Coronary Intervention In High-risk Patients Research Articles

Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial

The optimal antiplatelet regimen after percutaneous coronary intervention (PCI) in patients with peripheral artery disease (PAD) is still debated. This analysis aimed to compare the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients with PAD undergoing PCI. In the TWILIGHT trial, patients at high ischemic or bleeding risk that underwent PCI were randomized after 3 months of dual antiplatelet therapy (DAPT) to aspirin or matching placebo in addition to open-label ticagrelor for 12 additional months. In this post-hoc analysis, patient cohorts were examined according to the presence or absence of PAD. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction (MI), or stroke. Endpoints were assessed at 12 months after randomization. Among 7,119 patients, 489 (7%) had PAD and were older, more likely to have comorbidities, and multivessel disease. PAD patients had more bleeding or ischemic complications than no-PAD patients. Ticagrelor monotherapy compared to ticagrelor plus aspirin was associated with less BARC 2, 3, or 5 bleeding in PAD (4.6% vs 8.7%; HR 0.52; 95%CI 0.25-1.07) and no-PAD patients (4.0% vs 7.0%; HR 0.56; 95%CI 0.45-0.69; interaction P-value .830) and a similar risk of death, MI, or stroke in these 2 groups (interaction P-value .446). Despite their higher ischemic and bleeding risk, patients with PAD undergoing PCI derived a consistent benefit from ticagrelor monotherapy after 3 months of DAPT in terms of bleeding reduction without any relevant increase in ischemic events. CLINICAL TRIAL REGISTRY INFORMATION:: https://www. gov/study/NCT02270242.

12 years of implementation of cardiovascular intervention techniques at of Hue University of Medicine and Pharmacy Hospital

Background: Cardiovascular Center has implemented interventional cardiology techniques since 2009 including coronary stenting, congenital heart intervention and pacemaker placement. Percutaneous coronary intervention is currently an effective treatment method for coronary artery disease. Congenital heart diseases by Amplatzer device is an effective method of treatment of congenital heart diseases. Permanent pacemaker implantation is currently the most effective modern treatment for dangerous bradyarrhythmias. Methods: All cases of coronary artery stenosis with indications for intervention, congenital heart disease including atrial septal defect, ventricular septal defect, and ductus arteriosus with the indication for intervention by percutaneous occlusion, bradyarrhythmias have indications for pacemaker placement were included in the study. Methods of book research, retrospective. Results: 1) The rate of emergency coronary intervention 26.7%. The success rate of the procedure is 95.0%. The complication rate of coronary intervention in highrisk patients was 9.4%. 2) There were 254 (68.8%) cases of VVI(R) single-chamber pacemaker and 115 (31.2%) cases of dual-chamber pacing. The complication rate was 4.6%. The success rate of the procedure is 98.7%. 3) The results of the percutaneous septal defect occlusion procedure achieved a complete success of 93.33%, ductal occlusion achieved a complete success of 100%, and ventricular septal defect occlusion with the Amplatzer instrument achieved 100% success. 100% successful results after 3 months of follow-up. Complications in patients after occlusion of atrial septal defect with Amplatzer device were 6.67%, and no complications in the group with ductus arteriosus and ventricular septal defect were noted. Conclusion: Interventional coronary stenting, pacemaker placement, and congenital heart disease interventions are safe and effective methods with high success rates. Key words: Cardiovascular intervention, deployment

Clinical outcomes of percutaneous coronary intervention in high-risk patients turned down for surgical revascularization.

There are limited data on outcomes of PCI in surgical turndown patientsespecially in those presenting with ACS. A retrospective analysis of prospectively collected data of patients who were turned down for CABG and had PCI between 2013 and 2020. All consecutive patients (449), ACS (n = 245) and no-ACS(n = 204) were included. In-hospital complications occurred in 28 patients (6.2%). At 30 days, 27 patients (6.0%) died (18 patients in the ACS group [7.3%] vs. 9 patients in the no-ACS group [4.4%], p = 0.23). Following multivariate analysis, no significant difference in long-term mortality was observed between the two groups (median follow-up of 4 [2-6] years, hazard ratio [HR]: 1.08, 95% confidence interval [CI]: 0.75-1.58, p = 0.667). In propensity score-matched analysis, the adjusted mortality risk was also not different between the groups (HR: 0.74, 95% CI: 0.25-1.26, p = 0.374). Independent predictors of mortality included chronic kidney disease stage ≥ 3 (HR:1.64, 95% CI: 1.13-2.39, p = 0.009), high European System for Cardiac Operative Risk Evaluation II(HR:1.02, 95% CI: 1.00-1.05, p = 0.035), and laser atherectomy use (HR:3.35, 95% CI: 1.32-8.54, p = 0.011). PCI in surgical patients turndown patients appears safe. ACSpresentation was associated with more comorbid illnesses; however, afteradjustment, ACS did not independently confer additional risk of mortality.

291 Ticagrelor monotherapy after percutaneous coronary intervention in high-risk patients with prior myocardial infarction: a prespecified twilight substudy

Abstract Aims Patients with history of myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) remain at risk of recurrent ischaemic events. The optimal antithrombotic strategy for this cohort remains debated. Methods and results In this prespecified analysis of the TWILIGHT trial, we evaluated the impact of prior MI on treatment effect of ticagrelor monotherapy vs. ticagrelor plus aspirin in patients undergoing PCI with at least one clinical and one angiographic high-risk feature and free from adverse events at 3 months after the index PCI. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5, the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization. 1937 (29.7%) patients with and 4595 (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. Patients with prior MI had increased rates of death, MI or stroke (5.7 vs. 3.2%, P < 0.001) but similar BARC 2–5 bleeding (5.0 vs. 5.5%, P = 0.677). Ticagrelor monotherapy reduced the risk of BARC 2–5 bleeding in patients with [3.4% vs. 6.7%; hazard ratio (HR): 0.50; 95% confidence interval (CI): 0.33–0.76] and without prior MI [4.2% vs. 7.0%; HR: 0.58; 95% CI: 0.45–0.76; pinteraction = 0.54). Rates of the key secondary ischaemic outcome were similar between treatment groups irrespective of history of MI (prior MI: 6.0% vs. 5.5%; HR: 1.09; 95% CI: 0.75–1.58; no prior MI: 3.1% vs. 3.3%; HR: 0.92; 95% CI: 0.67–1.28; pinteraction = 0.52). Conclusions Ticagrelor monotherapy is associated with significantly lower risk of bleeding events as compared to ticagrelor plus aspirin without any compromise in ischaemic prevention among high-risk patients with history of MI undergoing PCI.

TCT-375 High Syntax Score and Left Main Percutaneous Coronary Intervention in High-Risk Patients: Long-Term Follow-Up Real-World Experience of a Single Center Without On-Site Cardiac Surgery

TCT-375 High Syntax Score and Left Main Percutaneous Coronary Intervention in High-Risk Patients: Long-Term Follow-Up Real-World Experience of a Single Center Without On-Site Cardiac Surgery

Long-term Outcomes of Clopidogrel Monotherapy versus Prolonged Dual Antiplatelet Therapy beyond 12 Months after Percutaneous Coronary Intervention in High-risk Patients.

BackgroundThere are no data on comparison between clopidogrel monotherapy and prolonged dual antiplatelet therapy (DAPT) in patients at high-risk undergoing percutaneous coronary intervention (PCI).MethodsOf 2,082 consecutive patients undergoing PCI using second-generation drug-eluting stent (DES), we studied 637 patients at high-risk either angiographically or clinically who received clopidogrel longer than 24 months and were event-free at 12 months after index PCI. Patients were divided into 2 groups: the clopidogrel monotherapy group and the prolonged DAPT group. The primary outcome was a composite of all-cause death, non-fatal myocardial infarction (MI), definite or probable stent thrombosis, or stroke between 12 months and 36 months after the index PCI.ResultsIn propensity score-matched population (246 pairs), the cumulative rate of primary outcome was 4.5% in the clopidogrel monotherapy group and 4.9% in the prolonged DAPT group (hazard ratio, 1.21; 95% confidence interval, 0.54–2.75; P = 0.643). There was no significant difference in all-cause death, MI, stent thrombosis, stroke between the clopidogrel monotherapy group and the prolonged DAPT group.ConclusionCompared with prolonged DAPT, clopidogrel monotherapy showed similar long-term outcomes in patients at high-risk after second-generation DES implantation.

Benefits and Risks of Prolonged Duration Dual Antiplatelet Therapy (Clopidogrel and Aspirin) After Percutaneous Coronary Intervention in High-Risk Patients With Diabetes Mellitus

The efficacy and safety of prolonged (>1-year) dual antiplatelet therapy (DAPT) duration in high-risk patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain unknown. All patients undergoing PCI at Fuwai hospital between January 2013 and December 2013 were prospectively enrolled into the Fuwai PCI registry. A total of 3,696 high-risk diabetics patients with at least one additional atherothrombotic risk factor were screened for inclusion. The primary efficacy outcome was the composite of all-cause mortality, myocardial infarction, or stroke. The median follow-up duration was 887 days. 69.8% of DM patients were on DAPT at 1 year without discontinuation. Based on multivariate Cox regression model and inverse probability of treatment weighting (IPTW) analysis, long-term (>1-year) DAPT reduced the risk of primary efficacy outcome (1.7% vs 4.1%; adjusted hazard ratio [adjHR]: 0.382, 95% confidence interval [CI]: 0.252 to 0.577; IPTW-HR: 0.362 [0.241 to 0.542]), as well as cardiovascular death and definite/probable stent thrombosis, compared with short-course (≤1-year) DAPT. Risk of the safety end point of clinically relevant bleeding (adjHR: 0.920 [0.467 to 1.816]; IPTW-HR: 0.969 [0.486 to 1.932]) was comparable between longer DAPT and shorter DAPT. A lower number of net clinical benefit adverse outcomes was observed with >1-year DAPT versus ≤1-year DAPT (adjHR: 0.471 [0.331 to 0.671]; IPTW-HR: 0.462 [0.327 to 0.652]), which appeared increasingly favorable in those with multiple atherothrombotic risk characteristics. In high-risk patients with DM receiving PCI who were event free at 1 year, DAPT prolongation resulted in significant reduction in the risk of ischemic events not offset by increase of clinically meaningful bleeding events, thereby achieving a net clinical benefit. Extending DAPT beyond the period mandated by guidelines seems reasonable in high-risk DM patients not deemed at high bleeding risk.

Circulatory support with larger volume intra-aortic balloon pump vs. standard volume or no-balloon pump during high-risk percutaneous coronary interventions. A randomised study.

IntroductionPercutaneous coronary intervention in high-risk patients (HRPCI) is associated with increased risk of periprocedural complications such as hypotension and shock. Mechanical circulatory support devices may the bridge patient safely throughout the procedure and are often used in this setting.AimWe assessed the outcomes of patients subjected to HRPCI and supported with intra-aortic balloon pump (IABP) of larger volume (MEGA) compared to standard volume (STRD) or no balloon support at all (CTRL).Material and methodsIn this single-centre, open-label, randomised, controlled trial, HRPCI patients were randomly assigned to three groups: MEGA, STRD, and CTRL in a 1 : 1 : 1 scheme. Screening failure patients were assigned to the registry (REG). Composite haemodynamic endpoint (CHEP) was assessed during the procedure and major adverse cardiac even (MACE)/safety endpoints up to 1-year follow-up (FU).ResultsA total of 36 patients were randomised (13 MEGA, 14 STRD, and 9 CTRL). The incidence of in-hospital MACE was observed in 23.1% of MEGA, 7.1% of STRD and 33.3% of CTRL (p = 0.25) patients; MACE at FU in 50.0%, 35.7%, and 55.6% (p = 0.61); major bleeding in 46.2%, 28.6%, and 22.2%, (p = 0.45); and CHEP in 15.4%, 50.0%, and 44.4%, respectively (p = 0.13). On per-treatment (PT) analysis (16 MEGA, 10 STRD, and 21 CTRL), including 11 patients from REG, in-hospital MACE was observed in 18.8% of MEGA, 10.0% of STRD, and 23.8% of CTRL (p = 0.64) patients; MACE at FU in 53.3%, 20.0%, and 57.1% (p = 0.12); major bleeding in 37.5%, 20.0%, and 33.3% (p = 0.62); and CHEP in 15.5%, 50.0%, and 52.4%, respectively (p = 0.023).ConclusionsLarger volume intra-aortic balloon pump might be effective at reducing haemodynamic instability during HRPCI without a statistically significant effect on safety endpoints or MACE.

Mechanical Circulatory Support for Semi-Elective Percutaneous Coronary Intervention in High-Risk Patients with Intra-Aortic Balloon Pump Counter Pulsation and Extracorporeal Membranous Oxygenation

Background: Intra-aortic balloon pump (IABP) and veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provide consistent augmentation of cardiac output, which can alleviate haemodynamic fluctuations during high-risk percutaneous coronary intervention (PCI). Paucity of data exists.

Transradial percutaneous coronary intervention in high-risk patients

Percutaneous coronary intervention (PCI) is the commonest form of revascularization in patients with coronary heart disease. The benefit of early invasive treatment with PCI in patients presenting with acute coronary syndromes are well accepted. Traditionally, PCI has been performed via the femoral access with significant risks for the development of access site-related bleeding complications. Increased international adoption of the transradial access site for PCI procedures has been shown to reduce such major access site-related bleeding complications and mortality, especially in the high-risk patient groups. We provide a brief overview of the historical perspective on transradial approach and the evidence supporting its use. We then discuss the current data supporting transradial access in high-risk populations and factors that have limited its adoption.

The Impact of Concomitant Percutaneous Coronary Intervention in High-Risk Patients with Aortic Stenosis and Coronary Artery Disease on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation

OP-082 Combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) in patients with aortic stenosis (AS) and concomitant coronary artery disease (CAD) is associated with increased operative risks. There is little knowledge on the outcome associated with performing

Successful high‐risk percutaneous coronary intervention with the use of minimal extracorporeal circulation system

Minimal extracorporeal circulation (MECC) represents a contemporary system which integrates several advances in cardiopulmonary bypass technology in a single circuit. We challenged the efficacy of the MECC system to support the circulation in elective high-risk percutaneous coronary intervention (PCI). A 78-year-old patient with complex coronary disease who would have been otherwise rejected for interventional therapy underwent PCI with rotablation on MECC support. The MECC system provided hemodynamic support at a flow of 1.8 L min(-1) m(-2) while perfusion pressure was kept at a minimum of 70 mm Hg. This allowed for successful angioplasty of the left main stem and a chronically occluded right coronary artery, which otherwise produced significant hemodynamic compromise. This case illustrates that mechanical circulatory support with the MECC system could provide a stable environment and a "safety net" for carrying out complex percutaneous coronary intervention in high-risk patients.

Impact of an Initial Strategy of Medical Therapy Without Percutaneous Coronary Intervention in High-Risk Patients From the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) Trial

We explored the safety and quality-of-life consequences of treating patients with stable coronary disease and high-risk features initially with optimal medical therapy (OMT) alone compared to OMT plus percutaneous coronary intervention. This was a post hoc analysis of Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial patients. We defined high risk as the onset of Canadian Cardiovascular Society class III angina within 2 months or stabilized acute coronary syndrome within 2 weeks of enrollment. The primary end point was death or myocardial infarction after 4.6 years. Of the 2,287 patients enrolled in the COURAGE trial, 264 (12%) were high risk and had a relative risk of 1.56 for death or myocardial infarction (p = 0.0008) compared to those with non-high-risk features. A total of 35 primary events occurred in the OMT group and 32 in the percutaneous coronary intervention plus OMT group (hazard ratio 1.11, 95% confidence interval 0.69 to 1.79; p = 0.68). No significant difference was found in the prevalence of angina between the 2 groups at 1 year. During the first year of follow-up, 30% of the OMT patients crossed over to the revascularization group. In conclusion, an initial strategy of OMT alone for high-risk patients in the COURAGE trial did not result in increased death or myocardial infarction at 4.6 years or worse angina at 1 year, but it was associated with a high rate of crossover to revascularization.

Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study

We evaluated the acute and long-term results of the use of a new intracardiac microaxial pump, the Impella Recover LP 2.5, during elective high-risk percutaneous coronary interventions in a two-centre registry. Ten consecutive patients with poor left ventricular function and multivessel or left main coronary artery disease were considered at high risk of haemodynamic compromise and underwent percutaneous coronary interventions with preintervention Impella implantation. Procedural complications, 30-day and 12-month clinical outcome were recorded. Left ventricular ejection fraction was assessed by echocardiography before procedure and after at least 6 months. The Impella was implanted before percutaneous coronary interventions by femoral approach and percutaneous coronary interventions were successfully performed (by contra lateral femoral or radial approach) in all cases. After percutaneous coronary intervention, Impella was removed in all patients, and haemostasis was obtained by prolonged manual compression or by double suture device preimplantation technique. No access-site complication was observed and no patient required transfusions. One patient died after Impella removal due to acute stent thrombosis. The other patients had an uncomplicated in-hospital course and were discharged within 5 days. At 1-year follow-up, no patient died nor suffered acute myocardial infarction, whereas two patients underwent re-percutaneous coronary intervention. Left ventricular ejection fraction at follow-up increased significantly in this study population (from 31 +/- 7% to 41% +/- 13%, P = 0.02). Our results support the feasibility and safety of Impella-assisted percutaneous coronary intervention in high-risk patients. Prospective randomized trials are needed to test the clinical impact of such an innovative approach.

P1228 Outcome differences in women and men after early percutaneous coronary intervention in high-risk patients with acute coronary syndromes

P1228 Outcome differences in women and men after early percutaneous coronary intervention in high-risk patients with acute coronary syndromes

Abciximab Usage in Percutaneous Coronary Intervention in High-Risk Patients: Early and Late Outcomes

Background: Clinical adverse cardiac events have been significantly reduced by the adjunctive usage of Glycoprotein IIb/IIIa receptor inhibitors in patients undergoing percutaneous coronary intervention (PCI). However, no information on its safety and efficacy is available for Asian. Methods: All patients who had PCI together with abciximab in the Prince of Wales Hospital from August 1998 to December 2000 were included. Hospital records, ECG records and laboratory results were reviewed retrospectively. The primary composite endpoint including death, myocardial infarction, target vessel revascularization or bypass surgery was assessed at index hospitalization, at 1 month, and 6 months after PCI. The safety of abciximab and any difference in outcomes between the prophylactic and standby group were studied. Results: One hundreds and five patients had PCI together with abciximab during the study period. All received bolus abciximab of 0.25 mg/kg followed by 0.125 µg/kg/min infusion over 12 hours. Twenty-one patients had experienced the primary endpoint at the index hospitalization (7 from the prophylactic group and 14 from the standby group). Additional 3 patients in the prophylactic group had reached primary endpoint at 1 month. At 6 months, another 1 in the prophylactic group and 4 in the standby group reached primary endpoint. Total 5 deaths occurred during the index hospitalization, 2 from prophylactic group and 3 from standby group. The bleeding complication was similar in both groups and most of them were minor bleeding only. Three patients had severe thrombocytopenia (platelet count less than 20x109 /l) and total 6 patients had thrombocytopenia of <50x109/l. Conclusion: There was a trend towards better clinical outcome in the abciximab prophylactic group and the benefit seemed to be sustained at 6 months. Low incidence of major bleeding was observed in the usage of abciximab, but the incidence of thrombocytopenia after abciximab usage in Chinese was much higher than reported in current published studies.

Prognostic value of cardiac troponin I re-elevation following percutaneous coronary intervention in high-risk patients with acute coronary syndromes

Troponin I is a predictive marker of short- and intermediate-term adverse cardiac events in patients with acute coronary syndromes (ACS). These high-risk patients may benefit from early percutaneous coronary intervention. However, whether additional myocardial injury, defined as postprocedural troponin I elevation, may be associated with adverse short- and intermediate-term outcomes has not been fully explored. Accordingly, we studied 132 consecutive patients with non–ST-elevation ACS (62% with non–Q-wave myocardial infarction) and elevated troponin I levels at admission (>0.15 ng/ml) who underwent percutaneous coronary intervention ≥48 hours after admission. Troponin I levels were routinely measured at 6 and 18 to 24 hours after intervention and patients were stratified according to the presence or absence of troponin I re-elevation, defined as postprocedural troponin I levels >1 times the admission levels. In-hospital and cumulative 6-month clinical outcomes were compared between groups. Patients with troponin I re-elevation (n = 51) were older (68 ± 13 vs 64 ± 12 years, p = 0.05) and had experienced prior myocardial infarction more frequently (92.5 vs 82.1, p = 0.09), but otherwise had similar baseline clinical characteristics. Patients with troponin I re-elevation had significantly higher in-hospital mortality (9.8% vs 0%, p = 0.016) and a higher 6-month cumulative death rate (24% vs 3.7%, p = 0.001). There was a trend for an increased 6-month myocardial infarction rate in patients with troponin I re-elevation (13.7% vs 3.7%, p = 0.11) and target vessel revascularization was similar between groups (16.7% vs 17.4%, p = 0.92). By multivariate analysis, troponin I re-elevation (odds ratio [OR] 6.2, p = 0.011) and diabetes mellitus (OR 5.7, p = 0.014) were the strongest independent predictors for increased 6-month cumulative mortality, whereas creatine kinase MB-fraction re-elevation had no prognostic value. We conclude that troponin I re-elevation after percutaneous coronary intervention in high-risk patients with ACS is associated with a substantial increase in mortality and reduced event-free survival at 6-month follow-up.