Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI.</p><p><b>METHODS</b>Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison.</p><p><b>RESULTS</b>A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months.</p><p><b>CONCLUSION</b>The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients.</p><p><b>TRIAL REGISTRATION</b>ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.</p>

Clinical utility of the ratio between circulating fibrinogen and fibrin (ogen) degradation products for evaluating coronary artery disease in type 2 diabetic patients / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>We investigated whether and to what extent the ratio between circulating fibrinogen (Fg) and its degradation products (FDP) reflects the severity of coronary artery disease (CAD) in type 2 diabetic patients.</p><p><b>METHODS</b>Plasma levels of Fg and FDP were determined, and Fg/FDP ratio was calculated in 344 consecutive patients with type 2 diabetes and chest pain on exertion undergoing coronary angiography. The severity of CAD was evaluated by the number of significant CAD (>50% luminal diameter narrowing) and Gensini score.</p><p><b>RESULTS</b>Plasma Fg was higher, but Fg/FDP ratio was lower in patients with significant CAD (n = 255) compared with those without (n = 89), due to a disproportionate increase in FDP. Fg and FDP correlated positively, while Fg/FDP ratio negatively, with the number of diseased coronary arteries and the tertile of Gensini score (all P values for trend < 0.01). After adjusting for age, sex, risk factors for CAD, lipid profiles, glycosylated hemoglobin A1c, creatinine, leukocyte count, and high-sensitivity C-reactive protein, Fg/FDP ratio remained an independent determinant for multivessel coronary disease (MVD) (odds ratio [OR], 0.869; 95% confidence interval [CI], 0.788-0.958, P = 0.005) and high tertile of Gensini score (OR, 0.797, 95% CI, 0.682-0.930, P = 0.004). The area under the curve of Fg/FDP ratio was larger than that of Fg for predicting the presence of MVD (0.647 vs. 0.563, P = 0.048) and Gensini score ≥ 30 (0.656 vs. 0.538, P = 0.026).</p><p><b>CONCLUSIONS</b>Elevated plasma Fg and FDP level and reduced Fg/FDP ratio are associated with presence of CAD, and Fg/FDP ratio is superior to Fg in reflecting severe coronary atherosclerosis for patients with type 2 diabetes.</p>

Efficacy and safety of FIREHAWK® abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK(®) stent in long coronary artery disease.</p><p><b>METHODS</b>The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention (PCI) for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion(s) with diameter stenosis ≥ 70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month.</p><p><b>RESULTS</b>Fifty patients (mean age (57.6 ± 10.2) years) with 59 de novo long lesions (reference vessel diameter (2.85 ± 0.44) mm, lesion length (35.2 ± 9.4) mm, and stent length (41.8 ± 11.3) mm) were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was (0.16 ± 0.16) mm. Proximal edge, distal edge and in-segment late loss (mm) were 0.21 ± 0.35, 0.03 ± 0.33, and 0.07 ± 0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction (MI), or stent thrombosis occurred. Non-Q-wave MI occurred in two patients (4%) due to procedural complications.</p><p><b>CONCLUSIONS</b>Treatment of long coronary lesions with the FIREHAWK(®) stent is able to produce similar results as observed in the FIREHAWK(®) FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK(®) for long coronary lesions.</p>

Improved outcomes from transradial over transfemoral access in primary percutaneous coronary intervention for patients with acute ST-segment elevation myocardial infarction and upstream use of tirofiban / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Transradial access has been increasingly used during primary percutaneous coronary intervention (PCI) for patients with acute ST-segment elevation myocardial infarction (STEMI) in last decade. Clinical benefits of upstream use of tirfiban therapy in STEMI patients treated by primary PCI have been reported. We investigated the merits of transradial vs. transfemoral access in primary PCI for STEMI patients with upstream use of tirofiban.</p><p><b>METHODS</b>Patients with STEMI treated with tirofiban between December 2006 and October 2012 then by primary PCI were compared between transradial (n = 298) and transfemoral (n = 314) access. Baseline demographics, angiographic and PCI features and primary endpoint of major adverse cardiac events (MACE) at 30-day clinical follow-up were recorded.</p><p><b>RESULTS</b>Baseline and procedural characteristics were comparable between the two groups, apart from more patients in transradial group had hypertension and were treated by thrombus aspiration during primary PCI. Significantly fewer MACE occurred in the transradial group (5.4%) compared with the transfemoral group (9.9%) at 30-day clinical follow-up. Major bleeding events at 30-day clinical follow-up were 0 in transradial group and in 2.9% of transfemoral group. Multivariate analysis confirmed transradial approach as an independent negative predictor of 30-day MACE (HR 0.68; 95%CI 0.35 - 0.91; P = 0.03).</p><p><b>CONCLUSIONS</b>Using transradial approach in primary PCI for acute STEMI infarction patients treated with tirofiban was clearly beneficial in reducing bleeding complications and improving 30-day clinical outcomes.</p>

Randomized comparison of intracoronary tirofiban versus urokinase as an adjunct to primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: results of the ICTUS-AMI trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>No randomized trial has been performed to compare the efficacy of an intracoronary bolus of tirofiban versus urokinase during primary percutaneous coronary intervention (PCI). We investigated whether the effects of adjunctive therapy with an intracoronary bolus of urokinase was noninferior to the effects of an intracoronary bolus of tirofiban in patients with ST-elevation myocardial infarction (STEMI) undergoing PCI.</p><p><b>METHODS</b>A total of 490 patients with acute STEMI undergoing primary PCI were randomized to an intracoronary bolus of tirofiban (10 µg/kg; n = 247) or urokinase (250 kU/20 ml; n = 243). Serum levels of P-selectin, von Willebrand factor (vWF), CD40 ligand (CD40L), and serum amyloid A (SAA) in the coronary sinus were measured before and after intracoronary drug administration. The primary endpoint was the rate of complete ( ≥ 70%) ST-segment resolution (STR) at 90 minutes after intervention, and the noninferiority margin was set to 15%.</p><p><b>RESULTS</b>In the intention-to-treat analysis, complete STR was achieved in 54.4% of patients treated with an intracoronary bolus of urokinase and in 60.6% of those treated with an intracoronary bolus of tirofiban (adjusted difference: -7.0%; 95% confidence interval: -15.7% to 1.8%). The corrected TIMI frame count of the infarct-related artery was lower, left ventricular ejection fraction was higher, and the 6-month major adverse cardiac event-free survival tended to be better in the intracoronary tirofiban group. An intracoronary bolus of tirofiban resulted in lower levels of P-selectin, vWF, CD40L, and SAA in the coronary sinus compared with an intracoronary bolus of urokinase after primary PCI (P < 0.05).</p><p><b>CONCLUSIONS</b>An intracoronary bolus of urokinase as an adjunct to primary PCI for acute STEMI is not equally effective to an intracoronary bolus of tirofiban with respect to improvement in myocardial reperfusion assessed by STR. This may be caused by less reduction in coronary circulatory platelet activation and inflammation.</p>

Impact of angina prior to acute ST-elevation myocardial infarction on short-term outcomes after primary percutaneous coronary intervention: results from the Shanghai Registry of Acute Coronary Syndrome (SRACE) / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The clinical significance of ischemic chest pain before acute ST-elevation myocardial infarction (STEMI) remains an interesting issue of investigation particularly in the era of percutaneous coronary intervention (PCI). This study aimed to assess the impact of angina prior to STEMI on short-term clinical outcomes in patients with acute STEMI undergoing primary PCI.</p><p><b>METHODS</b>Among a total of 875 consecutive patients with STEMI undergoing primary PCI, 292 had episodes of angina within 24 hours of STEMI (PA group) and the remaining 583 were free of anginal symptoms (non-PA group). Clinical characteristics, angiographic and procedural features, and in-hospital and 30-day outcomes were compared between the two groups.</p><p><b>RESULTS</b>Diabetes was less common (17.5% vs. 23.3%, P = 0.04) and symptom-to-door time was shortened ((191.6 ± 96.8) minutes vs. (357.2 ± 341.9) minutes, P < 0.001) in the PA group than in the non-PA group. Patients with angina prior to STEMI had fewer totally or nearly totally occluded infarct-related artery (TIMI flow grade 0 - 1) at initial angiography (75.0% vs. 90.7%, P < 0.001), and achieved more TIMI flow grade 3 after primary PCI (84.2% vs. 78.2%, P = 0.04). These were associated with higher rates of overall procedural success (95.9% vs. 91.8%, P = 0.02) and of complete ST-segment resolution at 90 minutes after the procedure (51.7% vs. 40.3%, P = 0.001). During a 30-day clinical follow-up, the left ventricular ejection fraction was significantly improved ((53.0 ± 8.6)% vs. (51.1 ± 9.7)%, P = 0.002) and the primary endpoint of major adverse cardiac events was reduced in the PA group (7.2% vs. 12.7%, P = 0.01).</p><p><b>CONCLUSION</b>Presence of angina prior to acute STEMI is associated with better outcome at a 30-day clinical follow-up in patients undergoing primary PCI.</p>

Impact of weight gain following smoking cessation on one-year outcome after drug-eluting stent implantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Weight gain following smoking cessation increases cardiovascular risk, but its effects on prognosis after percutaneous coronary intervention (PCI) remain unclear. This study aimed to investigate the relationship between weight gain post smoking cessation and one-year clinical outcome in patients who underwent PCI with drug-eluting stent (DES).</p><p><b>METHODS</b>A total of 895 consecutive male smoking patients were divided into quitters (n = 437) and continuers (n = 458) according to their smoking status after PCI. Weight gain, major adverse cardiac events (MACE, including cardiac deaths, myocardial infarction and revascularization), and recurrent angina were recorded during follow-up for one year.</p><p><b>RESULTS</b>Average weight gain in quitters was more than that in continuers (1.5 kg vs. -0.03 kg, P < 0.001). Weight was unchanged or increased by more than 1.5 kg in 78.17% of continuers, while 50.57% of quitters had a weight gain of less than 1.5 kg. Compared with continuers, MACE in quitters was significantly reduced after PCI (6.12% vs. 4.81%, P = 0.049), especially recurrent angina (13.97% in continuers vs. 9.84% in quitters, P = 0.027). After adjusting for weight gain and other factors, smoking cessation was independently associated with a lower risk of MACE and recurrent angina (OR = 0.73, P = 0.035). However, weight gain > 1.5 kg (OR = 1.55, P = 0.026) could curtail the benefits from smoking cessation.</p><p><b>CONCLUSIONS</b>Weight gain may reduce the benefits of smoking cessation after PCI with DES implantation. Thus, although smoking cessation is recommended after PCI, weight control should also be highly encouraged for these patients.</p>

Polymorphism on chromosome 9p21.3 contributes to early-onset and severity of coronary artery disease in non-diabetic and type 2 diabetic patients / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Susceptibility to coronary artery disease (CAD) and diabetes is encoded by distinct, tightly-linked single nucleotide polymorphisms on chromosome 9p21. This study aimed to examine the association of variant rs1333049 on chromosome 9p21.3 with early-onset and severity of CAD in Chinese patients with and without type 2 diabetes, and to determine the possible impact of rs1333049 on glucose metabolism and inflammation pathways.</p><p><b>METHODS</b>Genotyping of variant rs1333049 on chromosome 9p21.3 was performed in 2387 patients with and without diabetes who were undergoing coronary angiography to evaluate suspected or established CAD. Serum levels of glucose, glycosylated hemoglobin A(1c) (HbA(1c)), insulin, high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin-6 were also measured, and compared with each patient's genotype.</p><p><b>RESULTS</b>The homozygous CC genotype of rs1333049 was significantly associated with CAD in diabetic (OR: 1.270, P = 0.044) and non-diabetic (OR: 1.369, P = 0.011) patients after adjusting for traditional risk factors. There was an association between CC genotype and number of diseased vessels in diabetics (P = 0.019), but not in non-diabetics (P = 0.126). Among diabetic patients, CC genotype carriers had an increased risk of early-onset CAD (OR: 2.367, P = 0.008) and greater cumulative atherosclerotic burden compared with non-CC genotype carriers (Gensini score: 31.80 ± 17.20 vs. 23.09 ± 21.63, P = 0.039). No significant differences were observed between genotypes of rs1333049 in serum levels of glucose, insulin, HbA(1c), or inflammatory cytokines for diabetic or non-diabetic patients with CAD.</p><p><b>CONCLUSIONS</b>This study demonstrated a significant association of rs1333049 polymorphism on chromosome 9p21.3 with CAD in Chinese diabetic and non-diabetic patients. The homozygous CC genotype of rs1333049 confers a magnified risk of early-onset and more severe CAD in diabetic patients through a novel biological pathway unrelated to glucose metabolism or inflammation.</p>

Direct ambulance transport to catheterization laboratory reduces door-to-balloon time in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: the DIRECT-STEMI study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Primary percutaneous coronary intervention (PCI) has been clearly identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction (STEMI). The importance of reducing door-to-balloon (D2B) time has gained increased recognition. This study aimed to assess the feasibility, safety and efficacy of the strategy of direct ambulance transportation of patients with acute STEMI to catheterization lab to receive primary PCI.</p><p><b>METHODS</b>The study population included 141 consecutive patients with chest pain and ST-segment elevation who were admitted to the catheterization laboratory directly by the ambulance and underwent primary PCI (DIRECT group). Another 145 patients with STEMI randomly selected from the PCI database, were served as control group (conventional group); they were transported to catheterization laboratory from emergency room (ER). The primary endpoint of D2B time, and secondary endpoint of in-hospital and 30-day major adverse cardiac events (MACE, including death, non-fatal reinfarction, and target vessel revascularization) were compared.</p><p><b>RESULTS</b>Baseline and procedural characteristics between the two groups were comparable, except more patients in the DIRECT group presented TIMI 0-1 flow in culprit vessel at initial angiogram (80.1% and 73.8%, P = 0.04). Comparing to conventional group, the primary endpoint of D2B time was reduced ((54 ± 18) minutes and (112 ± 55) minutes, P < 0.0001) and the percentage of patients with D2B < 90 minutes was increased in the DIRECT group (96.9% and 27.0%, P < 0.0001). The success rate of primary PCI with stent implantation with final Thrombolysis in Myocardial Infarction (TIMI) 3 flow was significantly higher in the DIRECT group (93.8% and 85.2%, P = 0.03). Although no significant difference was found at 30-day MACE free survival rate between the two groups (95.0% and 89.0%, P = 0.06), a trend in improving survival status in the DIRECT group was demonstrated by Kaplan-Meier analysis.</p><p><b>CONCLUSION</b>Direct ambulance transport of STEMI patients to the catheterization laboratory could significantly reduce D2B time and improve success rate of primary PCI and 30-day clinical outcomes.</p>

Intravascular ultrasound evaluation on the efficacy of national made Firebird stents comparing with Cypher stents / 中华心血管病杂志

<p><b>OBJECTIVE</b>Intravascular ultrasound (IVUS) was used to compare the effects on neointimal hyperplasia inhibition between national made Firebird stents and Cypher stents in patients with coronary artery disease.</p><p><b>METHODS</b>From May 2003 to March 2007, 215 patients with 317 native lesions received either Firebird stent (147 lesions of 108 patients, Firebird group) or Cypher stent implantation (138 lesions of 107 patients, Cypher group). Quantitative coronary angiography (QCA) and IVUS were performed at one-year follow-up.</p><p><b>RESULTS</b>The baseline clinical and angiographic characteristics between the two groups were similar, but post procedural minimal lumen diameter was significantly larger in Firebird group than that in Cypher group [(2.88 +/- 0.43) mm vs. (2.78 +/- 0.33) mm, P < 0.05]. follow-up QCA results showed that in-stent late loss [(0.17 +/- 0.29) mm vs. (0.16 +/- 0.27) mm, P > 0.05] and in-segment late loss [(0.18 +/- 0.36) mm vs. (0.20 +/- 0.32) mm, P > 0.05] was similar between Firebird group and Cypher group, while stent cross sectional area (CSA) [(6.99 +/- 2.25) mm(2) vs. (6.46 +/- 1.71) mm(2), P < 0.05], lumen CSA [(6.89 +/- 2.30) mm(2) vs. (6.36 +/- 1.73) mm(2), P < 0.05], stent volume [(162.5 +/- 68.9) m(3) vs. (140.8 +/- 57.9) mm(3), P < 0.01], lumen volume [(160.4 +/- 69.5) mm(3) vs. (138.6 +/- 57.6) mm(3), P < 0.01] and minimal stent CSA [(5.40 +/- 1.85) mm(2) vs. (4.92 +/- 1.43) mm(2), P < 0.05] were larger in Firebird group than those in Cypher group. IVUS analysis showed that there was no significant difference in neointimal hyperplasia volume [(2.09 +/- 5.46) mm(3) vs. (2.23 +/- 6.50) mm(3), P > 0.05] and percentage of volume obstruction [(1.68 +/- 5.84)% vs. (1.59 +/- 4.10)%, P > 0.05] between the two groups.</p><p><b>CONCLUSION</b>Implantation of Firebird stent was associated with low restenosis rate and both Firebird and Cypher stents equally and effectively inhibited neointimal hyperplasia.</p>

Absence of gender disparity in short-term clinical outcomes in patients with acute ST-segment elevation myocardial infarction undergoing sirolimus-eluting stent based primary coronary intervention: a report from Shanghai Acute Coronary Event (SACE) Registry / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Randomized, controlled trials have demonstrated the superiority of sirolimus-eluting stent (SES) implantation during primary percutaneous coronary intervention (PCI), as opposed to bare-metal stents, in patients with ST-elevation myocardial infarction (STEMI). This study aimed to test the hypothesis that clinical benefits of SES treatment were independent of gender in this setting.</p><p><b>METHODS</b>A total of 2042 patients with STEMI undergoing SES-based primary PCI were prospectively enrolled into Shanghai Acute Coronary Event (SACE) registry (1574 men and 468 women). Baseline demographics, angiographic and PCI features, and in-hospital and 30-day major adverse cardiac events (MACE) were analyzed as a function of gender.</p><p><b>RESULTS</b>Compared with men, women were older and more frequently had hypertension, diabetes, and hypercholesterolemia. Use of platelet glycoprotein IIb/IIIa receptor inhibitor (GPI, 65.5% vs. 62.2%, P = 0.10) and procedural success rate (95.0% vs. 94.2%, P = 0.52) were similar in both genders. In-hospital death and MACE occurred in 3.8% and 7.6%, and 4.5% and 8.1% in the male and female patients, respectively (all P > 0.05). At 30-day follow-up, survival (94.3% vs. 93.8%, P = 0.66) and MACE-free survival (90.2% vs. 89.3%, P = 0.52) did not significantly differ between men and women. After adjustment for differences in patient demographics, angiographic and procedural features, there were no significant difference in either in-hospital (OR = 0.77, 95%CI of 0.48 to 1.22, P = 0.30) or 30-day mortality (OR = 1.28, 95%CI of 0.73 to 2.23, P = 0.38) between women and men.</p><p><b>CONCLUSION</b>Despite more advanced age and clustering of risk factors in women, female patients with STEMI treated by SES-based primary PCI had similar in-hospital and short-term clinical outcomes as their male counterparts.</p>

Association between late incomplete stent apposition after sirolimus eluting stent implantation and clinical outcomes in patients with acute coronary syndrome / 中华心血管病杂志

<p><b>OBJECTIVE</b>The impact of late incomplete stent apposition (ISA) post sirolimus eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) on long-term clinical outcomes remains controversial. The aim of the present study was to evaluate the association between late ISA and clinical outcomes in patients with ACS compared with that with stable angina (SA).</p><p><b>METHODS</b>From February 2005 to March 2007, 54 ACS patients and 83 SA patients were enrolled in this study, late ISA was determined by means of three-dimensional volumetric intravascular ultrasound (IVUS) analyses one year after SES implantation and clinical outcomes one year post IVUS were obtained in these patients.</p><p><b>RESULTS</b>In 219 treated lesions of the 137 patients, late ISA was documented in 25 lesions in 16 patients (20 ISA in 12 ACS patients vs. 5 ISA in 4 SA patients, P<0.001). Though lumen area in reference and stented segment, neointimal hyperplasia (NIH) area and percentage of NIH in stented segment, and external elastic membrane (EEM) area in reference segment were similar between two groups, EEM area in stented segment [(15.34+/-5.44) mm2 vs. (13.83+/-4.51) mm2, P=0.026], stented/reference segment EEM area ratio (1.13+/-0.22 vs. 1.02+/-0.18, P<0.001), plaque and media area [(8.43+/-3.93) mm2 vs. (7.01+/-2.93) mm2, P=0.002] was significantly lager in ACS group than that in SA group. Multivariable logistic analysis showed that ACS (OR 6.477 with 95% CI from 2.297 to 18.263, P<0.001) and stent length>or=23 mm (OR 3.680 with 95% CI from 1.181 to 11.469, P=0.025) were main independent factors of occurrence of late ISA. Incidence of main adverse cardiac events (MACE) one year post IVUS was similar between the two groups.</p><p><b>CONCLUSION</b>Compared with patients with SA, ACS patients had larger stented segment EEM area, plaque and media area as well as increased incidence of ISA. However, the incidence of MACE was similar in ACS and SA patients one year after IVUS.</p>

Impact of different clinical pathways on outcomes of patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: the RAPID-AMI study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Current guidelines support primary percutaneous coronary intervention (primary PCI) as the first treatment of choice (as opposed to thrombolytic therapy) for patients with acute ST-segment elevation myocardial infarction (STEMI) especially when delivered within 12 hours of symptom onset. We aimed to evaluate the impact of different clinical pathways on reduction of reperfusion delay and subsequent improvement in outcomes in patients with STEMI.</p><p><b>METHODS</b>From November 2005 to November 2007, 546 consecutive patients with definite STEMI, who upon arrival at the emergency room were triaged to undergo primary PCI, were included. Of them, 271 patients were brought directly to catheterization laboratory (rapid group), and 275 patients were admitted to the coronary care unit (CCU) or cardiac ward first, and then transferred to the catheterization laboratory (non-rapid group). Primary endpoint was door-to-balloon (D2B) time, and secondary endpoints included infarct size assessed by peak CK-MB level and rates of major cardiac adverse events (MACE) including death, reinfarction, or target-vessel revascularization during hospitalization and at 30-day clinical follow-up.</p><p><b>RESULTS</b>Baseline clinical characteristics, angiographic features and procedural success rates were comparable between the two groups, except that more patients received glycoprotein IIb/IIIa receptor inhibitors before angiography (84.0% and 77.1, P = 0.042) and had TIMI 3 flow in the culprit vessel at initial angiogram (17.1% and 9.2%, P = 0.007) in the non-rapid group. The D2B time was shortened ((108 +/- 44) minutes and (138 +/- 31) minutes, P < 0.0001), and number of patients with D2B time < 90 minutes was greater (22.6% and 10.9%, P < 0.0001) in the rapid group. The advantages associated with rapid intra-hospital transfer were enhanced if the patients presented to the hospital at regular hours. Peak CK-MB level was significantly reduced in the rapid group. In-hospital mortality (4.1% and 5.8%) and cumulative MACE rate (7.0% and 9.8%) did not significantly differ between rapid and non-rapid groups. At 30 days, cumulative death- and MACE-free survival rates were improved in the rapid group (94.5% and 89.5%, P = 0.035; 90.1% and 84.0%, P = 0.034, respectively).</p><p><b>CONCLUSIONS</b>Clinical pathway with bypass of CCU/cardiac ward admission was associated with rapid reperfusion, smaller infarct size, and improved short-term survival for patients with STEMI undergoing primary PCI. In the future, it is essential to reduce the time delay for patients presenting at off-hours.</p>

Impact of statins on clopidogrel platelet inhibition in patients with acute coronary syndrome or stable angina / 中华心血管病杂志

<p><b>OBJECTIVE</b>This prospective registered study was conducted to investigate the impact of statins (pravastatin, fluvastatin, atorvastatin) on clopidogrel platelet inhibition in patients with acute coronary syndrome (ACS) or stable angina.</p><p><b>METHODS</b>A total of 1015 consecutive patients with ACS or stable angina underwent coronary angiography/percutaneous coronary intervention (PCI) were allocated to pravastatin group (n = 228), fluvastatin group (n = 179), atorvastatin group (n = 481) or placebo control group (n = 127). Baseline characteristics, coronary angiography/PCI features and acute stent thrombosis, platelet aggregation induced by 2, 5, 10 and 20 micromol adenosine diphosphate (ADP) at 1 minute (ADP-1), 5 minutes (ADP-5) and maximal platelet aggregation (ADP-M) were compared among groups.</p><p><b>RESULTS</b>Baseline and procedural characteristics were comparable among the four groups. Acute stent thrombosis (pravastatin group 0.9%, fluvastatin group 1.1%, atorvastatin group 1.0% and control group 0.8%, all P > 0.05), ADP-1, ADP-5, and ADP-M (all P > 0.05) were also similar among groups. Multivariate liner and ordinal logistic analysis revealed that age (B = 0.21, P = 0.001), dose of clopidogrel (B = 7.30, P = 0.002) and use of low-molecular heparin (OR = 6.71, P = 0.01) were independent factors for platelet aggregation inhibition efficacy by clopidogrel.</p><p><b>CONCLUSION</b>Inhibition of platelet aggregation with clopidogrel was influenced by age, clopidogrel dose and low-molecular heparin but not by various statin treatments.</p>

Prospective multicenter randomized trial comparing physician versus patient transfer for primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Primary percutaneous coronary intervention (PCI) has been identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction (STEMI). The strategy of transferring patient to a PCI center was recently recommended for those with acute STEMI who were present to PCI incapable hospitals, which include lack of facilities or experienced operators. In China, some local hospitals have been equipped with PCI facilities, but they have no interventional physicians qualified for performing primary PCI. This study was conducted to assess the feasibility, safety and efficacy of the strategy of transferring physician to a PCI-equipped hospital to perform primary PCI for patients with acute STEMI.</p><p><b>METHODS</b>Three hundred and thirty-four consecutive STEMI patients with symptom presentation = 12 hours in five local hospitals from November 2005 to November 2007 were randomized to receive primary PCI by either physician transfer (physician transfer group, n=165) or patient transfer (patient transfer group, n=169) strategy. Door-to-balloon time, in-hospital and 30-day major adverse cardiac events (MACE, including death, non-fatal re-infarction, and target vessel revascularization) were compared between the two groups.</p><p><b>RESULTS</b>Baseline characteristics between the two groups were comparable. Thrombolysis in myocardial infarction (TIMI) 3 flow was revealed in more patients in the physician transfer group at initial angiography (17.6% vs 10.1%, P<0.05). The success rate of primary PCI (96.3% vs 95.4%, P>0.05) and length of hospital stay were similar between the two groups ((15+/-4) days vs (14+/-3) days, P>0.05). In the physician transfer group, door-to-balloon time was significantly shortened ((95+/-20) minutes vs (147+/-29) minutes, P<0.0001) and more patients received primary PCI with door-to-balloon time less than 90 minutes (21.2% vs 7.7%, P<0.001). During hospitalization, MACE occurred in 6.7% and 11.2% of patients in the physician and patient transfer groups, respectively (P=0.14). At 30-day clinical follow-up, the occurrence rates of death, non-fatal re-infarction, and target vessel revascularization (TVR) were 3.6% vs 5.9%, 4.2% vs 8.9%, and 1.2% vs 2.4% in the physician and patient transfer groups, respectively (all P>0.05). The cumulative composite of MACE was significantly reduced (8.9% vs 17.2%, P=0.03) and MACE free survival (91.0% vs 82.9%, P<0.05) was significantly improved in the physician transfer group at 30 days.</p><p><b>CONCLUSION</b>The strategy of transferring physician to local hospital to perform primary PCI for patients with acute STEMI is feasible, safe and efficient in reducing the door-to-balloon time and 30-day MACE rate.</p>

Sirolimus-eluting cobalt-chromium stents: two-year clinical results from first-in-man study on the Firebird 2 stent / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Drug-eluting stents (DES) have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease (CAD). This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2 stents in the treatment of patients with CAD.</p><p><b>METHODS</b>This first-in-man study using the Firebird 2 stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent (Firebird 2, Microport Shanghai, Firebird 2 group), compared to another 49 patients treated with a bare cobalt alloy stent (Driver, Medtronic, control group). Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events (MACE) including cardiac death, reinfarction and target lesion revascularization (TLR) and stent thrombosis were compared between the two groups.</p><p><b>RESULTS</b>All patients in the Firebird 2 group (100.0%) and 48 patients in the control group (98.0%) completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR (26.5% in the control group and 1.5% in the Firebird 2 group, P<0.0001). A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% (P<0.0001). Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group (P>0.05). There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively (all P<0.0001). The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group (log rank P<0.0001). No case of stent thrombosis occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis in the control group at 19-month post-stenting: this patient presented with unstable angina pectoris and was treated by balloon angioplasty.</p><p><b>CONCLUSIONS</b>Compared with the bare cobalt alloy stent, the Firebird 2 sirolimus-eluting cobalt-chromium stent is safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and significantly lower rate of TLR and MACE up to 2 years post-stenting.</p>

Long-term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent (SES) in coronary artery disease.</p><p><b>METHODS</b>The sample was 509 consecutive patients with coronary artery disease (CAD) who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events (MACE) and Academic Research Consortium defined stent thrombosis (ST) were evaluated in patients with and without diabetes mellitus.</p><p><b>RESULTS</b>Three hundred and thirty three patients (65.4%) were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year's and 3 years' clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE (13.7% vs 6.4%, P < 0.05) and TVR (9.8% vs 4.0%, P < 0.05) and the cumulative MACE free survival rate was very significantly lower in the DM group (86.4% vs 93.6%, P < 0.05). ST occurred in 7 patients (1.4%) at the end of 3 years' follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label (1.5%) and on label groups (1.1%, P = 0.07).</p><p><b>CONCLUSIONS</b>In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.</p>

Impact of admission creatinine level on clinical outcomes of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention with drug-eluting stent implantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Prognosis of patients with acute ST-elevation myocardial infarction (STEMI) and renal dysfunction (RD) who received primary percutaneous coronary intervention (PCI) has not been fully investigated in the drug-eluting stent (DES) era. This study aimed to evaluate the impact of admission serum creatinine level on short-term outcomes in patients with acute STEMI undergoing DES-based primary PCI.</p><p><b>METHODS</b>Primary PCI with DES implantation was attempted in 619 consecutive STEMI patients within 12 hours of symptom onset. Among them, 86 patients had a serum creatinine level > or = 115 micromol/L on admission (RD group), and the remaining 533 patients had normal renal function (non-RD group). The primary endpoint was 30-day major adverse cardiac events (MACE, including death, non-fatal reinfarction, and target vessel revascularization), and the secondary endpoint was subacute stent thrombosis.</p><p><b>RESULTS</b>Patients in the RD group were older than those in the non-RD group. There are more female patients in the RD group and they had a history of hypertension, myocardial infarction and revascularization. The occurrence rates of Killip class > or = 2 (29.1% vs 18.6%, P = 0.02) and multi-vessel (62.8% vs 44.5%, P = 0.001) and triple vessel disease (32.6% vs 18.2%, P = 0.002), in-hospital mortality (9.3% vs 3.8%, P = 0.03), and MACE rate during hospitalization (17.4% vs 7.7%, P = 0.006) were higher in the RD group than those in the non-RD group. At a 30-day clinical follow-up, the MACE-free survival rate was significantly reduced in the RD group (76.7% vs 89.9%, P = 0.0003). Angiographic stent thrombosis occurred in 3 (3.5%) and 7 (1.3%) of patients in the RD group and non-RD group, respectively (P = 0.15). Multivariate analysis revealed that the serum creatinine level > or = 115 micromol/L on admission was an independent predictor for MACE rate at a 30-day follow-up (Hazard ratio (HR) 3.31, 95% CI 1.19 - 9.18, P < 0.001).</p><p><b>CONCLUSION</b>Despite similar prevalence of stent thrombosis at a 30-day clinical follow-up, the short-term prognosis of STEMI patients with elevated serum creatinine on admission undergoing DES-based primary PCI remains unfavorable.</p>

Acute coronary syndrome is an independent risk factor for late incomplete stent apposition after sirolimus-eluting stent implantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Late incomplete stent apposition (ISA) may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) by means of three-dimensional volumetric intravascular ultrasound (IVUS) analyses.</p><p><b>METHODS</b>One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure.</p><p><b>RESULTS</b>In overall 219 treated lesions (137 patients), late ISA was identified in 25 lesions (16 patients). Clinical diagnosis of acute coronary syndrome (ACS) and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane (EEM) area in stented segment ((15.34 +/- 5.44) vs (13.83 +/- 4.51) mm(2), P = 0.026), stented-to-reference segment EEM area ratio (1.13 +/- 0.22 vs 1.02 +/- 0.18, P < 0.001), and plaque and media area ((8.43 +/- 3.93) vs (7.01 +/- 2.93) mm(2), P = 0.002) than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA (OR 6.477, 95% CI 2.297 - 18.263, P < 0.001; OR 3.680, 95% CI 1.181 - 11.469, P = 0.025; respectively). During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA (18.7% vs 3.3%, P = 0.051).</p><p><b>CONCLUSIONS</b>The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.</p>

Clinical outcomes and safety of primary percutaneous coronary intervention combined with tirofiban therapy in patients with acute ST-segment elevation myocardial infarction / 中华心血管病杂志

<p><b>OBJECTIVE</b>This prospective study was conducted to investigate the clinical outcomes and safety of primary percutaneous coronary intervention (PCI) combined with tirofiban therapy in patients with acute ST-segment elevation myocardial infarction (STEMI).</p><p><b>METHODS</b>One hundred and sixty consecutive patients with acute STEMI were randomly allocated to either primary PCI combined with tirofiban therapy (Tirofiban group, n = 80) or primary PCI treatment alone (Control group, n = 80). Baseline characteristics, PCI features and clinical outcomes during hospitalization were compared between the two groups. Left ventricular ejection fraction (LVEF) and major adverse cardiac events (MACE, including death, re-infarction and target vessel revascularization) at 30 and 180 days after discharge were also compared.</p><p><b>RESULTS</b>The baseline clinical characteristics were comparable between the two groups. Despite similar TIMI grade 3 flow (95% vs. 87.5%, P > 0.05) between the tirofiban and control groups immediately after the procedure, TMP grade 3 (75% vs. 56.3%, P < 0.05), corrected TIMI frame count (cTFC, 23.56 +/- 5.19 vs. 31.05 +/- 6.92, P < 0.01), resolution of sum of ST-segment elevation (6.51 +/- 3.56 mm vs. 4.53 +/- 2.47 mm, P < 0.01), peak value of CK-MB (225.02 +/- 105.81 microg/L vs. 269.20 +/- 110.88 microg/L, P < 0.05) and TnI (45.25 +/- 33.00 microg/L vs. 56.46 +/- 29.48 microg/L, P < 0.05) in tirofiban group were significantly superior to the control group related to a shorter hospital stay (11.38 +/- 4.63 days vs. 14.68 +/- 6.90 days, P < 0.01). Compared to control group, the MACE rates at 30 days (5.0% vs. 16.3%, P < 0.05) and 180 days (7.5% vs. 18.8%, P < 0.05) were also significantly reduced and LVEF was significantly improved (30 days: 53% +/- 7% vs. 49% +/- 9%, P < 0.01; 180 days: 59% +/- 8% vs. 53% +/- 9%, P < 0.01) in tirofiban group. Multivariate logistic analysis revealed that age > 65 years (OR = 3.42, P < 0.01), tirofiban therapy (OR = 0.56, P < 0.05) and LVEF < 0.5 during hospitalization (OR = 2.56, P < 0.01) were independent predictors of MACE rates at 180 days follow up. There was no significant difference in hemorrhagic complications between the two groups (16.3% vs. 7.5%, P > 0.05).</p><p><b>CONCLUSION</b>Adjunctive therapy with tirofiban for patients with acute STEMI who undergo primary PCI is safe and can significantly improve re-perfusion in the infarct area and clinical outcomes at 30 as well as 180 days after procedure.</p>