This study aimed to evaluate the association between intraoperative blood loss and myocardial injury after non-cardiac surgery (MINS), which is a severe and common postoperative complication.
We ...compared the incidence of MINS based on significant intraoperative bleeding, defined as an absolute hemoglobin level < 7 g/dL, a relative hemoglobin level less than 50% of the preoperative measurement, or need for packed red cell transfusion. We also estimated a threshold for intraoperative hemoglobin level associated with MINS.
We stratified a total of 15,926 non-cardiac surgical patients with intraoperative hemoglobin and postoperative cardiac troponin (cTn) measurements according to the occurrence of significant intraoperative bleeding; 13,416 (84.2%) had no significant bleeding while 2,510 (15.8%) did have significant bleeding. After an adjustment with inverse probability weighting, the incidence of MINS was higher in the significant bleeding group (35.2% vs. 16.4%; odds ratio, 1.58; 95% confidence interval, 1.43-1.75; p < 0.001). The threshold of intraoperative hemoglobin associated with MINS was estimated to be 9.9 g/dL with an area under the curve of 0.643.
Intraoperative blood loss appeared to be associated with MINS. Further studies are needed to confirm these findings.
The cohort was registered before patient enrollment at https://cris.nih.go.kr (KCT0004244).
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Myocardial injury after noncardiac surgery (MINS) is recently accepted as a strong predictor of mortality, regardless of symptoms. However, anticoagulation is the only established treatment. This ...study aimed to evaluate the association between statin treatment and mortality after MINS. From January 2010 to June 2019, a total of 5,267 adult patients who were discharged after the occurrence of MINS were enrolled. The patients were divided into two groups according to statin prescription at discharge. The outcomes were 1-year and overall mortalities. Of the total 5,109 patients, 1,331 (26.1%) patients were in the statin group and 3,778 (73.9%) patients were in the no statin group. The 1-year and overall mortalities were significantly lower in the statin group compared with the no statin group (6.1% vs. 13.3%; hazard ratio HR, 0.55; 95% confidence interval CI, 0.41-0.74; p < 0.001 for 1-year mortality and 15.0% vs. 25.0%; HR, 0.62; 95% CI, 0.51-0.76; p < 0.001 for overall mortality). Analyses after inverse probability treatment weighting showed similar results (HR, 0.61; 95% CI, 0.50-0.74; p < 0.001 for 1-year mortality and HR, 0.70; 95% CI, 0.54-0.90; p = 0.006 for overall mortality), and the mortalities did not differ according to the dose of statin. Our results suggest that statin treatment may be associated with improved survival after MINS. A trial is needed to confirm this finding and establish causality.
Background
Defining the optimal conduction of percutaneous‐coronary‐intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting ...technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison.
Methods
The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro‐computed‐tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice.
Results
An updated Main‐Across‐Distal‐Side (MADS)‐2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC‐promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1‐stent techniques (“provisional” and “inverted provisional”) and (b) 2‐stent techniques (“T/TAP,” “culotte,” and “DK‐crush”).
Conclusions
The present EBC‐promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.
Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary ...syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population.
We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2–5 bleeding at 18 months after the index procedure. The primary endpoint was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453.
Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in 1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; pnon-inferiority=0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly between the 6-month DAPT group and the 12-month or longer DAPT group (35 2·6% patients vs 39 2·9%; hazard ratio HR 0·90 95% CI 0·57–1·42; p=0·90) and neither did stroke (11 0·8% patients vs 12 0·9%; 0·92 0·41–2·08; p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer DAPT group (24 1·8% patients vs ten 0·8%; 2·41 1·15–5·05; p=0·02). 15 (1·1%) patients had stent thrombosis in the 6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 95% CI 0·68–3·35; p=0·32). The rate of BARC type 2–5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) in the 12-month or longer DAPT group (HR 0·69 95% CI 0·45–1·05; p=0·09). Results from the per-protocol analysis were similar to those from the intention-to-treat analysis.
The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care.
Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST.
AbstractObjectiveTo assess the risks and benefits of P2Y12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients’ ...characteristics.DesignIndividual patient level meta-analysis of randomised controlled trials.Data sourcesSearches were conducted in Ovid Medline, Embase, and three websites (www.tctmd.com, www.escardio.org, www.acc.org/cardiosourceplus) from inception to 16 July 2020. The primary authors provided individual participant data.Eligibility criteriaRandomised controlled trials comparing effects of oral P2Y12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation.Main outcome measuresThe primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.ResultsThe meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ2=0.00) and in 303 (2.94%) with P2Y12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ2=0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ2=0.03), which was consistent across subgroups, except for type of P2Y12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y12 inhibitor rather than clopidogrel was part of the DAPT regimen.ConclusionsP2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT.RegistrationPROSPERO CRD42020176853.
Patients with unprotected left main coronary artery stenosis were assigned to either CABG or PCI with sirolimus-eluting stents. At 1 year, with a wide prespecified noninferiority margin, PCI was ...found to be noninferior to CABG.
Anumber of registry reports, as well as a substudy from a large, randomized trial, have indicated that percutaneous coronary intervention (PCI) may be an acceptable alternative to coronary-artery bypass grafting (CABG) in some patients with unprotected left main coronary artery stenosis.
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Recent clinical guidelines have accordingly stated that elective PCI can be considered for patients who have unprotected left main coronary artery disease, although they suggest that the aggregated evidence favors CABG.
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Whether the outcomes after PCI are similar to those after CABG remains uncertain, however, owing to the lack of large, randomized clinical trials. Registry results have . . .
IMPORTANCE: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited. OBJECTIVE: To determine ...whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. DESIGN, SETTING, AND PARTICIPANTS: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018. INTERVENTIONS: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498). MAIN OUTCOMES AND MEASURES: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%. RESULTS: Among 2993 patients who were randomized (mean age, 64 years; 795 women 26.6%), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3% of the P2Y12 inhibitor monotherapy group and 95.2% of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% 1-sided 95% CI, –∞% to 1.3%; P = .007 for noninferiority). There were no significant differences in all-cause death (21 1.4% vs 18 1.2%; hazard ratio HR, 1.18; 95% CI, 0.63-2.21; P = .61), myocardial infarction (11 0.8% vs 17 1.2%; HR, 0.66; 95% CI, 0.31-1.40; P = .28), or stroke (11 0.8% vs 5 0.3%; HR, 2.23; 95% CI, 0.78-6.43; P = .14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95% CI, 0.36-0.92; P = .02). CONCLUSIONS AND RELEVANCE: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02079194
In a randomized trial of imaging-guided or angiography-guided PCI for complex coronary lesion revascularization procedures, imaging-guided PCI led to a lower risk of target-vessel failure than ...angiography-guided PCI.
This study sought to determine whether intravascular ultrasound (IVUS) guidance compared with angiographic guidance reduces long-term risk of cardiac death in patients undergoing complex percutaneous ...coronary intervention (PCI).
Although IVUS is a useful tool for accurate assessment of lesion profiles and optimal stent implantation, there are limited data on long-term clinical outcomes between IVUS-guided and angiography-guided PCI for patients with complex lesions.
From March 2003 through December 2015, a total of 6,005 patients undergoing PCI for complex lesions with drug-eluting stents were enrolled from a prospective institutional registry. All enrolled subjects had at least 1 complex lesion (defined as bifurcation, chronic total occlusion, left main disease, long lesion, multivessel PCI, multiple stent implantation, in-stent restenosis, or heavily calcified lesion). Patients were classified according to use of IVUS or not. Multiple sensitivity analyses, including multivariable adjustment, propensity-score matching, and inverse-probability-weighted method, were performed to adjust baseline differences.
Among the study population, IVUS was used in 1,674 patients (27.9%) during complex PCI. The IVUS-guided PCI group had a significantly larger mean stent diameter (3.2 ± 0.4 vs. 3.0 ± 0.4; p < 0.001), and more frequent use of post-dilatation (49.0% vs. 17.9%; p < 0.001) compared with the angiography-guided PCI group. IVUS-guided PCI was associated with a significantly lower risk of cardiac death during 64 months of median follow-up compared with angiography-guided PCI (10.2% vs. 16.9%; hazard ratio: 0.573; 95% confidence interval: 0.460 to 0.714; p < 0.001). Results were consistent after multivariable regression, propensity-score matching, and inverse-probability-weighted method. The risks of all-cause death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, and major adverse cardiac events were also significantly lower in the IVUS-guided PCI group.
Among patients with complex coronary artery lesion, IVUS-guided PCI was associated with the lower long-term risk of cardiac death and adverse cardiac events compared with angiography-guided PCI. Use of IVUS should be actively considered for complex PCI.
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The objective of this work was to investigate the long-term safety and efficacy of renal denervation in Korean patients from the Global SYMPLICITY Registry (GSR). GSR Korea is a substudy of GSR with ...additional inclusion and exclusion criteria compared to GSR, including inclusion criteria of office systolic blood pressure ≥160 mmHg, or ≥150 mmHg for type 2 diabetes patients, while receiving 3 or more antihypertensive medications without changes for 2 weeks prior to enrollment. Renal denervation was performed using a Symplicity Flex catheter for ablation in the main renal arteries. Changes in office systolic blood pressure and adverse events were collected for up to 36 months of follow-up for 102 patients in GSR Korea. In addition, adverse events and reductions in office systolic blood pressure were analyzed for patients with and without type II diabetes mellitus. Renal denervation led to mean (± standard deviation) reductions in office systolic blood pressure at 12, 24, and 36 months in GSR Korea (-26.7 ± 18.5, -30.1 ± 21.6 mmHg, and -32.5 ± 18.8, respectively). The proportion of patients with a ≥10 mmHg office systolic blood pressure reduction from baseline was 86.3% at 12 months, 86.5% at 24 months, and 89.7% at 36 months. Adverse events at 3 years were rare. In addition, reductions in office systolic blood pressure were similar for patients with vs. without diabetes mellitus (p > 0.05 at all timepoints). Office systolic blood pressure was safely reduced at up to 36 months post-renal denervation in GSR Korea, and adverse events were rare. In addition, patients with and without diabetes had similar office systolic blood pressure reductions.
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