BACKGROUNDWith the advent of drug-eluting stents (DES) and much lower rates of target vessel revascularization (TVR), whether adjunctive balloon postdilatation can further optimize outcome is still unknown. The present study was to compare the outcomes of postdilatation with un-postdilatation following deployment of DES.

METHODSFrom April 2004 to September 2006, 6479 consecutive Chinese patients who underwent DES implantation, including 1769 with postdilatation (1454 male, (57.9+/-10.8) years old) and 4710 without postdilatation (3819 male, (57.9+/-10.6) years old) were analyzed. Clinical and angiographic follow-up was performed at 7 months.

RESULTSCompared with the un-postdilatation group, the postdilatation group had more complex lesions and larger relevant vessel diameter (RVD). In the postdilatation group, in-stent residual restenosis was significantly improved right after the procedure ((16.80+/-5.88)% vs (19.60+/-6.07)%; P=0.000). There was no statistical difference in the major adverse cardiac events (MACE) rate between the groups (2.9% vs 3.3%; P=0.420), and there were also no statistical differences in death, acute myocardial infarction (AMI) and target lesion revascularization (TLR) rates in the two groups (0.1% vs 0.4%, P=0.127; 1.7% vs 1.3%, P=0.229; and 1.5% vs 2.0%, P=0.206, respectively). The in-stent thrombosis rate was almost the same in both groups (0.5% vs 0.5%; P=1.000). Seven months angiographic follow-up results showed that both in-stent and in-segment restenosis rates were lower in the postdilatation group (8.8% vs 15.6%, P=0.000; and 10.5% vs 17.3%, P=0.000), and so were in-stent and in-segment late loss ((0.32+/-0.12) mm vs (0.49+/-0.13) mm, P=0.000; and (0.24+/-0.08) mm vs (0.36+/-0.09) mm, P=0.001).

CONCLUSIONPostdilatation after DES deployment was safe and could reduce the restenosis rate, especially for more complex lesions.

Adult ; Aged ; Angioplasty, Balloon, Coronary ; Coronary Angiography ; Coronary Restenosis ; prevention & control ; Drug-Eluting Stents ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Thrombosis ; epidemiology

OBJECTIVETo observe the intervention effect of Liangxue Shengji Recipe (LSR) on incidence of post-percutaneous coronary intervention (post-PCI) restenosis and adverse cardiovascular events.

METHODSWith a randomized, single-blinded methods adopted, 100 patients with coronary artery disease (CHD) and underwent stent implantation were randomized into two groups, the control group and the treated group, conventional Western treatment was administered to them all, but with LSR to patients in the treated group additionally. They were followed up for at least six months. The incidences of post-PCI restenosis and adverse events, including cardiogenic death, acute myocardial infarction, recurrent angina pectoris, severe heart failure, further intervention and coronary artery bypass grafting, were observed to estimate the effect of LSR.

RESULTSNo statistically significant difference between the two groups was shown in terms of incidences of intra-stent restenosis, recurrent angina pectoris, estimator of restenosis and its cumulative risk, as well as in reducing the incidence of single adverse event, but did show statistically significant difference between groups in reducing the incidence of united cardiovascular event (P=0.032) and its cumulative risk (P=0.036).

CONCLUSIONAdministration of LSR in post-PCI stage could significantly reduce the probability and cumulative risk of united cardiovascular events, and the beneficial effect presents at about six months post-PCI.

Angioplasty, Balloon, Coronary ; Coronary Disease ; therapy ; Coronary Restenosis ; epidemiology ; prevention & control ; Drugs, Chinese Herbal ; therapeutic use ; Heart Valve Diseases ; epidemiology ; prevention & control ; Humans ; Incidence ; Phytotherapy ; Risk Factors ; Single-Blind Method

BACKGROUNDXS0601, consisting of active ingredients (Chuangxiongol and paeoniflorin), has been shown to inhibit arterial neointimal hyperplasia in animal models and in preliminary human studies. The objective of this study was to evaluate the safety and efficacy of XS0601 in preventing restenosis following percutaneous coronary intervention (PCI).

METHODSA multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 patients were randomized into treatment with the oral administration of XS0601, or a placebo for 6 months after successful PCI. Angiographic follow-up was scheduled at 6 months, and clinical follow-ups performed at 1, 3 and 6 months after PCI. The primary end point was angiographic restenosis. The secondary end points were the combined incidence of death, target lesion nonfatal myocardial infarction, repeat angioplasty, and coronary artery bypass graft surgery.

RESULTSA total of 308 patients (91.9%) completed the study and 145 cases (47.1%) received angiographic follow-up. The restenosis rates were significantly reduced in the XS0601 group as compared with the placebo group (26.0% vs. 47.2%, P < 0.05), and the minimum lumen diameter (MLD) was greater [(2.08 +/- 0.89) mm for XS0601 vs. (1.73 +/- 0.94) mm for placebo, P < 0.05]. XS0601 also significantly reduced the combined incidence of major adverse cardiac event (10.4% in the XS0601 group vs. 22.7% in the placebo group, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in XS0601 group (7.1% and 11.0%) as compared with those in placebo group (19.5% and 42.9%) (P < 0.05). No significant side effects occurred within the 6-month follow-up period in the XS0601 group.

CONCLUSIONAdministration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients.

Adult ; Aged ; Angina Pectoris ; prevention & control ; Angioplasty, Balloon, Coronary ; Coronary Restenosis ; epidemiology ; prevention & control ; Double-Blind Method ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Female ; Humans ; Incidence ; Male ; Middle Aged ; Prospective Studies ; Stents

OBJECTIVETo evaluate the safety and efficacy of Xiongshao Capsule (XS), consisting of Chuangxiongol and paeoniflorin, in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients.

METHODSA multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS, or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1, 3 and 6 months after PCI and an angiographic follow-up was scheduled at 6 months. The primary endpoint was angiographic restenosis defined as a luminal stenosis ≥ 50% in follow-up. The secondary endpoints were combined incidence of death, target lesion nonfatal myocardial infarction, repeat target-vessel angioplasty, and coronary artery bypass graft surgery (CABG). The follow-up for the above clinical endpoint events was continued to 1 year after PCI.

RESULTSThe subgroup analysis of 152 senile patients (68 cases angiographic follow-up) showed that the restenosis rates tended to reduce in the XS group as compared with that in the placebo group (24.32% vs. 38.71%, P > 0.05), and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 ± 0.84 for XS vs. 1.73 ± 0.91 for placebo, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in the XS group (4.11% and 12.33%) as compared with those in the placebo group (17.72% and 43.04%), but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group, P > 0.05). No significant adverse reactions occurred within the 6-month follow-up period in the XS group.

CONCLUSIONAdministration of XS in addition to standardized Western medication for 6 months is demonstrated to be safe and effective in reducing post-PCI recurrent angina and inhibiting luminal restenosis after PCI in senile CHD patients.

Aged ; Angina Pectoris ; complications ; diagnostic imaging ; epidemiology ; Angioplasty, Balloon, Coronary ; adverse effects ; Capsules ; China ; epidemiology ; Coronary Angiography ; Coronary Restenosis ; diagnostic imaging ; drug therapy ; etiology ; prevention & control ; Double-Blind Method ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Endpoint Determination ; Female ; Humans ; Male ; Placebos ; Recurrence

BACKGROUND: Previously, the inhibition of coronary restenosis with Abciximab (ReoPro (R) ) -coated stent in a porcine model was reported. ReoPro (R) inhibits platelet aggregation, the proliferation of vascular smooth muscle cells and the inflammatory reaction. METHODS: A prospective randomized trial was performed to compare two types of stent for revascularization in the native coronary artery. The primary effective end points were major adverse coronary events (MACE) : cardiac death, acute myocardial infarction, target vessel revascularization (TVR) and restenosis at the 6-month clinical and angiographic follow-ups. RESULTS: One hundred and fifty-five patients were enrolled between August 2001 and June 2003. The mean ages (56.0 +/- 10.0 vs. 56.9 +/- 10.8 years), baseline diameter of stenosis and minimal luminal diameter were no different between the two groups. There was one myocardial infarction and revascularization during the hospital stay in control stent group. During the clinical follow-up there were two myocardial infarctions in control group. Follow-up coronary angiograms were performed in 62.3% (48/77) and 65.4% (51/78) of the coated and control groups, respectively. The diameter of stenosis and late loss were significantly less in the ReoPro (R) -coated stent group compared with the controls (16.4 +/- 5.8% vs. 34.3 +/- 6.1%, p=0.009; and 0.33 +/- 0.28 mm vs. 0.88 +/- 0.41 mm; p=0.002). The restenosis and TVR rates of the ReoPro (R) -coated stent were relatively lower compared with the control stent [14.6% (7/48) vs. 29.4% (15/51), p=0.062; and 9.2% (7/76) vs. 14.7% (11/75) ; p=0.327]. CONCLUSION: A ReoPro (R) -coated stent is safe, and may be effective in the prevention of coronary restenosis.
Antibodies, Monoclonal/pharmacokinetics/*therapeutic use ; Coated Materials, Biocompatible/pharmacokinetics/*therapeutic use ; Coronary Arteriosclerosis/*surgery ; Coronary Restenosis/epidemiology/prevention & control ; Female ; Humans ; Immunoglobulins, Fab/*therapeutic use ; Korea/epidemiology ; Male ; Middle Aged ; Platelet Aggregation Inhibitors/pharmacokinetics/*therapeutic use ; Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors ; Prospective Studies ; Research Support, Non-U.S. Gov't ; *Stents

Stent fracture (SF) has been implicated as a risk factor for in-stent restenosis, but its incidence and clinical characteristics are not well established. Therefore we investigated the conditions associated with stent fracture and its clinical presentation and outcome. Between 2004 and 2007, consecutive cases of SF were collected from the Seoul National University Hospital. Clinical characteristics and outcome of patients with fractured stents were compared with a ten-fold cohort of age and gender matched controls (n = 236). A total of 4,845 patients received percutaneous coronary intervention and 3,315 patients (68.4%) underwent angiographic follow-up. Twenty-eight fractured stents were observed in 24 patients. The incidence of SF was 0.89% for sirolimus-eluting stents (SES) and 0.09% for paclitaxel-eluting stents. Chronic kidney disease, stent implantation in the right coronary artery (RCA), and SES use were independent predictors of drug-eluting stent fracture by multivariate analysis. SF was significantly associated with binary restenosis (11.4% vs 41.7%, P < 0.001) and increased risk of target lesion revascularization (8.1% vs 33.3%, P = 0.001). Patients with SF but without significant restenosis showed excellent outcome despite only medical treatment. In conclusion, SF is associated with increased rates of restenosis and repeat revascularization. Significant risk factors include chronic kidney disease, RCA intervention, and SES use.
Age Factors ; Aged ; Cardiovascular Agents/administration & dosage ; Cohort Studies ; Coronary Angiography ; Coronary Restenosis/diagnosis/*epidemiology/prevention & control ; Coronary Stenosis/radiography/therapy ; *Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; *Prosthesis Failure ; Registries ; Risk Factors ; Sex Factors ; Sirolimus/administration & dosage

Stent fracture (SF) has been implicated as a risk factor for in-stent restenosis, but its incidence and clinical characteristics are not well established. Therefore we investigated the conditions associated with stent fracture and its clinical presentation and outcome. Between 2004 and 2007, consecutive cases of SF were collected from the Seoul National University Hospital. Clinical characteristics and outcome of patients with fractured stents were compared with a ten-fold cohort of age and gender matched controls (n = 236). A total of 4,845 patients received percutaneous coronary intervention and 3,315 patients (68.4%) underwent angiographic follow-up. Twenty-eight fractured stents were observed in 24 patients. The incidence of SF was 0.89% for sirolimus-eluting stents (SES) and 0.09% for paclitaxel-eluting stents. Chronic kidney disease, stent implantation in the right coronary artery (RCA), and SES use were independent predictors of drug-eluting stent fracture by multivariate analysis. SF was significantly associated with binary restenosis (11.4% vs 41.7%, P < 0.001) and increased risk of target lesion revascularization (8.1% vs 33.3%, P = 0.001). Patients with SF but without significant restenosis showed excellent outcome despite only medical treatment. In conclusion, SF is associated with increased rates of restenosis and repeat revascularization. Significant risk factors include chronic kidney disease, RCA intervention, and SES use.
Age Factors ; Aged ; Cardiovascular Agents/administration & dosage ; Cohort Studies ; Coronary Angiography ; Coronary Restenosis/diagnosis/*epidemiology/prevention & control ; Coronary Stenosis/radiography/therapy ; *Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; *Prosthesis Failure ; Registries ; Risk Factors ; Sex Factors ; Sirolimus/administration & dosage