Daily Cardiology Research Analysis
Three impactful cardiology studies stand out today: a multicenter randomized trial shows a novel sirolimus-eluting "bioadaptor" implant reduces 2-year target lesion failure versus a contemporary drug-eluting stent; a systematic review/meta-analysis supports transcatheter edge-to-edge repair for severe mitral regurgitation in cardiogenic shock with high device success and acceptable mortality; and a meta-analysis suggests adding stress CT perfusion to coronary CTA reduces unnecessary invasive ang
Summary
Three impactful cardiology studies stand out today: a multicenter randomized trial shows a novel sirolimus-eluting "bioadaptor" implant reduces 2-year target lesion failure versus a contemporary drug-eluting stent; a systematic review/meta-analysis supports transcatheter edge-to-edge repair for severe mitral regurgitation in cardiogenic shock with high device success and acceptable mortality; and a meta-analysis suggests adding stress CT perfusion to coronary CTA reduces unnecessary invasive angiography without increasing adverse events.
Research Themes
- Coronary device innovation and long-term outcomes
- Structural heart intervention in cardiogenic shock
- Functional imaging to optimize chest pain pathways
Selected Articles
1. Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT.
In a multicenter, single-blind RCT (n=440 per-protocol) of de novo lesions, the sirolimus-eluting bioadaptor reduced 2-year target lesion failure (1.8% vs 5.5%; P=0.044) and target vessel failure (1.8% vs 5.9%; P=0.027) compared with a contemporary drug-eluting stent, with no increase in definite/probable device thrombosis (0% vs 0.5%). The design aims to restore arterial hemodynamics after polymer resorption.
Impact: This is the first randomized 2-year comparison of a bioadaptor scaffold against a contemporary DES showing fewer failures, supporting a new device class that restores vessel physiology.
Clinical Implications: For suitable de novo lesions, bioadaptor implants may offer lower 2-year TLF/TVF with maintained safety, potentially shifting device selection in PCI toward physiology-restoring scaffolds pending broader confirmation.
Key Findings
- 2-year TLF was lower with bioadaptor vs DES (1.8% vs 5.5%; risk difference −3.6%; P=0.044).
- 2-year target vessel failure was reduced with bioadaptor (1.8% vs 5.9%; risk difference −4.1%; P=0.027).
- Definite/probable device thrombosis was not increased (0% vs 0.5%; P=0.32).
Methodological Strengths
- Multicenter, randomized, single-blind design with contemporary comparator.
- Prespecified long-term (2-year) outcomes with Kaplan–Meier estimates.
Limitations
- Per-protocol analysis excludes some randomized patients; potential bias vs ITT.
- Modest sample size limits rare safety event detection and subgroup granularity.
Future Directions: Larger, ITT-focused RCTs with diverse anatomies and imaging endpoints, plus head-to-head comparisons versus new-generation DES, to confirm durability, vasomotion restoration, and clinical benefit.
BACKGROUND: The sirolimus-eluting bioadaptor is a novel coronary implant that unlocks, separates, and maintains dynamic support of the vessel at the lesion site 6 months after percutaneous coronary intervention when the polymer coating covering the helical strands resorbs. This enables the bioadaptor to maintain the established flow lumen and to restore hemodynamic modulation of the artery, including cyclic pulsatility, vasomotion, and adaptive remodeling. OBJECTIVES: The purpose of this study was to report the first randomized clinical evidence of the DynamX bioadaptor implant through 2 years compared with the Resolute Onyx contemporary drug-eluting stent. METHODS: This multicenter, single-blind, 1:1 randomized clinical trial was conducted at 34 hospitals in Japan, Europe, and New Zealand. The eligibility criterion was de novo coronary lesions in up to 2 vessels. The sample size was based on the primary endpoint, noninferiority of 12-month target lesion failure (TLF). The authors herein report 2-year outcomes. RESULTS: In total, 445 patients were enrolled; 3 patients treated for in-stent restenosis and 2 who did not receive the assigned study device because of randomization error were excluded from the analysis. In the per-protocol population of patients with de novo native coronary lesions treated with the assigned device (n = 440), 2-year Kaplan-Meier estimates of TLF and target vessel failure rates in the bioadaptor group were lower (1.8% [4 of 219] vs 5.5% [12 of 221], risk difference -3.6% [95% CI: -7.8% to -0.0%; P = 0.044], and 1.8% [4 of 219] vs 5.9% (13 of 221), risk difference -4.1% [95% CI: -7.2% to -1.0%; P = 0.027], respectively). One clinically driven target lesion revascularization occurred between 6 months and 2 years in the bioadaptor group, whereas 2 cardiovascular deaths and 4 clinically driven target lesion revascularizations occurred in the drug-eluting stent group. The 2-year rate of definite or probable device thrombosis was 0.0% vs 0.5% (n = 1) (P = 0.32), respectively. CONCLUSIONS: This is the first report of 2-year outcomes comparing the bioadaptor implant with a contemporary drug-eluting stent. At 2-year follow-up, fewer TLF events were observed in patients treated with the bioadaptor. (The Elixir Bioadaptor vs. the Onyx Stent in De Novo Native Coronary Arteries [BIOADAPTOR RCT];
2. Transcatheter Edge-to-Edge Repair for Severe Mitral Regurgitation in Patients With Cardiogenic Shock: A Systematic Review and Meta-Analysis.
Across 24 studies (n=5,428) of severe MR with cardiogenic shock, TEER achieved 86% device success and reduced MR to ≤2+ in 89%, with a pooled 30-day mortality of 14% and low stroke (2%). Outcomes were similar in AMI-related shock, though mortality was higher in this subgroup.
Impact: Synthesizing the largest evidence base to date, this analysis supports TEER as a feasible option in cardiogenic shock, informing heart team decision-making in a high-risk population.
Clinical Implications: In selected patients with cardiogenic shock and severe MR, TEER can provide hemodynamic stabilization with acceptable early risk; institutions should develop protocols and selection criteria, while recognizing evidence is largely observational.
Key Findings
- Pooled device success was 86% and MR reduction to ≤2+ was 89%.
- 30-day all-cause mortality was 14%; stroke 2%, MI 15%, HF hospitalization 9%.
- In AMI-related shock, device success 81% and 30-day mortality 20%; non-AMI 30-day mortality 13%.
Methodological Strengths
- Comprehensive search across major databases with predefined outcomes.
- Large pooled sample enabling precise estimates of short-term outcomes.
Limitations
- Predominantly observational studies with potential selection bias and heterogeneity.
- Fixed-effects pooling may under-account for between-study variability.
Future Directions: Prospective registries and pragmatic trials comparing TEER to alternative strategies (eg, medical therapy, surgery, MCS±TEER) with standardized shock phenotyping and core-lab adjudication.
BACKGROUND: Patients with severe mitral regurgitation and cardiogenic shock demonstrate a poor prognosis. Mitral transcatheter edge-to-edge repair could alter patient management. METHODS AND RESULTS: We systematically reviewed PubMed/Medline, Scopus, and Cochrane Library until January 2023, including studies assessing transcatheter edge-to-edge repair in patients with severe mitral regurgitation and cardiogenic shock. Studies with <5 patients were excluded. The primary outcome was device success and all-cause death, while secondary outcomes included myocardial infarction, stroke, and heart failure hospitalization rates at 30-day and intermediate-term follow-up. A fixed-effects meta-analysis was used to estimate pooled rates. Risk of bias was assessed with the Newcastle-Ottawa Scale. A total of 24 studies and 5428 patients were included, with a mean age of 71.2±3.3 years and a high mean Society of Thoracic Surgery score (15.2±8.9). Device success was achieved in 86% (95% CI, 85%-87%) and mitral regurgitation ≤2+ in 89% (95% CI: 88%-90%). The 30-day all-cause mortality rate was 14% (95% CI, 13%-15%). Stroke, myocardial infarction, and heart failure hospitalization rates were 2% (95% CI, 1%-2%), 15% (95% CI, 13%-18%), and 9% (95% CI, 8%-10%), respectively. Patients with acute myocardial infarction had similar device success (81% [95% CI, 74%-87%]), a 30-day mortality rate of 20% (95% CI, 16%-25%), and intermediate-term mortality rate of 14% (95% CI, 9%-19%). In non-myocardial infarction populations, the 30-day mortality rate was 13% (95% CI, 13%-14%), and the intermediate-term mortality rate was 35% (95% CI, 34%-36%). CONCLUSIONS: In patients with mitral regurgitation and cardiogenic shock, transcatheter edge-to-edge repair is associated with favorable 30-day and intermediate-term outcomes. Limitations, including the observational design of included studies and considerable heterogeneity, necessitate further research in this setting.
3. Coronary CT angiography alone versus with CT perfusion: a systematic review and meta-analysis assessing approaches for chest pain.
Across 3,587 patients, adding stress CTP to CCTA did not change MACE or mortality up to ~2 years but significantly reduced total ICA and ICA without revascularization, while enriching ICA with actionable lesions. This supports functional-anatomic CTA pathways to curb low-yield invasive testing.
Impact: The study offers outcome-oriented evidence that functional stress CTP adds value by reducing unnecessary invasive angiography without compromising safety, informing chest pain diagnostic pathways.
Clinical Implications: Chest pain pathways may integrate stress CTP after CCTA in intermediate-risk patients to lower low-yield ICA and focus revascularization on truly ischemic lesions, balancing resource use and patient safety.
Key Findings
- No significant differences in MACE (OR 1.19; p=0.21) or all-cause death (OR 0.41; p=0.17) between CCTA+CTP and CCTA alone at median 17 months.
- CCTA-alone pathways had higher total ICA (OR 2.42) and ICA without revascularization (OR 2.85).
- CCTA+CTP pathways had higher rate of ICA leading to revascularization (OR 0.39 indicating favoring CTP for actionable lesions).
Methodological Strengths
- Includes randomized and observational studies with prespecified primary/secondary outcomes.
- Consistent findings across primary and secondary analyses.
Limitations
- Heterogeneity in study designs and CTP protocols; limited number of RCTs.
- Potential referral and verification biases inherent to imaging pathways.
Future Directions: Head-to-head pragmatic RCTs comparing CCTA-first vs CCTA+CTP-first strategies with cost-effectiveness, patient-reported outcomes, and standardized revascularization criteria.
OBJECTIVES: To evaluate the prognostic value of stress Computed Tomography Perfusion (CTP) in patients with suspected or known coronary artery disease. MATERIALS AND METHODS: All studies evaluating patients with chest pain with CTP plus coronary computed tomography angiography (CCTA) alone or versus CCTA were included. The primary analysis included studies comparing CCTA plus CTP vs CCTA alone, while in the secondary analysis we analyzed the incidence of each outcome across all seven studies, two- and single-arm. RESULTS: Seven double- and single-arm studies were included (two randomized controlled trials and five observational ones) with 3587 patients (2101 evaluated with CTP plus CCTA and 1486 with CCTA alone).In the primary analysis including 4 studies, after a median follow-up of 17 months, the rates of MACEs (OR 1.19, 95% CI 0.91-1.57, p = 0.21) and all-cause death (OR 0.41, 0.11-1.47, p = 0.17) were similar. Patients managed according to CCTA alone had higher rates of total ICA (OR 2.42, 1.99-2.94, p < 0.00001) and ICA without subsequent revascularization (OR 2.85, 1.23-6.61, p = 0.01). Conversely, the rate of ICA with subsequent revascularization was higher in patients who underwent CCTA plus CTP (OR 0.39, 0.22-0.69, p = 0.001). There were no significant differences in terms of recurrent MI (OR 0.94, 0.15-5.83, p = 0.95) and unplanned revascularization (OR 0.69, 0.19-2.51, p = 0.57, all CI 95%) between the two approaches. These results were confirmed in the secondary analysis. CONCLUSION: A coronary imaging approach based on perfusion evaluation in addition to anatomic assessment was comparable to CCTA alone in terms of MACE, myocardial infarctions and unplanned revascularizations up to 2 years. Patients evaluated with CTP less frequently underwent ICA, which did, however, result in a higher rate of stent implantation. KEY POINTS: Question Does the addition of stress Computed Tomography Perfusion (CTP) to coronary computed tomography angiography (CCTA) improve the diagnostic and prognostic evaluation of patients with chest pain compared to CCTA alone? Findings Stress CTP combined with CCTA reduces unnecessary invasive coronary angiography and increases revascularization rates without significantly impacting MACE, myocardial infarction, or unplanned revascularization. Clinical relevance Incorporating stress CTP into CCTA optimizes care by reducing unnecessary invasive procedures and improving tailored treatment strategies for patients with stable and unstable chest pain.