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Background: Antiplatelet therapy deescalation has been suggested as an alternative to standard treatment with potent dual antiplatelet therapy (DAPT) for 1 year in low bleeding risk patients with acute coronary syndromes undergoing percutaneous coronary intervention to mitigate the increased risk of bleeding. Whether this strategy preserves the ischemic and survival benefits of potent DAPT is uncertain. Methods: We performed a pairwise meta-analysis in patients with acute coronary syndrome undergoing percutaneous coronary intervention treated with either 1-year standard potent DAPT versus deescalation therapy (potent DAPT for 1–3 months followed by either reduced potency DAPT or ticagrelor monotherapy for up to 1 year). Randomized trials comparing standard DAPT versus deescalation therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary end point was 1-year all-cause mortality. Results: The meta-analysis included 6 trials in which 20 837 patients were randomized to potent DAPT for 1 to 3 months followed by deescalation therapy for up to 1 year (n=10 392) or standard potent DAPT for 1 year (n=10 445). Deescalation therapy was associated with lower 1-year rates of all-cause mortality compared with standard therapy (odds ratio, 0.75 [95% CI, 0.59–0.95]; P =0.02). Deescalation therapy was also associated with lower rates of major bleeding (odds ratio, 0.59 [95% CI, 0.48–0.72]; P <0.0001), with no significant difference in major adverse cardiac events (major adverse cardiovascular events; odds ratio, 0.89 [95% CI, 0.77–1.04]; P =0.14). Conclusions: In low bleeding risk patients with acute coronary syndrome undergoing percutaneous coronary intervention, compared with 1-year of potent DAPT, antiplatelet therapy deescalation therapy after 1 to 3 months was associated with decreased mortality and major bleeding with similar rates of major adverse cardiovascular events. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although clinical benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions have been observed in previous trials, the cost-effectiveness of this strategy is uncertain. METHODS: RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance vs Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) was conducted in Korea between May 2018 and May 2021. This prespecified cost-effectiveness substudy was conducted using Markov model that simulated 3 states: (1) post-PCI, (2) spontaneous myocardial infarction, and (3) death. A simulated cohort was derived from the intention-to-treat population, and input parameters were extracted from either the trial data or previous publications. Cost-effectiveness was evaluated using time horizon of 3 years (within trial) and lifetime. The primary outcome was incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life years (QALYs) gained, in intravascular imaging-guided PCI compared with angiography-guided PCI. The current analysis was performed using the Korean health care sector perspective with reporting the results in US dollar (1200 Korean Won, ₩=1 dollar, $). Willingness to pay threshold was $35 000 per QALY gained. RESULTS: A total of 1639 patients were included in the trial. During 3-year follow-up, medical costs ($8661 versus $7236; incremental cost, $1426) and QALY (2.34 versus 2.31; incremental QALY, 0.025) were both higher in intravascular imaging-guided PCI than angiography-guided PCI, resulting incremental cost-effectiveness ratio of $57 040 per QALY gained within trial data. Conversely, lifetime simulation showed total cumulative medical cost was reversed between the 2 groups ($40 455 versus $49 519; incremental cost, −$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis. CONCLUSIONS: The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872. [ABSTRACT FROM AUTHOR]

Background: Data regarding prognosis and management after nuisance bleeding (NB) is limited. The purpose was to examine the prognostic significance of NB in patients receiving potent dual antiplatelet treatment (DAPT) after acute myocardial infarction and the impact of de-escalation of DAPT on clinical outcomes thereafter. Methods: From the TALOS-AMI trial (Ticagrelor Versus Clopidogrel in Stabilized Patients With Acute Myocardial Infarction)‚ 2583 patients were used to investigate the clinical impact of NB (defined as Bleeding Academic Research Consortium [BARC] 1 bleeding) during 1-month treatment with ticagrelor-based DAPT after acute myocardial infarction. We assessed the associations between NB within 1 month and BARC 2, 3, or 5 bleeding and major adverse cardiovascular event (a composite of cardiovascular death, myocardial infarction, stroke) from 1 to 12 months. We also evaluated the effect of de-escalation to clopidogrel in patients with or without NB. Results: NB occurred in 416 patients (16.7%) after 1 month of ticagrelor-based DAPT. At 1 year, NB was not associated with increase in BARC 2, 3, or 5 bleeding (hazard ratio [HR]‚ 1.29 [95% CI‚ 0.7–2.14]) and major adverse cardiovascular event (HR‚ 1.72 [95% CI‚ 0.87–3.39]). However, patients with NB had an increased risk of BARC 2, 3, or 5 bleeding at 6 months (HR, 1.94 [95% CI, 1.08–3.48]; P =0.026), which diminished over the next 6 months. De-escalation from ticagrelor to clopidogrel reduced the incidence of BARC 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in NB (HR‚ 0.31 [95% CI‚ 0.10–0.92]) and non-NB patients (HR‚ 0.58 [95% CI‚ 0.37–0.90]) without heterogeneity (P interaction=0.291). There was no increase in major adverse cardiovascular event after DAPT de-escalation, irrespective of NB. Conclusions: NB was frequent in patients with acute myocardial infarction on 1-month ticagrelor-based DAPT and was associated with an early increase of bleeding. DAPT de-escalation after NB may reduce bleeding without increasing ischemic events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02018055. [ABSTRACT FROM AUTHOR]

The efficacy of renal sympathetic denervation in end-stage renal disease patients under hemodialysis Chan Joon Kim, Kiyuk Chang, Daewon Kim, Manwon Park, Jung Sun Cho, Sung-Ho Her Introduction: The end-stage renal disease (ESRD) patients who are under under renal replacement therapy, have often have uncontrolled, resistant hypertension. Renal sympathetic denervation (RDN) with radiofrequency ablation catheter has shown promising results in resistant hypertension. The purpose this pilot study is to assess the efficacy of RDN in resistant hypertension in ESRD patients. Method: Patients who are under renal hemodialysis and inter-dialytic SBP > 160 mmHg despite of three or more antihypertensives were eligible for enrollment. 8 patients were allocated to either medical therapy group or RDN group by randomization. RDN was performed with Symplicity RDN catheter (Medtronic®).The primary outcome was change in SBP change in an inter-dialytic day in 3 months. The secondary outcome was change in DBP in 3 months, left ventricular mass index (LVMI). Results: The baseline SBP/DBP were 172.2 ± 9.5/ 88.7 ± 12.1 mmHg for the intervention group and 164.0 ± 6.9/84.7 ± 13.4 for medical group. Baseline ambulatory SBP was 164.8 ± 4.4 for the intervention group and 162 ± 8.4 mmHg for medical therapy group. The 3 month SBP/DBP were 155.5 ± 12.2/80.2 ± 7.7 for the intervention group and 167.5 ± 10.3/83.6 mmHg for medical therapy group. The mean change in SBP was 18.4 ± 4.5 mmHg for the intervention group and 2.8 mmHg ± 3.8 mmHg for the medical group (p =0.03). The mean LVMI 194.3 ± 10.4 g/m2 for the intervention group and 187.4 ± 11.5 g/m2 for the medical therapy group. The mean change in LVMI was 41.4 ± 3.5 g/m2 for the intervention group and 1.1 g ± 4.4 g/m2 for the medical group (p =0.03). Conclusion: This pilot study suggests that RDN may have therapeutic effect in resistant hypertension in ESRD patients and may have a role in regression in left ventricular hypertrophy. [ABSTRACT FROM AUTHOR]

The impact of the CYP2C19∗17 polymorphism on the clinical outcome in Asians undergoing percutaneous coronary intervention (PCI) is unknown. We sought to assess the long-term impact of CYP2C19∗17 on the risk for adverse clinical events in 2188 Korean patients taking clopidogrel after PCI. The prevalence of the CYP2C19∗17 allele [∗wt/∗17: 2.4% (n=53), ∗17/∗17: 0%] was very low. The 2-year cumulative event rates for bleeding [∗wt/∗17 vs. ∗wt/∗wt: 2 vs. 2.3%; adjusted hazard ratio (HR), 1.23; 95% confidence interval (CI), 0.16-9.45], stent thrombosis (2 vs. 1.1%; HR, 3.98; 95% CI, 0.49-31.6) or composite of any death, and myocardial infarction or stroke (5.4 vs. 7.1%; HR, 1.37; 95% CI, 0.32-5.73) did not differ on the basis of the presence of CYP2C19∗17. In conclusion, in our study population of Asian patients, the CYP2C19∗17 polymorphism was not associated with adverse clinical outcomes after PCI because of its low prevalence, the rarity of homozygotes, and the relatively low rate of adverse clinical events. [ABSTRACT FROM AUTHOR]

Background: The Murray law-based quantitative flow ratio (μFR) is an emerging technique that requires only 1 projection of coronary angiography with similar accuracy to quantitative flow ratio (QFR). However, it has not been validated for the evaluation of noninfarct-related artery (non-IRA) in acute myocardial infarction (AMI) settings. Therefore, our study aimed to evaluate the diagnostic accuracy of μFR and the safety of deferring non-IRA lesions with μFR >0.80 in the setting of AMI., Methods: μFR and QFR were analyzed for non-IRA lesions of patients with AMI enrolled in the FRAME-AMI trial (Fractional Flow Reserve Versus Angiography-Guided Strategy for Management of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction), consisting of fractional flow reserve (FFR)-guided percutaneous coronary intervention and angiography-guided percutaneous coronary intervention groups. The diagnostic accuracy of μFR was compared with QFR and FFR. Patients were classified by the non-IRA μFR value of 0.80 as a cutoff value. The primary outcome was a vessel-oriented composite outcome, a composite of cardiac death, non-IRA-related myocardial infarction, and non-IRA-related repeat revascularization., Results: μFR and QFR analyses were feasible in 443 patients (552 lesions). μFR showed acceptable correlation with FFR (R=0.777; P <0.001), comparable C-index with QFR to predict FFR ≤0.80 (μFR versus QFR: 0.926 versus 0.961, P =0.070), and shorter total analysis time (mean, 32.7 versus 186.9 s; P <0.001). Non-IRA with μFR >0.80 and deferred percutaneous coronary intervention had a significantly lower risk of vessel-oriented composite outcome than non-IRA with performed percutaneous coronary intervention (3.4% versus 10.5%; hazard ratio, 0.37 [95% CI, 0.14-0.99]; P =0.048)., Conclusions: In patients with multivessel AMI, μFR of non-IRA showed acceptable diagnostic accuracy comparable to that of QFR to predict FFR ≤0.80. Deferred non-IRA with μFR >0.80 showed a lower risk of vessel-oriented composite outcome than revascularized non-IRA., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02715518., Competing Interests: Disclosures Dr Seung Hun Lee received an institutional research grant from Abbott Vascular. Dr Hahn received an institutional research grant from the National Evidence-Based Healthcare Collaborating Agency; Ministry of Health and Welfare, Republic of Korea; Abbott Vascular; Biosensors; Boston Scientific; Daiichi Sankyo; Dong-A ST, and Medtronic, Inc. Dr Gwon received an institutional research grant from Abbott Vascular, Boston Scientific, and Medtronic, Inc. Dr Joo Myung Lee received an institutional research grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Dong-A ST, Yuhan Pharmaceutical, and ZOLL Medical. The other authors report no conflicts.

Background: The benefit of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for noninfarct-related artery (IRA) lesions with angiographically severe stenosis in patients with acute myocardial infarction is unclear., Methods: Among 562 patients from the FRAME-AMI trial (Fractional Flow Reserve Versus Angiography-Guided Strategy for Management of Non-Infraction Related Artery Stenosis in Patients With Acute Myocardial Infarction) who were randomly allocated into either FFR-guided or angiography-guided PCI for non-IRA lesions, the current study evaluated the relationship between non-IRA stenosis measured by quantitative coronary angiography (QCA) and the efficacy of FFR-guided PCI. The incidence of the primary end point (death, myocardial infarction, or repeat revascularization) was compared between FFR- and angiography-guided PCI according to non-IRA stenosis severity (QCA stenosis ≥70% or <70%)., Results: A total of 562 patients were assigned to FFR-guided (n=284) versus angiography-guided PCI (n=278). At a median follow-up of 3.5 years, the primary end point occurred in 14 of 181 patients with FFR-guided PCI and 31 of 197 patients with angiography-guided PCI among patients with QCA stenosis ≥70% (8.5% versus 19.2%; hazard ratio, 0.41 [95% CI, 0.22-0.80]; P =0.008), while occurred in 4 of 103 patients with FFR-guided PCI and 9 of 81 patients with angiography-guided PCI among those with QCA stenosis <70% (3.9% versus 11.1%; P =0.315). There was no significant interaction between treatment strategy and non-IRA stenosis severity ( P for interaction=0.636). FFR-guided PCI was associated with the reduction of death and myocardial infarction in both patients with QCA stenosis ≥70% (6.7% versus 15.1%; P =0.008) and those with QCA stenosis <70% (1.0% versus 9.6%; P =0.042) compared with angiography-guided PCI., Conclusions: In patients with acute myocardial infarction and multivessel disease, FFR-guided PCI tended to have a lower risk of primary end point than angiography-guided PCI regardless of non-IRA stenosis severity without significant interaction., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02715518., Competing Interests: Disclosures Dr Hahn received an Institutional Research Grant from National Evidence-Based Healthcare Collaborating Agency, Ministry of Health and Welfare, Republic of Korea, Abbott Vascular, Biosensors, Boston Scientific, Daiichi Sankyo, Donga-ST, and Medtronic, Inc. Dr Lee received an Institutional Research Grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Donga-ST, Zoll Medical, and Yuhan Pharmaceutical. Dr Gwon received an Institutional Research Grant from Abbott Vascular, Boston Scientific, and Medtronic, Inc. The other authors report no conflicts.

Background: The RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) demonstrated that intravascular imaging-guided percutaneous coronary intervention (PCI) improved clinical outcome compared with angiography-guided PCI for patients with complex coronary artery lesions. This study aims to assess whether the prognostic benefit of intravascular imaging-guided procedural optimization persists in patients undergoing PCI for left main coronary artery disease., Methods: Of 1639 patients enrolled in the RENOVATE-COMPLEX-PCI, 192 patients with left main coronary artery disease were selected for the current prespecified substudy. Selected patients were randomly assigned to either the intravascular imaging-guided PCI group (n=138) or the angiography-guided PCI group (n=54). The primary end point was target vessel failure defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization., Results: At a median follow-up of 2.1 years (interquartile range 1.1 to 3.0 years), intravascular imaging-guided PCI was associated with lower incidence of primary end point compared with angiography-guided PCI (6.8% versus 25.1%; hazard ratio, 0.31 [95% CI, 0.13-0.76]; P =0.010). This significant reduction in primary end point was mainly driven by a lower risk of cardiac death or spontaneous target vessel-related myocardial infarction (1.6% versus 12.7%; hazard ratio, 0.16 [95% CI, 0.03-0.82]; P =0.028). Intravascular imaging-guided PCI was independently associated with a lower risk of primary end point, even after adjusting for various clinical factors (hazard ratio, 0.29 [95% CI, 0.12-0.72]; P =0.007)., Conclusions: Intravascular imaging-guided PCI showed clinical benefit over angiography-guided PCI for left main coronary artery disease in reducing the risk of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872., Competing Interests: Disclosures Dr Lee received an Institutional Research Grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Zoll Medical, and Donga-ST. Dr Hahn received an Institutional Research Grant from National Evidence-based Healthcare Collaborating Agency, Ministry of Health & Welfare, Korea, Abbott Vascular, Biosensors, Boston Scientific, Daiichi Sankyo, Donga-ST, Hanmi Pharmaceutical, and Medtronic, Inc. Dr Gwon received an Institutional Research Grant from Boston Scientific, Genoss, and Medtronic, Inc. The other authors report no conflicts.

Competing Interests: Disclosures Dr Joo Myung Lee received institutional research grants from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Zoll Medical, and Donga-ST. Dr Joo-Yong Hahn received institutional research grants from National Evidence-Based Healthcare Collaborating Agency; Ministry of Health & Welfare, Korea; Abbott Vascular; Biosensors; Boston Scientific; Daiichi Sankyo; Donga-ST; Hanmi Pharmaceutical; and Medtronic Inc. Dr Hyeon-Cheol Gwon received institutional research grants from Boston Scientific, Genoss, and Medtronic Inc. The other authors declare that there are no competing interests to declare.

Stent fracture is an uncommon complication of drug-eluting stent implantation, but it has a clinical significance because of its potential association with adverse cardiac events such as in-stent restenosis, target lesion revascularization, and stent thrombosis. Multiple stent fractures account for a small proportion, but they may lead to more serious complications. Newer generation drug-eluting stents are designed for improved safety and efficacy compared with early generation drug-eluting stents. Multiple stent fractures after newer generation drug-eluting stent implantation are a rare case.We report a case of 25-year-old male who presented with acute myocardial infarction caused by multiple stent fractures after everolimus-eluting stents implantation and was treated by balloon angioplasty.Physicians should be aware of the possibility of multiple stent fractures even after newer generation drug-eluting stent implantation.

Background: Anemia is associated with an increased risk of mortality in patients who underwent percutaneous coronary intervention (PCI) in the bare-metal stent era. However, there have been no data concerning the clinical importance of anemia improvement during the follow-up period after discharge from the hospital during the drug-eluting stent era., Methods and Results: To assess anemia, the hemoglobin level was measured at the time of index PCI with drug-eluting stents and at the subsequent outpatient visit between 3 and 12 months later. Improvement of anemia was defined by the normalization of the hemoglobin level at the follow-up laboratory examination. We analyzed 4300 patients who were tested for initial and follow-up hemoglobin levels. We compared major adverse cardiac and cerebrovascular events (MACCE) between the normal group and the anemia group and between the improved anemia group and the sustained anemia group. The median follow-up period was 25.4 months. There was poorer clinical outcome in the anemia group than in the normal group in terms of MACCE (adjusted hazard ratio 1.479, 95% confidence interval 1.025-2.134, P=0.037). Furthermore, the sustained anemia group showed poorer MACCE than did the improved anemia group (hazard ratio 3.558, 95% confidence interval 2.285-5.539, P<0.0001). On the basis of the multivariate Cox hazard regression model and propensity-score matching, the overall findings were consistent between sustained and improved anemia groups., Conclusion: The follow-up of hemoglobin level is important, and improvement of anemia is associated with favorable long-term clinical outcomes.