BACKGROUND: Small vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels. OBJECTIVE: We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. RESULTS: The study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74-1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93-5.00, p = 0.07. CONCLUSIONS: One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.
- Klíčová slova
- Anti-CD34, Dual therapy stent, Endothelial progenitor cell capture, Percutaneous coronary intervention, Small vessel coronary disease,
- MeSH
- koronární angioplastika * MeSH
- lidé MeSH
- nemoci koronárních tepen * MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- stenty * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
BACKGROUND: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.
- Klíčová slova
- Absorb, Bioresorbable scaffold, Coronary artery disease,
- MeSH
- balónková koronární angioplastika škodlivé účinky přístrojové vybavení mortalita MeSH
- časové faktory MeSH
- dospělí MeSH
- hodnocení rizik MeSH
- jednoduchá slepá metoda MeSH
- koronární restenóza diagnostické zobrazování etiologie mortalita prevence a kontrola MeSH
- kovy * MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- multicentrické studie jako téma MeSH
- nemoci koronárních tepen diagnostické zobrazování mortalita terapie MeSH
- ochranné faktory MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- senioři MeSH
- stenty * MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- kovy * MeSH
AIMS: To establish the relationship between renal insufficiency, bleeding and prescription of cardiovascular medication. METHODS AND RESULTS: This was a prospective, multi-center, cohort study of consecutive patients undergoing PCI during three NHLBI Dynamic Registry recruitment waves. Major and minor bleeding, access site bleeding and rates of prescription of cardiovascular medication at discharge were determined based on estimated glomerular filtration rate (eGFR). Renal insufficiency was an independent predictor of major adverse cardiovascular events (MACE). Bleeding events and access site bleeding requiring transfusion were significantly associated with degrees of renal insufficiency (p<0.001). There was an incremental decline in prescription of cardiovascular medication at discharge proportionate to the degree of renal impairment (aspirin, thienopyridine, statin, coumadin (overall p<0.001), beta blocker (overall p=0.003), ACE inhibitor (overall p=0.02). Bleeders were less likely to be discharged on a thienopyridine (95.4% versus 89.9% for bleeding, p<0.001 and 95.3% versus 87.9% for access site bleeding, p=0.005), but not aspirin (96.3% versus 96.2%, p=0.97 and 96.3% versus 93.6%, p=0.29 respectively). Failure to prescribe anti-platelet therapy at discharge was strongly associated with increased MACE at one year. CONCLUSIONS: Renal insufficiency is associated with bleeding in patients undergoing PCI. Patients with renal insufficiency are less likely to receive recommended discharge pharmacotherapy.
- Klíčová slova
- Antiplatelet, Cardiovascular medication, Percutaneous coronary intervention, Renal insufficiency,
- MeSH
- časové faktory MeSH
- dialýza ledvin MeSH
- hodnocení rizik MeSH
- hodnoty glomerulární filtrace MeSH
- infarkt myokardu komplikace diagnóza mortalita terapie MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- kardiovaskulární látky škodlivé účinky terapeutické užití MeSH
- koronární angioplastika škodlivé účinky mortalita MeSH
- krevní transfuze MeSH
- krvácení chemicky indukované etiologie mortalita terapie MeSH
- ledviny patofyziologie MeSH
- lékové předpisy MeSH
- lidé středního věku MeSH
- lidé MeSH
- National Heart, Lung, and Blood Institute (U.S.) * MeSH
- propuštění pacienta * MeSH
- prospektivní studie MeSH
- recidiva MeSH
- registrace MeSH
- renální insuficience komplikace mortalita patofyziologie terapie MeSH
- rizikové faktory MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
- Kanada MeSH
- Spojené státy americké MeSH
- Názvy látek
- inhibitory agregace trombocytů MeSH
- kardiovaskulární látky MeSH