Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-Up Outcomes of Multicenter Randomized Controlled BEST Trial.

BACKGROUND: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease. METHODS: This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization. RESULTS: During a median follow-up of 11.8 years (interquartile range, 10.6-12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR], 1.18 [95% CI, 0.88-1.56]; P=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 [95% CI, 0.75-1.53]; P=0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 [95% CI, 0.65-1.67]; P=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 [95% CI, 1.06-3.27]; P=0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 [95% CI, 1.58-2.32]; P<0.001) were more frequent after PCI than after CABG. CONCLUSIONS: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05125367 and NCT00997828.

Thin Strut CoCr Biodegradable Polymer Biolimus A9-Eluting Stents versus Thicker Strut Stainless Steel Biodegradable Polymer Biolimus A9-Eluting Stents: Two-Year Clinical Outcomes.

BACKGROUND: While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). METHODS: In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. RESULTS: MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31-0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35-0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11-0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43-0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4-1.00]; P=0.078). CONCLUSION: At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.

Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.

AIM: The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS: In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). CONCLUSION: For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting. STUDY REGISTRATION: http://www.clinicaltrials.com; Identifier: NCT02284750.

Trial of everolimus-eluting stents or bypass surgery for coronary disease.

BACKGROUND: Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. METHODS: We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. RESULTS: After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. CONCLUSIONS: Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.

OBJECTIVE: To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years. BACKGROUND: After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. METHODS: In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study. RESULTS: At 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred. CONCLUSIONS: The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.

Demographics and Outcomes of Percutaneous Coronary Intervention in Thailand: Data from Thai Percutaneous Coronary Intervention Registry.

Background: Percutaneous coronary intervention (PCI) has been and continues to be standard treatment in patients with coronary artery disease. The data for demographic and outcomes in Thailand are limited. Objective: To study data and characteristics relating to patients, the procedure, and outcomes of percutaneous coronary intervention in the Thai population. Material and Method: The Thai Percutaneous Coronary Intervention Registry (TPCIR) was established in 2006, consisting of 27 hospitals in Thailand that perform the PCI procedure. All patients who underwent PCI between May 2006 and October 2006 in participating hospitals were asked to participate in this registry. Data was recorded in case record form and then entered into the web-based registry. Key variables include demographic data, risk factors, indications for PCI, outcomes, and complications. Results: Four thousand one hundred fifty six patients were enrolled; 69.2% were male. Average age of PCI patients was 62.7 years. Indications for PCI were ST segment elevation myocardial infarction (14%), Non-ST segment elevation acute coronary syndrome (37.3%), and stable coronary artery disease (48.7%). PCI was successfully performed in 92.5% of lesions or 89.6% of cases with in-hospital complications reported in 12% of cases. Conclusion: This was the first nationwide multi-center study of PCI in Thailand. The overall PCI procedure success rate was 92.5%.

In-Hospital Outcomes after Rescue Percutaneous Coronary Intervention in Patients with ST Segment Elevation Myocardial Infarction.

Objective: To investigate the outcomes of patients who underwent rescue percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI) after failed thrombolytic therapy. Material and Method: This observational cohort study was conducted between June 1, 2008 and May 31, 2013. Consecutive STEMI patients who underwent either emergency rescue PCI or primary PCI were included. Rescue PCI patients were compared with primary PCI patients. Clinical data including baseline characteristics, angiographic results, periprocedural details, and in-hospital adverse events were reviewed. Results: Three hundred sixteen patients were enrolled, of which 72.5% were male. Mean age of participants was 59.5 years. Rescue PCI and primary PCI was performed in 24 and 292 patients, respectively. Median time from symptom onset to emergency room (ER) arrival was 175 minutes and not statistically different between groups. Thirteen percent of patients were critically ill and in cardiogenic shock upon arrival. Radial artery access was significantly more frequently used in the rescue PCI group. The rescue PCI group had a significantly higher proportion of initial TIMI grade 3 flow than the primary PCI group (rescue PCI 33.3% vs. primary PCI 13.4%, p = 0.042). No significant differences were observed in final TIMI grade 3 between the two groups (rescue PCI 87.5% vs. primary PCI 89.7%, p = 0.77). Rate of platelet glycoprotein IIb/IIIa receptor blocker use was significantly higher in the primary PCI group (41.4% vs. 4.2%, p<0.001). Left ventricular ejection fraction was significantly higher in the rescue PCI group (rescue PCI 57.7% vs. primary PCI 50%, p = 0.013). There were no significant differences between groups for angiographic success rate (rescue PCI 83.3% vs. primary PCI 88.7%, p = 0.229) or procedural success rate (rescue PCI 79.2% vs. primary PCI 85.6%, p = 0.164). Forty-one patients (14%) in primary PCI group and two patients (8.3%) in rescue PCI group died during hospitalization (p = 0.75). Stroke and reinfarction were rare events in this study. Hemorrhagic stroke occurred in one patient in each group. There were no significant differences in major bleeding or major vascular complications between groups. Conclusion: The angiographic outcome and procedural success rates in patients who underwent rescue PCI were not significantly different from rates in patients who underwent primary PCI. Rescue PCI in STEMI can be performed with favorable success rates and in-hospital outcomes and should be considered in patients that experience failure after thrombolytic therapy.

Differentiation of Takotsubo Cardiomyopathy from ST Elevation Myocardial Infarction in Patients Activated for Fast-Track Coronary Angiography.

Objective: To compare clinical and electrocardiographic (ECG) features between Takotsubo cardiomyopathy (TC) and ST-elevation myocardial infarction (STEMI). Material and Method: We retrospectively reviewed clinical, electrocardiographic, and laboratory features of 20 consecutive TC patients and 155 consecutive STEMI patients who were activated for fast-track coronary angiography and were ultimately diagnosed with either TC or STEMI and compared these data between the two groups. Results: Patients with TC were older (p = 0.001), more often female (p = 0.001), had more often been triggered by intense emotional or physical stress (p = 0.001) or illness (p = 0.001), and had a lower rate of smoking (p = 0.005) than STEMI patients. Compared with patients who presented with anterior wall STEMI, those with TC less commonly had Q waves (30.0% vs. 62.9%, p = 0.007) and reciprocal change (0.0% vs. 37.1%, p = 0.001), and had a lower rate of ST-segment elevation in lead V1 (5.0% vs. 59.8%, p = 0.001). ST-segment depression was also more common in TC in lead aVR (20.0% vs. 2.1%, p = 0.008). Previously proposed ECG criteria had low sensitivity, but high specificity in our patients. Our proposed point scoring model includes the use of both clinical and ECG findings. According to our proposed model, a score ≥4 had 90% sensitivity and 98% specificity in differentiating TC from acute anterior STEMI (AUC = 0.976, p<0.001). Conclusion: In patients activated for fast-track coronary angiography because of acute coronary ST-segment elevation syndrome, a number of clinical and ECG features differ between TC patients and patients with true STEMI. Our proposed point scoring model that uses clinical and ECG findings demonstrated improved diagnostic accuracy in differentiating TC from acute anterior STEMI.

Effect of renal nerve denervation for resistant hypertension in Thai patients: a report of the first cases series in Thailand.

BACKGROUND: Hypertension is a major contributor to death. A significant portion of the patients is still in resistant hypertension with current medical treatment. Renal nerve denervation can reduce sympathetic activity, and subsequently reduce BP in western population. OBJECTIVE: To evaluate the effect of renal nerve denervation in treatment of resistant hypertension in Thai patients. MATERIAL AND METHOD: The present study is a case series of the first four Thai patients who underwent renal nerve denervation at Faculty of Medicine Siriraj Hospital. All patients had resistant hypertension. Baseline medical records, including demographic data, baseline systolic and diastolic blood pressure (BP), ambulatory BP monitoring, number and dose of anti-hypertensive medications before and after renal nerve denervation, were recorded. Patients were followed-up at 1 month, 3 month and 6 months after the procedure. RESULTS: Patients were taking antihypertensive medications ranging from 5 to 8 types of drug classes, but in all cases, their blood pressure was still not under control at baseline range from 160-190 of systolic BP and 100-120 mean BP. One of the patients had a history of hemorrhagic stroke as a consequence of un-control hypertension. All of them had blood pressure reduction immediately at the end of the first 24 hrs, and this was sustained until follow-up at 3-6 months. The mean of systolic BP reduction is 35.2 +/- 9.9 mmHg at 3-months follow-up. The mean reduction of the number of anti-hypertensive medications was 3.5 +/- 3.0 at 3-month follow-up. CONCLUSION: The authors found that the percutaneous renal nerve denervation was very effective in blood pressure reduction in these first four cases of Thai patients with resistant hypertension.

Predictors of in-hospital adverse events after PCI for NSTEMI in the National Percutaneous Coronary Intervention (PCI) Registry.

OBJECTIVE: Evaluate the in-hospital major adverse cardiovascular events (MACE) and clinical predictors of non-ST-T Mt that undergoing percutaneous coronary interventions (PCI) in Thailand. MATERIAL AND METHOD: Thailand National PCI Registry enrolled 4156 patients that underwent PCI in Thailand between May 1 and October 31, 2006. Four hundred eighty three patients underwent PCI with indication of non-ST-T MI. Baseline demographic and angiographic characteristic were recorded. MACE included CV death, M, and stroke. RESULTS: In-hospital MACE occurred in 27 patients (5.6%), included CV death in 15 patients (3.1%), MI in 14 patients (2.9%), and stroke in 2 patients (0.4%). In-hospital MACE were higher in patients with previous history of CABG (19.2% versus 4.8%, p = 0.01), cardiogenic shock at presentation (29.3% versus 3.4%, p<0.001), significant left main disease (19.4% versus 4.6%, p = 0.005), baseline ejection fraction <30% (25% versus 4.4%, p = 0.003), and used of intra-aortic balloon counter pulsation (IABP) during PCI (26.3% versus 3.8%, p<0.001). After multiple logistic regression analysis, prior history of CABG (OR = 6.1, 95% CI: 1.1-32.4, p = 0.03), baseline ejection fraction <30% (OR = 6.5, 95% CI: 1.7-24.4, p = 0.005), and used of lABP during PCI (OR = 4.7, 95% CI: 1.3-16.8, p = 0.01) are the strongest predictors of in-hospital MACE. CONCLUSION: In the National Thai PCI Registry, patients with non-ST-T MI undergoing PCI had in-hospital major adverse events rate at 5.6%. Prior CABG, low EF <30%, unstable hemodynamic required used of lABP during PCI and procedure scheduled as an urgent or emergent were predictors of in-hospital MACE.

First medical contact to device time in the Thailand percutaneous coronary intervention (PCI) registry.

OBJECTIVE: The aim of this study is to evaluate the first medical contact (FMC) to device time in the Thai national PCI registry 2006, and its effect on the clinical outcome. MATERIAL AND METHOD: Thailand national PCI registry enrolled 4,156 patients who underwent PCI from the all catheterization laboratories in Thailand between May 1st and October 31st, 2006. RESULTS: 581 patients with acute myocardial infarction (AMI), 352 patients underwent primary angioplasty, 229 patients underwent rescue angioplasty/facilitated PCI or after successful thrombolytic. Median FMC.to device time in primary angioplasty group was 115 minutes (range 24-1335 minutes); only 29.8% of patients who able to achieve FMC to device time ≤ 90 minutes. Cardiogenic shock was significant lower if FMC to device time ≤ 90 minutes (2.1% (1/48) versus 12.4% (14/113) if FMC to device time > 90, p = 0.040). In-hospital mortality occurred for 4.8% (2/48) ifFMC to device time ≤ 90 minutes and was 8.8% (10/113) if FMC to device time > 90 minutes, p = 0.510). Death occurred in 4.2% (2/48) if FMC to device time ≤ 90 minutes, 6.3% (5/79) if FMC to device time between 91-180 minutes, 6.7% (1/15) if FMC to device time between 181-270 minutes, 42.9% (3/7) if FMC to device time between 271-360 minutes and 8.3% (1/12) if FMC to device time > 360 minutes, (p = 0.040). CONCLUSION: FMC to device time is strongly associated with the risk ofcardiogenic shock and mortality. In Thailand national PCI registry in 2006, the majority of the patients did not receive primary PCI in timely fashion.

One-year clinical outcomes of ST segment elevation myocardial infarction patients treated with emergent percutaneous coronary intervention: the impact of thrombus burden.

OBJECTIVE: To investigate the impact of thrombus burden on 1-year clinical outcomes in patients who underwent emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI). MATERIAL AND METHOD: Angiographic evidence of intracoronary thrombus adversely affects the outcome of PCI in STEMI. Large thrombus burden (> or = 2 times vessel diameter) has been shown to be a significant predictor of major adverse cardiac events (MACE). The impact of thrombus burden in Asian patients who undergo PCI in STEMI has not been described. This is an observational cohort of patients with STEMI from June 1, 2008 through May 31, 2011, who underwent emergent PCI (primary or rescue). The patients were categorized into two groups according to the angiographic thrombus burden, large thrombus burden (> or = 2X vessel diameter size, LTB) and small thrombus burden (< 2X vessel diameter size, STB). MACE was defined as the composite of death, repeat myocardial infarction, target vessel revascularization and stent thrombosis. RESULTS: 202 patients were enrolled, 72% were male and the mean age was 60 years old. 134 patients (66%) presented with an occluded infarct related artery. Primary PCI was performed in 90.6% of the patients and the remainder underwent rescue PCI. One hundred eleven (55%) patients were categorized into the STB group and 91 patients (45%) into the LTB group. The use of aspiration thrombectomy was significant higher in the LTB group (LTB 80.2% vs. STB 60.44%, p = 0.002). A higher proportion of patients in the STB group underwent direct stenting strategy (STB 32.4% vs. LTB 18.7%, p = 0.027). There were no significant differences in final TIMI grade 3 flows and procedural success between the groups. Overall, in hospital, mortality was 13.4% and there were no significant differences among the groups. At 1-year follow-up, there was no significant difference in cumulative MACE-free survival in the LTB vs. STB group (82.4% vs. 79.3%, 95% confidence interval for the difference: -8.0% to 13.8%, p = 0.59). CONCLUSION: In the current study, large thrombus burden is not an independent predictor of 1-year cumulative MACE in STEMI patients who were treated with emergent PCI.

High on-clopidogrel treatment platelet reactivity in Thai patients with chronic stable angina scheduled for percutaneous coronary intervention.

OBJECTIVE: To determine the prevalence, clinical profile, and risk factors of high on-clopidogrel treatment platelet reactivity in Thai patients with chronic stable angina scheduled for percutaneous coronary intervention. MATERIAL AND METHOD: The patients were prospectively recruited from the consecutive patients undergoing coronary angiography and planned for elective percutaneous coronary intervention (PCI). Ten ml of blood samples were cautiously drawn from the antecubital vein of the patients to determine the hemoglobin and platelet count. Platelet aggregation test was performed by light transmittance aggregometry using platelet-rich plasma. Platelets were stimulated with 5 microM adenosine diphosphate (ADP). Platelet aggregation was expressed as the maximal percent change in light transmittance from baseline. High on-clopidogrel treatment platelet reactivity was defined as post treatment maximal platelet aggregation > 46% with 5 micromol/l ADP used as agonist. RESULTS: The present study consecutively enrolled two hundred four patients diagnosed with chronic stable angina planned for PCI. Seventy-nine patients demonstrated the high on-clopidogrel treatment platelet reactivity (38.7%). Among these patients, 48% were men with a mean age of 66 years. Diabetes mellitus and chronic kidney disease were detected in 34.2%. Original clopidogrel (Plavix) was prescribed in 72% of the patients and 28% received generic clopidogrel (Apolets). The prevalence of high on-clopidogrel treatment platelet reactivity increased in the older patients, patients with CKD and patients receiving angiotensin receptor blockers (ARB). However from multivariate analysis, none of the risk factors, including age, BMl, diabetes mellitus, smoking, CKD, ARB use, and type of clopidogrel (Plavix versus Apolets) had a statistically significant association with the high on-clopidogrel treatment platelet reactivity. CONCLUSION: The prevalence of high on-clopidogrel treatment platelet reactivity in the present study was 38.7%. No significant association was demonstrated between age, BMI, diabetes mellitus, smoking, CKD, ARB use, type of clopidogrel, and high on-clopidogrel treatment platelet reactivity.

Aspirin resistance in Thai patients with chronic stable angina.

OBJECTIVE: To determine the prevalence, clinical profile and risk factors of aspirin resistance in Thai patients with chronic stable angina. MATERIAL AND METHOD: The patients were prospectively recruited from the consecutive patients diagnosed chronic stable angina at Siriraj Hospital during March 2011 to February 2012. Ten milliliter of blood samples were cautiously drawn from the antecubital vein of the patients to determine the hemoglobin, platelet count and platelet aggregation test performed by light transmittance aggregometry using platelet-rich plasma. Platelets were stimulated with 0.5 mg/ml of arachidonic acid and 10 mM adenosine diphosphate. Platelet aggregation was expressed as the maximal percent change in light transmittance from baseline. Aspirin resistance was defined as the mean platelet aggregation of > or = 70% with 10 mM ADP and the mean platelet aggregation of > or = 20% with 0.5 mg/ml of arachidonic acid. RESULTS: One-hundred and fifty seven patients diagnosed chronic stable angina were enrolled in the present study. There were 34 patients (21.6%) demonstrating aspirin resistance. The clinical characteristic of these patients included male 58.8% with mean age of 66 years, body mass index 27.5 kg/m2, diabetes mellitus 52.9%, smoking 8.8%, hypercholesterolemia 70.6% and proton pump inhibitor use 23.5%. Multivariate analysis demonstrated none of the risk factors including age, female, body mass index, diabetes mellitus, hypercholesterolemia, smoking and proton pump inhibitor (PPI) use had a statistically significant association with aspirin resistance. CONCLUSION: Our study demonstrated that the prevalence of aspirin resistance in Thai patients with chronic stable angina was 21.6%. No significant association was demonstrated between age, female, body mass index, diabetes mellitus, hypercholesterolemia, smoking, proton pump inhibitor (PPI) use and aspirin resistance.

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study.

BACKGROUND: Diabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD). OBJECTIVES: This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial. METHODS: Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years). RESULTS: In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; Pinteraction= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group. CONCLUSIONS: In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828).

Apolipoprotein E gene polymorphism: effects on plasma lipids and risk of type 2 diabetes and coronary artery disease.

BACKGROUND: The most common apolipoprotein E (apoE) gene polymorphism has been found to influence plasma lipid concentration and its correlation with coronary artery disease (CAD) has been extensively investigated in the last decade. It is, however, unclear whether apoE gene polymorphism is also associated with increased risk of type 2 diabetes mellitus (T2DM). The knowledge of this study may provide the primary prevention for T2DM and CAD development before its initiation and progression. Therefore, this study was carried out to determine the association between apoE gene polymorphism and T2DM with and without CAD and its role in lipid metabolism. METHODS: The case-control study was carried out on a total of 451 samples including 149 normal control subjects, 155 subjects with T2DM, and 147 subjects with T2DM complicated with CAD. The apoE gene polymorphism was tested by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Univariable and multivariable logistic regression analyses were used to identify the possible risks of T2DM and CAD. RESULTS: A significantly increased frequency of E3/E4 genotype was observed only in T2DM with CAD group (p = 0.0004), whereas the ε4 allele was significantly higher in both T2DM (p = 0.047) and T2DM with CAD (p = 0.009) as compared with controls. E3/E4 genotype was also the independent risk in developing CAD after adjusting with established risk factors with adjusted odds ratio (OR) 2.52 (95%CI 1.28-4.97, p = 0.008). The independent predictor of individuals carrying ε4 allele still remained significantly associated with both CAD (adjusted OR 2.32, 95%CI 1.17-4.61, p = 0.016) and T2DM (adjusted OR 2.04, 95%CI 1.07-3.86, p = 0.029). After simultaneously examining the joint association of E3/E4 genotype combined with either obesity or smoking the risk increased to approximately 5-fold in T2DM (adjusted OR 4.93, 95%CI 1.74-13.98, p = 0.003) and 10-fold in CAD (adjusted OR 10.48, 95%CI 3.56-30.79, p < 0.0001). The association between apoE genotypes on plasma lipid levels was compared between E3/E3 as a reference and E4-bearing genotypes. E4-bearing genotypes showed lower HDL-C and higher VLDL-C and TG, whereas other values of plasma lipid concentrations showed no significant difference. CONCLUSIONS: These results indicate that ε4 allele has influence on lipid profiles and is associated with the development of both T2DM with and without CAD, and furthermore, it increased the risk among the subjects with obesity and/or smoking, the conditions associated with high oxidative stress.

The 'all comer' Coroflex Please drug-eluting stent registry in Europe and Asia - an overall and transcontinental assessment of the 10-month major adverse cardiac events.

BACKGROUND: Randomized trials assess the potential of a medical device in well defined indications while "all comer studies" reveal the device performance in the real clinical environment. AIMS: This 'all comers' registry assessed the 10-month outcome of the Coroflex(®) Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events. METHODS: The Coroflex(®) Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses. RESULTS: Of the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate. CONCLUSIONS: TLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization.

A comparison of outcomes between percutaneous coronary intervention versus coronary artery bypass surgery in octogenarian patients.

BACKGROUND: Percutaneous Coronary Intervention (PCI) is emerging as new revascularization procedure for coronary artery disease patients. The octogenarians are the most fragile and vulnerable age group for any type of revascularization therapy and usually discarded from any randomized trials. There is no consensus in the choice of treatment among octogenarians including PCI and coronary artery bypass grafting (CABG). OBJECTIVE: To compare PCI and CABG among Thai octogenarians (> or = 80 years old) with coronary artery disease for immediate and 24-month clinical outcomes. MATERIAL AND METHOD: Retrospective cohort study was conducted at Siriraj Hospital from January 2005 to December 2007 to obtain a complete 24-month follow-up period after revascularization. From CALYSTO database, a list of all octogenarians was retrieved (n = 333); after cleaning of the data, 265 patients (PCIn = 202, CABG n = 63) were enrolled for the present study. The primary endpoint is defined as a 30-day major adverse cardiac and cerebral event (MACCE). Secondary endpoint is a 24-month major adverse event (MACE). RESULTS: The 30-day MACCE were 11.4% in PCI group vs. 44.4% in CABG group (p < 0.001), all cause-mortality was 2.5% in PCI group vs. 8.3% in CABG group (p = 0.05), cardiovascular mortality was 1% vs. 5% (p = 0.046), mortality from sepsis was 1.5% vs. 1.5% (p = 1.0). Recurrent MI was 5.4% vs. 4.8% (p = 0.74). Cerebrovascular event occurred in 0.5% vs. 1.6% (p = 0.10). There was a crossover treatment as 0.5% vs. 0% (p = 1.0). There was no repeat target revascularization at 30-day in both groups. Major vascular complication due to bleeding requiring > or = 5 of pack-red cell transfusion was more common in CABG group (1.5% vs. 31.8%, p < 0.001). At 24-month follow-up, MACE were 35.2% in PCI group vs. 27.9% in CABG group (p = 0.36), all cause-mortality was 11.3% vs. 27.9% (p = 0.002), cardiovascular mortality was 1.5% vs. 11.5% (p < 0.001). Sepsis mortality was 2.5% vs. 11.1% (p = 0.05). MI occurred in 7.4% vs. 6.3% (p = 1.0). Repeat target revascularization was higher in PCI group (20.3% vs. 0%, p < 0.001). However, hospital stay was longer in CABG group (4.7 +/- 9 vs. 16.8 +/- 17.4 days, p = 0.01). CONCLUSION: The current revascularization strategy was evaluated. These results reflect our physician selection, patient willingness to undergo the treatment option. Lesser 30-day and 24-month all-caused mortality, cardiovascular mortality, hospital stay was observed in PCI treated octogenarians with a trade off of more frequent repeat target revascularization.

Utilizing a registry for ST segment elevation myocardial infarction from a tertiary care hospital in Thailand: opportunities to improve the quality of care.

BACKGROUND: Treatment of acute coronary syndrome requires a reliable measurement of quality for ensuring evidence-based care. Clinical registries have been used to support quality improvement activities in some countries, but there are few data concerning their implementation in developing countries. In 2008, a multidisciplinary Siriraj ST segment elevation myocardial infarction (STEMI) registry team was formed with the intention to improve the process of care. This report summarizes observational data collected within the first year to characterize the clinical profile, management and in-hospital outcomes of STEMI patients at the author's institute. MATERIAL AND METHOD: The present study is a prospective, observational study. From June 2008 through June 2009, data from all consecutive patients presenting within 24 hours of STEMI at Siriraj Hospital were collected. The patient's data on demographics, procedures, medications and in-hospital outcomes were collected. RESULTS: During the 1-year period, 112 patients with STEMI were enrolled. The mean age was 59.3 years old and 81.3% were males. There was a high prevalence of diabetes, hypertension, dyslipidemia and current smoking. Median time from symptom onset to presentation was 120 minutes. 98 patients (84.8% of the patients) received reperfusion therapy in the form of thrombolytic therapy (21.4%) or primary percutaneous coronary intervention (PCI, 63.40%). For thrombolytic therapy, the median door to needle time was 68 minutes. Rescue PCI was performed in 20.8% of the thrombolytic treated patients. For primary PCI, the median door to balloon time was 118 minutes. In-hospital coronary artery bypass graft surgery was performed in 6% of the patients. In-hospital mortality rate was 9.8%. Re-infarction and stroke were rare events. CONCLUSION: Despite a high utilization rate of reperfusion therapy the time to reperfusion therapy exceeds the length of time recommended by current guidelines. The authors' findings provide important data for future benchmarking and represent a significant opportunity for quality improvement in STEMI-related care and outcomes.