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Clinical Data

Solutions backed by decades of data

Nothing speaks louder than data

Whether you’re evaluating a new treatment, product, or technique, nothing speaks louder than clinical data. Every offering in our Percutaneous Coronary Interventions (PCI) portfolio represents a body of research spanning four decades. No matter what you need, our portfolio delivers the safety, efficacy, and performance you demand- backed by data you can trust.


The importance of IVUS and physiology-guided procedures

In a recent study intravascular ultrasound (IVUS) use changed the procedure 74% of the time. Utilizing IVUS can help optimize your approach and lead to better outcomes. IVUS-guidance led to the use of larger stents or balloons, more post-dilation, additional stenting, or higher pressures in patients- resulting in lower rates of Stent Thrombosis (ST), Myocardial Infarction (MI) and Target Lesion Revascularization (TLR).¹

IVUS use changed the procedure 74% of the time.

1. Maehara A. ADAPT-DES IVUS Substudy: Utility of IVUS in Delineating the Mechanism of and Preventing Stent Thrombosis. Cardiovascular Research Foundation/Columbia University Medical Center, NY.


Physiology assessment

Through SYNTAX II and other related research, we know that comprehensive assessment of functional patient information can inform treatment decisions and preparation and provide clinical value post-PCI. This includes FFR and IFR, which is essential in PCI vs CABG treatment decisions.

46% reduction of the three-vessel ischemic disease diagnosis compared to when no physiology was used.

1. The SYNTAX II Trial studied the SYNERGY Bioabsorbable Polymer Stent in patients with either CTO or three vessel disease. The SYNTAX I trial studied the TAXUS Express2 drug eluting stent in patients with either Left Main or three vessel disease. Banning, Adrian, MBBS, MD. Clinical outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 5-year results of the SYNTAX II study. ESC Congress 2021.


Lesion preparation

Studies confirm the importance of tailoring strategies for managing coronary artery disease (CAD). Effective interventions require thorough assessment and tailored lesion modification strategies. Real-world evidence shows that different tools and techniques produce different outcomes. Compare head-to-head results: rotational vs. orbital, cutting balloon vs. POBA, and more.

Treat the vessel

Drug coated balloons demonstrate superior outcomes in ISR patients

AGENT IDE is a prospective, multicenter, randomized controlled trial in the United States designed to evaluate the safety and effectiveness of the AGENT™ Drug-Coated Balloon (DCB) compared to balloon angioplasty in patients with in-stent restenosis (ISR).1  At one year, AGENT DCB demonstrated statistically lower event rates.1

AGENT DCB showed statistically superior outcomes compared to balloon angioplasty for TLF at 1 year (17.9% versus 28.6% P= 0.003).

TLF relative risk reduction from using AGENT DCB was approximately 41%.

Chart

Consistently low ST rates even in complex cases

Permanent polymer stents are linked with a continuous accrual of events. Unlike permanent polymer drug-eluting stent (DES) technology, SYNERGY Stent’s Bioabsorbable Polymer (BP) is gone shortly after the drug is completely eluted. In studies of more than 35,000 patients, SYNERGY BP Stent provided outstanding safety and consistently low ST rates across various patient and lesion complexities.

Kang Network Meta-Analysis

SYNERGY BP Stent ranked #1 for the lowest relative risk of def/prob ST at 1-year.2

Kang Network Meta-Analysis

SCAAR Registry

Lowest ST rate compared to newer generation DES (n-DES) despite use in patients with statistically more Class b2/C lesions, diabetes, prior PCI and 3VD.3

SCAAR Registry

 

1. Yeh RW, Bachinsky W, Stoler R, et al. Rationale and design of a randomized study comparing the AGENT drug-coated balloon to plain old balloon angioplasty in patients with in-stent restenosis. Am Heart J. 2021;241:101–107.

2. Kang S et al. J Am Coll Cardiol. Intv.doi:10.1016/j.jcin.2016.03.038.

3. Sarno G et al. Cathet. Cardiovasc. Intervent.. doi:10.1002/ccd.27030.


SYNTAX II: The Path to Modern PCI

The SYNTAX II Clinical Trial1 is a landmark study that explores the impact of systematically doing the best possible PCI. This includes gathering and assessing more patient information, adopting state-of-the-art techniques, and integrating proven best practices. SYNTAX II, supported by an ecosystem of clinical evidence, provides a blueprint for a holistic, individualized approach to PCI that can lead to significant reductions in negative clinical endpoints and improvements in procedure outcomes. The main takeaway? PCI patients can experience excellent, CABG-like outcomes out to five years and beyond.

87%
34% increase in CTO success from SYNTAX I

1. The SYNTAX II Trial studied the SYNERGY Bioabsorbable Polymer Stent in patients with either CTO or three vessel disease. The SYNTAX I trial studied the TAXUS Express2 drug eluting stent in patients with either Left Main or three vessel disease. Banning, Adrian, MBBS, MD. Clinical outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 5-year results of the SYNTAX II study. ESC Congress 2021.


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