Lower Rate Of Target Lesion Revascularization Research Articles

Safety and efficacy of second-generation drug-eluting stents compared with bare-metal stents: An updated meta-analysis and regression of 9 randomized clinical trials.

The efficacy of second-generation drug-eluting stents (DES; eg, everolimus and zotarolimus) compared with bare-metal stents (BMS) in patients undergoing percutaneous coronary intervention was challenged recently by new evidence from large clinical trials. Thus, we aimed to conduct an updated systematic review and meta-analysis of randomized clinical trials (RCTs) evaluating the efficacy and safety of second-generation DES compared with BMS. Electronic databases were systematically searched for all RCTs comparing second-generation DES with BMS and reporting clinical outcomes. The primary efficacy outcome was major adverse cardiac events (MACE); the primary safety outcome was definite stent thrombosis. The DerSimonian and Laird method was used for estimation of summary risk ratios (RR). A total of 9 trials involving 17 682 patients were included in the final analysis. Compared with BMS, second-generation DES were associated with decreased incidence of MACE (RR: 0.78, 95% confidence interval [CI]: 0.69-0.88), driven by the decreased incidence of myocardial infarction (MI) (RR: 0.67, 95% CI: 0.48-0.95), target-lesion revascularization (RR: 0.47, 95% CI: 0.42-0.53), definite stent thrombosis (RR: 0.57, 95% CI: 0.41-0.78), and definite/probable stent thrombosis (RR: 0.54, 95% CI: 0.38-0.80). The incidence of all-cause mortality was similar between groups (RR: 0.94, 95% CI: 0.79-1.10). Meta-regression showed lower incidences of MI with DES implantation in elderly and diabetic patients (P = 0.026 and P < 0.0001, respectively). Compared with BMS, second-generation DES appear to be associated with a lower incidence of MACE, mainly driven by lower rates of target-lesion revascularization, MI, and stent thrombosis. However, all-cause mortality appears similar between groups.

Drug-delivering endovascular treatment versus angioplasty in artery occlusion diseases: a systematic review and meta-analysis

Objective: The best management of patients with femoropopliteal and infrapopliteal artery occlusion disease is not clear. This study aimed to compare the efficacy of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal or infrapopliteal arterial occlusive disease.Methods: Medline, Cochrane, Embase, and Google Scholar databases were searched for randomized controlled trials from 1 January 2000 until 30 June 2016.Results: Compared with PTA, significant benefits in favor of DCB and DES were found for target lesion revascularization (TLR) (OR = 0.38, 95% CI = 0.22 to 0.66, p = .001 for DCB; OR = 0.51, 95% CI = 0.32 to 0.81, p < .001 for DES). Primary patency rate was greater with DCB (p = .001) and DES (p < .001) than PTA. Compared with PTA, a significant reduction in mortality was observed in the DCB group (p = .039) but not in the DES group. Subgroup analysis found a lower rate of TLR and a higher rate of primary patency in the active group (DCB and DES) compared with the control group (PTA) in patients with femoropopliteal arterial occlusion (p ≤ .016) but not in patients with infrapopliteal arterial occlusion (p ≥ .063). Mortality was similar between active replacement and control groups both in the femoropopliteal arterial occlusion and the infrapopliteal arterial occlusion subgroups (all p > .05).Conclusions: Significantly better TLR and primary patency rate were found in the drug-delivering endovascular treatments compared with the PTA group for patients with femoropopliteal arterial occlusion but not for patients with infrapopliteal arterial occlusion.

Clinical outcomes following bifurcation double-stenting with bioresorbable scaffolds.

To investigate outcomes following bifurcation double-stenting utilizing a bioresorbable scaffold (BRS) in the main branch (MB) and either a BRS or metallic drug-eluting stent (DES) in the side branch (SB). Data on outcomes of bifurcation lesions treated with BRSs, especially with double-stenting, are currently lacking. Data were examined from 42 de novo bifurcation lesions (41 patients) treated with double-stenting utilizing Absorb BRS in MB and BRS/DES in SB. Clinical outcomes including cardiac death, follow-up myocardial infarction, target lesion revascularization (TLR), and definite scaffold/stent thrombosis (ST) were investigated. The majority of target lesions were left anterior descending artery (LAD) bifurcations, and intravascular imaging was used in the majority of cases (92.9%). In SBs, BRSs were utilized in 19 lesions (19 patients) and DESs in 23 lesions (22 patients). Angiographic success was achieved in all lesions. The median follow-up was 594 days (interquartile range 214 - 838 days). The overall TLR-rates were 9.7% at 1 year and 14.0% at 2 years (MB-TLR: 6.9% at 1 year and 11.1% at 2 years; SB TLR: 9.7% at 1 year and 14.0% at 2 years). No definite ST was observed during follow-up. TLR rates in both the MB and SB tended to be higher in the SB-BRS group when compared to the SB-DES group. Mid-term clinical outcomes following double-stenting using BRS were acceptable. Bifurcation lesions treated with DES in SB tended to have lower TLR rates in both the MB and SB when compared to implanting BRS in both branches. © 2016 Wiley Periodicals, Inc.

JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries

Purpose: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment. Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9±11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4±13.1 cm. The primary effectiveness outcome was acute success (≤30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory. Results: Treated length was 19.5±12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6±3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months. Conclusion: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results.

The Leipzig Prospective Drug-Eluting Balloon-Registry – Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

Drug-eluting balloons (DEB) are an alternative treatment of in-stent restenosis (ISR), but data regarding outcomes of DEB in de novo lesions are lacking. We investigated the effect of DEB on target lesion revascularization (TLR), procedural complications (coronary dissection/rupture, pericardial effusion, stent thrombosis, peri-interventional NSTEMI, stroke), major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction, TLR, stroke) in patients with ISR and de novo lesions in an all-comers setting. Between April 2009 and October 2013, 484 consecutive patients (mean age 68.4 years; 77.9% male) were enrolled in a prospective registry. TLR rate was 4.9% at 12 months and 8.7% at long-term follow-up of 2.3 years. Subgroup analysis confirmed a TLR rate of 8.9% after DEB treatment of ISR in bare-metal stents (21/235 lesions), 13.0% in drug-eluting stents (21/161 lesions) and 0% for de novo lesions (0/76 lesions). At long-term follow-up, all-cause mortality/cardiac mortality was 8.7% (42/484)/3.3% (16/484) and MACCE rate was 18.4% (89/484 patients), with no differences between DEB for ISR compared with de novo lesions. DEB for ISR resulted in a low rate of TLR. Our data support DEB in ISR as an effective treatment option. DEB in small coronary vessels in our limited cohort appeared to be safe. Larger, randomized trials in small coronary vessels should be undertaken to verify the long-term results of the current trial.

Impact of intravascular ultrasound on the long‐term clinical outcomes in the treatment of coronary ostial lesions

To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS). A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease. From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance. Ostial lesions included both native aorto-ostial or major coronary vessel (left anterior descending, left circumflex, and ramus intermedius) lesions. Clinical outcomes [cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR)] at a mean follow-up of 4.2 ± 2.5 years were compared between patients undergoing PCI of an ostial lesion with and without use of IVUS using univariate and propensity score adjusted analyses. Aorto-ostial lesions (n = 109) comprised 47% of lesions, whereas the remaining lesions (53%) involved major coronary vessels. After propensity score adjustment, IVUS use was associated with lower rates of the composite of cardiovascular death, MI, or TLR (HR 0.54, 95% CI 0.29-0.99; P = 0.04), composite MI or TLR (HR 0.39, 95% CI 0.18-0.83; P = 0.01), and MI (HR 0.31, 95% CI 0.11-0.85; P = 0.02) as compared with no IVUS. The use of IVUS was also associated with a trend towards a lower rate of TLR (HR 0.42, 95% CI 0.17-1.02; P = 0.06). PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events.

Long-term follow-up of the platinum chromium TAXUS Element (ION) stent: The PERSEUS Workhorse and Small Vessel trial five-year results.

The TAXUS Element (ION) platinum chromium paclitaxel-eluting stent (PtCr-PES) incorporates a thin (81 μm) strut design with a similar polymer and drug dose density as prior PES. The pivotal PERSEUS trial program consisted of two studies: PERSEUS Workhorse (WH) and PERSEUS Small Vessel (SV). The PERSEUS WH trial demonstrated the PtCr-PES to be non-inferior to the predicate TAXUS Express PES (TE-PES) for target lesion failure (TLF) at 1 year and in-segment angiographic percent diameter stenosis at 9 months. The PERSEUS SV trial demonstrated the PtCr-PES to be superior to a historical bare metal stent (BMS) for angiographic late lumen loss at 9 months. Long-term (5-year) clinical outcomes following PtCr-PES have not been previously reported. PERSEUS WH was a prospective, Bayesian, 3:1 randomized (PtCr-PES vs. TE-PES) trial in patients with lesion length ≤28 mm and vessel diameter ≥2.75 to ≤4.0 mm. PERSEUS SV was a prospective, single-arm trial in patients with lesion length ≤20 mm and vessel diameter ≥2.25 to <2.75 mm comparing PtCr-PES to a matched historical BMS control. Among randomized subjects in the PERSEUS WH study, clinical event rates at 5 years were similar between treatment groups, including TLF (12.9% TE-PES vs. 12.1% PtCr-PES; P = 0.66). In the PERSEUS SV study, 5-year rates of MACE, and TLF were significantly lower for PtCr-PES (vs. BMS) following adjustment for baseline characteristics and were primarily due to lower target lesion revascularization rates (27.2% BMS vs. 14.9% PtCr-PES; P = 0.049). At 5 years, the PtCr-PES provides efficacy and safety that is comparable to the TE-PES and superior efficacy with similar safety when compared with BMS in smaller caliber vessels. Cumulative stent thrombosis rates remained low and similar through 5 years for both DES platforms.

0165: Outcome after drug-eluting stents for cardiac allograft vasculopathy

Cardiac allograft vasculopathy (CAV) constitues a primary cause of death after heart transplantation. Bare metal stents (BMS) have been used for revascularization, but they are associated with a high-risk of restenosis. Abstract 0474 – Figure: Kaplan-Meier estimates of one-year mortality Limited data have shown favourable results with percutaneous coronary interventions (PCI) using drug-eluting stents (DES) in this specific population. Our study focuses on intra-stent restenosis (ISR) for DES in CAV, on new revascularisation and mortality. 97 consecutive heart transplant recipients with successful PCI were treated with DES (n=106) and BMS (n=25). They were prospectively followed-up at one year after PCI. An angiographic lesion-based analysis at 12-month follow-up and a patient-based survival analysis were performed. The lesion-based analysis within 12 months after PCI showed an ISR rate with BMS of 12% and an ISR rate with DES of 3.8%. The target lesion revascularization (TLR) was 8% for BMS and 2.8% for DES. However, the target vessel revascularization was higher (16.5%) and the remote lesion revascularization was 8.7%, indicating the rapid occurrence of new significant lesions. Cardiac mortality at one year was 9.7% and extra- cardiac mortality was 2.9%. DES are associated with a low rate of TLR and can safely be used in heart transplant recipients with coronary artery disease. However, new significant lesions occurred at one year indicating a progression of CAV.

Long-term Clinical and Angiographic Outcomes of the Mini-STAR Technique as a Bailout Strategy for Percutaneous Coronary Intervention of Chronic Total Occlusion

BackgroundA promising variant of the subintimal tracking and re-entry (STAR) technique, called “mini-STAR,” has been recently described as a successful rescue technique after revascularization failure by conventional techniques for coronary chronic total occlusion (CTO). MethodsThe current study enrolled patients with CTO who underwent successful revascularization by the mini-STAR technique as a bailout strategy. Two-year clinical follow-up and angiographic control procedures were performed. ResultsFrom March 2009-September 2011, 100 of 117 patients (mean age, 61.4 ± 10.9 years) underwent successful recanalization of CTO by the mini-STAR technique as a bailout strategy. Drug-eluting stents (DESs) were implanted in all cases. At 2-year follow-up, the major adverse cardiac events (MACE)-free survival was 89.2%, with a target lesion revascularization (TLR) rate of 6.5%. Angiographic follow-up was performed in 72% of patients. CTO target lesion restenosis was observed in 25% of patients, whereas the reocclusion rate was 12.5%. At multivariate Cox analysis, final thrombolysis in myocardial infarction (TIMI) flow < grade 3 was related to occurrence of MACE (hazard ratio, 5.9; 95% confidence interval [CI], 1.4-24.4; P = 0.013). Final TIMI flow < grade 3 (odds ratio [OR], 5.41; 95% CI, 1.05-27.73; P = 0.043) and CTO stent length (OR, 0.96; 95% CI, 0.93-0.99; P = 0.017) were independent predictors of reocclusion. The independent variables related to restenosis were first-generation DESs (OR, 4.10; 95% CI, 1.23-13.64; P = 0.022) and CTO stent length (OR, 0.97; 95% CI, 0.95-0.99; P = 0.027). ConclusionsAs bailout strategy for CTO revascularization, the mini-STAR technique shows low MACE and TLR rates at long-term follow-up.

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Mid‐term outcomes following endovascular re‐intervention for iliac artery in‐stent restenosis

We sought to evaluate the procedural characteristics and clinical outcomes of endovascular repair for iliac artery (IA) in-stent restenosis (ISR). An increasing percentage of patients with complex IA occlusive disease are treated with an endovascular approach, but the outcomes of IA-ISR have not been well described. We analyzed all endovascular procedures for treatment of IA-ISR performed at our institution between July 2006-December 2010. The primary outcome was primary patency, defined as <50% stenosis as assessed by clinical examination and duplex ultrasonography (DUS). Forty-one lesions in 24 patients who underwent repeated endovascular intervention for treatment of IA-ISR. Most lesions were unilateral and involved the common IA (66%). The mean length of ISR was 30.1 ± 14.1 mm with type I (focal) and II (diffuse) ISR occurring with the greatest frequency (34% and 39%, respectively). All patients underwent balloon angioplasty; adjunctive stenting zwas performed in 27 (66%) of the lesions. Type II ISR lesions more frequently required stenting (13/16 lesions, P = 0.02 compared with other patterns of ISR). Procedural success was 100% with a mean gain of 0.13 in the ankle-brachial index (P = 0.001). The 6- and 12-month primary patency rates were 96% and 82%, respectively. The 12-month primary-assisted patency rate was 90% with clinically driven target lesion revascularization (TLR) in three patients. Endovascular treatment of IA-ISR using an approach of balloon angioplasty followed by selective stenting is associated with high-patency rates and low rates of TLR at 1 year.

Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent: A Randomized, Controlled, Noninferiority Trial

NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year. Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited. The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618). At 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (p for noninferiority <0.0001, and p for superiority = 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% vs. 0.06%, p = 0.18). An angiographic substudy enrolling 528 patients (BES: n = 263, and EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs. 0.06 ± 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 ± 43 days after stent implantation. One-year clinical and angiographic outcome after BES implantation was noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES and EES use was excellent, with a low rate of TLR and extremely low rate of stent thrombosis.

Clinical outcomes in real‐world patients with acute myocardial infarction receiving XIENCE V® everolimus‐eluting stents

The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.

Long-Term Outcome of Drug-Eluting vs. Bare-Metal Stents in Patients With Acute Myocardial Infarction

The purpose of the present study was to compare the 5-year clinical outcomes after implantation of drug-eluting stent (DES) and bare-metal stent (BMS) in Japanese patients with acute myocardial infarction (AMI). This study was a subgroup analysis of the Nagoya Acute Myocardial Infarction Study (NAMIS). It included 658 AMI patients, of which 280 were treated with a DES and 378 with a BMS. The major adverse cardiac event (MACE)-free rates during the 5-year follow-up period were similar between the 2 groups (95.7% vs. 96.8%, P=0.482). A significant difference was seen, however, in the target lesion revascularization (TLR) rates (7.9% vs. 17.7%, P<0.0001). Interestingly, there was no significant difference between the 2 groups from year 1 to 5 with regard to late TLR (2.5% vs. 2.1%, P=0.906), despite the markedly lower incidence of TLR within the first year in the DES group compared with the BMS group (5.4% vs. 15.6%, P<0.0001). In this long-term follow-up analysis of DES compared to BMS in Japanese patients with AMI, there was no significant difference in the incidence of MACE. Although a lower rate of TLR was observed in DES group within the first year, the superiority of DES in relation to the incidence of TLR disappeared after the first year following primary percutaneous coronary intervention.

Biodegradable versus durable polymer drug eluting stents in coronary artery disease: Insights from a meta-analysis of 5834 patients

Biodegradable polymer drug eluting stents (BP-DES) have been developed to overcome the limitations of first generation durable polymer DES (DP-DES) but the clinical results of different BP-DES are not consistent. We performed a meta-analysis to compare the outcomes of BP-DES and DP-DES in the treatment of coronary artery disease (CAD). Online databases including MEDLINE were searched for studies comparing BP-DES and DP-DES for obstructive CAD that reported rates for overall mortality, myocardial infarction (MI), late stent thrombosis (LST), target lesion revascularization (TLR) and late lumen loss (LLL) with a follow-up of ≥ 6 months. Ten studies (5834 patients) with a 1-year median follow-up were included in the meta-analysis. When comparing patients treated with DP-DES and BP-DES those treated with BP-DES had lower LLL (in-stent: weighted mean difference (WMD) -0.10 mm, 95% CI = -0.17 to -0.03 mm, p = 0.004; in-segment: WMD -0.06 mm, 95% CI = -0.10 to -0.01 mm, p = 0.01) with lower TLR rates (OR 0.67, 95% CI = 0.47 to 0.98, p = 0.04). However, BP-DES did not improve mortality (OR 0.97, 95% CI = 0.73 to 1.29, p = 0.83), MI (OR 1.13, 95% CI = 0.87 to 1.46, p = 0.36) or LST rates (OR 0.64, 95% CI = 0.36 to 1.16, p = 0.14). A pre-specified subgroup analysis of Biolimus BP-DES confirmed significant LLL reduction without differences in other clinical endpoints. Meta-regression analysis demonstrated a strong significant inverse correlation between LLL and reference coronary diameter (p < 0.001). Our present meta-analysis showed that BP-DES when compared with DP-DES significantly reduced LLL and TVR but without clear benefits on mortality, MI and LST rates. (Clinicaltrials.gov identifier: NCT01466634).

Lower Limb Multilevel Treatment With Drug-Eluting Balloons:6-Month Results From the DEBELLUM Randomized Trial

To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB). Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66±4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5±3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis. Late lumen loss was lower in the DEB group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The ankle-brachial index improved to a greater degree in the DEB group: 0.87±0.22 vs. 0.70±0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04). The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.

SeQuent Please World Wide Registry: Clinical Results of SeQuent Please Paclitaxel-Coated Balloon Angioplasty in a Large-Scale, Prospective Registry Study

This study sought to assess the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an international, multicenter, prospective, large-scale registry study. In small randomized trials, PCB angioplasty was superior to uncoated balloon angioplasty for treatment of bare-metal stent (BMS) and drug-eluting stent (DES) restenosis. Patients treated with SeQuent Please PCBs were included. The primary outcome measure was the clinically driven target lesion revascularization (TLR) rate at 9 months. At 75 centers, 2,095 patients with 2,234 lesions were included. The TLR rate was 5.2% after 9.4 months. Definite vessel thrombosis occurred in 0.1%. PCB angioplasty was performed in 1,523 patients (72.7%) with DES or BMS restenosis and 572 patients (27.3%) with de novo lesions. The TLR rate was significantly lower in patients with PCB angioplasty for BMS restenosis compared with DES restenosis (3.8% vs. 9.6%, p < 0.001). The TLR rate did not differ for PCB angioplasty of paclitaxel-eluting stent and non-paclitaxel-eluting sten restenosis (8.3% vs. 10.8%, p = 0.46). In de novo lesions (small vessels), the TLR rate was low and did not differ between PCB angioplasty with and without additional BMS implantation (p = 0.31). PCB angioplasty in an all-comers, prospective, multicenter registry was safe and confirmed in a large population the low TLR rates seen in randomized clinical trials. PCB angioplasty was more effective in BMS restenosis compared with DES restenosis, with no difference regarding the type of DES.

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

Background— Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Methods and Results— Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES ( P noninferiority &lt;0.0001, and P superiority =0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P =0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P noninferiority &lt;0.0001, and P superiority =0.24) at 278±63 days after index stent implantation. Conclusions— One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01035450.

Choice of stent and outcomes after treatment of drug‐eluting stent restenosis in highly complex lesions

Our aim was to compare the outcomes of a same versus different drug-eluting stent (DES) implantation strategy for the treatment of DES instent restenosis (ISR). The absence of clear data renders the treatment of DES ISR one of the most challenging situations in interventional cardiology. We identified all cases of DES ISR treated with a second DES between January 2004 and January 2009. The lesions were divided into those treated with the same DES as the initial one that restenosed and those treated with a different DES. The main end-point was repeat target lesion revascularization (TLR). We included 116 patients with a total of 132 lesions. The patient population was highly complex: 55.5% with diabetes, 56% with type-C lesions, 15.9% with lesions previously stented with BMS and 18.2% with fluoroscopic evidence of stent fracture. A same and different stent strategy was conducted in 41 lesions (31%) and 91 lesions (69%), respectively. Overall TLR was 31.1% and occurred in 46.3% of patients treated with the same stent and 24.4% of those with a different stent (P = 0.012). Multivariable analysis found same stent strategy (OR 2.84, 95%CI 1.23-6.57;P = 0.014) and occurrence of stent fracture (OR 4.03, 95%CI 1.33-12.01;P = 0.012) to be the only independent predictors of TLR after a median follow-up of 20.4 [12.1-30.2] months. In highly complex lesions, DES implantation for DES ISR is linked to a high need of future revascularization. An association between implanting a DES type other than the original and lower rate of TLR is suggested.

Clinical usefulness of the Driver® stent in a retrospective, collaborative, multicenter, open-label study in Japanese real-world patients with coronary artery disease and the drug-eluting stent era

The objectives of the present study were to determine predictors for target lesion revascularization (TLR) and to examine the clinical usefulness of the Driver(®) stent (a cobalt alloy, modular-type) in Japanese patients with coronary artery disease. Data on 631 Japanese patients including 241 with stable angina and 361 with acute coronary syndrome-who had been implanted with the Driver(®) stent (805 lesions) between August 2004 and February 2005-were collected retrospectively; 95.0 and 81.7% of these lesions were de novo and ACC/AHA classification B2/C type, respectively. Early angiography of 622 patients revealed 1) the preprocedural minimal lumen diameter (MLD) of 0.80±0.51mm, with lesion lengths of 17.1±7.3mm, and 2) the postprocedural MLD of 2.95±0.55mm, with MLD gains of 2.14±0.68mm. At 270days of clinical follow-up, the incidences of major adverse cardiac events (MACE), TLR, and early stent thrombosis (ST) were 18.8, 14.7, and 0.2%, respectively; the TLR rate decreased statistically significantly to 5.3 and 5.9% when implanting the Driver(®) stent (3.5 and 4.0mm) and by IVUS, respectively. Absence rate of diabetes mellitus, presence rate of AMI, presence rate of stent diameters of ≥3.5mm, and presence rate of IVUS-guided PCI showed lower TLR rates, with statistically significant differences. Uni- and multivariate analyses revealed that AMI and stent diameter (≥3.5mm) are significant predictors for TLR (0.048 and 0.047, respectively), indicating that physicians are recommended to consider these variables when selecting candidate real-world patients for IVUS-guided PCI.