Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon.

OBJECTIVES: The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR. METHODS: Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 µg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 µg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups. CONCLUSIONS: This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).

Cerebrovascular accidents after percutaneous coronary interventions from 2002 to 2014: Incidence, outcomes, and associated variables.

BACKGROUND: Cerebrovascular accident (CVA) and transient ischemic attack (TIA) related to percutaneous coronary intervention (PCI) are relatively rare complications, but they are associated with high morbidity and mortality. Given the evolution of both CVA risk and PCI techniques over time, this study was conducted to evaluate trends in CVA and TIA associated with PCI and to identify variables associated with neurologic events. METHODS: Consecutive patients undergoing PCI at the Washington Hospital Center between January 2002 and June 2015 were included. Prespecified data were prospectively collected, including baseline and procedural characteristics, in-hospital outcomes, and 1-year mortality. The subjects who had a CVA or TIA during or immediately after PCI were compared with those without procedure-associated CVA or TIA. RESULTS: Overall, 25,626 patients were included in the study. The mean age was 65.0 ± 12.4 years, 16,949 (65.2%) were male, and 7,436 (28.6%) were African American. From 2002 to 2015, 110 neurologic events post-PCI were diagnosed (0.43%); this included 86 CVAs (0.34%) and 24 TIAs (0.09%). The annual rate of postprocedural neurologic events was 0.42% ± 0.12%. There were significant changes in baseline risk factors over time, with increasing age, incidence of insulin-dependent diabetes, and chronic kidney disease. Patients with neurologic events were more often African American (43.6% vs 28.6%, P < .001) with prior history of CVA (24.5% vs 7.8%, P < .001), chronic renal insufficiency (26.6% vs 15.2%, P < .001), and insulin-dependent diabetes (19.1% vs 12.4%, P = .03). Acute myocardial infarction (56% vs 30.4%, P < .001) and cardiogenic shock (20.2% vs 3%, P < .001) were also more common among patients with neurologic events post-PCI. After multivariable adjustment, use of an intraaortic balloon pump was strongly associated with neurologic events (odds ratio [OR] 4.9, 95% CI 2.7-8.8, P < .001), as was prior CVA (OR 2.4, 95% CI 1.4-4.4, P = .002) and African American race (OR 2.4, 95% CI 1.5-3.9, P < .001); there was a borderline association with the use of a thrombus extraction device (OR 1.7, 95% CI 0.9-3.2, P = .09). In-hospital mortality (20.0% vs 1.5%, P < .001) and 1-year mortality (45.0% vs 7.3%, P < .001) were also much higher in patients with neurologic events. CONCLUSION: Neurologic events post-PCI are associated with markedly worse in-hospital outcomes. The incidence of CVA and TIA post-PCI, however, remained stable over the last 12 years despite an increase in risk factors for CVA.

The effect of complete percutaneous revascularisation with and without intravascular ultrasound guidance in the drugeluting stent era.

AIMS: Our aim was to compare the outcomes of complete revascularisation (CR) and incomplete revascularisation (IR) in multivessel coronary artery disease (CAD), with and without intravascular ultrasound (IVUS) guidance, in the drug-eluting stent (DES) era. METHODS AND RESULTS: Overall, 2,132 consecutive patients with multivessel CAD, defined as at least two epicardial vessels with >70% stenosis, had at least one DES implant. Chronic total occlusions were not analysed. Successful treatment of epicardial vessels and significant branches was termed CR; otherwise, treatment was defined as IR. CR and IR were further categorised according to the use of IVUS. The primary outcome was death or Q-wave myocardial infarction (QWMI). Secondary outcomes included the rates of non-QWMI and repeat revascularisation, the latter assessed as either target vessel revascularisation (TVR) or target lesion revascularisation (TLR) at one year. CR was associated with lower rates of death/QWMI (HR 0.66 [0.4-0.9]; p=0.048) and non-QWMI at one year (1.1% vs. 2.6%; p=0.017). Completeness of revascularisation was not independently associated with repeat intervention, but rates of both TVR (89% vs. 93%; p<0.001) and TLR (91% vs. 95%; p<0.001) were higher with CR than IR. IVUS decreased the rates of TLR irrespective of completeness of revascularisation (p-interaction=0.75). CONCLUSIONS: CR in selected patients gives better outcomes than IR in multivessel CAD at one year. IVUS guidance can further improve results by reducing rates of repeat intervention irrespective of completeness of revascularisation.

Clinical presentation and outcomes of coronary in-stent restenosis across 3-stent generations.

BACKGROUND: Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first- and second-generation drug-eluting stents (DESs) remains under-reported. METHODS AND RESULTS: The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction (MI) and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78-5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60-4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12-1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84-8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01-3.87; P=0.046). CONCLUSIONS: ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized.

Current application and bioavailability of drug-eluting stents.

INTRODUCTION: Drug-eluting stents (DES) were developed to reduce the restenosis rate of bare metal stents (BMS) and comprises three main components: i) a metallic scaffold; ii) an antiproliferative drug to reduce or abolish the formation of the neointima; and iii) the polymer, which both enables and controls drug elution into the vessel wall. Over the years, growing evidence has been reported on the safety and efficacy for different indications of DES. AREAS COVERED: Since the introduction of first-generation DES, the technology has been refined, including changes in the alloy, stent design, polymer, drug and drug dose. In 2014, we will usher in a third generation of DES, which will include biodegradable polymers, polymer-free DES and bioabsorbable scaffolds. EXPERT OPINION: In recent years, considerable progress has been made in DES development. The BMS platform set the groundwork for the development of metal scaffolds with drug-eluting capability to prevent restenosis. Importantly, extensive research has shown long-term safety and efficacy of the newer generation DES. Available data suggest that DES can be safely and effectively used to treat a complex subset of patients and lesions, including patients presenting with acute myocardial infarction, lesions in saphenous vein grafts, chronic total occlusions, multivessel disease, small vessels, long lesions and bifurcations. One of the safety targets is to eliminate stent thrombosis.