Alessandro Aprile

Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome: the RIFLE STEACS Study

OBJECTIVES The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

Strut Coverage and Vessel Wall Response to a New-Generation Paclitaxel-Eluting Stent With an Ultrathin Biodegradable Abluminal Polymer Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI)

Background—Polymer-coated drug-eluting stents are effective in preventing restenosis but have been associated with delayed healing and incomplete strut coverage. It is unknown whether paclitaxel-eluting stents (PES) with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia. Using optical coherence tomography (OCT) as a primary imaging modality, we assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (<1 &mgr;m) biodegradable abluminal polymers. Methods and Results—In this pilot trial, 60 patients with de novo lesions (⩽25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberté PES or JACTAX PES, a Liberté stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 &mgr;g each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 &mgr;g each). OCT follow-up occurred at 6 months with clinical follow-up through 1 year. The primary end point was percent uncovered struts by OCT. An independent core laboratory blinded to stent assignment analyzed images. The 6-month rate of uncovered struts per patient was 5.3±14.7% for TAXUS Liberté, 7.0±12.2% for JACTAX HD, and 4.6±7.3% for JACTAX LD (P=0.81); percent malapposed struts was 1.4±4.4%, 0.8±1.9%, and 1.1±2.8%, respectively (P=0.86). Strut-level intimal thickness was 0.20±0.10, 0.22±0.15, and 0.24±0.15 mm (P=0.64); percent volume obstruction by OCT was 22.2±12.8, 22.5±16.2, and 25.8±15.2 (P=0.69). There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year. Conclusions—JACTAX PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with TAXUS Liberté. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.

Strut Coverage and Vessel Wall Response to a New-Generation Paclitaxel-Eluting Stent With an Ultrathin Biodegradable Abluminal Polymer

Background—Polymer-coated drug-eluting stents are effective in preventing restenosis but have been associated with delayed healing and incomplete strut coverage. It is unknown whether paclitaxel-eluting stents (PES) with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia. Using optical coherence tomography (OCT) as a primary imaging modality, we assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (<1 &mgr;m) biodegradable abluminal polymers. Methods and Results—In this pilot trial, 60 patients with de novo lesions (⩽25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberté PES or JACTAX PES, a Liberté stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 &mgr;g each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 &mgr;g each). OCT follow-up occurred at 6 months with clinical follow-up through 1 year. The primary end point was percent uncovered struts by OCT. An independent core laboratory blinded to stent assignment analyzed images. The 6-month rate of uncovered struts per patient was 5.3±14.7% for TAXUS Liberté, 7.0±12.2% for JACTAX HD, and 4.6±7.3% for JACTAX LD (P=0.81); percent malapposed struts was 1.4±4.4%, 0.8±1.9%, and 1.1±2.8%, respectively (P=0.86). Strut-level intimal thickness was 0.20±0.10, 0.22±0.15, and 0.24±0.15 mm (P=0.64); percent volume obstruction by OCT was 22.2±12.8, 22.5±16.2, and 25.8±15.2 (P=0.69). There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year. Conclusions—JACTAX PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with TAXUS Liberté. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.

Does optimal lesion preparation reduce the amount of acute recoil of the absorbe BVS? Insights from a real‐world population

To evaluate the acute recoil of the ABSORB bioabsorbable vascular scaffold (BVS) and its relationship with procedural characteristics in a real world population.

Pioneer re-entry device for iliac chronic total occlusion: truly a paradigm shift

The number of percutaneous revascularization procedures performed for symptomatic peripheral arterial disease has significantly increased over the past several years. Traditionally, the use of percutaneous techniques were limited to certain anatomic subsets, such as stenosis or focal occlusions, with surgical treatment preferred for more extensive disease. More recently, endovascular specialists are facing the challenge of peripheral chronic total occlusions. Furthermore, unlike the coronary circulation, these occlusions are often very long and associated with other features of complexity such as severe calcifications. One of the primary issues concerning these lesions is the ability to safely achieve initial angiographic success. This article focus indeed on the Pioneer catheter, a new lumen re‐entry device exploiting intravascular ultrasound imaging that was used in a case of totally occluded left common iliac artery with favorable results. The details of this technique, and how this catheter helped in re‐entering the true lumen at the aortic bifurcation after subintimal dissection, are thoroughly discussed.

Long-term outcomes in patients undergoing percutaneous coronary intervention with drug-eluting stents

Drug-eluting stents substantially reduce restenosis compared with bare-metal stents and represent a significant advance in percutaneous coronary interventions. Accordingly, drug-eluting stents have been rapidly adopted into practice and are currently used in the vast majority of complex percutaneous coronary procedures. However, in the last 2 years, concerns have been raised regarding their long-term safety, especially regarding the risk of late and very-late stent thrombosis. Delayed endothelial coverage after drug-eluting stent implantation is thought to prolong the window of vulnerability to stent thrombosis, which requires a prolonged dual antiplatelet therapy. Recent registry studies and meta-analyses seem to have provided reassuring results regarding the long-term rates of death and myocardial infarction associated with the use of drug-eluting stents compared with bare-metal stents. However, data are not consistent and concerns remain.