Rajesh Dave

Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery Twelve-Month Results From the RESILIENT Randomized Trial

Background—Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results—A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions—In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal ArteryClinical Perspective

Background—Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results—A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions—In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

Nitinol Stent Implantation vs. Balloon Angioplasty for Lesions in the Superficial Femoral and Proximal Popliteal Arteries of Patients With Claudication: Three-Year Follow-up From the RESILIENT Randomized Trial:

Purpose To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. Methods Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. Results The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. Conclusion In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients.

Previously, the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE) randomized trial showed that carotid artery stenting (CAS) was not inferior to carotid endarterectomy (CEA) in the treatment of high‐surgical risk patients.

Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: The USpella Registry

Objectives: We report on the real‐world, multicenter experience of the Impella 2.5 circulatory support system during high‐risk PCI, a subset of the larger USpella Registry. Background: Standard of care for most patients with compromised ventricular function with multivessel or high‐risk coronary lesions has been coronary artery bypass grafting. In poor operative candidates, high‐risk PCI is increasingly considered, despite an increased risk for periprocedural hemodynamic compromise. Methods: 175 consecutive patients who underwent high‐risk PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related to the device and patient outcomes, including survival at 12 months. Results: Overall angiographic revascularization was successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of the mean SYNTAX score post‐PCI from 36 ± 15 to 18 ± 15 (P < 0.0001) and an improvement of the ejection fraction (from 31 ± 15% to 36 ± 14%, P < 0.0001). In 51% of patients, the functional status improved by one or more NYHA class (P < 0.001). At 30‐day follow‐up, the rate of MACE was 8%, and survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Conclusions: The use of Impella 2.5 in high‐risk PCI appeared feasible and safe in the real‐world setting. The utilization of the Impella 2.5 was successful, resulting in favorable short‐ and midterm angiographic, procedural and clinical outcomes.

Excimer Laser Recanalization of Femoropopliteal Lesions and 1-Year Patency: Results of the CELLO Registry

Purpose: To evaluate the safety and efficacy of a modified laser catheter designed for the endovascular treatment of peripheral artery disease (PAD) affecting the superficial femoral artery (SFA) and proximal popliteal artery. Methods: The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) study was a single-arm, prospective registry conducted at 17 investigational sites in the United States. The primary endpoint was the reduction in index lesion percent diameter stenosis (% DS) measured by Doppler ultrasound following laser ablation prior to any adjunctive therapy. The primary safety endpoint was major adverse events at 6 months. Sixty-five patients (39 men; mean age 68.3±10.1 years) with intermittent claudication, stenotic lesions >70% by visual assessment, a reference vessel diameter ≥4.0 and ≤7.0 mm, and a total lesion length ≥1.0 and ≤15.0 cm underwent laser-assisted recanalization with optional balloon angioplasty (BA) or BA + stenting. Sixty-five de novo lesions (5.6±4.7 cm) in 13 occluded and 52 stenotic arteries were treated. Results: Laser ablation reduced the % DS from 77%±15% at baseline to 34.7%±17.8%, which was reduced to 21%±14.5% after adjunctive therapy with BA (n=42, 64.6%) or BA + stenting (n=15, 23.3%). Eight (12.3%) patients did not receive post laser adjunctive therapy. Patency rates (% DS <50%) were 59% and 54% at 6 and 12 months, respectively. Target lesion revascularization was not required in 76.9% of CELLO participants within the 1-year follow-up. There were no major adverse events. The study cohort demonstrated a statistically significant improvement in the walking impairment and functional status assessments during follow-up. Conclusion: The data validate the safety and efficacy of the investigational device, with a high clinical success rate and 12-month data indicating freedom from reintervention in the majority of patients treated.

Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction

BACKGROUND Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies. DESIGN INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding. SUMMARY INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.

Carotid artery revascularisation in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ: 3-year results from the CABERNET trial

Aims: To investigate long-term outcomes achieved in high-surgical-risk patients and other clinically-relevant subgroups after carotid stenting with the NexStent and Filterwire EX/EZ devices. Methods and results: CABERNET, a prospective, multicentre, single-arm trial, enrolled 454 patients with extracranial internal carotid artery stenosis (symptomatic ≥50%, n=110; asymptomatic >60%, n=344). Early outcomes at one year have been reported. The 3-year Kaplan-Meier estimated event rates were: 7.2%, all stroke; 2.8%, major stroke; 4.8%, ipsilateral stroke; 17.7%, all death; 7.1%, myocardial infarction; 4.4%, target vessel revascularisation. Asymptomatic patients had significantly fewer major strokes than symptomatic patients (1.9% vs. 5.7%, P=0.03) and patients <80 years had significantly fewer ipsilateral strokes than those ≥80 years (3.2% vs. 10.7%, P=0.002). Stroke outcomes did not differ significantly between patients with anatomical risk factors compared with those with comorbid medical risk factors. Conclusions: Long-term outcomes achieved in high-surgical-risk patients with the NexStent and Filterwire EX/EZ devices are favourable. Outcomes may be better in asymptomatic patients or those younger than 80 years of age. These data will be helpful in estimating short-term risks of carotid stenting and balancing these risks against the long-term benefit of stroke prevention.

Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery

Background—Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results—A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions—In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.