Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial.

BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Drug-eluting balloon for treatment of in-stent restenosis after carotid artery stenting: preliminary report.

PURPOSE: To evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS). METHODS: Among 830 consecutive patients undergoing CAS between November 2001 and June 2012, significant ISR (>80% stenosis) occurred in 10 (1.2%) asymptomatic patients. Angioplasty with DEB treatment was performed in 7 patients (6 internal and 1 common carotid arteries) at a mean of 20.9 ± 19.4 months (median 12.1) after CAS. Intravascular ultrasound (IVUS)-guided predilation with distal cerebral protection was carried out with a cutting balloon followed by inflation of a DEB with a 1:1 stent-to-balloon size ratio. RESULTS: Technical/procedural success was achieved in all cases. Angiographic stenosis decreased from 83%± 5% to 18%± 6%. At IVUS evaluation, minimal lumen area increased from 3.19 ± 1.73 to 12.78 ± 1.97 mm(2) (p=0.0001), stent area was unchanged (from 17.36 ± 4.36 to 17.52 ± 4.34 mm(2), p=0.70), and the restenosis area decreased from 13.58 ± 5.27 to 4.71 ± 3.06 mm(2) (p=0.0005). At a mean follow-up of 13.7 ± 1.5 months (median 13.7), 1 patient had a minor stroke ipsilateral to the ISR vessel 2 months after DEB treatment; the stent was widely patent on duplex ultrasound and angiographic images. Overall, the average PSV decreased from 4.0 ± 1.0 to 0.9 ± 0.1 m/s (p=0.0001). At 6 and 12 months, PSVs after DEB treatment were significantly lower compared to those assessed at comparable intervals after CAS. CONCLUSION: The use of DEBs to treat ISR after CAS shows promising acute and midterm results.

Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study.

AIMS: The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.

Outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent in patients with chronic total occlusions: A multicenter registry.

BACKGROUND: We aimed to evaluate the mid-term outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), as compared with durable-polymer everolimus-eluting stents (EES). METHODS: We compiled a multicenter registry of patients undergoing CTO recanalization followed by BP-SES or EES implantation. The primary endpoint was the incidence of target-lesion failure (TLF, a composite of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization) at one year. Propensity score matching (PSM) was used to adjust for case mix. RESULTS: Overall, 413 patients were included (BP-SES n = 242, EES n = 171). PSM resulted in 131 matched pairs, which represented the subject of the main analysis. Antegrade wire escalation was the most successful crossing technique (66% vs. 63%, p = 0.98) in both the BP-SES and EES groups, respectively. Procedural success rates were similar between groups (BP-SES 96% vs. EES 93%, p = 0.24). At one-year follow-up, there were no differences in the primary endpoint of TLF (5.7% vs. 8.3%, p = 0.44), and in cardiac death (0.9% vs. 2.8%, p = 0.32), target-vessel myocardial infarction (0.9% vs 1.9%, p = 0.57), target-lesion revascularization (3.7% vs 3.7%, p = 0.99), or stent thrombosis (0.9% vs. 1.9%, p = 0.57), in BP-SES vs. EES, respectively. CONCLUSIONS: Patients undergoing CTO PCI with BP-SES suffer a low rate of TLF at one-year follow-up, which is similar to that of subjects treated with durable-polymer EES.

Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study.

OBJECTIVES: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). BACKGROUND: The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. METHODS: The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. RESULTS: Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint. CONCLUSIONS: The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

BACKGROUND: Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. METHODS AND RESULTS: We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). CONCLUSIONS: The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

Large coronary aneurysm complicated by acute myocardial infarction: combined intravascular ultrasound imaging and doppler flow assessment before and after PTFE-covered stent implantation.

Although most patients with coronary artery aneurysms are asymptomatic, manifestations of myocardial ischemia may occur. However, the role that a coronary aneurysm may play in impairing arterial flow of an otherwise normal coronary circulation is not completely known. A 64-year-old woman with previous anteroseptal myocardial infarction was found to have a large aneurysm of the proximal left anterior descending (LAD) coronary artery without angiographic evidence of atherosclerotic disease. IVUS evaluation revealed an 18 mm long and 12.2 x 10.8 mm wide aneurysm without atherosclerosis, thrombus or calcification. Pulsed wave Doppler showed significant reduction of LAD flow reserve, which normalized after successful obliteration of the aneurysm with polytetrafluoroethylene (PTFE)-covered stent implantation. Severe in-stent graft restenosis was found at 7-month angiographic and intravascular ultrasound follow-up, which was managed successfully with minimally invasive direct coronary bypass surgery. The patient did well, without symptoms over the following year.

Incidence of stent fractures and patency after femoropopliteal stenting with the nitinol self-expandable SMART stent: a single-center study.

OBJECTIVE: The aim of the study was to investigate long-term incidence of stent fractures and patency after femoropopliteal stenting. METHODS: Sixty consecutive patients (mean age 70 + or - 7 years) were treated with implantation of single (31 patients) or multiple (29 patients) self-expandable nitinol SMART stents (Cordis, Miami, Florida, USA; mean stent length 108.8 + or - 73 mm) between year 2000 and 2005. At a mean follow-up of 66 + or - 20 months, 37 patients (85% men, mean age 71 + or - 7 years) were alive and underwent plain radiograph and color-coded duplex sonography. A peak systolic velocity was measured proximally, intrastent and distally. RESULTS: Stent fractures were detected by radiograph in three of the 39 (7.7%) legs (mean stented segment 207 + or - 64 mm). In one case, a moderate strut fracture was associated with in-stent occlusive restenosis confirmed by angiography. Color-coded duplex sonography revealed a mean in-lesion peak systolic velocity of 73 + or - 35 cm/s, six (15%) in-stent restenoses and four (11%) total occlusions. Primary patency rate 5 years after nitinol SMART stent implantation was 74.6%. Patients symptomatic for claudication or presenting with diagnosis of in-stent restenosis underwent angiography. CONCLUSION: Long-term femoral SMART stenting showed minimal incidence of fractures compared with previously published data with different stent types. In-stent restenosis and occlusive restenosis seem to be correlated with stented segment length.

Sirolimus-eluting stent implantation for bare-metal in-stent restenosis: is there any evidence for a late catch-up phenomenon?

OBJECTIVES: In-stent restenosis occurs not infrequently after intracoronary implantation of bare-metal stents. Many techniques have been proposed for the treatment of in-stent restenosis, but drug-eluting stents seem to provide the best early and mid-term results. We aimed to appraise whether the effectiveness of drug-eluting stents for in-stent restenosis is maintained even in the long term. METHODS: Participants in this prospective multicenter study were patients with in-stent restenosis treated with sirolimus-eluting stents. The primary endpoint was freedom from major adverse cardiovascular events (i.e. death, nonfatal myocardial infarction, target vessel revascularization, or stent thrombosis) in the long term (> or =24 months), with 6-month angiography planned for all patients. RESULTS: A total of 271 consecutive patients were enrolled (332 sirolimus-eluting stents). Procedural success was obtained in all patients, with no case of in-hospital death, acute/subacute stent thrombosis, stroke, or urgent coronary bypass. Survival free from major cardiovascular events decreased progressively from 98.8% at 1 month, to 95.7, 83.7, 75.4, and 65.8% at 6, 12, 24, and 30 months, respectively. A similar attrition in freedom from repeat target vessel was found from 97.6% at 6 months to 76.7% at 30 months. A total of four possible and one definite stent thromboses (2.6%) were noted, all occurring several months after clopidogrel discontinuation and in patients on life-long aspirin. CONCLUSION: The present study supports the mid-term safety and effectiveness of sirolimus-eluting stents for the treatment of in-stent restenosis in comparison with the other available treatments. Whether the late catch-up phenomenon observed in repeat target revascularization and stent thrombosis is an incidental finding deserves further rigorous scrutiny.

Stent thrombosis after sirolimus- and paclitaxel-eluting stent implantation in daily clinical practice: analysis of a single center registry.

OBJECTIVES: To evaluate stent thrombosis (ST) rate after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice. BACKGROUND: The safety profile of drug-eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES. METHODS: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center. RESULTS: Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 +/- 0.8 stents per patient were implanted (stented segment length: 32 +/- 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six-month follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST-elevation or non-ST-elevation myocardial infarction (MI) through the 12-month follow-up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months. CONCLUSIONS: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials.

Synergy of passive coating and targeted drug delivery: the tacrolimus-eluting Janus CarboStent.

Stents represent a major step forward in the treatment of coronary artery disease since the introduction of balloon angioplasty. They have demonstrated the reduction of angiographic indexes of restenosis and rates of repeat revascularization. However, in-stent neointimal proliferation represents the persisting limitation and challenge. Local delivery using a stent platform for deposition of therapeutic drug concentration in the arterial wall has emerged as an effective strategy to reduce in-stent neointimal hyperplasia and restenosis. The purpose of this article is to describe the design characteristics of a new drug-eluting stent. Its unique features consist of integral Carbofilm thromboresistant coating combined with the capability to load the drug into and to release it from deep sculptures made on the external surface of the stent. The advantages of this design are the possibility to load higher amounts of drug, to selectively deliver it to the vessel wall without loss in the blood stream, and to improve the biocompatibility and thromboresistance of the stent. Preclinical studies, using tacrolimus as the biological agent, showed excellent vessel tissue response and mild inflammation scores. A significant reduction of intimal proliferation was observed in comparison with a control stent. The enrollment in a safety first-in-man evaluation has been successfully completed. A randomized, double-blind, multicenter study is expected to start at the completion of the "safety" evaluation.

Aspirin alone antiplatelet regimen after intracoronary placement of the Carbostent: the ANTARES study.

The effect of stent coatings in preventing early thrombotic occlusion remains to be proved. The purpose of this study was to evaluate the safety and efficacy of the Carbostent, a new coronary stent with a nonthrombogenic coating (Carbofilm), in 110 consecutive patients (73.6% men, mean age 61 +/- 9 years) who met prespecified clinical and angiographic inclusion criteria and were treated with aspirin monotherapy after stenting. Stable angina (75.5%), unstable angina (18.2%), and silent ischemia (6.3%) were clinical indications for coronary revascularization. Patients received 10,000 U of heparin and no IIb/IIIa inhibitors or postprocedural heparin. Complex lesion characteristics (B2, C) were present in 39 out of 129 (30.2%) lesions. Mean lesion length was 15.6 +/- 7.4 mm, and 32% of the lesions were >15 mm (range 16-52 mm). Small coronary vessels (<3.0 mm) were treated in 28% of the cases. A total of 165 Carbostent were used in 129 coronary lesions of the 110 patients. Single-vessel stenting was performed in 97 (88%) patients and multivessel stent placement in 13 (12%) patients. The mean length of the stented segment was 21 +/- 13 mm (range 9-95 mm). Procedural and clinical success was achieved in all patients. At 1-month follow-up, there were no stent thrombosis or other major adverse cardiac events. We observed 2 (1.8%) non-Q-wave myocardial infarctions and 2 (1.8%) vascular complications. This study indicates that the Carbostent may prevent stent thrombosis in selected patients treated with aspirin only. A randomized study comparing aspirin alone versus combined ticlopidine and aspirin after Carbostent implantation will be needed to confirm these results.