Interventional Cardiology | Links Medicus Content Curation & Alerts in Medicine

RCT: QFR Not Non-Inferior to FFR in Guiding Revascularization of Intermediate Coronary Stenoses

10 Nov, 2024 | 13:23h | UTC

Background: Fractional flow reserve (FFR) is the gold standard for assessing the functional significance of intermediate coronary stenoses and guiding revascularization decisions. Quantitative flow ratio (QFR) is a novel, noninvasive computational method for estimating FFR from angiography without the need for pressure wires. Despite promising diagnostic accuracy, the efficacy of QFR compared to FFR in clinical outcomes remains uncertain.

Objective: To determine whether a QFR-guided strategy is non-inferior to an FFR-guided strategy regarding 12-month clinical outcomes in patients with intermediate coronary stenosis.

Methods: In this multicentre, randomized, open-label, non-inferiority trial (FAVOR III Europe), 2,000 patients from 34 European centers with intermediate coronary stenosis (40–90% diameter stenosis) were randomized 1:1 to QFR-guided or FFR-guided revascularization strategies. The primary endpoint was a composite of death, myocardial infarction, and unplanned revascularisation at 12 months.

Results: At 12 months, the primary endpoint occurred in 6.7% of patients in the QFR group and 4.2% in the FFR group (hazard ratio [HR] 1.63; 95% CI 1.11–2.41). The upper limit of the 90% CI exceeded the predefined non-inferiority margin, indicating that QFR did not meet non-inferiority to FFR. Additionally, more patients underwent revascularisation in the QFR group (67.5%) compared to the FFR group (59.9%).

Conclusions: A QFR-guided strategy did not demonstrate non-inferiority to an FFR-guided strategy for guiding coronary revascularization in patients with intermediate stenoses. The use of QFR led to more revascularizations without an improvement in clinical outcomes.

Implications for Practice: While QFR offers a non-invasive alternative to FFR, these findings suggest that QFR should not replace FFR when available for guiding revascularization decisions in intermediate coronary stenosis.

Study Strengths and Limitations: Strengths include a large sample size and a multicentre design enhancing generalisability. Limitations encompass the lack of blinding, potential operator learning curves with QFR, and a lower-than-expected event rate in the FFR group, which may have affected the non-inferiority assessment.

Future Research: Further studies are warranted to refine QFR technology and evaluate its role in different patient populations and clinical settings where FFR is not readily available.

Reference: Andersen BK, Sejr-Hansen M, Maillard L, et al. Quantitative flow ratio versus fractional flow reserve for coronary revascularisation guidance (FAVOR III Europe): a multicentre, randomized, non-inferiority trial. The Lancet. 2024;404(10465):1835–1846. DOI: http://doi.org/10.1016/S0140-6736(24)02175-5

Cohort Study: Late Ventricular Arrhythmias After Primary PCI for STEMI Are Rare but Increase Mortality

5 Nov, 2024 | 15:24h | UTC

Background: Ventricular tachycardia (VT) and ventricular fibrillation (VF) are critical complications following ST-segment elevation myocardial infarction (STEMI). While early VT/VF typically occurs before or shortly after reperfusion, contemporary data on the incidence of late VT/VF post-primary percutaneous coronary intervention (PCI) are limited. Understanding the risk of late VT/VF is essential for optimizing in-hospital monitoring and discharge timing.

Objective: To assess the risk of late VT and VF after primary PCI in patients with STEMI, identify associated factors, and evaluate their impact on in-hospital mortality.

Methods: This cohort study analyzed data from 174,126 adults with STEMI treated with primary PCI between January 1, 2015, and December 31, 2018, using the National Cardiovascular Data Registry Chest Pain–MI Registry. Late VT/VF was defined as events occurring one or more days after PCI. Multivariable logistic regression was employed to identify factors associated with late VT/VF and its association with in-hospital mortality.

Results: Among the patients, 8.9% experienced VT or VF after primary PCI. Late VT/VF occurred in 2.4% of patients overall and 1.7% of those with uncomplicated STEMI. Late VT/VF associated with cardiac arrest was rare, occurring in 0.4% of all patients and 0.1% of patients with uncomplicated STEMI. Decreased left ventricular ejection fraction (LVEF) was the most significant factor associated with late VT/VF with cardiac arrest (adjusted odds ratio [AOR] for every 5-unit decrease ≤40%: 1.67; 95% CI, 1.54–1.85). Late VT/VF was linked to increased odds of in-hospital mortality (AOR, 6.40; 95% CI, 5.63–7.29).

Conclusions: Late VT/VF after primary PCI for STEMI is infrequent, particularly in patients with uncomplicated presentations. However, when late VT/VF occurs, it is associated with a significantly higher risk of in-hospital mortality.

Implications for Practice: While vigilant monitoring remains crucial, patients with uncomplicated STEMI may be candidates for earlier discharge through shared decision-making. Identifying high-risk patients for late VT/VF can enable tailored monitoring strategies to improve outcomes.

Study Strengths and Limitations: Strengths include a large, contemporary cohort and detailed data on in-hospital VT/VF events. Limitations involve the observational design, potential unmeasured confounders, and the inability to differentiate between VT and VF due to registry definitions.

Future Research: Further studies are warranted to develop precise risk prediction models for late VT/VF and to explore effective out-of-hospital monitoring strategies post-STEMI.

Reference: Rymer JA, Wegermann ZK, Wang TY, et al. Ventricular Arrhythmias After Primary Percutaneous Coronary Intervention for STEMI. JAMA Network Open. 2024;7(5). DOI: http://doi.org/10.1001/jamanetworkopen.2024.10288

Guideline: SCAI Expert Consensus on Management of STEMI Patients Undergoing Primary PCI

13 Oct, 2024 | 12:44h | UTC

Introduction: ST-elevation myocardial infarction (STEMI) is a leading cause of morbidity and mortality, requiring rapid diagnosis and timely reperfusion. While primary percutaneous coronary intervention (PCI) is the preferred reperfusion method, existing guidelines lack detailed procedural and technical recommendations for the cardiac catheterization laboratory (CCL). The Society for Cardiovascular Angiography & Interventions (SCAI) presents this expert consensus statement to provide best practices for CCL team readiness, optimal angiography and intervention techniques, management of special circumstances and anatomical subsets, and strategies to improve quality of care in STEMI patients undergoing primary PCI.

Key Recommendations:

CCL Team Readiness:
- Prehospital notification and ECG transmission expedite care.
- Implement emergency department (ED) bypass when feasible.
- Perform a focused cardiovascular assessment prior to PCI.
Arterial Access:
- Prefer transradial access over femoral to reduce complications.
- Use ultrasound guidance and contemporary techniques for femoral access when necessary.
Diagnostic Assessment:
- Conduct complete coronary angiography during the index procedure.
- Measure left ventricular end-diastolic pressure (LVEDP) to guide management.
Managing Thrombus:
- Assess thrombus burden after wire crossing.
- Use bail-out aspiration thrombectomy selectively for large thrombus burden.
- Consider parenteral or intracoronary antiplatelet agents for refractory thrombus.
Managing No-Reflow:
- Administer intracoronary vasodilators to the distal bed.
- Enhance coronary perfusion pressure by augmenting mean arterial pressure and reducing LVEDP.
Intracoronary Imaging:
- Encourage routine use of IVUS or OCT to guide PCI.
- Employ intracoronary imaging to investigate stent thrombosis or suspected nonatherosclerotic causes.
Special Circumstances:
- In cardiogenic shock, perform right heart catheterization and consider mechanical circulatory support.
- After failed fibrinolysis, proceed with immediate catheterization and rescue PCI.
- In multivessel disease, complete revascularization is recommended.
Anatomical Subsets:
- Use plaque modification techniques for calcified lesions.
- Prefer a provisional one-stent strategy in bifurcation lesions.
- Focus on restoring flow in coronary aneurysms.
Nonatherosclerotic STEMI Causes:
- Administer intracoronary nitroglycerin to identify epicardial vasospasm.
- Manage spontaneous coronary artery dissection conservatively if flow is preserved.
- Use thrombectomy for coronary embolism.
- Investigate MINOCA with additional imaging and testing.
Quality Improvement:
- Track all STEMI cases to assess treatment times and outcomes for continuous improvement.

Conclusion: Adherence to these recommendations is expected to enhance patient outcomes by optimizing procedural strategies, reducing complications, and improving survival in STEMI patients undergoing primary PCI.

Reference: Tamis-Holland JE, et al. (2024). SCAI Expert Consensus Statement on the Management of Patients With STEMI Referred for Primary PCI. Journal of of the Society for Cardiovascular Angiography and Interventions. DOI: http://doi.org/10.1016/j.jscai.2024.102294

RCT: PCI Reduces Major Adverse Cardiac Events in Patients Undergoing TAVI with Significant Coronary Artery Disease

14 Sep, 2024 | 19:09h | UTC

Background:

Severe aortic stenosis and coronary artery disease (CAD) frequently coexist, particularly in the elderly population. Approximately 50% of patients undergoing transcatheter aortic valve implantation (TAVI) have concurrent CAD. The optimal management of significant coronary lesions in patients undergoing TAVI remains uncertain, with guidelines providing no clear recommendations. Understanding whether percutaneous coronary intervention (PCI) improves outcomes in this setting is crucial for guiding clinical practice.

Objective:

To evaluate whether routine PCI of physiologically significant coronary lesions improves clinical outcomes compared to conservative management in patients with stable CAD undergoing TAVI.

Methods:

Design: International, multicenter, open-label, randomized controlled trial (NOTION-3).
Participants: 455 patients with severe symptomatic aortic stenosis scheduled for TAVI and at least one significant coronary lesion (defined as fractional flow reserve [FFR] ≤0.80 or diameter stenosis ≥90%).
Interventions:
- PCI Group (n=227): Underwent PCI of all eligible lesions followed by TAVI.
- Conservative Treatment Group (n=228): Received TAVI without prior PCI.
Primary Endpoint: Major adverse cardiac events (MACE), a composite of death from any cause, myocardial infarction (MI), or urgent revascularization.
Secondary Endpoints: Included individual components of the primary endpoint, bleeding events, stroke, hospital admissions for heart failure, and procedural complications.
Follow-Up: Median of 2 years (interquartile range, 1 to 4 years).

Results:

Baseline Characteristics: Median age was 82 years; 67% were men; median Society of Thoracic Surgeons–Procedural Risk of Mortality (STS-PROM) score was 3%.
Primary Endpoint (MACE):
- Occurred in 26% of patients in the PCI group versus 36% in the conservative group.
- Hazard Ratio (HR): 0.71 (95% Confidence Interval [CI], 0.51 to 0.99; P=0.04), indicating a 29% relative risk reduction with PCI.
Components of MACE:
- Myocardial Infarction:
  - Lower incidence in the PCI group.
- Urgent Revascularization:
  - Reduced need in the PCI group.
All-Cause Mortality:
- No significant difference between groups.
Bleeding Events:
- Higher in the PCI group (28% vs. 20%; HR, 1.51; 95% CI, 1.03 to 2.22).
- Bleeding assessed according to Valve Academic Research Consortium–2 criteria.
Procedural Complications:
- PCI-related complications occurred in 3% of patients in the PCI group.
Safety Endpoints:
- Similar rates of stroke and stent thrombosis between groups.
- Acute kidney injury was less frequent in the PCI group (5% vs. 11%; HR, 0.45; 95% CI, 0.23 to 0.89).

Conclusions:

In patients with stable CAD and severe symptomatic aortic stenosis undergoing TAVI, performing PCI on significant coronary lesions resulted in a statistically significant reduction in MACE over a median follow-up of 2 years compared to conservative management. The benefit was primarily due to reductions in myocardial infarction and urgent revascularization rates. However, this advantage was accompanied by an increased risk of bleeding events.

Clinical Implications:

Patient Selection: PCI should be considered in patients with physiologically significant coronary lesions (FFR ≤0.80 or diameter stenosis ≥90%) undergoing TAVI.
Risk–Benefit Analysis: Clinicians should balance the reduction in MACE against the increased bleeding risk when deciding on PCI.
Treatment Strategy: The findings support a strategy of routine revascularization in this patient population to improve cardiovascular outcomes.
Future Considerations: Further research is needed to determine the optimal timing of PCI relative to TAVI and to identify which patient subgroups may derive the most benefit.

Recommendations:

Guideline Update: The results may inform future guidelines to provide clearer recommendations on managing CAD in patients undergoing TAVI.
Individualized Care: Decisions regarding PCI should be individualized, considering patient comorbidities, anatomical complexity, and bleeding risk.
Antithrombotic Therapy: Attention to antiplatelet and anticoagulation strategies is important to mitigate bleeding risks.

Study Limitations:

Exclusion of patients with recent acute coronary syndromes and left main coronary artery disease limits the generalizability.
Changes in antithrombotic regimens over the study period reflect evolving clinical practice but may affect outcomes.
Majority of patients had low to intermediate SYNTAX scores, so results may not apply to those with more complex CAD.

Final Note:

The NOTION-3 trial provides valuable evidence supporting the use of PCI in patients with significant CAD undergoing TAVI, emphasizing the importance of comprehensive cardiovascular care in this high-risk population.

Reference: Lønborg, J., et al. (2024). PCI in patients undergoing transcatheter aortic-valve implantation. New England Journal of Medicine. DOI: https://doi.org/10.1056/NEJMoa2401513

RCT: Pulmonary Vein Isolation Reduces Atrial Fibrillation Burden and Improves Quality of Life vs. Sham Procedure

7 Sep, 2024 | 17:24h | UTC

Study Design and Population: This double-blind, randomized clinical trial (SHAM-PVI) compared pulmonary vein isolation (PVI) via cryoablation to a sham procedure in 126 patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). The study, conducted in two UK tertiary centers, enrolled patients between January 2020 and March 2024. Major exclusions included long-standing persistent AF, prior left atrial ablation, and ejection fraction below 35%. Patients were monitored using implantable loop recorders.

Main Findings: At 6 months, the PVI group demonstrated a significant reduction in AF burden (60.31%) compared to the sham group (35.0%), with a geometric mean difference of 0.25 (95% CI, 0.15-0.42; P < .001). Quality-of-life scores also improved more in the PVI group, with an 18.39-point difference (95% CI, 11.48-25.30). Symptom improvement was also marked, with a reduction in the Mayo AF-Specific Symptom Inventory frequency score of −6.36 points (95% CI, −8.46 to −4.26).

Implications for Practice: PVI significantly reduces AF burden and improves both symptoms and quality of life in patients with symptomatic AF, compared to a sham procedure. These findings support the efficacy of PVI beyond a placebo effect, making it a compelling option for managing AF in patients not responsive to antiarrhythmic drugs.

Reference: Dulai, R., Sulke, N., Freemantle, N., Lambiase, P. D., Farwell, D., Srinivasan, N. T., et al. (2024). Pulmonary vein isolation vs sham intervention in symptomatic atrial fibrillation: The SHAM-PVI randomized clinical trial. JAMA. http://doi.org/10.1001/jama.2024.17921

Link: https://jamanetwork.com/journals/jama/fullarticle/2823283

RCT: Optical Coherence Tomography (OCT)-Guided PCI Lowers Adverse Cardiac Events Compared to Angiography in Complex Lesions

7 Sep, 2024 | 17:08h | UTC

Study Design and Population: This multicenter, randomized, open-label superiority trial (OCCUPI) compared optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with angiography-guided PCI in patients with complex coronary lesions. The trial was conducted across 20 hospitals in South Korea, enrolling 1,604 patients aged 19–85 years requiring drug-eluting stents. Participants were randomized into OCT-guided PCI (n=803) or angiography-guided PCI (n=801), with outcomes assessed over 1 year.

Main Findings: At 1 year, major adverse cardiac events (MACE), including cardiac death, myocardial infarction, stent thrombosis, and ischemia-driven target-vessel revascularization, occurred in 5% of patients in the OCT-guided group compared to 7% in the angiography-guided group. The reduction in events was mainly driven by lower rates of spontaneous myocardial infarction and target-vessel revascularization in the OCT group. Secondary outcomes, such as stroke or contrast-induced nephropathy, showed no significant differences between groups.

Implications for Practice: OCT-guided PCI was associated with a lower incidence of MACE in patients with complex coronary lesions. These findings suggest that OCT guidance may provide additional benefit in stent optimization compared to angiography alone.

Reference: Hong SJ et al. (2024). Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea. The Lancet. DOI: https://doi.org/10.1016/S0140-6736(24)01454-5

link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01454-5/fulltext

Meta-Analysis: Ticagrelor Monotherapy Reduces Bleeding Without Increasing Ischemic Risk in Coronary Stent Patients

7 Sep, 2024 | 15:06h | UTC

Study Design and Population: This systematic review and individual patient-level meta-analysis pooled data from six randomized trials, comparing ticagrelor monotherapy after short-term dual antiplatelet therapy (DAPT) with standard 12-month DAPT in patients who underwent percutaneous coronary intervention with drug-eluting stents. The analysis included 23,256 patients in the per-protocol population and 24,407 in the intention-to-treat population, excluding those requiring long-term anticoagulants.

Main Findings: Ticagrelor monotherapy was found to be noninferior to 12-month DAPT for major adverse cardiovascular or cerebrovascular events (MACCE), with a hazard ratio (HR) of 0.91 (95% CI 0.78-1.07). It also reduced the risk of major bleeding (HR 0.43, p<0.0001) and all-cause mortality (HR 0.76, p=0.034). Subgroup analyses suggested possible benefits in women for mortality and in patients with acute coronary syndrome (ACS) for bleeding reduction.

Implications for Practice: Ticagrelor monotherapy may offer a safer alternative to prolonged DAPT by reducing bleeding risks without increasing ischemic events, particularly in ACS patients. Further research is needed to fully explore potential survival benefits, especially in women.

Reference: Valgimigli M, Hong S-J, Gragnano F, et al. (2024). De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials. Lancet. http://doi.org/10.1016/S0140-6736(24)01616-7

Link: https://www.sciencedirect.com/science/article/pii/S0140673624016167

RCT: Invasive Strategy Does Not Significantly Improve Cardiovascular Outcomes Over Conservative Management in Older Adults with NSTEMI

7 Sep, 2024 | 13:25h | UTC

Study Design and Population: This was a prospective, multicenter, randomized trial conducted across 48 sites in the UK, enrolling 1,518 patients aged 75 years or older with non-ST-segment elevation myocardial infarction (NSTEMI). Patients were randomly assigned to receive either the best available medical therapy alone (conservative strategy) or in combination with invasive treatment (coronary angiography and revascularization). The population included individuals who were frail or had high comorbidities, with a mean age of 82 years.

Main Findings: Over a median follow-up of 4.1 years, the primary outcome (a composite of cardiovascular death or nonfatal myocardial infarction) occurred in 25.6% of the invasive-strategy group and 26.3% of the conservative-strategy group (HR, 0.94; 95% CI, 0.77–1.14; P=0.53), showing no significant difference. Cardiovascular death rates were similar between the two groups, but nonfatal myocardial infarction was lower in the invasive group (11.7% vs. 15.0%; HR, 0.75; 95% CI, 0.57–0.99). Procedural complications were rare, affecting less than 1% of patients.

Implications for Practice: This trial suggests that in older adults with NSTEMI, an invasive strategy does not significantly reduce the risk of cardiovascular death or nonfatal myocardial infarction compared to a conservative approach. The findings support the consideration of conservative management in frail elderly patients or those with significant comorbidities, given the minimal additional benefit of invasive treatment.

Reference: Kunadian, V., Mossop, H., Shields, C., Bardgett, M., Watts, P., Teare, M. D., Pritchard, J., et al. (2024). Invasive treatment strategy for older patients with myocardial infarction. New England Journal of Medicine. http://doi.org/10.1056/NEJMoa2407791

Link: https://www.nejm.org/doi/10.1056/NEJMoa2407791

RCT: Interruption of Oral Anticoagulation during TAVI Reduces Bleeding Without Increasing Thromboembolic Events

7 Sep, 2024 | 12:43h | UTC

Study Design and Population: This international, open-label, randomized noninferiority trial examined 858 patients undergoing transcatheter aortic-valve implantation (TAVI) who had an indication for oral anticoagulation due to concomitant diseases. Patients were randomized 1:1 to either continue or interrupt their oral anticoagulation during the procedure, with the primary outcome being a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days.

Main Findings: Primary outcome events occurred in 16.5% of the continuation group and 14.8% of the interruption group, showing a non-significant risk difference of 1.7 percentage points (95% CI, -3.1 to 6.6). Thromboembolic events were similar between groups (8.8% in continuation vs. 8.2% in interruption). However, bleeding events were significantly higher in the continuation group (31.1% vs. 21.3%; risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).

Implications for Practice: Interrupting oral anticoagulation during TAVI significantly reduces bleeding without increasing thromboembolic risks, suggesting it may be a safer strategy for patients undergoing TAVI. These findings could influence clinical decision-making regarding anticoagulation management in this population.

Reference: van Ginkel, D.J. et al. (2024). Continuation versus Interruption of Oral Anticoagulation during TAVI. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2407794

News Release: SCOFF Trial Confirms Fasting Not Necessary Before Cardiac Catheterisation Procedures

7 Sep, 2024 | 10:10h | UTC

1 September 2024 – London, United Kingdom – New findings from the SCOFF trial, presented at ESC Congress 2024, suggest that fasting prior to minimally invasive cardiac catheterisation procedures under conscious sedation does not increase the risk of complications. The trial supports reconsidering current guidelines on pre-procedural fasting.

Key Points for Physicians:

– No increased complications: The SCOFF trial found no significant difference in adverse outcomes, such as aspiration pneumonia or hypoglycemia, between patients who fasted and those who ate normally before cardiac catheterisation.

– Improved patient satisfaction: Patients who did not fast reported higher satisfaction, with fewer complaints of discomfort and hunger.

– Potential guideline change: These findings, in line with previous studies like CHOW-NOW and TONIC, challenge the necessity of fasting before such procedures.

The trial’s lead investigator, Dr. David Ferreira (John Hunter Hospital, Australia), emphasized that avoiding fasting may improve patient experience without increasing risks, making it time to reconsider fasting guidelines for these procedures.

Study Overview:

– Trial design: Prospective, randomized, open-label, with blinded endpoint assessment.

– Participants: 716 patients undergoing coronary angiography, coronary intervention, or cardiac implantable electronic device procedures.

– Primary endpoint: Composite of hypotension, aspiration pneumonia, hyperglycemia, and hypoglycemia, showing a lower event rate in the non-fasting group (12.0%) compared to the fasting group (19.1%).

These results are likely to influence future clinical practice, providing greater flexibility for both patients and healthcare systems.

Source: https://www.escardio.org/The-ESC/Press-Office/Press-releases/SCOFF-trial-confirms-that-fasting-is-not-needed-before-cath-lab-procedures

Meta-Analysis: 1-Month Dual Antiplatelet Therapy Reduces Major Bleeding Without Increasing Stent Thrombosis After PCI with DES – Am J Cardiol

17 Aug, 2024 | 19:29h | UTC

Main Findings: The analysis found that 1-month DAPT significantly reduced the risk of major bleeding (OR 0.66, 95% CI 0.45-0.97, p = 0.03) compared to >1-month DAPT. Additionally, there was no significant difference in stent thrombosis rates between the groups (OR 1.08, 95% CI 0.81-1.44, p = 0.60). Secondary outcomes, including all-cause mortality, cardiovascular death, myocardial infarction, stroke, and major adverse cardiovascular or cerebrovascular events were also similar between the groups.

Implications for Practice: The findings support the use of 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor as a safer alternative to longer-term DAPT in patients undergoing PCI with DES. This strategy may help reduce bleeding risks without increasing the likelihood of thrombotic events, making it a viable option for routine clinical practice, particularly in patients at high risk for bleeding.

Reference: Bajraktari G, Bytyçi I, Abdyli G, et al. (2024). One-Month Dual Antiplatelet Therapy Reduces Major Bleeding Compared With Longer-Term Treatment Without Excess Stent Thrombosis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. The American Journal of Cardiology, 227, 91-97. DOI: https://doi.org/10.1016/j.amjcard.2024.07.010.

Cohort Study: Late ventricular arrhythmias are rare in STEMI patients without left ventricular dysfunction post-primary PCI – JAMA Netw Open

11 May, 2024 | 14:15h | UTC

Study Design and Population: This cohort study analyzed data from the US National Cardiovascular Data Registry Chest Pain–MI Registry, involving 174,126 adults with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) from 2015 to 2018. The population included a broad demographic with a focus on those experiencing late ventricular tachycardia (VT) or ventricular fibrillation (VF) post-PCI, specifically examining occurrences one day or more after the intervention.

Main Findings: The study found that 8.9% of the patients developed VT or VF after PCI, with 2.4% experiencing these arrhythmias late in the hospitalization period. Among patients with uncomplicated STEMI, late VT or VF with cardiac arrest was exceedingly rare, occurring in only 0.1%. Notably, reduced left ventricular ejection fraction was strongly associated with an increased risk of late VT or VF with cardiac arrest. The presence of late VT or VF significantly correlated with higher in-hospital mortality rates.

Implications for Practice: The findings suggest that late VT or VF after primary PCI in STEMI patients is infrequent, particularly among those without complications. This data supports the potential for safe earlier hospital discharge in uncomplicated cases. However, vigilance is advised due to the significant mortality risk associated with late VT or VF events. Clinicians should consider patient-specific risk factors such as left ventricular function when making discharge decisions.

Reference (link to free full-text):

Rymer JA et al. (2024). Ventricular Arrhythmias After Primary Percutaneous Coronary Intervention for STEMI. JAMA Network Open, 7(5), e2410288. DOI: 10.1001/jamanetworkopen.2024.10288.

RCT: Post-1 month ticagrelor monotherapy vs. dual antiplatelet therapy significantly reduces bleeding events in acute coronary syndromes

30 Apr, 2024 | 13:26h | UTC

In this randomized, placebo-controlled, double-blind clinical trial, 3400 patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI) were assessed to compare the effects of ticagrelor alone versus ticagrelor plus aspirin from 1 to 12 months post-PCI. The study aimed to determine if ticagrelor alone could reduce bleeding without increasing major adverse cardiovascular or cerebrovascular events (MACCE). The primary findings indicated that ticagrelor alone resulted in significantly lower clinically relevant bleeding (2.1% vs. 4.6%, p<0.0001) and demonstrated non-inferiority in MACCE rates compared to the dual therapy group (3.6% vs. 3.7%, pnon-inferiority<0.0001). These outcomes suggest that ticagrelor monotherapy, starting one month post-PCI, may be an effective alternative to standard dual antiplatelet therapy in reducing bleeding risks without compromising safety.

Commentary on X:

Ticagrelor, in combination with #aspirin for 1 month, followed by ticagrelor alone,
after #PCI (GLOBAL LEADERS): a randomised superiority trial https://t.co/Bo8gfHIZLe

Register now to freely access #ESCCongress #LancetCardiology content up to Sept 10! https://t.co/6wOSrV9yXM pic.twitter.com/8EV5d8s1c8

— The Lancet (@TheLancet) August 27, 2018

Reference (link to abstract – $ for full-text):

Ge Z. et al. (2024). Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial. The Lancet, 404(10102), 1173-1182. DOI: https://doi.org/10.1016/S0140-6736(24)00473-2.

RCT: Efficacy and safety of microaxial flow pump in STEMI-related cardiogenic shock

28 Apr, 2024 | 20:17h | UTC

This randomized clinical trial assessed the impact of a microaxial flow pump (Impella CP) on mortality in 355 patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock. Patients were randomly assigned to receive either the microaxial flow pump plus standard care or standard care alone. The primary outcome was mortality at 180 days. Results showed a significant reduction in death rates in the microaxial flow pump group (45.8%) compared to the standard care group (58.5%) with a hazard ratio of 0.74 (95% CI, 0.55 to 0.99; P=0.04). However, the incidence of severe adverse events was notably higher in the microaxial flow pump group, including severe bleeding and device-related complications.

Reference (link to abstract – $ for full-text):

Jacob E. Møller et al. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med, 390(15), 1382-1393. DOI: 10.1056/NEJMoa2312572

RCT: Reduction in cardiac events through preventive PCI in vulnerable atherosclerotic coronary plaques

28 Apr, 2024 | 17:39h | UTC

This multicenter, open-label, randomized controlled trial assessed the effectiveness of preventive percutaneous coronary intervention (PCI) versus optimal medical therapy alone in treating patients with non-flow-limiting vulnerable coronary plaques identified by intracoronary imaging. Conducted across 15 research hospitals in four countries, the trial enrolled 1,606 patients, with 803 in each treatment group. After 2 years, major adverse cardiac events were significantly lower in the PCI group (0.4%) compared to the medical therapy group (3.4%), with a p-value of 0.0003. These results suggest that preventive PCI can effectively reduce cardiac events in patients with high-risk vulnerable plaques, supporting the expansion of PCI indications to these patients.

Reference (link to abstract – $ for full-text):

Prof Seung-Jung Park et al. (2024). Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. The Lancet, Volume Not Specified (Issue Not Specified), Pages Not Specified. DOI: https://doi.org/10.1016/S0140-6736(24)00413-6

RCT: Intravascular ultrasound guidance improves outcomes in percutaneous coronary intervention for acute coronary syndrome

28 Apr, 2024 | 17:22h | UTC

This randomized clinical trial evaluated 3505 acute coronary syndrome (ACS) patients across 58 centers in China, Italy, Pakistan, and the UK, comparing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with angiography-guided PCI. The study’s primary endpoint was target vessel failure—comprising cardiac death, myocardial infarction, or revascularisation—after 1 year. The IVUS-guided group showed significantly lower rates of the primary endpoint (4.0%) compared to the angiography-guided group (7.3%), with a hazard ratio of 0.55. This outcome was primarily driven by reductions in myocardial infarction and revascularisation, with similar safety profiles between the two groups.

Reference (link to abstract – $ for full-text):

Xiaobo Li et al. (2024). Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial. The Lancet, Volume (Issue), Pages. DOI: https://doi.org/10.1016/S0140-6736(24)00282-4

PCI vs. CABG in left main coronary disease patients with and without diabetes—a pooled analysis of 4 trials

22 Mar, 2024 | 11:41h | UTC

Study Design and Population: This research pooled individual patient data from four randomized clinical trials (SYNTAX, PRECOMBAT, NOBLE, and EXCEL), comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in 4393 patients with left main coronary artery disease. The trials included both patients with and without diabetes, allowing for a comparative analysis of outcomes based on the revascularization method and the presence of diabetes.

Main Findings: Patients with diabetes exhibited higher rates of 5-year mortality, spontaneous myocardial infarction (MI), and repeat revascularization compared to those without diabetes. However, mortality rates following PCI vs. CABG were similar in diabetic (15.3% vs. 14.1%, respectively) and non-diabetic patients (9.7% vs. 8.9%, respectively). PCI was associated with a lower risk of stroke within the first year post-operation across all patients. Notably, diabetic patients underwent higher rates of spontaneous MI and repeat revascularization after PCI compared to CABG, with a more significant absolute excess risk observed beyond the first year compared to non-diabetic patients.

Implications for Practice: For patients with left main disease deemed suitable for either PCI or CABG, diabetes status significantly influences long-term outcomes, including death and cardiovascular events. While PCI offers a lower early risk of stroke, it is associated with increased risks of spontaneous MI and repeat revascularization, particularly in diabetic patients. These findings underscore the importance of considering patient-specific factors, such as diabetes status, in choosing between PCI and CABG for left main coronary artery disease revascularization.

Reference

Prakriti Gaba et al. (2024). Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With or Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation, 0. DOI: 10.1161/CIRCULATIONAHA.123.065571. Access the study here: Link

Meta-Analysis: No mortality benefit of early vs. delayed/selective coronary angiography in out-of-hospital cardiac arrest without ST-elevation

21 Mar, 2024 | 11:40h | UTC

Study Design and Population: This article presents a systematic review and meta-analysis of five randomized controlled trials comparing early/immediate versus delayed/selective coronary angiography (CAG) in 1512 patients who experienced out-of-hospital cardiac arrest (OHCA) without ST-segment elevation. The population had a mean age of 67 years, with 26% female and 23% having a prior myocardial infarction. Follow-up duration was at least 30 days across included studies.

Main Findings: The analysis revealed no significant difference in the odds of all-cause death between early/immediate and delayed/selective CAG strategies (Odds Ratio [OR] 1.12, 95% CI 0.91–1.38). Similar results were found for the composite outcome of all-cause death or neurological deficit (OR 1.10, 95% CI 0.89–1.36). Subgroup analysis showed no significant effect modification based on age, initial cardiac rhythm, history of coronary artery disease, the presumed ischemic cause of arrest, or time to return of spontaneous circulation. Interestingly, a trend toward increased odds of death was observed in women receiving early CAG compared to men, although this finding approached but did not reach statistical significance.

Implications for Practice: The findings suggest that for OHCA patients without ST-segment elevation, an early/immediate CAG strategy does not confer a mortality benefit over a delayed/selective approach across major subgroups. Notably, the potential for increased mortality risk in women with early CAG warrants further investigation. Clinicians should consider these results when deciding on the timing of CAG in this patient population, keeping in mind the overall lack of mortality benefit and the nuanced differences among subgroups.

Reference: Fardin Hamidi et al. (2023). Early versus delayed coronary angiography in patients with out-of-hospital cardiac arrest and no ST-segment elevation: a systematic review and meta-analysis of randomized controlled trials. Clinical Research in Cardiology, 113(561–569). Access the study here: [Link]

Review | An approach to non-left main bifurcation lesions

11 Aug, 2023 | 15:22h | UTC

An Approach to Non-left Main Bifurcation Lesions: A Contemporary Review – US Cardiology Review

Commentary on Twitter

?Do you know how to classify, assess, and treat non-left main bifurcation lesions with PCI?

New #USCardiology Review by @ANazmiCalik, @mirvatalasnag et al. @radcliffeCARDIO

?https://t.co/PeUcLxUerx pic.twitter.com/qh2FdUTbdE

— Amit Goyal MD MAS (@AmitGoyalMD) August 4, 2023