First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention.

BACKGROUND: Several studies have proved the safety and feasibility of robot-assisted percutaneous coronary intervention (PCI) in reducing the occupational hazards of interventionists while achieving precision medicine. However, an independently developed robot-assisted system for PCI in China has not yet emerged. This study aimed to evaluate the safety and feasibility of a robot-assisted system for elective PCI in China. METHODS: This preclinical trial included 22 experimental pigs and preliminarily supported the safety and feasibility of the ETcath200 robot-assisted system for PCI. Then, eleven patients with coronary heart disease who met the inclusion criteria and had clinical indications for elective PCI were enrolled. PCI was performed using a robot-assisted system. The primary outcomes were clinical success (defined as visual estimated residual stenosis < 30% after PCI and no major adverse cardiovascular events during hospitalization and within 30 days after PCI) and technical success (defined as the ability to use the robot-assisted system to complete PCI successfully without conversion to the traditional manual PCI). RESULTS: Eleven patients were included in this clinical trial. A drug-eluting stent with a diameter of 3 mm (interquartile range: 2.75-3.5 mm) and a length of 26 mm (interquartile range: 22-28 mm) was deployed in all patients. The clinical success rate was 100%, with no PCI-related complications and no in-hospital or 30-day major adverse cardiovascular events, and the technical success rate was 100%. CONCLUSIONS: The results strongly suggest that the use of the independently developed robot-assisted system in China for elective PCI is feasible, safe, and effective.

Association between baseline platelet count and severe adverse outcomes following percutaneous coronary intervention.

OBJECTIVE: The aim is to evaluate the association between baseline platelet count (PC) and severe adverse outcomes following percutaneous coronary intervention (PCI) in current real-world practice. METHODS: A total of 18,788 patients underwent PCI with drug-eluting stents constituted the study population. Patients were categorized as having low (< 150 × 1000/µL), normal (150-300 × 1000/µL), and high (≥ 300 × 1000/µL) baseline PC. The primary endpoints included in-hospital and follow-up all-cause mortality. The secondary endpoint was major bleeding requiring a blood transfusion. RESULTS: In-hospital mortality rates for patients with low, normal, and high baseline PC were 0.6%, 0.4%, and 0.4%, respectively (P = 0.259). Similarly, mortality rates during long-term follow-up (median 23.8 months) for patients with low, normal, and high baseline PC were 0.9%, 0.6%, and 0.7%, respectively (P = 0.079). After multivariate adjustment, patients with low or high baseline PC tended to have similar risks for both in-hospital and follow-up mortality compared with the normal group. Subgroup analyses failed to demonstrate an independent prognostic value of baseline PC in specific population groups except patients who undwent transfemoral PCI. There was also no significant difference in the incidence of major bleeding requiring a blood transfusion in the low, normal, and high groups (0.5%, 0.3%, and 0.3%, respectively; P = 0.320). After multivariate adjustment, low or high baseline PC did not significantly increase the risk of major bleeding. CONCLUSION: There is no significant association between baseline PC and severe adverse outcomes following PCI in current real-world practice.

Transient ulnar artery compression facilitates transradial access.

BACKGROUND: Unsuccessful radial artery puncture is one of the important causes of transradial procedure failure. Ulnar artery compression made the radial artery pulse stronger. Whether it would make transradial access easier, however, is uncertain. METHODS: A prospective randomized controlled trial was conducted among 446 patients who planned for transradial cardiac catheterization. Patients were randomized to receiving either transient ulnar artery compression (UC) or standard treatment (standard) for half an hour prior to needle insertion (217 UC, 229 standard). The diameters of right radial artery and ulnar artery were measured by ultrasound on admission and before artery puncture. Primary endpoints included the number of attempts to access, the rate of first-pass success, and time for a successful access. Secondary endpoints were the number of difficult procedures, and the incidence of puncture failure. RESULTS: The diameters of radial artery were larger after half an hour's ulnar artery compression, but there were no obvious changes in that of ulnar artery. As compared with standard group, the number of attempts was significantly decreased (1.42 ±â€Š1.10 vs 2.97 ±â€Š2.38, P <0.001), and the rate of first-pass success was greatly enhanced (73.27% vs 57.64%, P <0.001) in UC group. Meanwhile, the time for access was decreased (59 ±â€Š15 seconds vs 71 ±â€Š18 seconds, P <0.001) with UC. In addition, the proportion of difficult procedures of UC group was less than that of standard group (4.61% vs 10.92%, P = 0.013). No significant differences were found in failure rates of sheath insertion and puncture between the 2 groups. CONCLUSION: Transient ulnar artery compression enhances the efficacy and feasibility of radial artery intubatton in transradial catheterization.

The effect of intravenous vitamin C infusion on periprocedural myocardial injury for patients undergoing elective percutaneous coronary intervention.

BACKGROUND: This small study has determined the effect of vitamin C on myocardial reperfusion in patients undergoing elective percutaneous coronary intervention (PCI). This study was to explore whether antioxidant vitamin C infusion before the procedure is able to affect the incidence of periprocedural myocardial injury (PMI) in patients undergoing PCI. METHODS: In this prospective single-centre randomized study, 532 patients were randomized into 2 groups: the vitamin C group, which received a 3-g vitamin C infusion within 6 hours before PCI, and a control group, which received normal saline. The primary end point was the troponin I-defined PMI, and the second end point was the creatine kinase (CK)-MB-defined PMI. Separate analyses using both end points were performed. PMI was defined as an elevation of cardiac biomarker values (CK-MB or troponin I) > 5 times the upper limit of normal (ULN), alone or associated with chest pain or ST-segment or T-wave changes. RESULTS: After PCI, the incidence of PMI was reduced, whether defined by troponin or by CK-MB, compared with the control group (troponin I, 10.9% vs 18.4%; P = 0.016; CK-MB, 4.2% vs 8.6%; P = 0.035). Logistic multivariate analysis showed that preprocedure use of vitamin C is an independent predictor of PMI either defined by troponin I (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.33-0.97; P = 0.037) or by CK-MB (OR, 0.37; 95% CI, 0.14-0.99; P = 0.048). CONCLUSIONS: In patients undergoing elective PCI, preprocedure intravenous treatment with vitamin C is associated with less myocardial injury.

Safety and efficacy of transulnar approach for coronary angiography and intervention.

BACKGROUND: Transradial approach, which is now widely used in coronary angiography and intervention, may be advantageous with respect to the femoral access due to the lower incidence of vascular complications. Transulnar approach has been proposed for elective procedures in patients not suitable for transradial approach. The objective of this study was to evaluate the safety and efficacy of the transulnar approach versus the transradial approach for coronary angiography and intervention. METHODS: Two hundred and forty patients undergoing coronary angiography, followed or not by intervention, were randomized to transulnar (TUA) or transradial approach (TRA). Doppler ultrasound assessments of the forearm vessels were scheduled for all patients before procedures, 1 day and 30 days after procedures. The primary end point was access site vascular complications during hospitalization and 30 days follow-up. Major adverse cardiac events (MACE) as secondary end point was recorded till 30 days follow-up. RESULTS: Successful puncture was achieved in 98.3% (118/120) of patients in the TUA group, and in 100% (120/120) of patients in the TRA group. Coronary angiographies were performed in 40 and 39 patients in TUA and TRA group. Intervention procedures were performed in 78 and 83 patients in TUA and TRA group, respectively. The incidence of artery stenosis 1 day and 30 days after procedures was 11.0% vs.12.3% and 5.1% vs. 6.6% in TUA and TRA group, respectively. Asymptomatic access site artery occlusion occurred in 5.1% vs.1.7% of patients 1 day and 30 days after transulnar angioplasty, and in 6.6% vs. 4.9% of patients 1 day and 30 days after transradial angioplasty. Minor bleeding was still observed at the moment of the ultrasound assessment in 5.9% and 5.7% of patients in TUA and TRA group, respectively (P = 0.949). No big forearm hematoma, and A-V fistula were observed in both groups. Freedom from MACE at 30 days follow-up was observed in all patients. CONCLUSIONS: The transulnar approach is as safe and effective as the transradial approach for coronary angiography and intervention. It is an attractive opinion for experienced operators who are skilled in this technique, particularly in cases of anatomic variations of the radial artery, radial artery small-caliber or thin radial pulse.

[Randomized study on T stenting and small protrusion technique versus simple stenting for patients with coronary artery bifurcation lesions and with big size side branch].

OBJECTIVE: To explore the feasibility and safety of T stenting and small protrusion (TAP) technique and compare the efficacy with simple stenting in patients with coronary bifurcation lesions and with big size side branch. METHODS: A total of 142 eligible patients were recruited and 127 patients completed the study (simple stenting group 58 and TAP technique group 69). RESULTS: Major adverse cardiovascular event rate was similar at 12 months follow up between the groups (TAP technique group 13.0% versus simple stenting group 12.1%, P > 0.05). The rate of procedural-related myocardial infarction, procedure and fluoroscopy time, contrast volumes were also similar between 2 groups (all P > 0.05). At 8 months, coronary angiography revealed that the restenosis rate of the ostium of side branch in TAP group was significantly lower than that of simple stenting group (17.1% versus 3.8%, P < 0.05). Overall restenosis rate was similar between the groups (P > 0.05). CONCLUSION: Both TAP technique and simple stenting are feasible and effective strategies for treating patients with bifurcation lesions.

Feasibility and safety of transcatheter intervention for complex patent ductus arteriosus.

We evaluated the transcatheter intervention of complex patent ductus arteriosus (PDA) in Chinese adults. Between January 2004 and April 2008, 112 adult patients (43 males, 69 females, mean age 31 +/- 19 years) underwent intervention. Coils were used for patients with small PDA, and Amplatzer duct occluders or China-made mushroom-shaped occluders were used for patients with moderate-to-large PDA. The success rate of transcatheter intervention was 93.8%, and 9 patients (8.0%) had small residual shunts. At the end of 12 months follow-up, the rate of residual shunts was 1.8%. Peak systolic pulmonary pressure decreased from 94 +/- 21 mm Hg preintervention to 58 +/- 20 mm Hg postintervention (P < .001). No severe procedure-related complications (including death, dislocation of occluders, stenosis of aorta or pulmonary artery) occurred. Some patients developed hemolysis or vascular access complications, all resolved by conservative therapy. Transcatheter intervention is an effective and safe treatment for adult PDA patients with complex anatomic or hemodynamic conditions.

Effects of upstream tirofiban versus downstream tirofiban on myocardial damage and 180-day clinical outcomes in high-risk acute coronary syndromes patients undergoing percutaneous coronary interventions.

BACKGROUND: For patients with moderate to high-risk acute coronary syndromes (ACS) who undergo early, invasive treatment strategies, current guidelines recommend the usage of glycoprotein (GP) IIb/IIIa inhibitors as an upstream treatment for a coronary care unit or as an downstream provisional treatment for selected patients who are undergoing percutaneous coronary intervention (PCI). The relative advantage of either strategy is unknown. The purpose of this study was to evaluate the effects of upstream tirofiban versus the effects of downstream tirofiban on myocardial damage and 180-day major adverse cardiovascular events (MACE) after PCI in high-risk non-ST-segment elevation ACS (NSTE-ACS) undergoing PCI. METHODS: From July 2006 to July 2007, 160 high-risk NSTE-ACS undergoing PCI were randomized to receive upstream (within 4 - 6 hours before coronary angiography) tirofiban or downstream (the guidewire crossing the lesion) tirofiban, to evaluate the extent of myocardial damage after PCI by quantitatively and qualitatively analyzing the value of cardiac troponin I (cTnI) as well as MB isoenzyme of creatine kinase (CK-MB) before and after PCI. The incidences of 24-hour, 3-day, 7-day, 30-day and 180-day MACE after PCI were followed up and the rates of bleeding complications and thrombocytopenia during tirofiban administration were recorded. RESULTS: The peak release and cumulative release of cTnI levels within 48 hours after PCI were significantly lower with upstream tirofiban than downstream tirofiban (0.45 vs 0.63 and 0.32 vs 0.43, respectively; P < 0.05). Post-procedural cTnI elevation within 48 hours was significantly less frequent among patients who received the upstream tirofiban than those who received the downstream tirofiban (66.3% vs 87.5%, P < 0.05). The peak and cumulative release of CK-MB levels as well as post-procedural CK-MB elevation within 48 hours after PCI were not significantly different between the two groups (16 vs 14 , 5 vs 3 and 26.3% vs 36.3%, respectively; P > 0.05). The incidences of 24-hour, 3-day, and 7-day MACE after PCI were the same between the two groups (0 vs 0, 0 vs 0 and 1.25% vs 1.25%, respectively). Although the incidences of 30-day and 180-day MACE after PCI were not statistically different between the two groups, the incidences were consistently lower with upstream tirofiban (3.75% vs 6.25% and 12.99% vs 16.67%; P > 0.05). Aging (OR = 1.164, P < 0.001), hypertension (OR = 4.165, P = 0.037) and type 2 diabetes (OR = 13.628, P < 0.001) were independent risk factors of MACE. The timing of administrating the tirofiban (OR = 2.416, P = 0.153) plays an extensive role in the incidence of MACE. The incidences of major and minor bleeding complications as well as mild thrombocytopenia during the administration of tirofiban were similar between the two groups (2.50% vs 1.25%, 1.25% vs 1.25% and 1.25% vs 1.25%, respectively; P > 0.05). CONCLUSIONS: Based on the pretreatment with aspirin and clopidogrel, upstream tirofiban was associated with attenuated minor myocardial damage and the tendency of reducing incidences of 180-day MACE after PCI among high-risk NSTE-ACS patients undergoing PCI. Aging, hypertension and type 2 diabetes were independent risk factors of MACE in high-risk NSTE-ACS patients undergoing PCI associated with tirofiban.

[Effects of upstream tirofiban versus downstream tirofiban on platelet aggregation and clinical outcomes in patients with high-risk acute coronary syndromes undergoing percutaneous coronary interventions].

OBJECTIVE: To observe the effects of upstream versus downstream application of tirofiban on platelet aggregation and clinical outcomes (major adverse cardiovascular event, MACE) in patients with high-risk non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI). METHODS: From July 2006 to July 2007, 160 high-risk NSTE-ACS patients undergoing PCI were randomized to receive upstream (4-6 h prior PCI) tirofiban and downstream (immediately prior to PCI) tirofiban. Platelet aggregation inhibition was determined at admission, before coronary angiography and after PCI. Incidences of MACE at 1, 3, 7, 30 and 180 days after PCI were compared. The incidences of bleeding complications and thrombocytopenia during tirofiban treatments were recorded. RESULTS: The extent of platelet aggregation inhibition post tirofiban was significantly greater in upstream tirofiban than that in downstream tirofiban group (8% vs. 42%, P<0.05). The incidences of MACE at various time points were similar between the two groups (all P>0.05). Aging, hypertension and type-2 diabetes were independent risk factors of MACE. The incidences of major and minor bleeding complications as well as mild thrombocytopenia during tirofiban treatments were similar between the two groups (2.5% vs. 1.3%, 1.3% vs. 1.3% and 1.3% vs. 1.3%, respectively; all P>0.05). CONCLUSION: On top of aspirin and clopidogrel, upstream application of tirofiban is associated with increased platelet aggregation inhibition but the incidences of MACE up to 180 days post tirofiban are similar in the upstream and downstream tirofiban treated patients with high-risk NSTE-ACS after PCI. Aging, hypertension and type-2 diabetes were independent risk factors of MACE in these patients.

Comparison of drug-eluting stents and coronary artery bypass grafting for the treatment of multivessel coronary artery disease in patients with chronic kidney disease.

BACKGROUND: Chronic kidney disease (CKD) is a strong predictor of mortality after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), but the relative efficacy of the 2 revascularization strategies in this context remains unknown. METHODS AND RESULTS: The 1,069 patients with CKD undergoing revascularization for multivessel coronary disease were evaluated. Of them, 532 patients were treated for 2-vessel disease (97 CABG, 435 PCI) and 537 for 3-vessel disease (248 CABG, 289 PCI). CKD was defined as estimated glomerular filtration rate <60 ml/min. No differences between the PCI and CABG groups in the 2-vessel population were observed in the composite of death, myocardial infarction (MI) or cerebrovascular events (10.6% vs 8.2%, P=0.493) and repeat revascularization (6.7% vs 3.1%, P=0.181) during the 2-year follow-up. In the 3-vessel population, patients undergoing PCI showed similar rate for the composite endpoint (6.7% vs 3.1%, P=0.181), but had a higher incidence of repeat revascularization (12.5% vs 4.4%, P=0.001) compared with the CABG group. After multivariate adjustment, revascularization strategy was not an independent predictor of the composite endpoint. CONCLUSIONS: Compared with PCI with a drug-eluting stent, CABG showed a similar incidence of death, MI or cerebrovascular events in patients with multivessel disease and CKD, but was associated with decreased repeat revascularization in the 3-vessel population.

Impact of clopidogrel resistance on thrombotic events after percutaneous coronary intervention with drug-eluting stent.

OBJECTIVES: This study examines whether patient resistance to clopidogrel is associated with long-term thrombotic events after elective coronary drug-eluting stent (DES) implantation. METHODS: We prospectively enrolled 386 patients with stable angina who received elective percutaneous coronary intervention (PCI) with DES. Before the procedure, platelet reactivity was measured by light transmittance aggregometry (LTA) at baseline and approximately 24 h after the 300 mg loading dose of clopidogrel. Clopidogrel resistance was conservatively defined as < or = 10% absolute difference between baseline and post-treatment platelet aggregation. All patients received chronic dual antiplatelet treatment (aspirin 300 mg and clopidogrel 75 mg daily) for 12 months. Patients were followed for 1 year after coronary stenting for the occurrence of composite thrombotic events, including cardiovascular death, non-fatal myocardial infarction (MI), stent thrombosis or cerebrovascular ischemic accident (CVA). RESULTS: Clopidogrel resistance was present in 65 patients (16.8%). During follow-up, composite thrombotic events occurred in 16.9% of clopidogrel resistant patients, yet in only 6.2% of non-resistant patients (p = 0.010). The incidence of definite or probable stent thrombosis was 9.2% in clopidogrel resistant patients and 2.5% in non-resistant patients (p = 0.018). After adjustment for other factors that affect cardiovascular outcome, clopidogrel resistance, diabetes, and left ventricular (LV) dysfunction were independently associated with 1-year composite thrombotic events. The hazard ratio (HR) for clopidogrel resistance was 2.44 (95% CI = 1.09 to 5.45; p = 0.031). CONCLUSION: This study demonstrates the natural history of clopidogrel resistance among patients with stable cardiovascular disease, and shows that this resistance is an independent predictor of thrombotic events in patients undergoing PCI with DES.

[Safety and feasibility of transradial coronary angiography at the outpatient clinic].

OBJECTIVE: To evaluate the safety and feasibility of transradial coronary angiography at the outpatient clinic. METHODS: From February 2007 to June 2007, 100 outpatients who received transradial coronary angiography in Anzhen hospital were included in this analysis, 100 inpatients underwent coronary angiography were selected as control group. Primary endpoints included success rate, percent of angiographic catheter use with different diameters, adverse events during the procedure (such as death, malignant arrhythmia, acute myocardial infarction, coronary artery spasm, coronary artery dissection, perforation or occlusion, etc.) and after the procedure (such as death, acute myocardial infarction, upper limb haematoma, osteofascial compartment syndrome, radial artery pseudoaneurysm or occlusion, etc.). RESULTS: The success rate (100% vs. 100%), procedure duration time [(12.5 +/- 3.4) min vs.(10.8 +/- 3.6) min, P = 0.517] and exposition time [(4.3 +/- 1.0) min vs. (4.1 +/- 1.0) min, P = 0.629] were similar between the outpatient and inpatient groups. Radial and coronary artery spasm were the main adverse events during the angiography, and haematoma was the main adverse event after the angiography. There were no significant differences of adverse events between the 2 groups. The total cost of the outpatient group was significantly lower than the inpatient control group [(4012 +/- 238) yuan vs. (5329 +/- 371) yuan, P < 0.001]. Expenditure including chemical tests, medicine, nursing care, room and board all decreased significantly. CONCLUSION: Transradial coronary angiography application at the outpatient clinic was safe and feasible for stable patients, and this procedure could decrease the medical expenditure and shorten the admission time.

[Comparison between drug eluting stent and coronary artery bypass grafting surgery for the treatment of unprotected left main coronary artery disease in elderly patients].

OBJECTIVE: To compare the 2 years outcome of elderly patients with ULMCA stenosis undergoing coronary artery bypass grafting (CABG) or drug eluting stent (DES). METHODS: From January 2004 to June 2006, 295 patients with ULMCA stenosis and age > or = 70 years undergoing coronary revascularization with either CABG (n = 206) or DES (n = 89) were enrolled in this analysis. All-cause death, non-fatal myocardial infarction and target lesion revascularization (TLR) were recorded during 2 years follow-up. RESULTS: The cumulative rate of 2-year mortality were 10.2% (n = 21) in CABG-treated patients and 13.3% (n = 12) in DES-treated patients (P = 0.428). The survival rate during 2-year follow-up was 89.2% for CABG-treated patients and 86.4% for DES-treated patients (P = 0.668). The incidence of 2-year myocardial infarction was 7.8% (n = 16) in CABG-treated patients and 10.1% (n = 9) in DES-treated patients (P = 0.501). The incidence of target lesion revascularization (TLR) was 4.9% (n = 10) in CABG-treated patients and 13.5% (n = 12) in DES-treated patients (P = 0.015). In the multivariable analysis, age (HR: 1.04, 95% CI: 1.01-1.09, P = 0.024), left ventricular dysfunction (ejection fraction < 30%, HR: 4.97, 95% CI: 1.22-24.85, P = 0.018) and type 2 diabetes (HR: 2.22, 95% CI: 1.31-4.86, P = 0.001) were independent predictors of 2-year mortality. CONCLUSION: In this study, 2-year mortality was comparable in elderly patients with ULMCA stenosis underwent CABG or DES. However, the rate of TLR was significantly higher in patients treated with DES than that receiving CABG operation.

A prospective, double-blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention.

OBJECTIVES: This study was undertaken to compare the renal safety as well as cardiovascular (CV) effects and diagnostic image quality of iso-osmolar iodixanol vs. low-osmolar iopromide in patients with chronic kidney disease (CKD) undergoing coronary interventions. BACKGROUND: With the growing number of contrast-enhanced procedures being performed for coronary artery disease management, the safety and efficacy of iodinated contrast media (CM) have come under increased scrutiny. METHODS: : Patients with CKD (CrCl < or =60 mL/min) were randomized to iodixanol (n = 106) or iopromide (n = 102). The primary endpoint was incidence of contrast-induced nephropathy (CIN), defined as an increase in serum creatinine (SCr) > or =25% or 0.5 mg/dL within 72 hr of CM administration. Secondary endpoints were mean SCr increase, a composite of CV events in-hospital and 30 days postdischarge, and diagnostic image quality. RESULTS: : CIN incidence was significantly lower with iodixanol than iopromide (5.7% vs. 16.7%; P = 0.011). Baseline SCr (OR 2.21, 95% CI: 1.25-3.47; P = 0.031), iopromide use (OR 2.56, 95% CI: 1.18-5.76; P = 0.024), and CM volume (OR 2.01, 95% CI: 1.01-3.21; P = 0.038) were identified as independent risk factors for CIN. Cardiovascular events were reduced with iodixanol (1.9% vs. 8.8%; P = 0.025); diagnostic image quality was similar for both CM (P = 0.353). CONCLUSIONS: : Consistent with several previous trials comparing iso-osmolar iodixanol and low-osmolar comparator CM, iodixanol was associated with a lower incidence of CIN and fewer CV events than iopromide.

Safety and feasibility of transradial approach for primary percutaneous coronary intervention in elderly patients with acute myocardial infarction.

BACKGROUND: Transradial coronary intervention has been widely used because of its effects in lowering the incidence of complications in vascular access site and improving patient satisfaction compared to the femoral approach. This study aimed to investigate the safety and feasibility of transradial approach for primary percutaneous coronary intervention (PCI) in elderly patients with acute myocardial infarction (AMI). METHODS: A total of 103 consecutive elderly patients (age = 65 years) who were diagnosed as having AMI were indicated for PCI. Among them, 57 patients received primary PCI via the transradial approach (transradial intervention, TRI group), and 46 underwent primary PCI via the transfemoral approach (transfemoral intervention, TFI group). The success rate of puncture, puncture time, cannulation time, reperfusion time, the total time for PCI, the success rate of PCI, the use rates of temporary pacemaker and intra-aortic balloon pump (IABP), and the total length of hospital stay of the patients in the two groups were compared. After the procedure, vascular access site complications and major adverse cardiovascular events (MACE) in the two groups in one month were observed. RESULTS: The success rates of puncture (98.2% vs 100.0%) and PCI (96.5% vs 95.7%) for the patients in the TRI and TFI groups were not statistically significant (P > 0.05). The puncture time ((2.4 +/- 1.1) vs (2.0 +/- 0.9) minutes), cannulation time ((2.7 +/- 0.5) vs (2.6 +/- 0.5) minutes), reperfusion time ((16.2 +/- 4.5) vs (15.4 +/- 3.6) minutes), total time of the procedure ((44.1 +/- 6.8) vs (41.2 +/- 5.7) minutes), use rates of temporary pacemaker (1.8% vs 2.2%) and IABP (0 vs 2.2%) in the two groups were not statistically significant (P > 0.05), but the hospital stay of the TFI group was longer than that of the TRI group ((10.1 +/- 4.6) vs (7.2 +/- 2.6) days, P < 0.01). A radial occlusion was observed in the TRI group, but no ischemic syndrome in hand. In the TFI group, 4 patients had hematosis, 1 had pseudoaneurysm, and 1 had major bleeding. Statistical significance in vascular access site complications was seen in the two groups (1.8 % vs 13.1%, P < 0.05). Three patients died in the two groups respectively in one month, and there was no statistical significance in MACE in the two groups (5.3% vs 6.5%, P > 0.05). CONCLUSION: The transradial approach for primary PCI is safe and feasible for elderly patients with AMI.

Long-term outcome of patients of over 85 years old with acute coronary syndrome undergoing percutaneous coronary stenting: a comparison of bare metal stent and drug eluting stent.

BACKGROUND: Patients aged over 85 years have been under-represented in percutaneous coronary intervention (PCI) trials despite an increase in referrals for PCI. The long-term safety and efficacy of percutaneous coronary stenting in patients aged over 85 years with acute coronary syndrome (ACS) remain unclear. Moreover it is unknown whether there are differences between bare metal stent (BMS) and drug eluting stent (DES) in this special population. METHODS: A total of 80 patients with ACS aged over 85 years undergoing stenting (BMS group n = 21 vs DES group n = 59) were retrospectively studied. In-hospital, one year and overall clinical follow-up (12 - 36 months) of major adverse cardiac events (MACEs) including cardiac deaths, myocardial infarction, target lesion revascularization (TLR) and target vessel revascularization (TVR) as well as stroke and other major bleeding were compared between the two groups. RESULTS: In the entire cohort, the procedure success rate was 93.8% with TIMI-3 coronary flow post-PCI in 93.8% of the vessels and the procedure related complication was 17.5%. The incidence of in-hospital MACEs in BMS group was higher (14.3% vs 6.8%, P = 0.30). The 1-year incidence of MACEs in DES group was 7.0% while there was no MACE in the BMS group. Clinical follow-up for 12 - 36 months showed that the overall survival free from MACE was 82.9% and the incidence of MACE in the BMS group was lower (5.3% vs 21.1%, P = 0.20). Multivariate regression analysis showed that the creatinine level (OR: 1.013; 95% CI: 1.006 - 1.020; P = 0.004) and hypertension (OR: 3.201; 95% CI: 1.000 - 10.663; P = 0.04) are two major factors affecting the long-term MACE. CONCLUSIONS: Percutaneous coronary stenting in patients aged over 85 years is safe and provides good short and long-term efficacy. Patients with renal dysfunction and hypertension may have a relatively high incidence of MACE.

Transradial approach for coronary angioplasty in Chinese elderly patients.

BACKGROUND: The radial artery is currently regarded as a useful vascular access site for coronary procedures. This study was conducted to investigate the feasibility and safety of the percutaneous radial artery approach for angioplasty in the elderly. METHODS: Two thousand and fifty-eight consecutive patients (762 elderly, age = 65 years; and 1296 non-elderly, age < 65 years, respectively) who underwent transradial coronary angioplasty were recruited in this study. Study endpoints included procedure success rate, procedure time, vascular complications at access site, and major adverse cardiac and cerebrovascular events during hospitalization. RESULTS: Elderly patients were more likely to present with unstable angina and renal dysfunction. The incidence of radial and brachiocephalic trunk anatomical tortuosity was higher in elderly patients than that in non-elderly patients (11.5% vs 3.7%; 8.9% vs 2.6%, P < 0.01, respectively). However, procedural success rate (94.7% vs 95.6%) and total mean procedure time ((67.9 +/- 27.3) minutes vs (58.6 +/- 38.5) minutes) for transradial coronary angioplasty were not significantly different between the two groups. Clinical course during the hospitalization was slightly worse in the elderly patients because of more adverse cardiac and cerebrovascular events after the procedure. However, the incidence of vascular complications was not significantly different between the elderly and non-elderly patients. CONCLUSION: Although the incidence of radial and brachiocephalic trunk anatomical tortuosity is higher in elderly patients, transradial coronary intervention can be performed with similar safety and procedural success in these patients as compared with non-elderly patients.

[Incidence and risk factors of acute radial artery occlusion following transradial percutaneous coronary intervention].

OBJECTIVE: To elucidate the incidence and risk factors of acute radial artery occlusion (RAO) following transradial percutaneous coronary intervention (TRI). METHODS: A total of 7215 patients who underwent TRI were divided into normal group and RAO group, according to whether the patient without and with RAO. Risk factors of RAO were analyzed by logistic regression model. RESULTS: Acute RAO occurred in 68 patients (0.94%). As compared to the patients in normal group, there were more female and diabetes mellitus patients in RAO group. The dosage of heparin used in the operational procedure in RAO group were significantly less than normal group (3723 IU +/- 556 IU vs 7603 IU +/- 1533 IU, P < 0.01). The post-procedure duration of high-pressure compression hemostasis were longer in RAO patients than normal patients (103.8 min +/- 23.3 min vs 87.7 min +/- 31.2 min, P = 0.02). Logistic regression analyses showed that the dosage of heparin used in the procedure, the category and size of sheath and the post-procedure compression time were independent risk factors for RAO. CONCLUSION: The incidence of RAO can be minimized by appropriate anticoagulation, proper sheath selection, and avoiding prolonged duration of high-pressure compression hemostasis following the procedure.

Rosiglitazone could improve clinical outcomes after coronary stent implantation in nondiabetic patients with metabolic syndrome.

BACKGROUND: Recent studies have shown that thiazolidinediones (TZDs) could reduce in-stent restenosis and improve clinical outcomes in patients with type 2 diabetes after coronary stent implantation. It remains unclear whether nondiabetic patients with metabolic syndrome after stenting could also benefit from the treatment with TZDs. METHODS: Three hundred and sixty patients with metabolic syndrome who underwent coronary stent implantation were randomly assigned to a rosiglitazone group (n = 180) or a control group (n = 180). Patients in the rosiglitazone treatment group were treated with rosiglitazone 1 day before coronary stenting (4 mg once daily) and treatment was continued until the 9 months follow-up; while in the control group, patients were treated with placebo 1 day before the procedure and until the 9 months follow-up. Adverse events were death, myocardial infarction and urgent target vessel revascularization within 9 months after coronary stenting. RESULTS: One hundred and fifty two patients in the rosiglitazone group and 145 patients in the control group survived during the follow-up. Baseline characteristics among patients in the two groups were well balanced. There was no significant difference in target vessels or the procedure of stent implantation. Compared with the control group, treatment with rosiglitazone was associated with a lower rate of death, myocardial infarction and urgent target vessel revascularization (7.2% vs 14.5%, P = 0.044). CONCLUSION: Rosiglitazone could reduce the risk of the adverse cardiovascular event and improve clinical outcomes in nondiabetic patients with metabolic syndrome after coronary stent implantation.