One-year Outcomes in Patients with ST-segment Elevation Myocardial Infarction Caused by Unprotected Left Main Coronary Artery Occlusion Treated by Primary Percutaneous Coronary Intervention / 中华医学杂志(英文版)

<p><b>Background</b>Very few data have been reported for ST-segment elevation myocardial infarction (STEMI) caused by unprotected left main coronary artery (ULMCA) occlusion, and very little is known about the results of this subgroup of patients who underwent primary percutaneous coronary intervention (PCI). The aim of this study was to determine the clinical features and outcomes of patients with STEMI who underwent primary PCI for acute ULMCA occlusion.</p><p><b>Methods</b>From January 2000 to February 2014, 372 patients with STEMI caused by ULMCA acute occlusion (ULMCA-STEMI) who underwent primary PCI at one of two centers were enrolled. The 230 patients with non-ST-segment elevation MI (NSTEMI) caused by ULMCA lesion (ULMCA-NSTEMI) who underwent emergency PCI were designated the control group. The main indexes were the major adverse cardiac events (MACEs) in-hospital, at 1 month, and at 1 year.</p><p><b>Results</b>Compared to the NSTEMI patients, the patients with STEMI had significantly higher rates of Killip class≥III (21.2% vs. 3.5%, χ = 36.253, P < 0.001) and cardiac arrest (8.3% vs. 3.5%, χ = 5.529, P = 0.019). For both groups, the proportions of one-year cardiac death in the patients with a post-procedure thrombolysis in myocardial infarction (TIMI) flow grade<3 were significantly higher than those in the patients with a TIMI flow grade of 3 (STEMI group: 51.7% [15/29] vs. 4.1% [14/343], P < 0.001; NSTEMI group: 33.3% [3/9] vs. 13.6% [3/221], P = 0.001; respectively]. Landmark analysis showed that the patients in STEMI group were associated with higher risks of MACE (16.7% vs. 9.1%, P = 0.009) and cardiac death (5.4% vs. 1.3%, P = 0.011) compared with NSTEMI patients at 1 month. Meanwhile, in patients with ULMCA, the landmark analysis for incidences of MACE and cardiac death was similar between the STEMI and NSTEMI (all P = 0.72) in the intervals of 1-12 months. However, patients who were diagnosed with STEMI or NSTEMI had no significant difference in reinfarction (all P > 0.05) and TVR (all P > 0.05) in the intervals of 0-1 month as well as 1 month to 1 year. The results of Cox regression analysis showed that the differences in the independent predictors for MACE included the variables of Killip class ≥ III and intra-aortic balloon pump support for the STEMI patients and the variables of previous MI, ULMCA distal bifurcation, and 2-stent for distal ULMCA lesions for the NSTEMI patients.</p><p><b>Conclusions</b>Compared to the NSTEMI patients, the patients with STEMI and ULMCA lesions still remain at a much higher risk for adverse events at 1 year, especially on 1 month. If a successful PCI procedure is performed, the 1-year outcomes in those patients might improve.</p>

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study of the Effects of Tongxinluo Capsules in Acute Coronary Syndrome Patients with High On-Treatment Platelet Reactivity / 中华医学杂志(英文版)

<p><b>Background</b>High platelet reactivity (HPR) during clopidogrel treatment predicts postpercutaneous coronary intervention (PCI) ischemic events strongly and independently. Tongxinluo capsules (TCs) are a traditional Chinese medicine formulation used as antiplatelet treatment. However, its efficacy against HPR is not known. The aim of the present study was to evaluate the effects of TCs in acute coronary syndrome (ACS) patients with HPR.</p><p><b>Methods</b>This multicenter, randomized, double-blind, placebo-controlled study prospectively analyzed 136 ACS patients with HPR who underwent PCI. The patients were enrolled from November 2013 to May 2014 and randomized to receive placebo or TCs in addition to standard dual antiplatelet therapy (DAPT) with aspirin and clopidogrel. The primary end points were the prevalence of HPR at 30 days and the mean change in P2Yreaction units (PRUs) between baseline and 30 days. Survival curves were constructed with Kaplan-Meier estimates and compared by log-rank tests between the two groups.</p><p><b>Results</b>Both groups had a significantly reduced prevalence of HPR at 30 days versus baseline, but the TC group, compared with the placebo group, had greater reduction (15.8% vs. 24.8%, P = 0.013), especially among patients with one cytochrome P450 2C19 loss of function (LOF) allele (χ= 2.931, P = 0.047). The TC group also had a lower prevalence of HPR (33.3% vs. 54.2%, t = 5.284, P = 0.022) and superior performance in light transmittance aggregometry and higher levels of high-sensitivity C-reactive protein (hsCRP), but the composite prevalence of ischemic events did not differ significantly (χ= 1.587, P = 0.208).</p><p><b>Conclusions</b>In addition to standard DAPT with aspirin and clopidogrel, TCs further reduce PRU and hsCRP levels, especially in patients carrying only one LOF allele. The data suggest that TCs could be used in combination therapy for ACS patients with HPR undergoing PCI.</p>

A multicenter prospective registration study of iodixanol in the treatment of major adverse cardiovascular and cerebrovascular events and contrast-induced acute kidney injury, in Chinese patients with chronic kidrey disease undergoing percutaneous coronary intervention / 中国介入心脏病学杂志

Objective To evaluate the infl uence of iodixanol on Chinese patients who had chronic kidney disease(CKD) and received percutaneous coronary intervention complicated with major adverse cardiovascular and cerebrovascular events(MACCE) and contrast-induced acute kidney injury(CIAKI). Methods From 30th October 2013 to 7th October 2015, 3042 patients were enrolled in 30 centers in China. Patients were monitored in the hospital for 3 days and followed-up at 1 month. Patients were divided into chronic kidney disease group(n=105)and non chronic kidney disease group (n=2937) according to whether the patient has chronic nephropathy or not.The primary end point was the incidence rate of MACCE (re-revascularization of target lesions, stroke, stent thrombosis,cardiac death and myocardial infarction) and CIAKI in hospital 72 hours after PCI. The secondary end point was the incidence rate from 72 hours to 30 days post-PCI. Resuits (1)There were obvious differences between the two groups in baseline demographic date including age,BMI,comorbidities of hypertension,congestive heart failure, dyslipidemia,diabetes mellitus,peptic ulcer,ischemic stroke,previous use of antihypertensive drugs, diuretics,lipid-regulating drugs,hypoglycemic drugs,antiplatelet drugs and anticoagulants(all P<0.05).(2) There were obvious differences the CKD and non-CKD groups in perioperative date including operative route,preoperative hydration volume,postoperative hydration volume,total hydration volume,degree of postoporation lesion stenosis, contrast media used and machine injection rate(all P<0.05).(3)There were signifi cant diff erences between the two groups in the percentage of prescription of β-blocker,lipid-regulating drugs and antiplatelet drugs after PCI(all P<0.05).(4)There was not statistical diff erences between two groups in MACCE incidence in hospital and from 72 hours to 30 days post-PCI(P>0.05). (5)There was not statistical diff erences between two the groups in CIAKI incidence in hospital (P>0.05). Conclusions Iodixanol had no signifi cant eff ect on the incidence of MACCE and CIAKI in Chinese chronic kidney disease patients and non-CKD patients who received PCI.

Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Recent studies reported that percutaneous coronary intervention with stent implantation was safe and feasible for the treatment of left main coronary artery (LMCA) disease in select patients. However, it is unclear whether drug-eluting stents (DESs) have better outcomes in patients with LMCA disease compared with bare-metal stent (BMS) during long-term follow-up in Chinese populations.</p><p><b>METHODS</b>From a perspective multicenter registry, 1136 consecutive patients, who underwent BMS or DES implantation for unprotected LMCA stenosis, were divided into two groups: 1007 underwent DES implantation, and 129 underwent BMS implantation. The primary outcome was the rate of major adverse cardiac events (MACEs), including cardiovascular (CV) death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years postimplantation.</p><p><b>RESULTS</b>Patients in the DES group were older and more likely to have hyperlipidemia and bifurcation lesions. They had smaller vessels and longer lesions than patients in the BMS group. In the adjusted cohort of patients, the DES group had significantly lower 5 years rates of MACE (19.4% vs. 31.8%, P = 0.022), CV death (7.0% vs. 14.7%, P = 0.045), and MI (5.4% vs. 12.4%, P = 0.049) than the BMS group. There were no significant differences in the rate of TLR (10.9% vs. 17.8%, P = 0.110) and stent thrombosis (4.7% vs. 3.9%, P = 0.758). The rates of MACE (80.6% vs. 68.2%, P = 0.023), CV death (93.0% vs. 85.3%, P = 0.045), TLR (84.5% vs. 72.1%, P = 0.014), and MI (89.9% vs. 80.6%, P = 0.029) free survival were significantly higher in the DES group than in the BMS group. When the propensity score was included as a covariate in the Cox model, the adjusted hazard ratios for the risk of CV death and MI were 0.41 (95% confidence interval [CI]: 0.21-0.63, P = 0.029) and 0.29 (95% CI: 0.08-0.92, P = 0.037), respectively.</p><p><b>CONCLUSIONS</b>DES implantation was associated with more favorable clinical outcomes than BMS implantation for the treatment of LMCA disease even though there was no significant difference in the rate of TLR between the two groups.</p>

Short-term rosuvastatin treatment for the prevention of contrast-induced acute kidney injury in patients receiving moderate or high volumes of contrast media: a sub-analysis of the TRACK-D study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Current randomized trials have demonstrated the effects of short-term rosuvastatin therapy in preventing contrast-induced acute kidney injury (CIAKI). However, the consistency of these effects on patients administered different volumes of contrast media is unknown.</p><p><b>METHODS</b>In the TRACK-D trial, 2998 patients with type 2 diabetes and concomitant chronic kidney disease (CKD) who underwent coronary/peripheral arterial angiography with or without percutaneous intervention were randomized to short-term (2 days before and 3 days after procedure) rosuvastatin therapy or standard-of-care. This prespecified analysis compared the effects of rosuvastatin versus standard therapy in patients exposed to (moderate contrast volume [MCV], 200-300 ml, n = 712) or (high contrast volume [HCV], ≥ 300 ml, n = 220). The primary outcome was the incidence of CIAKI. The secondary outcome was a composite of death, dialysis/hemofiltration or worsened heart failure at 30 days.</p><p><b>RESULTS</b>Rosuvastatin treatment was associated with a significant reduction in CIAKI compared with the controls (2.1% vs. 4.4%, P = 0.050) in the overall cohort and in patients with MCV (1.7% vs. 4.5%, P = 0.029), whereas no benefit was observed in patients with HCV (3.4% vs. 3.9%, P = 0.834). The incidence of secondary outcomes was significantly lower in the rosuvastatin group compared with control group (2.7% vs. 5.3%, P = 0.049) in the overall cohort, but it was similar between the patients with MCV (2.0% vs. 4.2%, P = 0.081) or HCV (5.1% vs. 8.8%, P = 0.273).</p><p><b>CONCLUSIONS</b>Periprocedural short-term rosuvastatin treatment is effective in reducing CIAKI and adverse clinical events for patients with diabetes and CKD after their exposure to a moderate volume of contrast medium.</p>

Incidence and predictors of definite stent thrombosis after coronary stent implantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Coronary stents are widely used in percutaneous coronary intervention (PCI) procedures. We aimed to explore the incidence, predictors and characteristics of stent thrombosis (ST) after coronary stent implantation in routine clinical practice.</p><p><b>METHODS</b>From data of 18 063 consecutive patients who underwent successful stent implantation in Shenyang Northern Hospital from 2004 to 2010, we identified patients with definite ST (n = 140) and control patients (n = 280) matched on age, diagnosis, sex, current antiplatelet medication and stent type. The incidence, predictors and characteristics of ST after coronary stent implantation were investigated.</p><p><b>RESULTS</b>The incidence of angiographically confirmed ST was 0.78% (140/18 063). The time distribution of ST was acute in 43 (30.7%), subacute in 50 (35.7%), and late in 47 (33.6%) patients. Binary Logistic regression analysis identied the angiotensin-converting enzyme inhibitor (ACEI) (odds ratio (OR) = 0.472, 95%CI: 0.276 - 0.807, P = 0.006) and heparin (OR = 0.477, 95%CI: 0.278 - 0.819, P = 0.007) were associated with an reduced risk of cumulative ST. Stent length (OR = 1.042, 95%CI: 1.026 - 1.058, P < 0.001), serum creatinine total (OR = 1.020, 95%CI: 1.004 - 1.035, P = 0.04), cholesterol (OR = 1.267, 95%CI: 1.021 - 1.573, P = 0.032), glucose (OR = 1.086, 95%CI: 1.002 - 1.176, P = 0.044), and platelet aggregation (OR = 1.113, 95%CI: 1.075 - 1.154, P < 0.001) were associated with an increased risk of cumulative ST.</p><p><b>CONCLUSION</b>ST is associated with longer stent length and higher level of total cholesterol, glucose and platelet aggregation.</p>

Effects of intensive antiplatelet therapy for patients with high on-treatment platelet reactivity after coronary stent implantation / 中华心血管病杂志

<p><b>OBJECTIVE</b>To explore the effects of intensive antiplatelet therapy for patients with high on-treatment platelet reactivity (HPR) after coronary stent implantation.</p><p><b>METHODS</b>Between March 2009 and February 2011, a total of 3316 consecutive acute coronary syndrome patients undergoing drug-eluting stent implanting from 3 hospitals were enrolled. Among them, 840 patients (25.3%) were identified as HPR (defined as 20 µmol/L adenosine diphosphate induced platelet aggregation of ≥ 55% at 24 hours after administration of 300 mg clopidogrel loading dose and 300 mg aspirin). The HPR patients were randomly assigned to receive standard (aspirin 300 mg/d and clopidogrel 75 mg/d, n = 280) or intensified (n = 560) antiplatelet therapy by the ratio of 1:2. Patients in the intensive group were initially treated with a double maintenance dose of clopidogrel (150 mg/d) and aspirin (300 mg/d). After 3 days, patients with unsolved HPR received additional cilostazol treatment (50 - 100 mg, bid). The reversion rate of HPR and clinical events were observed.</p><p><b>RESULTS</b>In the intensive group, HPR reversed in 304 out of 560 patients (54.3%) at 3 days post therapy and the remaining 256 patients with HPR were treated with additional cilostazol regimen for another 3 days and the total reversion rate of HPR was 81.1% (454/560). The reversion rate of HPR at 30 days in the intensified group was significantly higher than that of the standard group (69.9% vs. 55.7%, P = 0.000). At 30 days after percutaneous coronary intervention, 1 patient suffered from subacute stent thrombosis (0.2%) in intensified group and no stent thrombosis was observed in standard group (P = 1.000). There were no death, major or minor bleeding in both two groups. Minimal bleeding was also similar in the two groups (intensive: 4.28% vs. standard: 2.14%, P = 0.166).</p><p><b>CONCLUSIONS</b>The intensified antiplatelet therapy regimens could significantly increase the reversion rate of HPR in acute coronary syndrome patients undergoing coronary stenting without increasing the risk of bleeding. The clinic impact of this strategy needs to be elucidated by long term follow-up outcome studies.</p>

Comparison of drug-eluting stents with bare metal stents implantation for the treatment of acute ST-elevation myocardial infarction: 2-year clinical outcomes from single-center registry / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aimed to investigate the impact of DES, in comparison with BMS, on the 2-year clinical outcomes in patients with ST-elevation myocardial infarction (STEMI).</p><p><b>METHODS</b>From January 2002 to December 2008, a total of 1301 consecutive STEMI patients treated with coronary stenting in Shenyang Northern Hospital were prospectively registered. Patients received BMS (n = 868) or DES (n = 435) implantation in the infarction related artery according to physician's discretion. A propensity score analysis was performed and two well matched subgroups were selected (BMS, n = 288; DES, n = 288) to evaluate the 2-year clinical outcomes. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, myocardial infarction (MI), or target vessel revascularization (TVR).</p><p><b>RESULTS</b>Survival salvage analysis showed that 2-year cumulative hazards were not significantly different between the two groups with respect to TVR (2.8% vs. 3.1%, log-rank P = 0.780), stent thrombosis (1.7% vs. 4.2%, log-rank P = 0.079) and MACE (8% vs. 10.8%, log-rank P = 0.236). Multivariate analysis showed that DES was an independent protective factor of MI (HR: 0.211, 95%CI: 0.049 to 0.908) and stent thrombosis (HR: 0.327, 95%CI: 0.107 to 0.994).</p><p><b>CONCLUSION</b>DES was associated with similar 2-year clinical outcomes to those of BMS for the treatment of STEMI in daily practice.</p>

Long-term efficacy and safety of drug-eluting stent implantation for patients with multiple coronary chronic total occlusions / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Data on the efficacy and safety of drug-eluting stent (DES) for treatment of multiple coronary chronic total occlusion (CTO) lesions are scanty. The aim of the present study was to compare the long-term outcomes of DES versus bare metal stent (BMS) implantation for multiple coronary CTO lesions.</p><p><b>METHODS</b>We analyzed 188 patients who underwent coronary stenting for at least two de novo CTO lesions in our center from November 2000 to November 2006. Among them, 118 patients (62.8%) received DES and 70 patients (37.2%) received BMS implantation after the recanalization for CTO lesions. All patients were followed up for up to 5 years for the occurrence of major adverse cardiac events (MACE). Long-term survival rates were estimated with the Kaplan-Meier method.</p><p><b>RESULTS</b>There were no significant differences in baseline clinical characteristics and procedural success rate between DES group and BMS group. Compared with the BMS group, the DES group showed a significantly higher rate of long CTO (> or = 15 mm) (62.0% vs. 50.6%, P = 0.023). The number of stents per lesion (1.39 +/- 0.71 vs. 1.17 +/- 0.66, P = 0.007) and the mean length of stents in the DES group were also higher than those in the BMS group ((40.8 +/- 11.4) mm vs. (23.4 +/- 8.7) mm, P < 0.001). But the mean diameter of stents in the DES group was smaller than that in the BMS group ((3.1 +/- 0.2) mm vs. (3.3 +/- 0.5) mm, P < 0.001). Average follow-up time was 4.8 +/- 0.7 (1.5 - 5.0) years in the BMS group and 4.3 +/- 0.5 (1.3 - 5.0) years in the DES group. Both the 5-year cumulative survival rates and the target vessel revascularization (TVR)-free survival rates of the DES group were significantly higher than those in the BMS group (83.1% vs. 72.9%, Log-rank P = 0.044; 77.1% vs. 62.9%, Log-rank P = 0.009). The cumulative MACE-free survival rates in the DES group were significantly higher than those in the BMS group (71.2% vs. 51.4%, Log-rank P = 0.001). Multivariable Cox regression analysis demonstrated that DES implantation for multiple CTO lesions could significantly reduce the long-term MACE risk after percutaneous coronary intervention (PCI) (HR: 0.436; 95%CI 0.327 - 0.665, P < 0.001). Age over 65 years (HR: 2.018; 95%CI 1.491 - 3.127, P < 0.001) and left ventricular ejection fraction < 50% (HR: 1.494; 95%CI 1.125 - 2.376, P < 0.001) were identified as the independent predictors of long-term MACE.</p><p><b>CONCLUSION</b>This study demonstrates the long-term (up to 5 years) efficacy and safety of DES for treatment of multiple coronary CTO lesions, and its superiority compared to BMS in reducing the rates of TVR and MACE.</p>

Elective percutaneous intervention for unprotected left main coronary artery stenosis complicated with left anterior descending artery chronic total occlusive lesions / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The patients with unprotected left main coronary artery (ULMCA) stenosis and chronic total occlusion (CTO) lesions at the left anterior descending (LAD) artery are often recommended for bypass surgery. However, some of these patients are deemed inoperable or are at high risk for surgery. In this study, we explored strategies and evaluated the efficacy of percutaneous coronary intervention for the treatment of ULMCA stenosis complicated by LAD CTO.</p><p><b>METHODS</b>From November 2001 to July 2009, 78 patients with ULMCA stenosis and LAD CTO lesions were selectively treated with stenting. Six patients (7.7%) refused surgery due to their young age (< or = 40 years), and the other 72 patients (92.3%) were unsuitable for surgery. Reasons for poor surgical candidacy included advanced age (> 80 years), chronic obstructive pulmonary, unsuitable distal target vessels for bypass, EuroSCORE > or = 6, and so on. Four different strategies were applied based on the degree of left main stenosis and the ostial diameter and involvement of the left circumflex.</p><p><b>RESULTS</b>Total procedural success was achieved in 94.9%, there were no deaths or thromboses. Five patients (6.4%) experienced non-Q-wave myocardial infarction in hospital. At long-term follow-up ((52 +/- 28) months), there were 3 cardiac deaths (3.8%) and 4 (5.1%) nonfatal myocardial infarctions. Angiographic follow-up was performed in 50 patients (64.1%), and target vessel revascularizations were required in 10 patients (12.8%), among which 4 nonfatal myocardial infarction patients included. The rate of major adverse cardiac events was 16.7% (13/78).</p><p><b>CONCLUSIONS</b>This study indicates that percutaneous intervention can be performed safely in high risk surgical patients with ULMCA and LAD CTO lesions based on individual therapeutic strategies. It may be feasible to apply this technique in selected patients mentioned above.</p>

Outcome of percutaneous coronary intervention of graft occlusion post coronary artery bypass graft / 中华心血管病杂志

<p><b>OBJECTIVE</b>To evaluate the feasibility and efficacy of percutaneous coronary intervention (PCI) for graft occlusion post coronary artery bypass graft (CABG).</p><p><b>METHODS</b>The clinical data of 135 post-CABG patients with bypass graft occlusion and angina pectoris symptoms admitted to our department between June 2003 and June 2007 were analyzed. The mean interval from CABG to index angiography was 33.8 +/- 23.5 months. Among 318 grafts, 29 left internal mammary artery (LIMA, 29/128, 22.7%) and 117 saphenous vein bypass grafts (117/188, 62.2%) were occluded. A total of 158 target lesions from these 146 vessels were treated with PCI. All target lesions were B2/C type lesion with 29.7% (47/158) chronic total occlusions.</p><p><b>RESULTS</b>A total of 310 DES were implanted. The total success rate of PCI procedure was 96. 3% (130/135), and lesion success rate was 96.8% (153/158). No major clinical complications occurred during peri-intervention period. All patients underwent PCI were followed at 12 month. Angiographic follow-up was obtained in 89 patients and the angiographic restenosis rate was 5.6% (5/89) in these patients. The major adverse cardiac events and target vessel revascularization rates were 5.4% (7/130) and 6.2% (8/130), respectively.</p><p><b>CONCLUSION</b>This study demonstrates that PCI procedure for graft occlusion post-CABG is feasible and safe and associated with a high procedure success rate and favorable long-term clinical and angiographic outcomes.</p>

Long-term clinical outcomes of patients undergoing successful or failed percutaneous coronary intervention for chronic total occlusions of coronary arteries / 中华心血管病杂志

<p><b>OBJECTIVE</b>To evaluate the long-term outcomes of successful or failed revascularization in patients with chronic total occlusions (CTO).</p><p><b>METHODS</b>The clinical data of 1332 consecutive patients underwent percutaneous coronary intervention (PCI) for CTO between June 1993 and December 2006 in our hospital were analyzed. These patients were divided into two groups according to the procedural success (n = 1202) or failure (n = 130).</p><p><b>RESULTS</b>Overall success rate of procedure was 90.2% (1202/1332). The patients in CTO success group experienced a superior 10-year survival rate (76.9% vs. 64.6%, log rank P = 0.012) and a significantly higher no major adverse cardiovascular event (MACE) survival rate (41.8% vs. 27.6%, log rank P < 0.001) compared to the patients in CTO failure group. During the long-term follow-up, the proportion of patients who accepted coronary artery bypass grafting (CABG) was significantly lower in CTO success group than that in the CTO failure group (4.3% vs. 14.6%, P < 0.001).</p><p><b>CONCLUSION</b>Successful PCI procedure leads to increased long-term survival and MACE-free survival and the reduced need for CABG for patients with CTO lesions.</p>

Long-term outcomes of drug-eluting versus bare-metal stent implantation in patients with chronic total coronary artery occlusions / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>There are limited data on the efficacy of drug-eluting stents (DES) for treatment of chronic total occlusions (CTO). The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent (BMS) implantation.</p><p><b>METHODS</b>Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 (55.7%) who underwent DES and 524 (44.3%) who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events (MACE). Long-term survival rates were estimated with the Kaplan-Meier method.</p><p><b>RESULTS</b>Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy ((7.4 +/- 2.5) months vs (1.7 +/- 0.8) months, P < 0.001). Average follow-up periods were (4.7 +/- 0.89) and (3.2 +/- 1.3) years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups (90.3% for DES group vs 89.6% for BMS group, Log-rank P = 0.38), but the 5-year target vessel revascularization (TVR)-free survival rate in the DES group was significantly higher than that in the BMS group (81.6% vs 73.5%, Log-rank P < 0.001). The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group (80.6% vs 71.5%, Log-rank P < 0.001). The rates of re-admission caused by cardiovascular disease (27.0% vs 37.8%, P < 0.001) and the need for bypass surgery were significantly lower in the DES group (1.5% vs 3.4%, P < 0.05). By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients (HR: 0.492; 95% CI 0.396 - 0.656, P < 0.001). Left ventricular ejection fraction < 50% and elderly (> or = 65 years) were identified as independent predictors of long-term MACE during follow-up.</p><p><b>CONCLUSION</b>This study demonstrates the long-term (up to 5 years) efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.</p>

A high maintenance dose of clopidogrel improves short-term clinical outcomes in patients with acute coronary syndrome undergoing drug-eluting stent implantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Recurrent ischemic events occurred even during routine use of 75 mg clopidogrel in addition to aspirin, that indicated a potentially insufficient maintenance dosage of clopidogrel. The aim of the present study was to evaluate the short-term efficacy and safety of a 150 mg maintenance dose of clopidogrel following a 600 mg loading dose in patients with an acute coronary syndrome (ACS) undergoing drug eluting stent (DES) implantation.</p><p><b>METHODS</b>Between November 2005 and November 2006, a total of 813 consecutive ACS patients undergoing DES implantation were enrolled. A 600 mg loading dose was administered before percutaneous coronary intervention (PCI) and patients were randomized to receive clopidogrel 75 mg or 150 mg for 30 days in addition to 300 mg aspirin daily. Primary end points were the composite of cardiac death, non-fatal myocardial infarction (MI) and urgent target vessel revascularization (UTVR). Secondary end points included stent thrombosis (ST), major and minor bleeding events at 30 days.</p><p><b>RESULTS</b>At a follow-up period of 30 days, 4 (1.0%) patients in the 150 mg group and 9 (2.2%) patients in the 75 mg group (P > 0.05) reached the primary end points. There was no significant difference in the incidences of MI (0.5% vs 1.2%, P > 0.05), UTVR (0.7% vs 2.0%, P > 0.05), and cardiac death (0.2% vs 0.2%, P > 0.05) between the two groups. The incidence of ST (0 vs 1.5%, P < 0.05) was significantly lower in the 150 mg group than that in the 75 mg group. There were no significant differences between both groups regarding the risk of major (0.2% vs 0, P > 0.05) or minor (0.5% vs 0.2%, P > 0.05) bleedings.</p><p><b>CONCLUSION</b>A high clopidogrel maintenance dose of 150 mg daily following a 600 mg loading dose for the first month after PCI procedure reduces the risk of ST and appears to be safe in patients with ACS undergoing DES implantation.</p>

Efficacy and safety of intra-aortic balloon pump-assisted interventional therapy in different age groups of patients with acute coronary syndrome / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Currently intra-aortic balloon pump (IABP) has been widely used in patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI). However, few studies have been done with regard to the clinical outcome and safety of IABP in assisting PCI in aged patients with ACS. The purpose of the present study was to evaluate the safety of IABP in different age groups of patients with ACS.</p><p><b>METHODS</b>Data on 292 ACS patients who received IABP-assisted PCI in Shenyang General Hospital of People's Liberation Army were retrospectively analyzed. More specifically, the successful rate, mortality and complications associated with the treatment were compared between the senior (>/= 60 years old) and the non-senior (< 60 years old) groups of patients.</p><p><b>RESULTS</b>The attack rate of non-ST segment elevation ACS was significantly higher in the senior group than in the non-senior group (38.8% vs 21.1%, P < 0.01). The incidence of the IABP-associated complications was not significantly different between both groups (P > 0.05).</p><p><b>CONCLUSION</b>The clinical outcome and safety of IABP-assisted PCI in the elderly patients were comparable to that for the non-elderly patients.</p>

Multi-wire plaque crushing as a novel technique in treating chronic total occlusions / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Failure of balloon catheter passing through the occluded segment accounts for 10% - 15% of all procedures during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). We sought to investigate an original technique for facilitating balloon catheter passing by multi-wire plaque crushing.</p><p><b>METHODS</b>Between July 2000 and October 2007, 152 patients with 164 CTO lesions who had failed balloon passing were treated by multi-wire plaque crushing technique. The main process of this technique was to insert 1 or 2 wires along with the original wire located in the true lumen of CTO lesions after balloon failure for plaque crushing and then to withdraw the crushing wires to get an enlarged lumen inside of the occlusion segment, thus facilitating the balloon passing.</p><p><b>RESULTS</b>Both overall lesion and technique success rates were 91.5% (150/164). A total of 211 crushing wires were used during PCI, including 1 crushing wire for 117 (71.3%) lesions and 2 crushing wires for 47 (28.7%) lesions. Approximately 57.3% (121/211) of all crushing wires were those already used in the same procedure. Technique failure occurred in 14 lesions (8.5%). Technique failure was due to crushing wires entering false lumen (92.9%, 13/14) and coronary perforation (7.1%, 1/14). Major procedural complications included coronary perforation (1 case) and severe coronary dissection (2 cases), all of which were successfully treated.</p><p><b>CONCLUSIONS</b>Multi-wire plaque crushing technique is effective in facilitating balloon catheter passing during CTO PCI. It is feasible, economical and relatively safe with a low rate of procedural complications.</p>

Acute angiographic and clinical outcomes of patients with calcified chronic total occlusion underwent percutaneous coronary intervention / 中华心血管病杂志

<p><b>OBJECTIVE</b>To evaluate the in-hospital outcome of patients with calcified chronic total occlusion (CTO) lesion underwent percutaneous coronary intervention (PCI).</p><p><b>METHODS</b>The clinic and lesion characteristics as well as acute PCI outcome were analyzed in 726 patients with calcified CTO [624 detected by coronary angiography (CAG) and 102 detected by intravascular ultrasound (IVUS)] and received PCI therapy from June 1995 to February 2007 in our department.</p><p><b>RESULTS</b>There were 728 diseased vessels with 732 lesions in these patients. Total procedure success rate (80.6% vs. 89.2%, P < 0.05) and the lesion success rate (80.2% vs. 88.2%, P < 0.05) were significantly lower in calcified CTO detected by CAG compared to that detected by IVUS. The causes of procedure failures in CAG detected patients were as follows: 87 guide failure, 21 balloon failure, 8 procedure related complications and 5 low TIMI blood flow (grade 2) at the end of PCI procedure. The causes of procedure failures in IVUS detected patients were as follows: 7 guide wire failure, 2 balloon failure, 1 procedure related complications and 1 patient with low TIMI blood flow (grade 2). The in-hospital major adverse cardiac events (MACE) rate was 1.1% in CAG detected calcified CTO and 1.0% in IVUS detected calcified CTO (P > 0.05).</p><p><b>CONCLUSION</b>PCI therapy resulted in satisfactory procedure success rate and in-hospital outcome for patients with calcified CTO and IVUS is helpful for further increasing the PCI procedure success rate in patients with calcified CTO.</p>

Comparative effects of percutaneous coronary intervention for infarct-related artery only or for both infarct- and non-infarct-related arteries in patients with ST-elevation myocardial infarction and multi-vessel disease / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Rapid recanalization of infarct-related artery (IRA) has become the major target during primary percutaneous coronary intervention (PCI) for patients with ST-elevation myocardial infarction (MI), but strategy for treatment of non-IRA lesions in this setting remains unclear. This study aimed to compare long-term effects between PCI for IRA only and that for both IRA and non-IRA in ST-elevation MI patients with multi-vessel disease.</p><p><b>METHODS</b>A total of 242 eligible patients with ST-elevation MI and at least two diseased coronary arteries (luminal narrowing > or = 70%) undergoing primary PCI were included. Of them, 149 patients underwent primary PCI for IRA only (group 1), and 93 received primary PCI for IRA followed by elective PCI for non-IRA 7 to 15 days after acute myocardial infarction (AMI) (group 2). Drug-eluting stents (DESs) were deployed in more than 90% of the patients.</p><p><b>RESULTS</b>The two groups did not differ with respect to baseline clinical and angiographic characteristics. No significant differences were observed in 12-month clinical follow-up results regarding major adverse cardiac events (11.5% vs 15.1%, P > 0.05) and target lesion revascularization (8.1% vs 7.6%, P > 0.05) between the two groups. However, patients in group 1 had higher rates of recurrent angina (10.1% vs 2.1%, P < 0.05) and depressed left ventricular ejection fraction evaluated by echocardiography (0.56 +/- 0.22 vs 0.63 +/- 0.25, P < 0.05).</p><p><b>CONCLUSION</b>With the use of DESs, complete revascularization with elective PCI for non-IRA after primary PCI may exert a beneficial effect on long-term symptomatology and left ventricular function in patients with ST-elevation MI and multi-vessel disease.</p>