Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

Aim To investigate the putative modifying effect of dual antiplatelet therapy (DAPT) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent (E-ZES) or Cypher sirolimus-eluting stent (C-SES). Methods and results Of 8709 patients in PROTECT, 4357 were randomized to E-ZES and 4352 to C-SES. Aspirin was to be given indefinitely, and clopidogrel/ticlopidine for ≥3 months or up to 12 months after implantation. Main outcome measures were definite or probable stent thrombosis at 3 years. Multivariable Cox regression analysis was applied, with stent type, DAPT, and their interaction as the main outcome determinants. Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups (79.6% at 1 year, 32.8% at 2 years, and 21.6% at 3 years). We observed a statistically significant (P = 0.0052) heterogeneity in treatment effect of stent type in relation to DAPT. In the absence of DAPT, stent thrombosis was lower with E-ZES vs. C-SES (adjusted hazard ratio 0.38, 95% confidence interval 0.19, 0.75; P = 0.0056). In the presence of DAPT, no difference was found (1.18; 0.79, 1.77; P = 0.43). Conclusion A strong interaction was observed between drug-eluting stent type and DAPT use, most likely prompted by the vascular healing response induced by the implanted DES system. These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use, and the optimal duration of DAPT will likely depend upon stent type (Clinicaltrials.gov number NCT00476957

Acute coronary syndrome in women of reproductive age

Nazimah Idris1, Sharifah Sulaiha Aznal1, Sze-Piaw Chin1, Wan Azman Wan Ahmad2, Azhari Rosman3, Sinnadurai Jeyaindran4, Omar Ismail5, Robaayah Zambahari3, Kui Huan Sim6 1International Medical University, Seremban; 2University Malaya Medical Centre, PJ; 3Institut Jantung Negara, KL; 4Hospital Kuala Lumpur, KL; 5Hospital Pulau Pinang; 6Hospital Umum Sarawak, Malaysia Background: There is scarce or no data on prevalence and presentation of acute coronary syndrome (ACS) among women of reproductive age. Furthermore, whether women of reproductive age presenting with ACS have the same risk factors as men and older women is not known. Objective: To analyze factors associated with ACS in women of reproductive age in comparison with older women and men of a similar age group. Methodology: A total of 9702 cases of acute coronary syndrome over a 3-year period (2006–2008) from the National Cardiovascular Disease database were analyzed, with focus on women of reproductive age (20–<40 years), looking into association with ethnicity, comorbid illness, and the ACS stratum. Comparison with older women (40–<60 years; Control 1) and men of similar age group (Control 2) was made and analyzed using Fisher's exact test and chi-square test when necessary. Results: From a total of 9702 cases, 2344 (24.2%) were women. Of these, 45 (1.9%) were women between 20 and <40 years, which is significantly lower than the two controls (older women 30.8%, and men of same age 6.2%, respectively; P < 0.0001). The distribution of ethnicity shows a similar pattern between the study group and the controls, but patients of Indian ethnicity were over-represented when compared with the Malaysian demographics of general population (31.3% versus 7.1%; P < 0.0001). ACS in women of reproductive age was associated with diabetes mellitus in 37.8%, hypertension in 40.0%, and dyslipidemia in 24.4% of cases, similar to men of the same age but significantly lower than the older women (P < 0.0001). Smoking is not a major risk factor in the study group, where only 6.7% ever smoked, similar to older women (6.8%, P = 1.000) and significantly much less compared with men of the same age (84.1%; P < 0.0001). Regarding the ACS stratum, a significantly higher percentage of women in the study group had ST-segment elevation myocardial infarction compared with older women (P = 0.0085) but less than that of men of similar age (P = 0.0187). Conclusion: ACS is rare in women of reproductive age. Diabetes, hypertension, and Indian ethnicity were identified as important contributors. Keywords: reproductive-aged women, comorbidities, risk factor

The journey of Malaysian NCVD-PCI (National Cardiovascular Disease Database-Percutaneous Coronary Intervention) Registry: A summary of three years report

INTRODUCTION: The Malaysian National Cardiovascular Disease Database (NCVD) team presents Percutaneous Coronary Intervention (PCI) Registry report for the year 2007 to 2009. It provides comprehensive information regarding practice and outcome of PCI in Malaysia. METHODOLOGY: It was a voluntary, multi-centered, observational, cohort study and included patients of 18years or above who underwent PCI at eleven participating centers in Malaysia from the year 2007 to 2009. RESULT: Ten thousand six hundred and two patients underwent 11,498 PCI procedures with 18,116 stents for 15,538 lesions. Mean age of the patients was 57years and more than 98% of patients had at least one cardiovascular risk factor. A significant number of our patients were diabetic (50%) and had renal impairment (44.7% had≤stage 3 chronic kidney disease) at the time of procedure. Fifty eight percent of the lesions were type B2 or type C lesion. Twenty eight percent of the lesions had high risk characteristics. Procedural success rate was about 97% and post-procedural complications were low. Overall in-hospital, all cause mortality was 1%, of which 85% were cardiac related deaths. The poor prognostic factors for in-hospital mortality were acute coronary syndrome cases, higher Killip class and increasing age. CONCLUSION: Compared to other registries, Malaysian patients undergoing PCI were much younger with high prevalence of risk factors. In spite of complex and high risk lesions, procedural success was high, with overall low mortality rate. NCVD-PCI Registry aims to improve over-all cardiac services in Malaysia through its ongoing journey

Clinical use of clopidogrel in acute coronary syndrome

Several therapeutic approaches have been developed to improve the outcome among patients with acute coronary syndrome (ACS). However, treatment with antithrombotic therapies such as oral glycoprotein IIb/IIIa inhibitors has been limited by the lack of efficacy and excess bleeding complications. As the publication of the landmark study Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE), the clinical benefit of early and intermediate-term use of combined antiplatelet agents – clopidogrel plus aspirin – in non-ST-segment elevation myocardial infarction (NSTEMI) patients became evident. Pretreatment and intermediate-term therapy with clopidogrel in NSTEMI ACS patients undergoing percutaneous coronary intervention (PCI) was further supported by the PCI–CURE trial. Recently, the results of two major trials Clopidogrel as Adjunctive Reperfusion Therapy–Thrombolysis in Myocardial Infarction 28, Clopidogrel and Metoprolol in Myocardial Infarction Trial established the pivotal role of clopidogrel in the other spectrum of ACS–STEMI. Coupled with the results from previous multicentre trials, these two studies provide a guide for the early and long-term use of clopidogrel in the whole spectrum of ACS. A review summarising the results of the recent clinical trials and a discussion on its implications for the clinical management of ACS is presented

Impact of age on the comparison between short-term vs 12-month dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-Year follow-up results of the REDUCE trial

BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (<or ≥ 75 years). Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleeding (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. RESULTS: From June 2014 to May 2016, 1496 patients were included in the study, of whom 205 (13.7%) ≥75 years of age. Among them, 50.7% of the elderly and 50.2% of younger patients were assigned to the 3-month DAPT treatment. Baseline characteristics were well matched between the two arms, except for a higher rate of males (p=0.02) and a reduced number of lesions on the right coronary artery (p=0.02) in elderly patients treated for the short DAPT duration. Median follow-up was 682.5 days [IQR:667-731]. At 12 months, no difference in the primary endpoint was observed according to DAPT duration in both patients aged ≥75 years (22.1% vs 18.8%, HR [95%CI] = 1.6 [0.73-3.5], p=0.24) and younger ones (9.7% vs 10.9%, HR [95%CI] = 0.85 [0.59-1.27], p=0.44; p INT = 0.15). Results were confirmed after correction for baseline differences among the elderly (adjusted HR [95%CI] = 1.7 [0.75-3.9], p=0.21). Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of age. CONCLUSIONS: The present study shows that among ACS patients randomized in the REDUCE trial, a 3-month DAPT strategy was comparable to a standard 12-month DAPT at a 2-year follow-up for both ischemic and bleeding endpoints, in elderly and younger patients. Thus, despite presenting the limitations of a subgroup analysis, our study strengthens the feasibility of a shorter DAPT duration even among high-risk subsets of ACS patients