Incidence Of Primary Endpoint Research Articles

Optimal antithrombotic therapy in patients with atrial fibrillation following percutaneous coronary intervention: A systemic review and meta-analysis.

A challenge for antithrombotic treatment is patients who present with atrial fibrillation (AF) and acute coronary syndrome, particularly in patients who have undergone coronary percutaneous intervention with stenting (PCIS). In the present study, a total of nine observational trials published prior to July 2017 that investigated the effects of dual antiplatelet therapy (DAPT; aspirin + clopidogrel) and triple oral antithrombotic therapy (TOAT; DAPT + warfarin) among patients with AF concurrent to PCIS were collected from the Medline, Cochrane and Embase databases and conference proceedings of cardiology, gastroenterology and neurology meetings. A meta-analysis was performed using fixed- or random-effect models according to heterogeneity. The subgroups were also analyzed on the occurrence of major adverse cardiac events (MACE), stroke and bleeding events in the two treatment groups. Analysis of baseline characteristics indicated that there was no significant difference in the history of coexistent disease or conventional therapies between the DAPT and TOAT groups. The primary end point incidence was 2,588 patients in the DAPT group (n=13,773) and 871 patients in the TOAT group (n=5,262) following pooling of all nine trials. There was no statistically significant difference in the incidence of primary end points between the DAPT and TOAT groups. Odds ratio (OR)=0.96, 95% confidence interval (CI)=0.73–1.27, P=0.79, with heterogeneity between trials (I2=82%, P<0.00001). Subsequently, on subgroup analysis, the results indicated no increased risk of major bleeding or ischemic stroke in the DAPT or TOAT group. However, compared with the TOAT group, there was an apparent increased risk of MACE plus ischemic stroke in the DAPT group (OR=1.62, 95% CI=1.43–1.83, P<0.00001) with heterogeneity between trials (I2=70%, P=0.01). In conclusion, the present meta-analysis suggests that TOAT (aspirin + clopidogrel + warfarin) therapy for patients with AF concurrent to PCIS significantly reduced the risk of MACE and stroke compared with DAPT (aspirin + clopidogrel) therapy. Further randomized controlled clinical trials are required to confirm the efficacy of the optimal antithrombotic therapy in patients with AF following PCIS.

Benefit of Switching Dual Antiplatelet Therapy After Acute Coronary Syndrome According to On-Treatment Platelet Reactivity: The TOPIC-VASP Pre-Specified Analysis of the TOPIC Randomized Study

ObjectivesThis study sought to evaluate the impact of initial platelet reactivity on the benefit of switched strategy. BackgroundTOPIC (Timing Of Platelet Inhibition after acute Coronary Syndrome) study suggested that switched dual antiplatelet therapy (DAPT) could improve net clinical benefit after acute coronary syndrome by preventing bleeding. MethodsAcute coronary syndrome patients, 1 month after coronary stenting and event free, were randomly assigned to aspirin and clopidogrel (switched DAPT) or continuation of drug regimen (unchanged DAPT). All patients underwent platelet function testing at this time and were classified as low on-treatment platelet reactivity (LTPR) (platelet reactivity index vasodilator-stimulated phosphoprotein ≤20%) or non-LTPR (platelet reactivity index vasodilator-stimulated phosphoprotein >20%). The primary endpoint aimed to evaluate the impact of platelet reactivity on clinical outcomes and benefit of switched DAPT strategy. ResultsA total of 645 patients were included, 305 (47%) of whom were classified as LTPR. LTPR patients were less often diabetic (p = 0.01), had lower body mass index (p < 0.01), and were more often on ticagrelor (p < 0.01). Patients defined as LTPR and randomized to unchanged DAPT were at the highest risk of primary endpoint occurrence (31%; p < 0.01). Conversely, in the switched arm, LTPR patients had no significant difference in primary outcome incidence compared with non-LTPR patients (hazard ratio [HR]: 0.78; 95% confidence interval [CI]: 0.40 to 1.49; p = 0.45). The switched strategy was associated with important reduction in primary endpoint incidence in LTPR patients (HR: 0.29; 95% CI: 0.17 to 0.51; p < 0.01) and only numerically lower incidence in non-LTPR patients (HR: 0.79; 95% CI: 0.46 to 1.35; p = 0.39). ConclusionsSwitched DAPT was superior regardless of initial platelet reactivity but the benefit was greater in LTPR patients. Indeed, the switched strategy was highly effective in this group, which had impaired prognosis with unchanged DAPT but similar prognosis after switching.

Effect of Chronic Total Occlusion Percutaneous Coronary Intervention on Clinical Outcomes in Elderly Patients

BackgroundThere are little published data reporting the effect of coronary artery chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on the prognosis of elderly patients with identified CTOs. We sought to evaluate the clinical effect of CTO PCI on the prognosis of elderly patients with CTOs. MethodsA total of 445 consecutive patients diagnosed with a CTO by angiography from January 2011 to December 2013 were enrolled. We compared long-term clinical outcomes between the elderly group (≥75 years; n = 120, 27.0%), and the nonelderly group (<75 years; n = 325, 73.0%) as well as between patients with unopened CTOs and patients with CTOs who were recanalized by PCI either during the index hospitalization or at a staged procedure within 30 days after discharge from the index hospitalization. The primary endpoint was defined as the composite of hospitalization from angina, reinfarction, heart failure or repeat revascularization and cardiac death at the 3-year follow-up. ResultsMore elderly CTO patients had left main (LM) disease (25.0 versus 15.1%, P = 0.015), 3-vessel disease (96.4% versus 73.8%, P < 0.001) and a Japan-CTO score ≥2 (36.7% versus 23.7%, P = 0.006) than nonelderly CTO patients. Furthermore, elderly patients had a higher syntax score than nonelderly patients (27.0 [25.0, 30.0] versus 26.0 [23.0, 30.0], P = 0.006). PCI was attempted for 33 out of 135 CTO lesions (24.4%) in the elderly group, and 127 out of 378 lesions (33.6%) in the nonelderly group (P = 0.049); however, there were no statistically significant differences in the CTO PCI success rates between the 2 groups (69.7% versus 82.7%, P = 0.097). The 3-year cardiac mortality rate was 15.0% and 4.6% (P < 0.011) for the elderly and nonelderly groups, respectively. Elderly patients with CTOs who were recanalized by PCI and those with unopened CTOs exhibited comparable 3-year cardiac mortality rates (15.0% versus 16.0%, P = 1.000). There was no significant difference in primary endpoint incidence (25.0% versus 33.0%, P = 0.486). Multivariate analysis revealed that after corrections for baseline and procedural differences, right coronary artery CTO (odds ratio = 4.600, 95% CI: 1.320-16.031; P = 0.017) and LM disease combined with 3-vessel disease (odds ratio = 4.296, 95% CI: 1.166-15.831; P = 0.028) were independent predictors of 3-year cardiac mortality among elderly patients with CTOs. ConclusionsElderly patients with CTOs presented with seriously diseased coronary arteries and poor prognoses. CTO PCI did not seem to significantly improve long-term clinical outcomes among elderly patients with CTOs. Right coronary artery CTO and LM disease combined with 3-vessel disease might be independent predictors of 3-year cardiac mortality in elderly CTO patients.

O25-1 - Hospitalization Period in AHF Patients Affects Prognosis after Discharge?

Background: Hospitalization of patients with acute heart failure (AHF) in Japan is extremely longer than that in Western countries. Longer stay is often due to social background rather than patient systemic status. Additionally, Japanese cardiologists tend to try to achieve complete restoration of decompensated HF to avoid rehospitalization and improve mortality after discharge. We aimed to evaluate the impact of hospital duration on clinical prognosis after discharge in patients with AHF. Methods and Results: This study included 1,070 consecutive patients who were urgently hospitalized due to AHF and discharged alive between 2013 and 2017. They were divided into 2 groups depending on a median hospital stay of enrolled patients (18.5 days); the Longer stay (n = 533) and Shorter stay group (n = 539). The primary endpoint was a combination of death from any cause and readmission due to worsening of HF. The Longer group had significantly higher BNP, lower cardiac function and poorer renal function, and were treated with higher dose of daily furosemide than Shorter group at baseline. After propensity score matching, during 275 days of median follow-up period, Kaplan-Meier analysis did not show a significant difference in the incidence of primary endpoint between the Shorter and Longer stay groups (n = 239 e.a., Log-rank: P = .97). Conclusions: Longer hospital stay did not achieve better clinical outcomes in patients with AHF after discharge alive.

Updated results from the phase III ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L) or their combination (L+T) in the adjuvant treatment of HER2-positive early breast cancer.

502 Background: Pre-specified 5-year analyses of the phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial defined in Amendments 11&amp;12. Methods: From June 2007 to July 2011, 8381 patients (pts) were randomised from 946 sites in 44 countries to receive either L+T, T→L, L, or T. In 2011, due to futility the L arm was closed and is not included in this analysis. The primary end point is disease-free survival (DFS). Secondary objectives include treatment comparisons with respect to overall survival (OS), time to recurrence (TTR), time to distant recurrence (TDR), cardiac and overall safety and tolerability. Primary analysis results of the study were published in JCO 2015 34:1034-1042. This updated analysis occurs at a 6.9 yrs median follow up (MFU). Results: All patients have reached 5-years of follow-up. 705 DFS events for L+T vs T have been observed. HR for DFS was 0.86 (95% CI, 0.74-1.00; 6-yr DFS%=85% vs 82%) for L+T vs T and 0.93 (95% CI, 0.81-1.08; 6-yr DFS%=84% vs 82%) for T→L vs. T. The 6-year OS was 93%, 92%, and 91% for L+T, T→L, and T, respectively. HR for OS was 0.86 (95% CI, 0.70-1.06) for L+T vs. T and 0.88 (95% CI, 0.71-1.08) for T→L vs. T. DFS differences for L+T vs. T were slightly higher for the hormone-receptor(ER)-negative [HR 0.80 (95% CI, 0.64-1.00; 6-yr DFS%=84% vs. 80%)] and the sequential chemotherapy [HR 0.83 (95% CI, 0.69-1.00; 6-yr DFS%=83% vs.79%)] subgroups. There were no differences in sites of first DFS events according to treatment arm for CNS, loco-regional, or distant recurrences. There were more AEs related to study treatment (L+T 93% vs T 64%). The incidence of primary cardiac end points was low: 1% for L+T, 0.5% for T→L and 0.9% for T. Conclusions: The HRs for this updated analysis are similar to those from the Primary Analysis and the event rate remains lower than anticipated (705 vs 850 planned). Cardiac toxicity remains low. This analysis suggests that HER2+/ER- tumors may have a different biology than HER2+/ER+ and may benefit more from dual HER2 blockade. Long-term follow up continues. Clinical trial information: NCT00490139.

Three-year follow-up of patients with acetylcholine-induced coronary artery spasm combined with insignificant coronary stenosis

BackgroundCoronary artery spasm (CAS) and significant coronary stenosis are known to be major causes of myocardial ischemia. However, their association and the impact of insignificant coronary stenosis (ICS) on long-term clinical outcomes of CAS patients are largely unknown. MethodsA total of 2797 patients without significant coronary artery disease (CAD) who underwent the acetylcholine (ACH) provocation test between November 2004 and October 2010 were enrolled. Significant CAS was defined as having ≥70% of temporary narrowing by ACH test and ICS as having <70% of fixed stenosis on angiography. Patients were divided into two groups: ICS group (n=764) and non-ICS group (n=845). To adjust potential confounders, a propensity score matching (PSM) analysis was performed using the logistic regression model. Primary endpoint was the composite of total death, myocardial infraction (MI), de novo percutaneous coronary intervention (PCI), and cerebrovascular accidents (CVA). Secondary endpoint was the incidence of recurrent angina requiring repeat coronary angiography (CAG) at 3years. ResultsAfter PSM analysis, two well-balanced groups (548 pairs, total=1096) were generated. The baseline clinical characteristics were similar between the two groups. During the ACH test, compared with the non-ICS group, the ICS group had smaller spastic narrowing diameter (0.69±0.35 vs. 0.73±0.37, P=0.039) and incidence of ST-segment depression (4.0% vs. 0.9%, P=0.001). The incidence of primary and secondary endpoints was similar between the two groups up to 3years. ConclusionsAlthough, the ICS group was expected to have more adverse long-term clinical outcomes, it was not associated with the increased incidence of major adverse clinical outcomes compared with the non-ICS group up to 3years. Longer term follow-up studies are needed.

Primary care diabetes prescribing rates: latest analysis shows continued rise in volume and cost

Primary care diabetes prescribing rates: latest analysis shows continued rise in volume and cost

Comparison of Clinical Effectiveness of Ticagrelor and Clopidogrel in Post Percutaneous Transluminal Coronary Angioplasty (PTCA) Patients Approaching A Tertiary Care Hospital in South India

Introduction: Dual antiplatelet therapy is recommended for prevention of secondary cardiovascular events in acute coronary syndrome patients who undergo percutaneous transluminal coronary angioplasty (PTCA). This therapy includes aspirin with either of a P 2 Y 12 platelet receptor inhibitor like clopidogrel or ticagrelor. Methodology: A retrospective cohort study with 1 year follow up which compared clopidogrel and ticagrelor for determining clinical effectiveness in post PTCA patients through the incidence of primary and secondary end points. Primary end points included cardiovascular death, Myocardial Infarction (MI), unstable angina, secondary revascularization and Congestive Heart Failure (CHF). Secondary end points were bleeding and dyspnea. Results: Age, gender, cardiovascular risk factors, concomitant medications administered and angioplasty specifications like the number of stents, type of stents and approach route were in comparable between clopidogrel and ticagrelor groups. The primary end points, a composite of cardiovascular death, unstable angina and secondary revascularization occurred more in the clopidogrel group (9%) than in ticagrelor group (5%) in 12 months follow up period. The secondary end points, a composite of bleeding and dyspnea were observed more in the ticagrelor group (11%) compared to clopidogrel group (5%). Conclusion: The use of ticagrelor prevents the incidence of secondary cardiovascular events in post PTCA patients to a greater degree than clopidogrel in comparable risk groups. Our observation revealed that ticagrelor was found to be better drug than clopidogrel as a prophylactic antiplatelet drug though there was increased incidence of dyspnea and bleeding in ticagrelor group. Key words: Antiplatelets, Ticagrelor, Clopidogrel.

Long-term follow-up of Chinese herbal medicines combined with conventional treatment in patients with acute coronary syndrome after percutaneous coronary intervention: A multicenter randomized controlled trial.

To evaluate the prognosis effect of Chinese herbal medicines (CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation (treatment group, 351 cases) or conventional treatment alone (control group, 351 cases) for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12th, 18th, 24th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization (PCI or coronary artery bypass grafting); and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events. A total of 621 (88.59%) patients completed 35.4±3.8 months follow-up, while 80 (11.41%) patients withdrew from the trial (41 in the treatment group and 39 in the control group). The incidence of primary endpoint was 5.7% (20 patients) in the treatment group versus 10.86% (38 patients) in the control group [relative risk (RR): 0.53; 95% confidence interval (CI): 0.30, 0.88; P=0.013; absolute risk reduction (ARR):-0.052, 95% CI: -0.06, 0.01]. The incidence of secondary endpoint was 5.98% (21 patients) in the treatment group versus 10.28% (36 patients) in control group (RR: 0.58, 95% CI: 0.33, 0.97, P=0.037; ARR: -0.043, 95% CI: 0.06, 0.01). Most of the primary and secondary endpoints were occurred in 18 months (84.50% in the treatment group versus 78.10% in the control group). CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.

Efficacy and safety of ticagrelor versus clopidogrel in acute coronary syndrome in Taiwan: A multicenter retrospective pilot study

BackgroundThe efficacy and safety of ticagrelor compared with clopidogrel in acute coronary syndrome has not previously been evaluated in an Eastern Asian population, which is recognized to have a different response to P2Y12 antagonists compared with the Caucasian population in real-life situations. MethodsA multicenter retrospective pilot study was performed to evaluate 928 consecutive patients with acute coronary syndrome, receiving aspirin and one P2Y12 antagonist (324 ticagrelor or 604 clopidogrel). Using propensity score matching, 448 patients were selected and divided into two equal groups. Kaplan–Meier analysis was used to study patient survival and event-free status using the log-rank test. Independent covariates were identified using univariate in a multivariate Cox proportional hazard model. ResultsIn the overall cohort, significant differences were observed for certain variables between the two groups. During the mean 164.3 (±116.4)-day follow-up in the overall cohort, ticagrelor treatment had no significant effect on the primary efficacy endpoint (myocardial infarction, stroke, or vascular death); however, in the matched cohort, ticagrelor showed a lower incidence of primary endpoint (hazard ratio: 0.56; 95% confidence interval: 0.30–1.04; p = 0.07) and stroke (hazard ratio: 0.15; 95% confidence interval: 0.02–1.24; p = 0.08) with marginal statistical significance, and a similar bleeding rate. The protective effect of ticagrelor treatment was consistent for all subgroups. More patients treated with ticagrelor experienced dyspnea (21.0% vs. 11.6%, p = 0.007), and P2Y12 antagonist treatment was consequently discontinued. ConclusionTicagrelor treatment could provide a marginally favorable effect at the expense of an increased risk of dyspnea in real-life situations. This pilot study provides a scientific basis to call for a larger, suitably powered Phase 4 prospective or observational study in this ethnic population.

Impact of subclinical coronary artery disease on the clinical outcomes of carotid endarterectomy.

OBJECTIVE Controversy persists regarding the optimal management of subclinical coronary artery disease (CAD) prior to carotid endarterectomy (CEA) and the impact of CAD on clinical outcomes after CEA. This study aimed to evaluate the short-term surgical risks and long-term outcomes of patients with subclinical CAD who underwent CEA. METHODS The authors performed a retrospective study of data from a prospective CEA registry. They analyzed a total of 702 cases involving patients without a history of CAD who received preoperative cardiac risk assessment by radionuclide myocardial perfusion imaging (MPI) and underwent CEA over a 10-year period. The management strategy (the necessity, sequence, and treatment modality of coronary revascularization and optimal perioperative medical treatment) was determined according to the presence, severity, and extent of CAD as determined by preoperative MPI and additional coronary computed tomography angiography and/or coronary angiography. Perioperative cardiac damage was defined on the basis of postoperative elevation of the blood level of cardiac troponin I (0.05-0.5 ng/ml) in the absence of myocardial ischemia. The primary endpoint was the composite of any stroke, myocardial infarction, or death during the perioperative period and all-cause mortality within 4 years of CEA. The associations between clinical outcomes after CEA and subclinical CAD were analyzed. RESULTS Concomitant subclinical CAD was observed in 81 patients (11.5%). These patients did have a higher incidence of perioperative cardiac damage (13.6% vs 0.5%, p < 0.01), but they had similar primary endpoint incidences during the perioperative period (2.5% vs.1.8%, p = 0.65) and similar estimated 4-year primary endpoint rates (13.6% vs 12.4%, p = 0.76) as the patients without subclinical CAD. Kaplan-Meier survival analysis showed that the 2 groups had similar rates of overall survival (p = 0.75). CONCLUSIONS Patients with subclinical CAD can undergo CEA with acceptable short- and long-term outcomes provided they receive selective coronary revascularization and optimal perioperative medical treatment.

The Importance of the Mean Platelet Aggregation Degree in Long-term Dual Antiplatelet Therapy Following Drug-Eluting Stent Implantation.

The dual antiplatelet therapy (DAPT) and the response of clopidogrel were two pivotal issues in drug-eluting stent (DES) era. To analyze the combined impacts of DAPT and the response to clopidogrel to evaluate their long-term effect on patients undergoing DES implantation. Platelet aggregation was serially measured by light transmission aggregometry in all eligible patients during the course of treatment with DAPT, and the mean platelet aggregation degree of each participant was calculated. Based on the duration of DAPT and the mean platelet aggregation degree, all the enrolled patients were then divided into four groups. The primary endpoint was a composite of major adverse cardiovascular events. We analyzed 1245 suitable patients in this study. They were divided into four groups: Group A (12-month DAPT & low platelet aggregation degree) with 233 subjects, Group B (12-month DAPT & high platelet aggregation degree) with 260 subjects, Group C (>12-month DAPT & low platelet aggregation degree) with 374 subjects, and Group D (>12-month DAPT & high platelet aggregation degree) with 378 subjects. Group C was associated with a decreased incidence of primary endpoints [HR 0.512, 95%CI (0.27-0.97); P=0.040]. The Cox proportional hazard model was further analyzed with Groups A and B combined as the reference category [HR for Group C vs. Group A, 0.84, 95%CI (0.33-2.15); P=0.719; HR for Group C vs. Group B, 0.45, 95%CI (0.21-0.98); P=0.043]. Their respective multivariate Cox proportional hazard regressions confirmed these trends. The mean platelet aggregation degree is of importance in long-term use of DAPT; extension of DAPT beyond 1 year should be implemented cautiously in patients implanted with DESs.

The value of the Clinical SYNTAX Score in predicting long-term prognosis in patients with ST-segment elevation myocardial infarction who have undergone primary percutaneous coronary intervention.

The Clinical SYNTAX Score (CSS) combines anatomical and clinical risk assessment. This study was designed to evaluate CSS as a predictor of prognosis in patients with ST-elevation myocardial infarction (STEMI) undergoing a primary percutaneous coronary intervention (p-PCI). We evaluated 433 patients who were diagnosed with STEMI and underwent p-PCI. CSS was calculated by multiplying the anatomically derived SYNTAX score (Sx) by the modified age, creatinine, and ejection fraction score. Patients were divided into tertiles according to the CSS: CSS(Low)≤14 (n=141), 14<CSS(Mid)≤26 (n=144), and CSS(High)>26 (n=148). The primary endpoints were defined as all-cause mortality, myocardial infarction, and cerebrovascular events over 15 months' follow-up. Primary endpoints were achieved in 9.2% of patients with CSS≤14, 12.5% of those with 14<CSS≤26, and 28.4% of those with CSS>26 (P<0.001). Kaplan-Meier analysis showed that the CSS>26 group had a significantly higher incidence of primary endpoints [P (log-rank)<0.001]. CSS>26 was identified as an independent predictor for all-cause mortality, myocardial infarction, and cerebrovascular events (hazard ratio 3.58, 95% confidence interval 1.68-7.60, P=0.001). Receiver operating characteristic analysis found areas under the curve of 0.66, 0.59, and 0.64 for CSS, Sx score, and age, creatinine, and ejection fraction score (P<0.001, P=0.01, P<0.001, respectively). CSS may be better than the Sx score for predicting long-term prognosis in patients with STEMI undergoing p-PCI.

Relationship between the mean platelet aggregation degree and the prognosis of patients underwent long-term dual antiplatelet therapy following drug eluting stent implantation

To evaluate the association between the mean platelet aggregation degree and the prognosis of patients underwent long-term dual antiplatelet therapy (DAPT more than 12 months) following drug eluting stent (DES) implantation. A total of 752 patients were retrospectively analyzed who were received DES between September 2006 and June 2009. Adenosine diphosphate-induced platelet aggregation (ADP) was monitored during the course of treatment with DAPT, and the mean platelet aggregation degree of each participant was calculated. Based on the mean platelet aggregation degree, patients were divided into the low ADP degree group (374 cases) and the high ADP degree group (378 cases). The median follow-up period was 32.2(25.1, 34.8) months. The comparison of the composite endpoints (all-cause death, nonfatal myocardial infarction, stent thrombosis, repeat revascularization and stroke) was performed between the two groups. Compared with the high ADP degree group, there were more male, younger and smoker patients in the low ADP degree group (all P<0.05). COX regression analysis showed that the low ADP degree group was associated with a decreased incidence of primary endpoints (HR=0.463, 95%CI 0.23-0.92, P=0.028). After adjustment with multivariable COX regression analysis, the relationship was proven to be independent of other risk factors (HR=0.495, 95%CI 0.25-0.99, P=0.046). The Kaplan-Meier curve demonstrated the incidence of the composite endpoints was significantly higher in high ADP degree group compared to that of low ADP degree group (log-rank χ(2)=5.042, P=0.025). The mean adenosine diphosphate-induced platelet aggregation degree is associated with the prognosis of patients underwent long term DAPT after DES implantation.

Comparison of second- and first-generation drug eluting stent for percutaneous coronary chronic total occlusion intervention

BackgroundThe performance of contemporary second-generation drug-eluting stents (DESs) for percutaneous chronic total occlusion (CTO) intervention is not well established. The present study compared the efficacy and safety outcomes of second-generation DESs with those of first-generation DESs in CTO-percutaneous coronary intervention (PCI). MethodsThis retrospective analysis included 1049 consecutive CTO patients who underwent successful DES implantation (first-generation; 487 vs. second-generation; 562 patients) between March 2003 and August 2014. The primary endpoint was the composite of all-cause death, Q-wave myocardial infarction (MI), or target-vessel revascularization (TVR). ResultsDuring a follow-up of 3years, the primary endpoint incidence was 10.1% for second- and 7.7% for first-generation DES (p=0.30). After multivariable adjustment, there was no significant difference between these groups in terms of the risk of composite of death, Q-wave MI, or TVR (Hazard ratio [HR] 1.42, 95% confidence interval [CI] 0.88–2.28, p=0.15) nor in the individual risks of death (adjusted HR 1.33, 95% CI 0.69–2.56, p=0.39), Q-wave MI (adjusted HR 1.15, 95% CI 0.30–4.47, p=0.84) and TVR (adjusted HR 1.06, 95% CI 0.52–2.15, p=0.87). The incidence of definite/probable stent thrombosis was relatively low (0.5% vs.0.9%, p=0.17) throughout the follow-up period. ConclusionThe 3-year clinical outcomes of patients treated with second-generation DESs are comparable to those treated with first-generation DESs for CTO–PCI.

Associated risk factors of ischemic events for spontaneous cervical artery dissection

This study sought to identify risk factors of ischemic events and predictors of outcome for spontaneous cervical artery dissection (sCAD). One hundred and sixty one patients diagnosed as sCAD were classified as patients with (n=77) and without (n=84) cerebral ischemia. Demographics, vascular risk factors and imaging features were compared between the two groups. Multivariate Cox regression analysis was performed to identify predictors of primary end-point events (all cause stroke and death) at follow-up. Patients with cerebral ischemia had a higher prevelence of hypertension and diabetes mellitus (62.3% vs 41.7%, 14.3% vs 6.2%, P<0.05). Patients with cerebral ischemia were more likely to present with stenosis (61.0% vs 23.8%, P<0.001) and less likely to present with aneurysmal dilatation (19.5% vs 44.0%, P<0.001) and double lumen (22.1% vs 38.1%, P<0.05). There was significant positive association of diabetes mellitus (odds ratio 3.095; 95% confidence interval, 1.273 to 7.524, P=0.013) and stenosis (odds ratio 4.335, 95% confidence interval, 2.123 to 8.854, P<0.001), and an inverse association of aneurysmal dilatation (odds ratio 0.429, 95% confidence interval, 0.198 to 0.930, P=0.032) with occurrence of ischemic events in patients with sCAD. At a mean follow-up of 16.0 months, overall incidence of primary end-point was 9.3% (n=15). Cox regression analysis showed cerebral ischemia at onset, arterial occlusion, obesity or overweightness were significant predictors of the primary endpoint. This study confirms that diabetes mellitus and arterial stenosis are risk factors of ischemic events for sCAD patients. Cerebral ischemia at onset, arterial occlusion, obesity or overweightness are predictors of primary endpoint at follow-up.

Early invasive versus early conservative strategy in non-ST-elevation acute coronary syndrome: An outcome research study.

An early invasive strategy (EIS) has been shown to yield a better clinical outcome than an early conservative strategy (ECS) in patients with non-ST-elevation acute coronary syndromes (NSTEACSs), particularly in those at higher risk according to the GRACE risk score. However, findings of the clinical trials have not been confirmed in registries. To investigate the outcome of patients with NSTEACS treated according to an EIS or a ECS in a real-world all-comers outcome research study. The primary hypothesis of the study was the non-inferiority of an ECS in comparison with an EIS as to a combined primary end-point of death, non-fatal myocardial infarction and hospital readmission for acute coronary syndromes at one year. Participating centres were divided into two groups: those with a pre-specified routine EIS and those with a pre-specified routine ECS. Two statistical analyses were performed: a) an 'intention to treat' analysis: all patients were considered to be treated according to the pre-specified routine strategy of that centre; b) a 'per protocol' analysis: patients were analysed according to the actual treatment applied. Cox model including propensity score correction was applied for all analyses. The intention to treat analysis showed an equivalence between EIS and ECS (11.4% vs. 11.1%) with regard to the primary end-point incidence at one year. In the three subgroups of patients according to the GRACE risk score (⩽ 108, 109-140, > 140), EIS and ECS confirmed their equivalence (5.3% vs. 3.9%, 8.4% vs. 7.6%, and 20.3% vs. 20.9%, respectively). When the per protocol analysis was applied, a reduction of the primary end-point at one year with EIS vs. ECS was demonstrated (6.2% vs. 15.3%, p=0.021); analysis of the subgroups according to the GRACE risk score numerically confirmed these data (3.1% vs. 6.5%, 5.1% vs. 10.0%, and 10.8% vs. 24.5%, respectively). In a real-life registry of all-comers NSTEACS patients, ECS was non-inferior to EIS; however, when EIS was applied according to clinical judgement, a reduction of clinical events at one year was demonstrated.

Prognostic significance of changes in cystatin C during treatment of acute cardiac decompensation

BackgroundThe long-term prognostic significance of in-hospital worsening renal function (WRF) during treatment of acute cardiac decompensation (ACD) remains controversial. MethodsWe analyzed data from 100 patients (mean age=75 years; 53% men) presenting with ACD, in whom the serum cystatin C (Cys-C) concentration was measured upon admission to the hospital and 4 days later. We examined the relationship between changes in Cys-C and primary study endpoint of risk of death and re-hospitalization for management of ACD, up to 180 days, searched for predictors by multiple variable analysis and calculated the hazard ratios (HR) and 95% confidence intervals (CI). ResultsA median (25th to 75th percentile) increase in Cys-C from 1.29 (0.88–1.66)mg/l on day 1 to 1.31 (1.00–1.84)mg/l on day 4, observed in 66% of all patients, was associated with a significant decrease (p=0.040) in the 180-day incidence of primary study endpoint. By multiple variable regression analysis, an increase in Cys-C was an independent predictor of death and re-hospitalization for management of ACD (HR 0.415; 95% CI 0.193–0.885; p=0.023). ConclusionsAn increase in serum Cys-C concentration after hospitalization for management of ACD was associated with a decreased, long-term incidence of primary study endpoint.

Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.

To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice. The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent. 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years. Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST. This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.

Comparison of Long-Term Clinical Outcomes after Drug-Eluting Stent Implantation in Patients with Coronary Artery Disease with and without Prior Cerebral Infarction.

To compare the clinical and angiographic outcomes after implantation of drug-eluting stents (DESs) in patients with coronary artery disease (CAD) with or without prior cerebral infarction. Ninety-eight consecutive patients (130 lesions) who underwent successful coronary DES implantation were prospectively classified into two groups: those with a clinical history of symptomatic cerebral infarction (cerebral infarction group, 49 patients, 69 lesions) and those without a clinical history of symptomatic cerebral infarction (noncerebral infarction group, 49 patients, 61 lesions). The primary endpoint was defined as death, nonfatal myocardial infarction, and cerebrovascular events. The Kaplan-Meier method was used to create a primary endpoint curves to determine the time-dependent cumulative primary endpoint-free rate, which were compared using the log-rank test. The incidence of primary endpoints was higher in the cerebral infarction group than in the noncerebral infarction group (p = 0.0075). The Cox proportional hazards regression model for primary endpoint identified prior cerebral infarction (p = 0.0331, hazard ratio = 2.827) and patients with peripheral artery disease (p = 0.0271, hazard ratio = 2.757) as explanatory factors. The results showed that clinical outcomes were poorer in patients with CAD who had prior cerebral infarctions than in those who did not have infarction.