1. Value of SYNTAX revascularization index on evaluating the long-term prognosis of coronary artery disease patients with biodegradable polymer drug-eluting stents implantation
Miaohan QIU ; Liya BIAN ; Chu'ai FANG ; Peng FAN ; Weichao ZHAO ; Jing LI ; Yi LI ; Yaling HAN
Chinese Journal of Cardiology 2019;47(10):790-797
Objective:
To explore the value of SYNTAX revascularization index (SRI) on evaluating the long-term prognosis of coronary artery disease (CAD) patients implanted with biodegradable polymer drug-eluting stents (BP-DES) and define the best threshold of SRI for predicting all-cause mortality in these patients.
Methods:
Data used in this study derived from the I-LOVE-IT 2 trial (evaluate safety and effectiveness of the Tivoli DES and the Firebird DES for treatment of coronary). I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, non-inferiority study. A total of 1 829 patients implanted with BP-DES were divided into 3 groups, namely SRI=100% group (
2. Evaluating the long-term prognosis of coronary artery disease patients undergoing percutaneous coronary intervention by risk stratification with ACC/AHA classification of coronary lesions
Miaohan QIU ; Weichao ZHAO ; Peng FAN ; Liya BIAN ; Jing LI ; Yi LI ; Yaling HAN
Chinese Journal of Cardiology 2020;48(2):111-117
Objective:
To evaluate the long-term prognosis of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) by risk stratification with American College of Cardiology (ACC)/American Heart Association (AHA) classification of coronary lesions.
Methods:
Data used in this study derived from the I-LOVE-IT 2 trial. I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, noninferiority study. A total of 1 255 patients in I-LOVE-IT 2 trial with only one lesion and underwent biodegradable polymer drug-eluting stent implantation were included and grouped according to ACC/AHA classification of coronary lesions, namely type A/B1 lesion group (
3.Value of SYNTAX revascularization index on evaluating the long?term prognosis of coronary artery disease patients with biodegradable polymer drug?eluting stents implantation
Miaohan QIU ; Liya BIAN ; Chu'ai FANG ; Peng FAN ; Weichao ZHAO ; Jing LI ; Yi LI ; Yaling HAN
Chinese Journal of Cardiology 2019;47(10):790-797
Objective To explore the value of SYNTAX revascularization index (SRI) on evaluating the long?term prognosis of coronary artery disease (CAD) patients implanted with biodegradable polymer drug?eluting stents (BP?DES) and define the best threshold of SRI for predicting all?cause mortality in these patients. Methods Data used in this study derived from the I?LOVE?IT 2 trial (evaluate safety and effectiveness of the Tivoli DES and the Firebird DES for treatment of coronary). I?LOVE?IT 2 trial was a prospective, multicenter, randomized, assessor?blinded, non?inferiority study. A total of 1 829 patients implanted with BP?DES were divided into 3 groups, namely SRI=100% group (n=963), 50%≤SRI<100% group (n=527) and SRI<50% group (n=339). The primary endpoint was 48?month patient?oriented composite endpoint (PoCE), a composite of all?cause mortality, myocardial infarction(MI), stroke, and / or any revascularization. The secondary endpoints were components of PoCE and definite/probable stent thrombosis at 48 months. The receiver operating characteristic curve was used to investigate the best cut?off point of SRI for 48?month all?cause mortality. The Cox regression analysis was used to identify independent predictors of the all?cause death and PoCE at 48 months. Results Incidence of PoCE at 48 months was significantly lower in SRI=100% group than patients with 50%≤SRI<100%(17.34% (167/963) vs. 22.20% (117/527), P<0.05) and SRI<50% (17.34% (167/963) vs. 24.78% (84/339), P<0.05). Comparing with SRI=100% group, the patients with 50%≤SRI<100% suffered higher rates of all MI (7.78% (41/527) vs. 4.26% (41/963), P<0.05) and target vessel MI (6.45% (34/527) vs. 4.26% (41/963), P<0.05); patients with SRI<50% had higher rates of all?cause mortality (5.90% (20/339) vs. 3.12% (30/963), P<0.05) and any revascularization (14.16% (48/339) vs. 3.12% (30/963), P<0.05). The receiver operating characteristic curve analysis showed that the SRI=65% was the best cut?off point to predict the all?cause mortality at 48 months (area under the curve was 0.58, sensitive was 0.47, specificity was 0.70). Meanwhile, SRI<65% was an independent predictor of 48?month all?cause mortality ( HR=2.06, 95%CI 1.25-3.38) and PoCE ( HR=1.34, 95%CI 1.09-1.66). Conclusions SRI serves as a good index for predicting long?term prognosis and SRI<65% is an independent predictor of 48?month PoCE and all?cause mortality for CAD patients with BP?DES implantation. Meanwhile, SRI≥65% might be a reasonable threshold of incomplete revascularization.
4.Comparison of the antiplatelet effects between vicagrel and clopidogrel in patients with different cytochrome P450 2C19 genotypes
Yinan CAO ; Zizhao QI ; Ling REN ; Jing LI ; Miaohan QIU ; Kexin WANG ; Hongbin SUN ; Yanchun GONG ; Yi LI ; Yaling HAN
Chinese Journal of Cardiology 2024;52(5):493-499
Objective:To compare the antiplatelet effects of vicagrel and clopidogrel in patients with different cytochrome P450 (CYP) 2C19 genotypes.Methods:This is a post-hoc analysis of a phase Ⅱ clinical trial of vicagrel, which included patients with coronary heart disease who underwent percutaneous coronary intervention from August 2018 to June 2019 in 18 centers. Patients were categorized based on the presence of CYP 2C19 *2 or *3 loss-of-function (LOF) alleles into LOF carrier group ( n=111) and non-LOF carrier group ( n=90). Each group included patients received vicagrel 5 mg, 6 mg, 7.5 mg, or clopidogrel 75 mg for 28 days per study protocol. P2Y 12 reaction units (PRU) were measured using VerifyNow at baseline, 6 to 8 hours after loading dose, 7 to 10 days after randomization, and 28 days after randomization and the percentage inhibition of platelet aggregation (%IPA) was calculated. The primary endpoint was %IPA on day 28. Within the patients from the General Hospital of Northern Theater Command, 8 to 12 patients in each study arms were enrolled in a prespecified pharmacokinetic sub-study, measuring the time to reach maximum plasma concentration (T max), peak plasma concentration (C max), and area under the plasma concentration-time curve (AUC). Results:Among 201 patients, the age was (58.8±8.5) years, and 139 (69.2%) were male. In non-LOF carriers, there was no significant differences in PRU values and %IPA between the vicagrel 5 mg, 6 mg, 7 mg, and clopidogrel groups at all time points (all P>0.05). In LOF carriers, %IPA was significantly higher in the vicagrel-treated groups than in the clopidogrel group at 6-8 hours after loading dose (22.9 (14.2, 31.5)% vs. 19.8 (11.0, 28.6)% vs. 29.5 (20.9, 38.0)% vs. 12.9 (3.9, 21.9)%, P=0.038) and 7-10 days after randomization (22.4 (14.2, 30.5)% vs. 34.4 (26.1, 42.6)% vs. 39.8 (31.8, 47.9)% vs. 24.7 (16.3, 33.2)%, P=0.001), with a trend towards higher %IPA in the vicagrel-treated groups at day 28 (30.4 (21.3, 39.6)% vs. 36.5 (27.2, 45.7)% vs. 40.8 (31.8, 49.8)% vs. 30.7(21.2, 40.2)%, P=0.056). Pharmacokinetic results of 35 patients showed that the C max and AUC of the active metabolite M15-2 of vicagrel was similar to that of clopidogrel in non-LOF carriers, but AUC between vicagrel 5 mg, 6 mg, 7 mg and clopidogrel were significantly different in LOF carriers ((5.6±0.6) h·μg -1·L -1 vs. (6.8±2.7) h·μg -1·L -1 vs. (9.2±3.3) h·μg -1·L -1 vs. (4.2±1.9) h·μg -1·ml -1, P=0.020). Conclusion:Vicagrel and clopidogrel have similar antiplatelet effects in non-LOF carriers, but vicagrel exhibits superior antiplatelet effects in LOF carriers.