Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial

Gj, Vlachojannis; Pc, Smits; Sh, Hofma; Togni, Mario; Vázquez, Nicolás; Valdés, Manuel; Voudris,; Puricel, Serban; Slagboom, Ton; J, Goy; P, den Heijer; M, van der Ent

doi:10.4244/eijv11i3a53

Cited by 54 publications

(69 citation statements)

References 22 publications

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“…Although BES were developed to decrease late adverse events, long-term follow-up from COMPARE II (3 years) and NEXT (2 years) showed no advantage over EES [28,29]. A sub-study of STEMI patients enrolled in COMPARE II reports increased rates of target lesion revascularization at 3 year follow-up with BES compared to EES (BES: 5.1% vs. EES: 1.5%; HR (95% CI): 3.43 (1.01-11.58), p b 0.05) [30].…”

Section: Discussionmentioning

confidence: 97%

Comparison of endothelium-dependent and -independent vasomotor response after abluminal biodegradable polymer biolimus-eluting stent and persistent polymer everolimus-eluting stent implantation (COMPARE-IT)

Puricel

Kallinikou

Espinola

et al. 2016

International Journal of Cardiology

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Section: Discussionmentioning

confidence: 97%

Comparison of endothelium-dependent and -independent vasomotor response after abluminal biodegradable polymer biolimus-eluting stent and persistent polymer everolimus-eluting stent implantation (COMPARE-IT)

Puricel

Kallinikou

Espinola

et al. 2016

International Journal of Cardiology

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“…Newer-generation DESs maintain solid results regarding long-term safety. [16][17][18][19][20] Major reductions in bleeding rates were found when triple therapy with warfarin, aspirin, and clopidogrel was reduced to dual therapy with dabigatran and clopidogrel in patients with atrial fibrillation. 50 Heparin was effective as bivalirudin in STEMI patients treated with PCI.…”

Section: Discussionmentioning

confidence: 99%

“…These follow-up studies are summarized in Table 1. [16][17][18][19][20] The overall picture from these comparisons based on non-inferiority trials suggests that the 1 year and long-term outcomes with newer-generation DES is very good without notable differences between brands. In a DES vs. DES comparison with 1-year follow-up available, the sirolimus-eluting, thin-strut biodegradable-polymer Orsiro stent was evaluated in the BIOFLOW V study (N = 1334) and compared with the durable-polymer Xience stent.…”

Section: Devices Drug-eluting Stentsmentioning

confidence: 99%

The year in cardiology 2017: coronary interventions

Kristensen

Mæng

Capodanno

et al. 2018

European Heart Journal

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PreambleThe first balloon coronary angioplasty was performed in Zurich by Andreas Grüntzig in 1977. The patient, a 38-year-old man with severe angina and a tight stenosis on the left anterior descending artery, is still alive, is doing well, and he celebrated the 40-year anniversary of his percutaneous coronary interventions (PCI) in 2017 ( Figure 1). During the last decades, PCI techniques have undergone major improvements with the first real game changer being the introduction of bare metal stents, which made PCI safer and improved longer-term outcomes. Later on, drug-eluting stents (DESs) were introduced, which resulted in a major reduction in restenosis and also-with the newer generation DES-a low rate of stent thrombosis. Further, the introduction of intracoronary pressure measurements for assessment of severity of coronary stenoses [fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR)] and intracoronary imaging [intravascular ultrasound (IVUS) and optical coherence tomography (OCT)] for lesion assessment has refined lesion and procedure assessment. Improved outcomes were also fostered by development of better and safer adjunctive antithrombotic drugs and secondary prevention, optimizing drug-device synergy. Still, 40 years later the research in the coronary interventional field is very intense, and we aim here to summarize major developments in PCI published in 2017. Myocardial revascularization Percutaneous coronary intervention techniqueThe SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) II study investigated the impact of a contemporary PCI strategy on clinical outcomes of 454 patients with three-vessel disease. 1Characteristics of the SYNTAX II strategy that captures all components of today's 'best of PCI practice' are summarized in Figure 2. Following this approach systematically, the authors demonstrated major adverse cardiac and cerebrovascular events (MACCE) at 1 year to be much improved with respect to a matched historical PCI cohort from the SYNTAX I trial (10.6% vs. 17.4%; P = 0.006). The better result of the contemporary PCI strategy compared with the procedural technique followed at the time of the SYNTAX I trial was driven by a lower risk of myocardial infarction (MI) and revascularization, with a parallel reduction in stent thrombosis. Overall, the SYNTAX II study suggests that the combination of best practice components in PCI technique portends improved patient outcomes beyond what can be achieved by introducing one single new element. Because these results outperform PCI results obtained in the earlier SYNTAX I trial, the hypothesis was generated that a new randomized study of modern best PCI practice in patients with three-vessel disease might show non-inferiority vs. coronary artery bypass grafting (CABG). 1Glimpsing to the future, the feasibility and technical success of robotically-assisted PCI for complex coronary lesions were investigated in 334 procedures from 315 patients included in the Complex Robotically Assisted Percutaneous Coronary Intervention (...

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“…For only 6 of these trials, follow-up data between 2 and 5 years were available. 36,41,43,48,50,52 At longerterm follow-up, a significantly lower risk of stent thrombosis was observed with BP-DES compared with PP-DES (odds ratio, 0.43; 95% CI, 0.25-0.73; Figure 2A-2D). Although promising, this finding should be interpreted with caution.…”

Section: Bp-based Dessmentioning

confidence: 98%

Stent Polymers

Rizas

Mehilli

2016

Circ: Cardiovascular Interventions

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W ith drug-eluting stent (DES) platforms representing the concept of combined mechanical stenosis repair and localized drug delivery, percutaneous coronary intervention became a pharmacomechanical therapy option for coronary artery disease. The concept of drug coating of metallic scaffolds is ≈20 years old and started with the aim to increase the hemocompatibility of metallic scaffolds. 1 In the era when plain balloon angioplasty was the default percutaneous coronary intervention option and the incidence of acute ischemic events was at double-digit levels, heparin-coated stents have been shown effective in reducing stent thrombosis without any measurable effect on neointimal formation.1,2 Development of heparin-coated stent platforms revealed the difficulties of producing a stable system able to deliver the needed amount of the active drug without compromising its chemical sequence. Different from physical adsorption and ionic binding techniques, copolymerization of heparin with a variety of polymers provided stable heparin binding on the stent surface. This experience, among others, explained later in this review, served as a prerequisite for development of various DES platforms, which have revolutionized the percutaneous coronary intervention field. Advantages With Nonbiodegradable PolymersSuccess of DES platforms in reduction of neointimal hyperplasia depends on the amount and kinetics of drug released. The experience with various formulations of polymer-free paclitaxel-eluting stents 4,5 or polymer-free sirolimus-eluting stents (SESs) 6 loaded with different increasing drug amounts demonstrated the importance of the drug amount for effective inhibition of neointima proliferation at an acceptable safety profile. The amount of drug loading through direct drug adsorption on the metallic surface is limited. Furthermore, most of the drugs are not able to adhere appropriately on the stent surface to insure controlled release. Therefore, polymer coating has become a key component of different DES platforms. Various permanent (biostable) and biodegradable polymers (BPs) have been used on DES platforms (Table 1). [7][8][9][10][11][12] Polymers selected to be used as a drug carrier should share following features: be biocompatible; do not interact with the active drug; provide a platform for appropriate drug-eluting kinetics; behave biologically inert after the drug has been completely eluted, and be mechanically stable at long-term in the dynamics of coronary circulation milieu.Poly-(n)-butyl methacrylate, an inert synthetic polymer, has been used as a drug carrier on the first-generation SES, Cypher stent (Cordis, Johnson & Johnson, Miami Lakes, FL). The complex drug-polymer matrix on the Cypher stent (Table 2) allows a slow sirolimus release resulting in elution of 80% of drug within the first 30 days after DES implantation.3 In contrast to this, the drug-polymer system of the paclitaxel-eluting stent, Taxus stent (Boston Scientific Corp, Natick, MA), based on a single layer of Translute (Table 1) polymer allows th...

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Abstract: At three-year follow-up, MACE as well as safety and efficacy measures including stent thrombosis were not statistically different between the biodegradable polymer-coated BES and the durable polymer-coated EES. ClinicalTrials.gov Identifier: NCT01233453.

Cited by 54 publications

References 22 publications

Comparison of endothelium-dependent and -independent vasomotor response after abluminal biodegradable polymer biolimus-eluting stent and persistent polymer everolimus-eluting stent implantation (COMPARE-IT)

Comparison of endothelium-dependent and -independent vasomotor response after abluminal biodegradable polymer biolimus-eluting stent and persistent polymer everolimus-eluting stent implantation (COMPARE-IT)

The year in cardiology 2017: coronary interventions

Stent Polymers

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