Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

BACKGROUND AND AIMS: Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. METHODS: This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. RESULTS: Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). CONCLUSIONS: Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Efficacy of single-dose evolocumab injection in early-phase acute myocardial infarction: a retrospective single-center study.

Background/Aims: Achieving rapid reduction of low-density lipoprotein cholesterol (LDL-C) levels below 55 mg/dL in patients with acute myocardial infarction (AMI) can be challenging with statins alone. This single-center, retrospective study aimed to assess the impact of single-dose injection of evolocumab 140 mg on LDL-C levels during the peri-percutaneous coronary intervention (PCI) period in patients with AMI. Methods: A total of 95 patients with AMI who underwent PCI were divided into the evolocumab (n = 50) and non-evolocumab (n = 45) groups. Results: The percentage change of LDL-C level at 1-3 weeks from baseline was 78.4 ± 13.4% reduction in the evolocumab group versus 45.6 ± 22.6% in the non-evolocumab group, with a mean difference of -33.5% between the groups (95% CI: -42.6 to -24.5%; p < 0.001). The achievement rate of LDL-C levels below 55 mg/dL at 1-3 weeks was significantly higher in the evolocumab group than in the non-evolocumab group (97.7% vs. 60.0%, p < 0.001). Conclusions: Patients with AMI who received single-dose injection of evolocumab 140 mg during the peri-PCI period had a significantly greater LDL-C reduction and higher proportion of patients achieved the target LDL-C level in the early phase AMI than those who did not receive evolocumab.

Invasive physiologic assessment of coronary artery stenosis by resting full-cycle ratio and fractional flow reserve: a prospective observational study.

Resting full-cycle ratio (RFR), an alternative to fractional flow reserve (FFR) for evaluating intermediate coronary artery stenosis, helps reduce patients' time, cost, and discomfort. However, the validation data for RFR and FFR are lacking. We aimed to assess the diagnostic accuracy of RFR and FFR and evaluate effective decision-making for revascularization using their values. Patients subjected to an invasive physiological study for intermediate coronary artery stenosis in Yongin Severance hospital between October 2020 and April 2022 were prospectively and consecutively recruited. We evaluated the correlation between RFR and FFR measurements and the diagnostic performance of RFR (≤ 0.89) versus FFR (≤ 0.80). In all, 474 intermediate coronary stenosis lesions from 400 patients were evaluated using RFR and FFR values. There was a strong linear relationship between RFR and FFR (r = 0.75, 95% CI 0.70-0.78, p < 0.01). Comparing diagnostic performance between RFR and FFR, RFR demonstrated diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 85.0%, 80.0%, 86.7%, 67.1%, and 92.7%, respectively. We analyzed the RFR value in the hyperemia zone (0.86-0.93) according to positive (RFR: 0.86-0.89) and negative (RFR: 0.90-0.93) areas. PPV in positive area is 47.8% (95% Confidence Interval [CI]: 33.8% to 62.0%) and NPV in negative area is 87.7% (95% CI: 80.3% to 93.1%). Excellent correlation exists between RFR and FFR and the diagnostic value of RFR without hyperemia compared with FFR in establishing the accurate functional significance of coronary artery stenosis was shown. RFR alone could evaluate the functional significance of coronary artery stenosis without unnecessary hyperemia, except in the positive area.Trial registration: URL: http://trialsearch.who.int ; Unique identifier: KCT0005255.

Efficacy of Percutaneous Coronary Intervention With Synergy Stents in Patients Aged ≥75 Years: 1-Year Clinical Outcomes from the Synergy Elderly Registry.

Data regarding the clinical outcomes of older patients after Synergy everolimus-eluting stent (S-EES) implantation are limited. This study investigated the 12-month clinical outcomes of older patients who underwent percutaneous coronary intervention with new-generation drug-eluting stents according to ischemic risks. This prospective multicenter study targeted patients aged ≥75 years who underwent S-EES implantation. The primary and secondary end points included 12-month device-oriented composite end point (DOCE) (cardiovascular death, target vessel myocardial infarction, or target lesion revascularization) and major adverse cardiac and cerebrovascular events (MACCEs; all-cause death, myocardial infarction, target vessel revascularization, stent thrombosis, or stroke), respectively. A stratified analysis was conducted according to high-ischemic risk (HIR), defined as complex coronary intervention (number of stents implanted ≥3, total stented length >60 mm, chronic total occlusion, left main, or bifurcation), diabetes, or chronic kidney disease. In total, 650 enrolled patients aged ≥75 years were categorized into HIR (n = 425) and non-HIR groups (n = 225). In the total population, the 1-year incidence of DOCEs was 2.5%. The rates of DOCEs were not significantly different between the HIR and the non-HIR groups, whereas the MACCE rate was higher in the HIR (9.4%) than the non-HIR group (4.9%, p = 0.035), and the DOCE and MACCE components did not differ significantly in the occurrence between the groups. The independent predictors for the DOCEs or MACCEs included age, anemia, or left ventricular ejection fraction <40%. In conclusion, in older patients, S-EES implantation demonstrated favorable device-related outcomes, regardless of procedural complexity or co-morbidities. However, it requires careful attention because older patients with HIR are associated with worse clinical outcomes.

Comparison of spasmolytic regimen for prevention of radial artery spasm during the distal radial approach: A single-center, randomized study.

Background: The distal radial approach (DRA) for coronary catheterization is increasingly being used worldwide yet the optimal medication regimen to prevent radial artery spasm (RAS), an important factor for the success of the procedure, remains unclear. The aim of this study is to examine the effectiveness of medication for preventing RAS via the DRA. Methods: This was a prospective, comparative randomized study including 400 patients who underwent coronary catheterization via DRA in single center by three experienced DRA operators. Patients were randomized to either nitroglycerin (NTG) injection (N = 200) or NTG plus verapamil (N = 200) to compare the effectiveness and safety of these regimens. Results: There were no differences between the groups in the changes in radial artery diameter at most spastic area (0.34 ± 0.20 in the NTG group, 0.35 ± 0.20 in the NTG plus verapamil group; P = 0.73). There was no difference between the groups in the ratio of patients without arm pain during the procedure (95.0% in the NTG group, 93.5% in the NTG plus verapamil group; P = 0.67). However, there was a greater reduction in diastolic blood pressure in the NTG plus verapamil group (-8.3 ± 7.9 mmHg) than in the NTG group (-6.6 ± 7.6 mmHg) (P = 0.03). Conclusion: Intra-arterial injection of NTG as a single agent is effective and safe in the prevention of RAS during coronary catheterization via the DRA compared with a cocktail regimen of NTG plus verapamil. Clinical trial registration: https://cris.nih.go.kr, identifier KCT0005177.

Bowel Preparation and Subsequent Colonoscopy Is Associated with the Risk of Atrial Fibrillation: A Population-Based Case-Crossover Study.

This study aimed to clarify the association of the risk of atrial fibrillation (AF) with bowel preparation and subsequent colonoscopy through population-based case-crossover analysis. Patients who developed new-onset AF after undergoing colonoscopy following bowel preparation were included. For each patient, one hazard period and four control periods were matched at specified time windows. Among 189,613 patients with AF, 84 patients (mean age: 72.4 years) finally met the inclusion criteria. Most patients used polyethylene glycol (PEG)-based solutions (2 L PEG + ascorbic acid (n = 56), 4 L PEG (n = 21)) as purgatives and had hypertension (n = 75). A significant association of bowel preparation and colonoscopy with AF occurrence was found in all time windows. The proportion of patients with bowel preparation and colonoscopy was higher during the hazard period than during the control periods. In the 1-, 2-, 4-, 8-, and 12-week time windows, the proportions were 11.9% vs. 4.2%, 13.1% vs. 4.8%, 16.7% vs. 6.3%, 28.6% vs. 11.9%, and 29.8% vs. 14.0%, and the odd ratios (ORs) were 3.11, 3.01, 3.00, 2.96, and 2.61, respectively. Bowel preparation and undergoing colonoscopy was associated with the risk of AF and this examination need to be performed with caution especially in elderly patients with hypertension.

Successful Primary Percutaneous Coronary Intervention without Stenting: Insight from Optimal Coherence Tomography.

For patients with acute myocardial infarction, current management guidelines recommend implantation of a drug-eluting stent, dual antiplatelet therapy (including potent P2Y12 inhibitors) for at least 1 year, and maintenance of life-long antiplatelet therapy. However, a pilot study showed favorable results with antithrombotic therapy without stent implantation when plaque erosion, not definite plaque rupture, was confirmed using optical coherence tomography (OCT), despite the patients having acute myocardial infarction. Here, we present a case where successful primary percutaneous coronary intervention was performed without stenting with the aid of OCT in a patient with ST-elevation myocardial infarction who developed thrombotic total occlusion of the right coronary artery.

Impact of antiplatelet agents and anticoagulants on the performance of fecal immunochemical tests: a systematic review and meta-analysis.

BACKGROUND: Antithrombotic agents may increase the bleeding tendency and affect the performance of fecal immunochemical test (FIT). We aimed to evaluate the impact of antithrombotic agents on the performance of FIT through a systematic review and meta-analysis. METHODS: All relevant studies published between January 1980 and September 2020 that examined the diagnostic performance of FIT were searched through MEDLINE, EMBASE, and Cochrane Library databases. We performed a meta-analysis for the positive predictive value (PPV) of FIT for detecting advanced colorectal neoplasia (ACRN) or colorectal cancer (CRC) according to the administration of antithrombotic agents including aspirin, antiplatelet agents, and oral anticoagulants (OACs). RESULTS: Thirteen studies with 27,518 patients were included. Of these, 11 studies with data required for the calculation of pooled PPV were included in the meta-analysis. The pooled PPV of FIT for detecting ACRN was significantly lower in antithrombotic agent users than in non-users (odds ratio [OR] [95% confidence interval [CI]]: aspirin, 0.82 [0.68-0.99]; antiplatelet agents, 0.82 [0.69-0.96]; OACs, 0.66 [0.52-0.84]). For detecting CRC, antithrombotic agent use tended to be associated with a reduced PPV (aspirin, 0.76 [0.51-1.14]; antiplatelet agents, 0.73 [0.52-1.02]; OACs, 0.60 [0.25-1.44]). In the subgroup analysis, a FIT cutoff value of 15 µg Hb/g feces tended to be associated with lower PPVs compared to a value of 20 µg Hb/g feces in antithrombotic agent users. CONCLUSIONS: Aspirin, antiplatelet agents, and OACs significantly lowered the PPV of FIT for detecting ACRN. These drugs may increase the false-positive of FIT.

Comparison of Distal Radial, Proximal Radial, and Femoral Access in Patients with ST-Elevation Myocardial Infarction.

Recent studies have indicated that distal radial access (DRA) is feasible in patients undergoing percutaneous coronary intervention (PCI). The present study aimed to compare DRA, proximal radial access (PRA), and femoral access (FA) in patients with ST-elevation myocardial infarction (STEMI) undergoing PCI. Data were analyzed for 109 patients with STEMI treated via primary PCI from March 2020 to May 2021. The success rate of DRA was 83.3% (35/42), including seven cases of failed puncture (puncture failure = 5, severe radial artery spasm = 2). Primary PCI via the DRA was successful in all 35 patients. After classifying the patients requiring crossover into a separate group, the percentage of the puncture time in the door-to-wiring time was 2.7% [2.2-4.3], 3.3% [2.3-4.0], 2.6% [1.2-4.9], and 27.0% [13.5-29.3] in the DRA (n = 35), PRA (n = 24), FA (n = 26), and crossover (n = 9) groups, respectively (p < 0.01). Only two local hematomas (≤5 cm) occurred in the DRA group, while one patient in the FA group required surgical treatment and a transfusion for an access-site vascular injury. When performed by an experienced operator, DRA may represent a feasible alternative to other access routes in select patients with STEMI undergoing PCI, such as those with a high risk of bleeding.

Use of Antiplatelet Agents Decreases the Positive Predictive Value of Fecal Immunochemical Tests for Colorectal Cancer but Does Not Affect Their Sensitivity.

Previous studies have evaluated the effects of antithrombotic agents on the performance of fecal immunochemical tests (FITs) for the detection of colorectal cancer (CRC), but the results were inconsistent and based on small sample sizes. We studied this topic using a large-scale population-based database. Using the Korean National Cancer Screening Program Database, we compared the performance of FITs for CRC detection between users and non-users of antiplatelet agents and warfarin. Non-users were matched according to age and sex. Among 5,426,469 eligible participants, 768,733 used antiplatelet agents (mono/dual/triple therapy, n = 701,683/63,211/3839), and 19,569 used warfarin, while 4,638,167 were non-users. Among antiplatelet agents, aspirin, clopidogrel, and cilostazol ranked first, second, and third, respectively, in terms of prescription rates. Users of antiplatelet agents (3.62% vs. 4.45%; relative risk (RR): 0.83; 95% confidence interval (CI): 0.78-0.88), aspirin (3.66% vs. 4.13%; RR: 0.90; 95% CI: 0.83-0.97), and clopidogrel (3.48% vs. 4.88%; RR: 0.72; 95% CI: 0.61-0.86) had lower positive predictive values (PPVs) for CRC detection than non-users. However, there were no significant differences in PPV between cilostazol vs. non-users and warfarin users vs. non-users. For PPV, the RR (users vs. non-users) for antiplatelet monotherapy was 0.86, while the RRs for dual and triple antiplatelet therapies (excluding cilostazol) were 0.67 and 0.22, respectively. For all antithrombotic agents, the sensitivity for CRC detection was not different between users and non-users. Use of antiplatelet agents, except cilostazol, may increase the false positives without improving the sensitivity of FITs for CRC detection.

The learning curve of the distal radial access for coronary intervention.

Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial access (DRA), are gaining attention owing to fewer complications. Despite the advantages of the DRA, there is difficulty to initiate this new vascular approach. The data from 1000 patients who underwent CAG and PCI via the DRA by a single experienced radial operator were retrospectively analyzed. The primary outcome was the success rate of the DRA per 100 cases. Moreover, the predictors of the failed DRA were analyzed. Overall, 952 (95.2%) of the total 1,000 patients underwent a successful DRA. After experiencing 200 cases, the DRA success rate was well maintained at > 94%, and there was no difference in success rate per 100 cases (Ptrend = 0.216). The predictors of failure were female sex [odds ratio (OR) 1.84, 95% confidence interval (CI) 1.01-3.39, P = 0.049] and systolic blood pressure (SBP) of < 120 mmHg (OR 1.87, 95% CI 1.04-3.36, P = 0.036). For achieving a stable DRA with the success rate of > 94%, 200 procedures would be needed. Moreover, this new approach could fail in women and patients with low SBP.Trial registration: https://cris.nih.go.kr/cris/index/index.do (Unique identifier: KCT0005349).

Safety and usefulness of a novel short track sliding balloon catheter.

OBJECTIVES: To evaluate the safety and technical utility of the short track sliding (STS) balloon catheter. BACKGROUND: An STS balloon catheter is designed to ensure a low profile at the shaft and perform distal anchoring using a single guidewire. However, its clinical practice with the STS balloon catheter has not been reported. METHODS: This prospective multi-center registry enrolled 100 patients with significant coronary artery disease who had undergone percutaneous coronary intervention using an STS balloon catheter at three hospitals in Korea from March 2019 to July 2020. Overall safety was assessed as any occurrences of device-related malfunction during the pre-dilation of the lesions. Its technical success rates of the kissing balloon technique or the distal anchoring technique using a single guidewire were also evaluated. RESULTS: Of the 118 lesions pre-dilated using the STS balloon, no significant complication was observed except for three significant coronary dissections, which were completely covered with stents. There was no incidence of balloon catheter malfunction, such as fracture, entrapment, or perforation. With 13 attempts of kissing ballooning techniques with the STS balloon with a 6F guiding catheter, all cases were successful. The distal anchoring techniques were attempted in 10 cases, the stent was successfully crossed to the target lesion in all 10 cases. CONCLUSIONS: The novel STS balloon catheter can be safely applied in routine coronary intervention with minimal complications. In addition, this catheter could be useful for performing the kissing balloon technique with a small-caliber guiding catheter and distal anchoring technique with a single guidewire.

Feasibility and Safety of the Left Distal Radial Approach in Percutaneous Coronary Intervention for Bifurcation Lesions.

Recently, the left distal radial approach (DRA) for percutaneous coronary intervention (PCI) has been shown to be a feasible option, but there are limited data regarding the feasibility of performing bifurcation PCI via the left DRA. Therefore, this study aimed to describe our experience with the contemporary left DRA to perform PCI of bifurcation lesions. Between December 2017 and December 2019, we identified 106 patients treated with bifurcation PCI via the left DRA. We evaluated the success rate of PCI, access-site complications including major bleeding requiring surgery or transfusion, hematoma, distal and forearm radial artery occlusion, and 30-day mortality. Eleven patients (10.4%) treated with left main bifurcation and true bifurcations accounted for 39.6% of cases, with the left anterior descending artery/diagonal branch being the most frequent bifurcation site (57.5%, 61/106). PCI was performed using a 6-French guiding catheter in 101 (95.3%) cases. Successful PCI for bifurcation lesions via the left DRA was achieved in all 106 patients without access-site cross-over. There was no major bleeding, distal and forearm radial artery occlusion, forearm hematoma, or mortality at 30 days. The left DRA is a safe and feasible alternative access site for bifurcation PCI in selected patients.

Impact of late stent malapposition after drug-eluting stent implantation on long-term clinical outcomes.

BACKGROUND AND AIMS: The impact of late drug-eluting stent (DES) malapposition detected by optical coherence tomography (OCT) on long-term clinical outcomes has not been clearly established. We evaluated long-term clinical outcomes of late stent malapposition (LSM) detected by OCT in a qualified study population. METHODS: A total of 428 patients were selected from previous randomized OCT studies that evaluated the degree of strut coverage of different DESs at a 3-12-month follow-up OCT examination. These patients were assigned to one of two groups based on the presence (n = 136) or absence (n = 292) of LSM on follow-up OCT images (performed at 7.0 ±â€¯3.4 months after DES implantation). The cumulative rates of composite events (cardiac death, target-vessel-related myocardial infarction, target-vessel revascularization, and stent thrombosis) were compared between the two groups. RESULTS: During 73.7 ±â€¯18.3 months of follow-up, cardiac death or (very) late stent thrombosis did not occur in either group. The cumulative rate of composite events was similar among the patients in each group (6.2% in patients with LSM vs. 11.7% in those without LSM) [hazard ratio (HR) = 0.569, 95% confidence interval (CI) = 0.257-1.257, p = 0.163]. Target vessel-related myocardial infarction occurred in 0.7% of patients with LSM vs. 1.5% of those without LSM (HR = 0.521, 95% CI = 0.058-4.670, p = 0.560). Target-vessel revascularization was performed in 5.4% of patients with LSM vs. 10.2% of those without LSM (HR = 0.574, 95% CI = 0.246-1.343, p = 0.201). CONCLUSIONS: Cardiac death or (very) late stent thrombosis did not occur in patients with OCT-detected LSM during long-term follow-up. The presence of OCT-detected LSM was not associated with adverse clinical events.

Severe Acute Stent Malapposition After Drug-Eluting Stent Implantation: Effects on Long-Term Clinical Outcomes.

Background The effects of severe acute stent malapposition ( ASM ) after drug-eluting stent implantation on long-term clinical outcomes are not clearly understood. We evaluated long-term clinical outcomes of severe ASM using optical coherence tomography. Methods and Results We pooled patient- and lesion-level data from 6 randomized studies. Five studies investigated follow-up drug-eluting stent strut coverage and one investigated ASM . In this data set, a total of 436 patients with 444 lesions underwent postintervention optical coherence tomography examination and these data were included in the analysis. Severe ASM was defined as lesions with ≥400 µm of maximum malapposed distance or ≥1 mm of maximum malapposed length. Composite events (cardiac death, target lesion-related myocardial infarction, target lesion revascularization, and stent thrombosis) were compared between patients with and without severe ASM . The postintervention optical coherence tomography findings indicated that 62 (14.2%) patients had lesions with ≥400 µm of maximum malapposed distance and 186 (42.7%) patients had lesions with ≥1 mm of maximum malapposed length. The 5-year clinical follow-up was completed in 371 (86.1%) of the eligible 431 patients. The cumulative rate of composite events was similar among the patients in each group during 5-year follow-up: 3.3% in patients with ASM ≥400 µm of maximum malapposed distance versus 3.1% in those with no ASM or ASM <400 µm of maximum malapposed distance ( P=0.89), and 1.2% in patients with ASM ≥1 mm of maximum malapposed length versus 4.6% in those with no ASM or ASM <1 mm of maximum malapposed length ( P=0.06). Conclusions During the 5-year follow-up, ASM severity was not associated with long-term clinical outcomes in patients treated with drug-eluting stents.

Long-Term Clinical Outcomes of Late Stent Malapposition Detected by Optical Coherence Tomography After Drug-Eluting Stent Implantation.

Background The relationship between late stent malapposition ( LSM ) and adverse cardiovascular events is controversial. Studies are needed to evaluate long-term (>5 years) clinical outcomes of LSM detected by optical coherence tomography ( OCT ) after drug-eluting stent implantation. Methods and Results We investigated long-term clinical outcomes of OCT -detected LSM in 351 patients who received drug-eluting stents and were examined by both poststent and follow-up OCT (175±60 days after drug-eluting stent implantation) from January 2009 to December 2011. LSM was observed in 99 patients (28%). We evaluated the cumulative rate of composite events (cardiovascular death, target-vessel-related myocardial infarction, target-vessel revascularization, and stent thrombosis). During 80.1±24.5 months of follow-up, very late stent thrombosis did not occur in any patients with LSM . The cumulative 8-year rate of composite events was 7.3% in patients with LSM and 10.5% in patients without LSM ( P=0.822, log-rank test). We further divided patients into the following 4 groups: patients with both late-persistent and late-acquired stent malapposition (n=23), patients with late-persistent stent malapposition alone (n=45), patients with late-acquired stent malapposition alone (n=31), and patients without LSM (n=252). The cumulative 8-year rates of composite events were similar among these 4 groups (0%, 9.6%, 9.7%, and 10.5%, respectively; P=0.468 by log-rank test). Conclusions During long-term follow-up (>5 years), very late stent thrombosis did not occur in patients with OCT -detected LSM . The rates of adverse clinical events were similar between patients with LSM versus those without LSM . Presence of OCT -detected LSM was not associated with unfavorable clinical outcomes.

Tratamiento de alta intensidad con estatinas para pacientes estables en monoterapia con ácido acetilsalicílico a los 12 meses de un implante de stent farmacoactivo: estudio aleatorizado / High-intensity statin treatments in clinically stable patients on aspirin monotherapy 12 months after drug-eluting stent implantation: A randomized study

Introducción y objetivos: La vigente guía de práctica clínica para el tratamiento de la hipercolesterolemia recomienda mantener la terapia intensiva con estatinas de los pacientes tratados con implante de stent farmacoactivo (SFA). Sin embargo, el tratamiento intensivo con estatinas, una vez estabilizado el paciente, con frecuencia no se lleva a cabo en la práctica clínica tras la revascularización con SFA. Actualmente se desconoce el impacto de mantener esa terapia intensiva con estatinas en estos pacientes estables. Se estudia la reducción de eventos adversos en pacientes clínicamente estables en monoterapia con ácido acetilsalicílico tras el implante de un SFA según la terapia de alta o baja intensidad con estatinas. Métodos: Se aleatorizó a pacientes estables a los 12 meses del implante de un SFA y en monoterapia con ácido acetilsalicílico a recibir terapia de alta intensidad con estatinas (atorvastatina 40 mg; n = 1.000) o terapia de baja intensidad (pravastatina 20 mg; n = 1.000). El objetivo primario fueron los eventos clínicos adversos a los 12 meses de seguimiento (objetivo compuesto de muerte, infarto de miocardio, revascularización, trombosis del stent, accidente cerebrovascular, insuficiencia renal, necesidad de intervención arterial periférica y nuevo ingreso hospitalario por eventos cardiacos). Resultados: El objetivo primario a los 12 meses de seguimiento se produjo en 25 pacientes (2,5%) en tratamiento de alta intensidad con estatinas y en 40 (4,1%) en tratamiento de baja intensidad (HR = 0,58; IC95%, 0,36-0,92; p = 0,018). Esta diferencia se debió principalmente a la menor incidencia de muerte cardiaca (0 frente al 0,4%; p = 0,025) y de infarto de miocardio no relacionado con el vaso diana (el 0,1 frente al 0,7%; p = 0,033) en el grupo de tratamiento de alta intensidad con estatinas. Conclusiones: Entre los pacientes clínicamente estables en monoterapia con ácido acetilsalicílico, el tratamiento de alta intensidad con estatinas redujo la incidencia de eventos comparado con el tratamiento de baja intensidad

Introduction and objectives: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. Methods: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40 mg atorvastatin, n = 1000) or low-intensity (20 mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). Results: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. Conclusions: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment

High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study.

INTRODUCTION AND OBJECTIVES: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. METHODS: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). RESULTS: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. CONCLUSIONS: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.