Drug coated balloons and their role in bifurcation coronary angioplasty: appraisal of the current evidence and future directions.

INTRODUCTION: Coronary Bifurcation lesions are technically more challenging and Bifurcation percutaneous coronary intervention (PCI) remains a challenge with unpredictable and sub-optimal clinical and angiographic results. Drug-Coated Balloons (DCB) are emerging devices in the field of coronary intervention with promising results that may overcome some of drug eluting stents limitations and may have potential advantages in complex bifurcation PCI. AREAS COVERED: We have performed a re-appraisal about the issues with current bifurcation PCI techniques and the use of DCB in the treatment of Bifurcation lesions. Several studies performed utilizing DCB are described and critically appraised. Over the recent years, there have been tremendous developments in the DCB technology, lesion preparation, clinical experience, and clinical data during bifurcation PCI. The current review describes the advances in the DCB technology, pharmacokinetics, role of excipients, and optimization of the technique. Special emphasis in lesion preparation and potential pathway of using DCB in bifurcation PCI is proposed. EXPERT OPINION: Although different proof of concept and pilot studies have shown promising results in treatment of bifurcation lesions with DCB, larger randomized trials and/or international consensus papers are required to enable worldwide translation of this idea to clinical practice.

Breve historia de los stents coronarios / A brief history of coronary artery stents

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Quantified degree of eccentricity of aortic valve calcification predicts risk of paravalvular regurgitation and response to balloon post-dilation after self-expandable transcatheter aortic valve replacement.

BACKGROUND: Limited data exist regarding the impact of aortic valve calcification (AVC) eccentricity on the risk of paravalvular regurgitation (PVR) and response to balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR). We investigated the prognostic value of AVC eccentricity in predicting the risk of PVR and response to BPD in patients undergoing TAVR. METHODS: We analyzed 85 patients with severe aortic stenosis who underwent self-expandable TAVR (43 women; 77.2±7.1years). AVC was quantified as the total amount of calcification (total AVC load) and as the eccentricity of calcium (EoC) using calcium volume scoring with contrast computed tomography angiography (CTA). The EoC was defined as the maximum absolute difference in calcium volume scores between 2 adjacent sectors (bi-partition method) or between sectors based on leaflets (leaflet-based method). RESULTS: Total AVC load and bi-partition EoC, but not leaflet-based EoC, were significant predictors for the occurrence of ≥moderate PVR, and bi-partition EoC had a better predictive value than total AVC load (area under the curve [AUC]=0.863 versus 0.760, p for difference=0.006). In multivariate analysis, bi-partition EoC was an independent predictor for the risk of ≥moderate PVR regardless of perimeter oversizing index. The greater bi-partition EoC was the only significant parameter to predict poor response to BPD (AUC=0.775, p=0.004). CONCLUSION: Pre-procedural assessment of AVC eccentricity using CTA as "bi-partition EoC" provides useful predictive information on the risk of significant PVR and response to BPD in patients undergoing TAVR with self-expandable valves.

Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12-year period.

BACKGROUND: The last decade, regarded as the DES era in PCI, has witnessed significant advances in the management of coronary disease. We aimed to assess temporal trends in the practice and outcome of percutaneous coronary intervention (PCI) during the drug eluting stent (DES) era. METHODS: We analyzed 18,641 consecutive PCI's performed between January 2004 and December 2016, distinguished by procedural date (Q1 : 2004-2006, n = 4,865; Q2 : 2007-2009, n = 4,977; Q3 : 2010-2012, n = 4,230; Q4 : 2013-2016, n = 4,569). RESULTS: At presentation, mean patients age was 65 (±11) years and 22.8% were females. Over time, there was a rise in the relative number of octogenarians (Q1 : 10.7% vs Q4 : 15.5%, P < 0.001) and an increase in the burden of most comorbidities (e.g., left ventricular dysfunction ≥ moderate and chronic kidney disease, P < 0.001 for both). Despite a 2-fold increase in the rate of complex interventions, and a 3-fold increase in the rate of unprotected left-main angioplasty (P < 0.001 for both), the radial approach was increasingly adopted (Q1 : 2% to Q4 : 63.5%, P < 0.001). DES implantation increased from 43% to 83% at the expense of bare metal stent (BMS) application, and accompanied by drug coated balloon sprout to 1.8%, P < 0.001. Kaplan-Meier survival curves revealed a time-based enhanced outcome, with a decreased rate of death, MI, target vessel revascularization and CABG over the years. CONCLUSIONS: In the last decade, PCI has evolved to offer better outcome to more elderly, sicker patient population, with more complex coronary disease interventions. The shift to second generation DES and to enhanced PCI techniques may explain part of this progress.

Estrategias de reperfusión en hospitales sin intervención coronaria percutánea primaria / Reperfusion strategies in hospitals without primary percutaneous coronary intervention

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Estrategias de reperfusión en hospitales sin intervención coronaria percutánea primaria. Respuesta / No disponible

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Effect of improved door-to-balloon time on clinical outcomes in patients with ST segment elevation myocardial infarction.

OBJECTIVE: Few studies have focused on the effects of an improved door-to-balloon time on clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to explore the effect of improving door-to-balloon time on prognosis and to identify major predictors of mortality. METHODS: From January 2005 to December 2014, 1751 patients experienced STEMI and received primary percutaneous intervention in our hospital. During a 10-year period, the patients were divided into two groups according to the time period. Since mid-2009, shortening door-to-balloon time has been an important concern of health care. As a result of targeted efforts, as of January 2010, door-to-balloon time shortened significantly. In our study, a total 853 patients were in group 1 during January 2005 to December 2009, and a total 898 patients were in group 2 during January 2010 to December 2014. RESULTS: The incidence of major adverse cardiac cerebral events (26.7% vs. 23.2%; p=0.120), the incidence of cardiovascular mortality (9.3% vs. 8.8%; p=0.741), and the incidence of all-cause mortality (12.6% vs. 12.2%; p=0.798) were similar between the two groups. The incidence of target vessel revascularization significantly decreased in group 2 (17.8% vs. 12.6%; p=0.008). However, the incidence of stroke increased in group 2 (1.8% vs. 3.6%; p=0.034). CONCLUSION: Improving door-to-balloon time could not improve 1-year cardiovascular mortality whether low-risk or high-risk patients. The improvement in the door-balloon time does not improve outcomes studied, probably because it is not accompanied by a reduction in total reperfusion time, which means from onset of symptoms to reperfusion.

Impact of door-to-balloon time on long-term mortality in high- and low-risk patients with ST-elevation myocardial infarction.

BACKGROUND: Door-to-balloon time (DTBT) less than 90min remains the benchmark of timely reperfusion in ST-elevation myocardial infarction (STEMI). The relative long-term benefit of timely reperfusion in STEMI patients with differing risk profiles is less certain. Thus, we aimed to assess the impact of DTBT on long-term mortality in high- and low-risk STEMI patients. METHOD: We analysed baseline clinical and procedural characteristics of 2539 consecutive STEMI patients who underwent primary percutaneous coronary intervention (PCI) from the Melbourne Interventional Group registry from 2004 to 2012. Patients were classified high risk (HR-STEMI) if they presented with cardiogenic shock, out-of-hospital cardiac arrest (OHCA) or Killip class ≥2; or low-risk (LR-STEMI) if there were no high-risk features. We then stratified high- and low-risk patients by DTBT (≤90min vs. >90min) and assessed long-term mortality. RESULT: Of the 2539 patients, 395 (16%) met the high-risk criteria. A DTBT ≤90min was achieved in 43% of HR-STEMI patients and in 55% of LR-STEMI patients. Patients in the HR-STEMI compared to LR-STEMI cohort had higher in-hospital (31% vs. 1%, p<0.01) and long-term mortality (37% vs. 7%, p<0.01). A DTBT ≤90min was associated with significant improvements in short- and long-term mortality in both groups. A DTBT ≤90min was an independent multivariate predictor of long-term survival in LR-STEMI (hazard ratio [HR] 0.5, 95% confidence interval [CI] 0.3-0.9, p=0.02) but not in HR-STEMI (HR 0.7, 95% CI 0.5-1.1, p=0.11). CONCLUSION: A DTBT ≤90min was associated with improved short- and long-term outcomes in high- and low-risk STEMI patients. However, it was only an independent predictor of long-term survival in LR-STEMI patients.

Lack of Serum Creatinine Decrease After Coronary Angiography Despite Prophylactic Hydration After Routine Coronary Angiography/Angioplasty in Stable Angina Patients--Pilot Study.

BACKGROUND/AIMS: To prevent contrast induced renal dysfunction a periprocedural prophylactic hydration is applied. Due to dilution it should cause a drop in serum creatinine concentration (SCR). Surprisingly, no reduction in SCR after contrast admission is found in up to 25% of patients as early as 12-18 hours after coronary angiography/angioplasty. This study aims to find a clinical explanation as well as predict circumstances for this phenomenon. METHODS: Retrospective clinical and laboratory data was used from 341 patients who underwent elective coronary angiography/angioplasty, received a prophylactic hydration, and had serum creatinine concentration measured prior to, and 12-18 hours after invasive procedure with iodine contrast administration. To exclude an improper hydration due to no creatinine decrease, the number of red blood cells was analysed as well as hemoglobin and hematocrit in blood donations collected during the study time points. RESULTS: The resulting lack of serum creatinine reduction could be explained by dehydration (measured by increase in number of RBC, HGB and HCT) only in 13.5% , 10.8%, and 20% of cases, respectively. Any form of abnormal glucose metabolism combined with either baseline serum creatinine concentration <0.87 mg/dL or creatinine clearance >86.77 mL/min, or GFR by CKD EPI >80.08 mL/min/1.73 m2, or GFR by MDRD >74.48 mL/min/1.73 m2 were the predictors for no creatinine decrease at outcome. Additionally, it was demonstrated that the lack of creatinine decrease was more often observed among those patients whose initial renal function was better than in the subjects with reduction of SCR. CONCLUSIONS: This observation requires further prospective investigation on extended group of patients.

Temporal trends in the epidemiology, management, and outcome of patients with cardiogenic shock complicating acute coronary syndromes.

AIMS: Despite advances in the management of patients with acute coronary syndrome (ACS), cardiogenic shock (CS) remains the leading cause of death in these patients. We describe the evolution of clinical characteristics, in-hospital management, and outcome of patients with CS complicating ACS. METHODS AND RESULTS: We analysed data from five Italian nationwide prospective registries, conducted between 2001 and 2014, including consecutive patients with ACS. Out of 28 217 ACS patients enrolled, 1209 (4.3%) had CS: 526 (44%) at the time of admission and 683 (56%) later on during hospitalization. Over the years, a reduction in the incidence of CS was observed, even though this was not statistically significant (P for trend = 0.17). The proportions of CS patients with a history of heart failure declined, whereas the proportion of those with hypertension, renal dysfunction, previous PCI, and AF significantly increased. The use of PCI considerably increased from 2001 to 2014 [19% to 60%; percentage change 41, 95% confidence interval (CI) 29-51]. In-hospital mortality of CS patients decreased from 68% (95% CI 59-76) in 2001 to 38% (95% CI 29-47) in 2014 (percentage change -30, 95% CI -41 to -18). Compared with 2001, the risk of death was significantly lower in all of the registries, with reductions in adjusted mortality between 45% and 66%. CONCLUSIONS: Over the last 14 years, substantial changes occurred in the clinical characteristics and management of patients with CS complicating ACS, with a greater use of PCI and a significant reduction in adjusted mortality rate.

Comprehensive Cardiovascular Risk Factor Control Improves Survival: The BARI 2D Trial.

BACKGROUND: It is unclear whether achieving multiple risk factor (RF) goals through protocol-guided intensive medical therapy is feasible or improves outcomes in type 2 diabetes mellitus. OBJECTIVES: This study sought to quantify the relationship between achieved RF goals in the BARI 2D (Bypass Angioplasty Investigation Revascularization 2 Diabetes) trial and cardiovascular events/survival. METHODS: We performed a nonrandomized analysis of survival/cardiovascular events and control of 6 RFs (no smoking, non-high-density lipoprotein cholesterol <130 mg/dl, triglycerides <150 mg/dl, blood pressure [systolic <130 mm Hg; diastolic <80 mm Hg], glycosylated hemoglobin <7%) in BARI 2D. Cox models with time-varying number of RFs in control were adjusted for baseline number of RFs in control, clinical characteristics, and trial randomization assignments. RESULTS: In 2,265 patients (mean age 62 years, 29% women) followed up for 5 years, the mean ± SD number of RFs in control improved from 3.5 ± 1.4 at baseline to 4.2 ± 1.3 at 5 years (p < 0.0001). The number of RFs in control during the trial was strongly related to death (global p = 0.0010) and the composite of death, myocardial infarction, and stroke (global p = 0.0035) in fully adjusted models. Participants with 0 to 2 RFs in control during follow-up had a 2-fold higher risk of death (hazard ratio: 2.0; 95% confidence interval: 1.3 to 3.3; p = 0.0031) and a 1.7-fold higher risk of the composite endpoint (hazard ratio: 1.7; 95% confidence interval: 1.2 to 2.5; p = 0.0043), compared with those with 6 RFs in control. CONCLUSIONS: Simultaneous control of multiple RFs through protocol-guided intensive medical therapy is feasible and relates to cardiovascular morbidity and mortality in patients with coronary disease and type 2 diabetes mellitus. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305).

Short and long-term mortality in women and men undergoing primary angioplasty: A comprehensive meta-analysis.

INTRODUCTION: Women with acute myocardial infarction are treated less aggressively than men and have a higher mortality. It is possible that these sex-related differences in outcome are a result of differences in baseline risk and management. METHODS AND RESULTS: We undertook a meta-analysis to study the differences in mortality among women and men with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (P-PCI). Studies reporting sex-specific crude mortality rates and/or adjusted effect estimates in STEMI patients undergoing P-PCI were identified. Among 48 studies, involving 103,895 patients, (26,556 women and 77,337 men), the crude in-hospital [pooled relative risk (RR): 1.94, 95% confidence interval (CI): 1.74-2.16, p<0.001; 23 studies (n=43,872)], 30-day [RR: 1.76, 95% CI: 1.50-2.07, p<0.001; 20 studies (n=43,279)], and long-term [RR: 1.60, 95% CI: 1.46-1.76, p<0.001; 26 studies (n=51,656)] mortality was significantly higher in women compared to men. When meta-analysis using adjusted effect estimates from individual studies was performed, in-hospital [RR: 1.31, 95% CI: 1.08-1.65, p=0.007; 14 studies (n=33,380)] and 30-day mortality [RR: 1.19, 95% CI: 1.01-1.39, p=0.03; 14 studies (n=28,564)] remained significant while long-term mortality [RR: 1.01, 95% CI: 0.93-1.11, p=0.75; 20 studies (n=52,492)] was no longer different between women and men. CONCLUSIONS: Sex-based differences exist in short and long-term mortality among patients with STEMI undergoing P-PCI. However, these differences were markedly attenuated following adjustment for clinical differences and/or hospital course. Despite adjustment, short-term mortality remains higher in women than men, while long-term mortality was no longer significantly different.

Temporal trends and patterns in percutaneous treatment of coronary artery disease in Poland in the years 2005-2011.

BACKGROUND: According to a recent survey, Poland is one of the leaders of interventional cardiology in Europe in terms of the number of primary percutaneous coronary intervention (PCI) procedures per million inhabitants. AIM: To present temporal trends in epidemiology, demographics, treatment, and periprocedural outcome of patients referred for percutaneous coronary angiography and angioplasty in Poland in 2005-2011, based on the Polish National PCI Registry. METHODS: Patients who underwent percutaneous coronary angiography (ANGIO group) and/or angioplasty (PCI group) were included in the Polish National PCI Registry - a prospective observational registry study in Poland. RESULTS: There were 935,429 patients in the ANGIO group and 501,117 in the PCI group in Poland in 2005-2011. The number of catheterisation labs increased from 75 to 137, angiography procedures rose from 99,195 to 180,935, and PCIs from 50,297 to 99,614. The procedural mortality and stroke rates for the ANGIO group have remained stable whereas for the PCI group procedural mortality has increased over the years. The use of drug eluting stents (DESs) rose from 32.8% to 55.3% in stable angina and the use of a radial approach from 26.8% to 39.1%. CONCLUSIONS: Use of modern attributes of interventional cardiology like DES stents, radial approach, and treatment of higher risk patients has increased in Poland in 2005-2011. The adoption of the "Stent for Life" initiative has resulted in an increasing number of percutaneous coronary procedures over the years.