RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate.

The therapeutic management of venous thromboembolism (VTE) is rapidly evolving. Following the positive results of pivotal large-scale randomised trials, the non-vitamin K antagonist oral anticoagulants (NOACs) represent an important alternative to standard anticoagulation. In phase III studies, dabigatran was as effective as, and significantly safer than warfarin. Additional information on real-world data of dabigatran is now warranted. RE-COVERY DVT/PE is a multi-centre, international, observational (i. e. non-interventional) study enrolling patients with acute DVT and/or PE within 30 days after objective diagnosis. The study is designed with two phases. Phase 1 has a cross-sectional design, enrolling approximately 6000 patients independently of treatment choice, with the aim of providing a contemporary picture of the management of VTE worldwide. Phase 2 has a prospective cohort design, with follow-up of one year, enrolling 8000 patients treated with dabigatran or vitamin K antagonists (VKAs) with the aim of comparing their safety, defined by the occurrence of major bleeding, and effectiveness, defined by the occurrence of symptomatic recurrent VTE. RE-COVERY DVT/PE will complement both the results of other observational studies in this field and the results of phase III studies with dabigatran, in particular by assessing its clinical benefit in various patient subgroups treated in routine clinical practice.

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 18 years 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 57 years 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.