Dual antiplatelet therapy over 6 months increases the risk of bleeding after biodegradable polymer-coated sirolimus eluting stents implantation: insights from the CREATE study.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains controversial. The primary aim of our study was to evaluate the impact of optimal DAPT duration on bleeding events between 6 and 12 months after biodegradable polymer-coated DES implantation. The secondary aim is to determine the predictors and prognostic implications of bleeding. METHODS: This study is a post hoc analysis of the Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents (CREATE) study population. A total of 2,040 patients surviving at 6 months were studied, including 1,639 (80.3%) who had received 6-month DAPT and 401 (19.7%) who had received DAPT greater than 6 months. Bleeding events were defined according to the bleeding academic research consortium (BARC) definitions as described previously and were classified as major/minor (BARC 2-5) and minimal (BARC 1). A left censored method with a landmark at 6 months was used to determine the incidence, predictors, and impact of bleeding on clinical prognosis between 6 and 12 months. RESULTS: At 1-year follow-up, patients who received prolonged DAPT longer than 6 months had a significantly higher incidence of overall (3.0% vs. 5.5%, P = 0.021) and major/minor bleeding (1.1% vs. 2.5%, P = 0.050) compared to the patients who received 6-month DAPT. Multivariate analysis showed that being elderly (OR = 1.882, 95% CI: 1.109-3.193, P = 0.019), having diabetes (OR = 1.735, 95% CI: 1.020-2.952, P = 0.042), having a history of coronary artery disease (OR = 2.163, 95% CI: 1.097-4.266, P = 0.026), and duration of DAPT longer than 6 months (OR = 1.814, 95% CI: 1.064-3.091, P = 0.029) were independent predictors of bleeding. Patients with bleeding events had a significantly higher incidence of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis. CONCLUSIONS: Prolonged DAPT (greater than 6 months) after biodegradable polymer-coated DES increases the risk of bleeding, and is associated with adverse cardiac events at 1-year follow-up. (J Interven Cardiol 2014;27:119-126).

[Clinical efficacy of intra-aortic balloon pumping in treating patients with acute myocardial infarction with left main coronary artery disease].

OBJECTIVE: To evaluate the efficacy and safety of intra-aortic balloon pump (IABP) counter pulsation in the treatment of ST-segment elevation myocardial infarction (STEMI) with concurrent left main coronary artery (LMCA) disease. METHODS: A retrospective analysis was performed on 305 patients with confirmed STEMI due to LMCA occlusion (≥ 50%) by coronary angiography. They were divided into IABP and non-IABP groups according to the application of IABP or not. Two groups were further divided into 2 subgroups according to the treatment with percutaneous coronary intervention (PCI) or drug alone. Short and long-term clinical efficacies and the incidence of complications caused by the application of IABP were analyzed in all groups and subgroups. RESULTS: (1) PCI procedure: Successful rate of immediate post-procedure was 100%. No death, major cardiovascular event and cerebrovascular accident occurred during the procedure. The average number of stents per patient was 2.1 ± 0.7 and the average diameter and length of stent were (3.9 ± 0.6) and (24.2 ± 7.1) mm respectively. (2) SAFETY: No significant difference existed between the IABP and non-IABP groups in in-hospital massive bleeding rate (0.94% vs 1.00%, P > 0.05). However, the IABP group had a higher prevalence of mild in-hospital bleeding than the non-IABP group. (3) In-hospital and long-term major adverse cardiac event (MACE) rate: (1) IABP group had a lower MACE rate (25.3% (24/95) vs 38.5% (57/148), P < 0.05). (2) In spite of IABP implantation, the PCI subgroup had significantly a lower mortality rate than the drug subgroup (7.2% (6/83) vs 25.0% (6/24), P < 0.05). (3) The combined use of PCI and IABP was superior to other regimens with regards to decreasing short and long-term mortality (11.2% (12/107) and 25.3% (50/198), P < 0.01). CONCLUSION: PCI is feasible and safe for the STEMI patients with LMCA and better short and long-term efficacies may be achieved. The use of IABP in the treatment of LMCA-related STEMI reduces MACE rate and improves survival rate.

[Effects of intensive antiplatelet therapy for patients with high on-treatment platelet reactivity after coronary stent implantation].

OBJECTIVE: To explore the effects of intensive antiplatelet therapy for patients with high on-treatment platelet reactivity (HPR) after coronary stent implantation. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

[Therapeutic effect and safety of drug eluting stent for patients with acute ST-elevation anterior wall myocardial infarction by left anterior descending artery occluded abruptly].

OBJECTIVE: To assess the therapeutic effect and safety of drug eluting stent for the patients with anterior wall myocardial infarction by left anterior descending artery occluded abruptly. METHODS: From January 2004 to December 2008, 302 patients with anterior wall myocardial infarction in 12 hours from chest pain to treatment were treated. But only 189 patients were recruited and randomly divided into drug eluting stent group (n = 95) and bare metal stent group (n = 94). The occurrence of cardiac death, stent thrombosis, reinfarction, target vessel revascularization and re-hospitalization because of heart function failure was compared. RESULTS: There was no difference in cardiac death [3/95 (3%) vs 7/94 (7%), P = 0.206], reinfarction [1/95 (1%) vs 5/94 (5%), P = 0.112] and re-hospitalization because of heart function failure [8 (8%) vs 5 (5%), P = 0.434]. Compared with those in bare metal stent group, the patients in drug eluting stent group has a lower rate of target vessel revascularization [2 (2%) vs 13 (14%), P = 0.009] and composite therapeutic effect endpoints [12 (13%) vs 25 (27%), P = 0.011]. There was no difference in safety endpoint or stent thrombosis [1 (1%) vs 4 (4%), P = 0.204]. CONCLUSION: In patients with anterior wall myocardial infarction by left anterior descending artery occluded abruptly, drug eluting stent decreases the rate of target vessel revascularization. But it has no increased stent thrombosis.

[Long-term clinical outcomes of patients undergoing successful or failed percutaneous coronary intervention for chronic total occlusions of coronary arteries].

OBJECTIVE: To evaluate the long-term outcomes of successful or failed revascularization in patients with chronic total occlusions (CTO). METHODS: 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). RESULTS: 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). CONCLUSION: Successful PCI procedure leads to increased long-term survival and MACE-free survival and the reduced need for CABG for patients with CTO lesions.

[Outcome of percutaneous coronary intervention of graft occlusion post coronary artery bypass graft].

OBJECTIVE: To evaluate the feasibility and efficacy of percutaneous coronary intervention (PCI) for graft occlusion post coronary artery bypass graft (CABG). METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Multi-wire plaque crushing as a novel technique in treating chronic total occlusions.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

[Acute angiographic and clinical outcomes of patients with calcified chronic total occlusion underwent percutaneous coronary intervention].

OBJECTIVE: To evaluate the in-hospital outcome of patients with calcified chronic total occlusion (CTO) lesion underwent percutaneous coronary intervention (PCI). METHODS: 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. RESULTS: 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). CONCLUSION: 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.

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.

BACKGROUND: 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. METHODS: 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. RESULTS: Compared to the NSTEMI patients, the patients with STEMI had significantly higher rates of Killip class≥III (21.2% vs. 3.5%, χ2 = 36.253, P < 0.001) and cardiac arrest (8.3% vs. 3.5%, χ2 = 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. CONCLUSIONS: 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.

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.

BACKGROUND: 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. METHODS: 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 P2Y12reaction 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. RESULTS: 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 (χ2 = 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 (χ2 = 1.587, P = 0.208). CONCLUSIONS: 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.

Midterm outcomes of prospective, randomized, single-center study of the Janus tacrolimus-eluting stent for treatment of native coronary artery lesions.

BACKGROUND: Long-term efficacy and safety of tacrolimus-eluting stent (Janus) for treatment of coronary artery disease in percutaneous coronary interventions (PCI) "real world" is uncertain. The aim of this study was to evaluate the efficacy and safety of Janus stent for treating coronary heart disease in PCI daily practice, the safety of 4-month clopidogrel therapy after Janus stent implantation and the feasibility for treating patients with acute myocardial infarction (AMI) for first time. METHODS: From February 20, 2006 to August 26, 2006, a total of 200 patients were enrolled and randomly assigned to receive either Janus stent (n = 100) or bare metal stent (Tecnic Carbostent, n = 100). All patients were administered with clopidogrel for 4 months and aspirin for life long after stenting. RESULTS: Baseline clinical and angiographic characteristics were comparable between the two groups. AMI was present in 37% of patients with Janus and 36% with Tecnic Carbostent. At an average of 246-day follow-up, major adverse cardiac events (MACE) was 6% with the Janus stent and 15% with the Tecnic Carbostent (P = 0.038). Primary events included 1 cardiac death, 1 myocardial infarction (MI) due to subacute stent thrombosis and 13 target lesion revascularizations (TLR) due to restenosis in patients with Tecnic Carbostent and 6 TLR due to restenosis in patients with Janus stent. Although all patients had discontinued clopidogrel for an average of 126 days, there was no additional thrombotic event in the two groups. CONCLUSIONS: Janus stent is efficient in reducing MACE compared with Tecnic Carbostent at an average of 8-month follow-up. Discontinuation of clopidogrel at 4 months after PCI is safe for patients with Janus stent, including AMI patients. Long-term efficacy of Janus stent in reducing restenosis requires further study.

[Efficacy of stenting for selective unprotected left main coronary artery disease: two-year follow-up of 416 patients].

OBJECTIVE: To evaluate the safety and effectiveness of stenting for selective unprotected left main coronary artery (ULMCA) disease. METHODS: The clinical data of 416 patients with ULMCA who underwent selective percutaneous coronary intervention (PCI) were analyzed. RESULTS: In 291 of the 416 patients (70.0%), the ULMCA lesions were located in the distal bifurcation site. A total of 503 stents were successfully deployed in 414 patients and the mean stent number was (1.2+/-0.7) stents per patient. The success rate of stenting procedure was 99.5%. During hospital stay, no patient died. The major adverse cardiac event (MACE) during in-hospitalization was 0.5% (2/416). The target lesion revascularization (TLR) rate was 4.9%. During the follow-up 16 (3.9%) patients died including 12 cases (2.9%) of cardiac death. Angiography during follow-up conducted on 136 (33.1%) patients showed that binary in-stent restenosis occurred in 20 patients (14.7%, 20/136). TLR was performed by coronary artery bypass graft in 14 patients and by drug eluting stent (DES) implantation in 6 patients respectively. The total MACE rate was 8.3% (34/411). CONCLUSION: Safe and with favorable clinical outcome, selective coronary stenting for ULMCA lesions can achieve a high technical success rate.

Lipid-modifying therapy in diabetic patients with high plasma non-high-density lipoprotein cholesterol after percutaneous coronary intervention.

OBJECTIVE: To investigate the effects of atorvastatin on long-term prognosis in diabetic patients with high plasma levels of non-high-density lipoprotein cholesterol (non-HDL-C) after percutaneous coronary intervention (PCI). METHODS: A total of 648 diabetic patients with high plasma levels of non-HDL-C who had undergone successful PCI were randomly assigned to therapy group (n=327, atorvastatin, 20 mg/day) or control group (n=321, without any lipid-modifying therapy). Study end points included all-cause death, fatal or nonfatal myocardial infarction (MI), and revascularization. RESULTS: The median follow-up was 21+/-2.9 months. Rates of MI (6.4% versus 12.3%, P=0.013), revascularization (19.2% versus 26.6%, P=0.029) and composite end points (26.9% versus 41.5%, P<0.001) were significantly lower in the atorvastatin group compared with those of the control group, although mortality rate (5.1% versus 7.9%, P=0.196) was not. Patients treated with atorvastatin had significantly improved adjusted event-free survival rate than controls (hazard ratio 0.52, 95% CI 0.30 to 0.91, P=0.022). CONCLUSION: Diabetic patients with high plasma levels of non-HDL-C should receive long-term lipid-modifying drugs after PCI to reduce MI and revascularization rates.

Percutaneous coronary intervention for chronic total occlusion in 1263 patients: a single-center report.

BACKGROUND: Coronary chronic total occlusion (CTO) remains one of the most challenging lesion subsets in interventional cardiology, even with the development of medical device and operator expertise. This study was conducted to examine the relationship between lesion characteristics and procedural success and the incidence of in-hospital major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) for CTO. METHODS: Clinical and coronary angiographic data of 1263 patients with CTO who underwent PCI between June 1995 and December 2005 in Shenyang General Hospital of PLA were retrospectively analyzed. RESULTS: There were 1625 CTO lesions located in 1596 vessels with a mean occlusion time of 48.9 months. A total of 1647 coronary stents were implanted to the target lesions. The overall patient and lesion success rates were 90.8% (1147/1263) and 88.9% (1445/1625), respectively. The success rate of PCI was declined with long duration of occlusion, abrupt missing stump, bridging collaterals > or = 15 mm in occluded length, moderate to severe calcification or tortuosity and ostial or distal location of CTO lesions (P < 0.05). Procedural failure occurred in 116 patients, caused by impossibility of guide-wire (81.0%) or balloon (19.0%) to pass through the occlusion. There was no death during procedure, but 2 patients suffered from acute stent thrombosis and other 9 patients had acute or late pericardial perforation. Those complications were all successfully treated. After procedure, 3 patients died, 4 experienced urgent target vessel revascularization because of subacute stent thrombosis and 1 underwent coronary bypass graft surgery due to coronary fistula during in-hospital period. The overall in-hospital MACE rate was 0.6% (8/1263). Drug-eluting stents were used in 198 patients without in-hospital MACE. CONCLUSIONS: In an experienced heart center, it is possible to obtain a relatively high success rate of PCI and favorable clinical outcomes for patients with coronary CTO lesions.

Efficacy of stenting for unprotected left main coronary artery disease in 297 patients.

BACKGROUND: Angioplasty in the unprotected left main coronary artery (LMCA) has been controversial. This study aims to evaluate the safety and clinical effectiveness of stenting, including bare metal stent and drug eluting stent (DES), for treatment of unprotected LMCA disease. METHODS: Between September 1997 and December 2005, a total of 297 consecutive patients underwent percutanous coronary intervention (PCI) on LMCA lesions in our hospital. Their in-hospital data and clinical follow-up outcomes were analyzed and those in pre-DES "era" (group I, from September 1997 to December 2002) were compared with those in DES "era" (group II, from January 2003 to December 2004. Patients in 2005 for the time of follow-up less than one year were not included in this group). RESULTS: Altogether 368 coronary stents were successfully deployed in 295 patients. Stents failed to be implanted after balloon predilation in two patients, who received coronary artery bypass graft (CABG) successfully. Bifurcation techniques for distal LMCA executed in 206 patients (69.4%, 206/297), included crossover stenting in 156 (75.7%), T stenting in 4 (1.9%), provisional T stenting in 28 (13.6%), kissing stenting in 5 (2.4%) and stent crushing in 13 (6.3%) patients. During their hospital stay, 5 (1.7%) patients died after PCI procedure, of which 4 died from cardiac origin and one of renal failure. The total in-hospital major adverse cardiac events (MACE) were 2.0% (6/297). In the follow-up period, 19 patients (6.5%) died [15 (5.1%) of cardiac death and 4 of non-fatal myocardial infarction (MI)]. Besides, 2 (0.7%) developed subacute thrombosis (SAT) and 16 (5.4%) performed target lesion revascularization (TLR). The total follow-up MACE was 14.5% (43/297). Further analysis also showed that, compared with patients in group I, those in group II apparently had more multi-vessel involvement (14.7% vs 81.9%, P < 0.001), and more bifurcation lesions (32.4% vs 72.2%, P < 0.001). After PCI, in-hospital MACE of group II was significantly lower than that in group I (1.1% vs 9.4%, P < 0.05). And the incidences of MACE, TLR and angiographic restenosis in group II were all significantly lower than those in group I (all P < 0.05) after one year follow-up. CONCLUSIONS: As new PCI strategies and intervention devices such as DES are developed, coronary stenting, which might have brought better in-hospital and long-term outcomes than CABG, are proved to be technically successful and can be safely applied for the treatment of LMCA lesions in the experienced center for coronary intervention.

[Short-term outcomes of triple antiplatelet therapy after percutaneous coronary intervention].

OBJECTIVE: To evaluate short-term efficacy and safety of triple antiplatelet regimen (cilostazol combined with clopidogrel and aspirin) in patients who underwent percutaneous coronary intervention (PCI). METHODS: From October 2001 to April 2005, a total of 3135 patients underwent PCI in the General Hospital of Shenyang Command, People's Liberation Army, of which 1103 were treated with cilostazol 100 mg twice a day for 6 months in addition to aspirin and clopidogrel for 3 - 12 months as triple antiplatelet therapy regimen (triple group) after PCI, and 2032 of which received aspirin and clopidogrel for 3 - 12 months as dual antiplatelet therapy regimen after PCI (control group). The data of the incidence rates of major adverse cardiac events (MACE), subacute in-stent thrombosis (SAT), and hemorrhage events within 30 days after PCI of the two groups were retrospectively analyzed. RESULTS: The baseline clinical characteristics were comparable between these two groups. However, the proportions of the patients receiving stent implantation, with multivessel coronary artery diseases, and receiving PCI for unprotected left main trunk diseases of the triple group (91.3%, 68.3%, and 7.1% respectively) were all significantly higher than those of the control group (89.1%, 63.3%, and 4.6%, P < 0.05, P < 0.01, and P < 0.01). The proportion of patients with chronic total occlusions who received PCI in the triple group was 10.8%, significantly lower than that of the control group (13.4%, P < 0.05). No death occurred during procedure in both groups. The 30 d mortality and the rate of MACE with 30 days after PCI of the triple group were 0.4% and 1.3%, both significantly lower than those of the control group (1.6%, and 2.6%, both P < 0.05). However, there were no significant differences in the incidence rates of SAT and major hemorrhage events between these 2 groups (0.7% vs 1.0% and 0.3% vs. 0.2% respectively, both P > 0.05). CONCLUSION: This novel triple antiplatelet regimen (aspirin and clopidogrel combined with cilostazol) for PCI patients is safe and more efficient than the dual antiplatelet therapy regimen (clopidogrel and aspirin) in reducing mortality and incidence of MACE in a short-term period.

[Post primary percutaneous coronary intervention no-reflow in patients with acute myocardial infarction: contributing factors and long-term prognostic impact].

OBJECTIVE: To elucidate the relative factors and prognostic impact for angiographic no-reflow phenomenon during primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). METHODS: A total of 930 patients with AMI who underwent primary PCI were divided into no-reflow group and normal-reflow group. Factors related to no-reflow were analyzed by logistic regression model and major adverse cardiac events (MACE) in-hospital as well as during long-term follow-up was also observed. RESULTS: No-reflow occurred in 82 out of 930 patients. Admission glucose level (9.8 +/- 4.3 mmol/L vs. 8.5 +/- 3.5 mmol/L, P = 0.001), peak CK-MB value (369.4 +/- 167.8 U/L vs. 282.3 +/- 161.7 U/L, P < 0.01) and percentage of TIMI flow grade 0 on initial angiogram (69.5% vs. 54.5%, P = 0.009) were significantly higher and pre-infarction angina (19.5% vs. 48.1%, P < 0.01) was significantly lower in no-flow patients than normal flow patients. Logistic regression analyses showed that admission glucose level, absence of pre-infarction angina, TIMI flow grade 0 on initial angiogram and pump failure were independent predictors of no reflow. In-hospital MACE (37.8% vs. 11.3%, P < 0.01) and follow-up MACE (37.5% vs. 17.4%, P < 0.01) were also significantly higher in no-flow patients than normal flow patients. Multivariate Cox regression analysis revealed that no-reflow was an independent predictor of long-term cardiac death (relative risk 3.83, 95% confidence interval 1.71 to 5.57). CONCLUSION: Admission glucose level, absence of pre-infarction angina, TIMI flow grade 0 on initial angiogram and pump failure were independent risk factors for no-reflow and no-flow is an independent predictor for increased in-hospital and follow-up MACE.

[Clinical characteristics and management of patients with acute or subacute coronary in-stent thrombosis].

OBJECTIVE: To determine risk factors and evaluate the efficacy of emergent PCI for acute or subacute coronary in-stent thrombosis. METHODS: Baseline and follow-up data of 6977 patients who underwent stent implantation in our institution between January 2000 and May 2006 were analyzed. RESULTS: Of 6977 patients, acute or subacute coronary in-stent thrombosis was confirmed in 52 (0.75%) patients by coronary angiogram. The in-stent thrombosis occurred between 30 minutes to 20 days post PCI (mean 3.6 +/- 4.2 days). Predictive factors for in-stent thrombosis showed by multivariate analysis were AMI, B2/C type lesions, multi-vessel diseases, heart failure and target lesions on left anterior descending artery (LAD). Among these 52 patients, 43 presented recurrent chest pain or ST elevation AMI, 6 suffered from cardiac arrests, 1 manifested hypotension and 2 showed no typical clinical symptoms and were diagnosed during scheduled PCI for other diseased vessels. Emergent coronary angiogram evidenced total thrombotic occlusion in 48 patients and 70% - 95% thrombotic stenosis in 4 patients. All 52 patients were treated with emergent PCI. Forty-seven patients survived and 5 patients died (mortality 9.6%). CONCLUSION: The risk of developing in-stent thrombosis was higher in patients with AMI, B2/C type lesions, multi-vessel diseases, heart failure and target lesions on LAD. Emergent PCI is the most effective method for treating in-stent thrombosis and should be carried out as early as possible in order to improve outcomes of this severe complication post stenting.

[Comparison of Rapamycin and Paclitaxel eluting stent in patients with multi-vessel coronary disease].

OBJECTIVE: To Compare the efficacy and safety of Rapamycin (Cypher) and Paclitaxel (TAXUS) eluting stents for multi-vessel coronary diseases. METHODS: From June 2003 to December 2004, a total of 416 patients with multi-vessel coronary diseases were randomly treated with Rapamycin (n = 210) and Paclitaxel (n = 206) eluting stents. Patients with left main lesion, acute myocardial infarction, revascularization were not included. Acute and long-term outcomes were compared between the two groups. RESULTS: Baseline clinical characteristics, including risk factors of coronary heart disease, coronary lesion type, heart function, rates of success and complication of percutaneous coronary intervention procedure in the two groups were comparable. Number of stents implanted was not significantly different between the two groups (3.24 +/- 1.25 vs 3.19 +/- 1.38, P > 0.05). Mean follow-up duration was (19.5 +/- 8.9) months. Follow-up rate (96.2 vs 95.1%), angina pectoris reoccurrence (4.0 vs 6.1%), restenosis (7.1 vs 9.6%), major adverse cardiac event (6.4 vs 8.8%) and event free survival (93.1 vs 91.3%) during follow-up were not significantly different between the two groups. Subacute stent thrombosis rate tended to be higher in Paclitaxel eluting stent group compared with Rapamycin eluting stent group (1.0% vs 0.5%, P > 0.05). At 6 to 9 months angiographic follow-up, the in-stent minimal lumen diameter (MLD) and the in-segment MLD were similar between the two groups. CONCLUSIONS: Satisfactory acute and long term outcomes for patients with multi-vessel coronary disease were achieved by both Cypher and TAXUS stent implantation and the safety and efficacy of the two kinds of stents were comparable.

Cost-Utility Analysis of Cataract Surgery in Advanced Glaucoma Patients.

PURPOSE: To assess the cost-effectiveness of cataract surgery in advanced glaucoma (AG) patients. MATERIALS AND METHODS: A total of 93 patients with AG who underwent cataract surgeries were collected prospectively from June 2010 through June 2013 in Shanghai First People's Hospital, Shanghai Jiao Tong University, Shanghai, and were followed up for at least 3 months. A standard phacoemulsification technique was used to remove cataract(s). No complications occurred intraoperatively or postoperatively. Costs associated with surgery were recorded. Utility values of cataract surgery were obtained by using time trade-off method. Quality-adjusted life-years (QALYs) were calculated using the patients' life expectancy at a 3% discounted rate. Incremental cost-utility analysis was performed (compared with no treatment) by calculating the incremental cost-effectiveness ratio (ICER), that is, the mean incremental cost for each QALY. The bootstrap method was used for statistical analysis, and sensitivity analyses were performed to test robustness of the results. RESULTS: The mean incremental cost of cataract surgery was 9876 Chinese yuan (CNY) [1593 US dollar (USD)] [95% confidence interval (CI), 9144-10,570 CNY (1475-1705 USD)].The mean additional QALYs gained were 2.20 (95% CI, 1.85-2.54), and the incremental cost for each additional QALY was 4508 CNY (727 USD) [95% CI, 3890-5234 CNY (627-844 USD)], far lower than the per capita annual disposable income in Shanghai, 40,188 CNY (6482 USD). CONCLUSION: For AG patients, cataract surgery does help obtain more QALYs and was highly cost effective.