Ajay Kirtane, MD on the US’ “embarrassing” delay in approving drug-coated balloons to treat coronary in-stent restenosis

Surgeries & Interventions

Promising Drug-Coated Balloon Results for In-Stent Restenosis

The United States has been way behind other nations in using drug-coated balloons (DCB) to treat coronary in-stent restenosis (ISR), but that might change soon thanks to the results from the AGENT IDE Trial. 

• Although drug-eluting stents have been used for years, a significant number of stents still experience reblockage, and US clinicians have been limited to less-effective ISR treatments like repeat balloon angioplasty.
• Boston Scientific’s AGENT DCB is a paclitaxel-coated balloon catheter, designed to re-open ISR vessels and then transfer the drug to the vessel wall to help prevent ISR reoccurrence.
• AGENT DCB already has regulatory approval in Europe and Japan, and has been used to treat 100k global patients, but it hasn’t gained FDA approval (yet).

A packed TCT 2023 assembly hall greeted the AGENT IDE Trial results with applause, after showing perhaps the strongest evidence yet that DCBs are safe, effective, and superior to balloon angioplasty. 

The study included 480 patients with ISR from 40 sites (44% w/ multiple stent layers, 51% diabetic), and showed that after one year Boston Scientific’s AGENT DCB was far superior to balloon angioplasty for…

• Target lesion failure (17.9% vs. 28.7%, the primary endpoint)
• Target lesion revascularization (12.4% vs. 24.0%) 
• Target vessel myocardial infarction (6.4% vs 12.3%)
• Stent thrombosis (0.0% vs. 3.9%)

Those results were enough for the study presenter, discussion participants, and online commenters to widely support AGENT DCB as a primary option for ISR in the US.

Although some questioned why AGENT DCB wasn’t compared against drug-eluting stents, the study authors decided against adding a third or fourth stent to these patients, and believed AGENT DCB would show similar advantages versus an additional DES.

The Takeaway

Based on reactions from the TCT audience and social media, it seems like these were the results that interventional cardiologists have been hoping for (and largely expecting), suggesting that AGENT DCB should become a go-to ISR treatment in the US once it gains FDA approval.

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The Wire

• Sapien 3 & Surgery Similar at 5 Years: A standing room only TCT crowd assembled to witness five-year outcomes data from the PARTNER 3 trial, which ended up showing relatively similar results for Edwards Lifesciences’ Sapien 3 TAVR valve and surgical aortic-valve replacement. In the randomized study of 1k low risk patients with severe aortic stenosis, a primary event (death, stroke or valve-related rehospitalization) occurred in 22.8% of the TAVR group versus 27.2% for SAVR (P=0.07), while the bioprosthetic-valve failure rate was 3.3% for TAVR and 3.8% for surgery.

• EVOLUT TAVR Beats Surgery at 4 Years: That same crowd heard a slightly different story from the Evolute Low Risk trial, which showed that Medtronic’s Evolut TAVR system was largely superior to SAVR after four years. Among 1,403 randomized low-risk patients, TAVR had a lower rate of all-cause mortality or stroke (10.7% vs. 14.1%, the primary endpoint), including lower rates of all-cause mortality (9% vs. 12.1%) and disabling stroke (2.9% vs. 3.8%) individually. These two TAVR trials aren’t intended to be compared, but many attendees compared them anyway.

• Vektor vMap’s CPT III Code: Vektor Medical took a major step towards landing reimbursements after the AMA CPT Editorial Panel approved a new Category III CPT code for Vektor’s vMap arrhythmia analysis and mapping system. The FDA-cleared, AI-based vMap solution supports EP procedures by mapping arrhythmias using patients’ 12-lead ECG data. CPT III codes are intended to help collect clinical data for emerging technologies / procedures to support future coverage and regulatory decisions, and although they don’t have RVUs, they do allow payors to grant reimbursements.

• Real-World Data Bolster iFR: Philips released real-world outcomes data at TCT 2023, showing that its instant-wave free ratio (iFR) technology is on par with fractional flow reserve (FFR) for guiding PCI. In the study of 42k PCI patients from the Swedeheart Quality Registry, after adjusting for confounding effects, the five-year rate of MACE was 32.2% for iFR and 31.3% for FFR (P=0.65). On an individual level, MACE types (death, heart attack, new revascularization) had similar event rates. 

• Inflammatory Markers Pinpoint T1D CAD Risk: Chronic low-grade inflammation, spurred by uncontrolled hyperglycemia, remains a key driver of coronary artery disease in type-1 diabetes patients. Researchers examined 22 inflammatory markers in serum samples from 1,222 subjects, finding that T1D patients with CAD had higher levels of sTNFRI, sTNFRII, and IGFBP6 (aOR: 2.18, 1.52, and 3.62). A composite risk score derived from these markers successfully categorized CAD patients into distinct risk tiers, highlighting how serum markers may help guide anti-inflammatory treatments for T1D patients.

• TeraRecon’s Cardiology Update: TeraRecon announced expansions to its cardiovascular solutions portfolio at TCT 2023. The company placed particular emphasis on its new Cardiology Suite, which combines Us2.ai’s echo AI solution and Coreline Soft’s chest CT tool within its Eureka Clinical AI platform. TeraRecon also added new cardiovascular functionality to its Intuition advanced visualization platform, including a dedicated Left Atrial Appendage (LAA) workflow and updated Transcatheter Mitral Valve Repair (TMVR) workflow, while announcing a partnership to offer FEops’ HEARTguide Digital Twin solution for LAA closure procedures.

• Esprit BTK Gives Hope for CLTI: Patients battling chronic limb-threatening ischemia (CLTI) have new reason for optimism, after a TCT 2023 study highlighted the safety and efficacy of Abbott’s Esprit BTK drug-eluting resorbable scaffold. One-year results from the LIFE-BTK trial (n = 261) revealed that Esprit BTK patients had significantly greater freedom from primary events than balloon angioplasty (74.5% vs 43.7%), which included amputation, target vessel occlusion, target lesion revascularization, and target lesion binary restenosis. Esprit BTK was also superior to balloon angioplasty for reducing vessel re-narrowing and sustaining vessel openness (25.8% & 14.2% improvements).

• Ventric Health’s HF 510(k): Ventric Health announced the FDA 510(k) clearance of its Vivio System, a mobile device that allows clinicians to non-invasively diagnose heart failure in the clinic and patient homes. The Vivio System uses advanced algorithms to non-invasively detect elevated left ventricular end-diastolic pressure in under five minutes, then provides clinicians with real time results to support their HF diagnosis.

• GLP-1’s Severe GI Implications: A study out of the University of British Columbia dampened the GLP-1 craze, adding more evidence that patients taking the medications are at an increased risk for severe gastrointestinal problems. In a cohort study that included 4,144 liraglutide and 613 semaglutide users (two main GLP-1 agonists), both drugs had a higher likelihood of causing stomach paralysis, pancreatitis, and bowel obstruction than patients using bupropion-naltrexone, a non-GLP-1 weight loss medication.

• GE & Boston Scientific Integrate: GE HealthCare announced that Boston Scientific’s AVVIGO+ Multi-Modality Guidance System will be the first third-party application controllable through the GE Allia interventional angiography platform’s INTERACT Touch interface. INTERACT Touch allows clinicians using the Allia platform to control up to three different third party devices through one single touch panel without breaking the sterile environment. The AVVIGO+ is Boston Scientific’s next-generation intravascular ultrasound and fractional flow reserve system intended for use during PCI procedures. 

• Elixir’s DESyne BDS Plus Results: Elixir Medical announced positive six-month RTC data evaluating its DESyne BDS Plus, a triple drug-eluting coronary implant with site-specific antithrombotic drug delivery. Patients who received the DESyne BDS Plus had far lower rates of target lesion failure than those who received a traditional polymer drug-eluting stent, both at day three or discharge (0.0% vs. 5%, the primary endpoint) and at six months (1% vs. 8.2%). DESyne BDS Plus patients also had lower target-vessel MI rates at six months (0% vs. 6.3%) and similar in-device late lumen loss (0.14±0.05 mm vs. 0.09±0.05 mm).

The First Step to Coronary Artery Disease Diagnosis

HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.

Reducing ECG Background Noise

Monebo’s Kinitec Rhythms ECG Algorithm separates true ECG signals from background noise, leading to more accurate diagnoses and improved operator efficiency. See for yourself how the algorithm measured up to a gold standard.

The Resource Wire

• There’s plenty of short term benefits to cardiology data analytics, but it’s just as important for providers to make sure they’re ready for the future of cardiology analytics. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, examines what technology leaders can do today to facilitate their future advancements in cardiovascular data and analytics. 

• The University College London National Amyloidosis Centre is the world’s largest cardiac amyloidosis care provider, making their echo assessments both crucial and high-labor. See how UCL researchers used Us2.ai’s AI echo software to accurately analyze echos from 1,200 patients with ATTR Amyloidosis in 24 hours, without requiring human interaction.

• For years, world-renowned prevention expert Dr. Arthur Agatston, author of The South Beach Diet and developer of the “Agatston Score,” had been looking for technology that could accurately identify all types of plaque in the heart. Then, he was introduced to Cleerly. Hear from Dr. Agatston on why he believes “Cleerly really is the holy grail of prevention.”

• Ready to enhance your cardiovascular CT services with automated CT-FFR integration? Tune-in to Keya Medical and Precision Image Analysis’s SCCT webinar and learn from industry experts how to solve the challenges of scaling CT-FFR services and overcome the complexity of CT-FFR implementation.