METHODS: The systematic review and meta-analysis covered the period from 1989 to 2023. Multiple databases, including Embase, PubMed, Scopus, Web of Sciences (WoS), MagIran, Scientific Information Database (SID), and Google Scholar, were searched using validated keywords with MeSH and Emtree. The I2 index was used to check for heterogeneity among studies.
RESULTS: The review of 8 studies, with a sample size of 397,298 participants, showed high heterogeneity (I2: 97.8 %). Therefore, the random effects method was used to analyze the results. The prevalence of bleeding after intervention in percutaneous coronary arteries was reported to be 4.4 % (95%CI: 2-9.1).
CONCLUSION: This meta-analysis showed a significant prevalence of bleeding after PCI, highlighting the need for health policymakers to pay more attention to the complications associated with PCI. Interventional cardiologists should consider the effective factors in these bleeding and how to treat and control them due to the importance of this complication.
DESIGN: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio.
SETTING: Tertiary and University hospitals.
INTERVENTIONS: Patients (n=10,600) undergoing coronary artery bypass graft will be randomized to receive either volatile anesthetic as part of the anesthetic plan, or total intravenous anesthesia.
MEASUREMENTS AND MAIN RESULTS: The primary end point of the study will be one-year mortality (any cause). Secondary endpoints will be 30-day mortality; 30-day death or non-fatal myocardial infarction (composite endpoint); cardiac mortality at 30day and at one year; incidence of hospital re-admission during the one year follow-up period and duration of intensive care unit, and hospital stay. The sample size is based on the hypothesis that volatile anesthetics will reduce 1-year unadjusted mortality from 3% to 2%, using a two-sided alpha error of 0.05, and a power of 0.9.
CONCLUSIONS: The trial will determine whether the simple intervention of adding a volatile anesthetic, an intervention that can be implemented by all anesthesiologists, can improve one-year survival in patients undergoing coronary artery bypass graft surgery.
METHODS AND RESULTS: A detailed questionnaire was distributed to 28 highly-experienced interventional cardiologists ('Authors') from 13 Asia-Pacific countries. The results were discussed at a meeting on patient selection, technical consideration, deployment practices and patient management. Potential patient benefits of Absorb compared to metallic DES, the learning curve for patient selection and preparation, device deployment, and subsequent patient management approaches are presented.
CONCLUSIONS: Current practices are derived from guidelines optimized for European patients. Differences in approach exist in the Asia-Pacific context, including limited access to imaging and frequency of occurrence of complex lesions. Nevertheless, the use of the Absorb BVS ('Absorb') in certain Asia-Pacific countries has flourished and practices here are continuing to mature.
OBJECTIVE: The primary objective of this study was to develop a new LSM scoring system and investigate the correlation between adherence to LSM and incidence of major adverse cardiac events (MACEs) at 12-month follow-up.
METHOD: A total of 1000 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) were included in this prospective single-center study. Manipal lifestyle modification score (MLSMS) was developed by using five lifestyle-related factors. Adherence to LSM at the baseline and subsequent follow-ups was determined by using MLSMS. The MACE at 1-, 6-, and 12-month follow-up were analyzed.
RESULTS: There was a significant reduction in overall adherence to LSM (p
METHODS: We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).
RESULTS: A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).
CONCLUSIONS: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.
METHODS: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.
RESULTS: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).
CONCLUSION: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS.
GOV IDENTIFIER: NCT02183454.
METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR).
RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups.
CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.