Francesco De Felice

A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels: The BELLO (Balloon Elution and Late Loss Optimization) Study

OBJECTIVES The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. BACKGROUND DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease. METHODS BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. RESULTS Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected]. CONCLUSIONS Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction: 3-Year Results of the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) Trial

OBJECTIVES The aim of this study was to investigate whether the reported favorable 1-year outcome of the sirolimus-eluting stent (SES) versus the bare-metal stent (BMS) in the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) trial, in the setting of ST-segment elevation myocardial infarction (STEMI), is maintained at 3-year follow-up. BACKGROUND At present, only long-term registry data, but not randomized trials, on the safety and effectiveness of SES in STEMI patients are available. METHODS Overall, 320 STEMI patients were randomized to receive SES or BMS. The primary end point was the incidence of major adverse cardiovascular events (MACE), at 3-year follow-up. The secondary end points were the rate of target lesion revascularization (TLR) and target vessel revascularization (TVR) and target vessel failure (TVF). The incidence of late events, starting from clopidogrel withdrawal, was also investigated. RESULTS The 3-year incidence of MACE was lower in the SES group compared with the BMS group (12.7% vs. 21%, p = 0.034), as were TLR (7% vs. 13.5%, p = 0.048), TVR (8% vs. 16%, p = 0.027), and TVF (11.5% vs. 20.5%, p = 0.028) rates. The 3-year survival rate free from MACE, TLR, and TVF was significantly higher in the SES group than in the BMS group (87%, 93%, and 89.5% vs. 79%, 86.5%, and 79.5%, respectively, p < 0.05). The lower incidence of adverse events in the SES group was driven by TLR reduction and achieved in the first year of follow-up. The cumulative incidence of death and recurrent myocardial infarction, starting from clopidogrel discontinuation, was comparable in the 2 groups. CONCLUSIONS The clinical benefits of SES have been shown to be greater than those of BMS at 3-year follow-up.

3-year clinical outcome of patients with chronic total occlusion treated with drug-eluting stents.

OBJECTIVES The aim of this study was to evaluate whether percutaneous coronary intervention (PCI) with drug-eluting stent (DES) reduces major adverse cardiac events (MACE) in patients with chronic coronary total occlusions (CTO) compared with bare-metal stent (BMS) during 3-year follow-up. BACKGROUND The long-term prognosis of patients with CTO treated with PCI and DES implantation is poorly investigated. METHODS We compared the 3-year clinical outcome of 124 patients with CTO after successful PCI with DES implantation with that of 159 patients with CTO previously treated with BMS. MACE were defined as death, myocardial infarction, and target lesion revascularization (repeat PCI or coronary artery bypass surgery) and were considered as combined primary end point. RESULTS After 3 years, the composite end point was significantly lower in the DES than in the BMS group: 18% versus 28%, respectively, (p < 0.05). The difference was due to the reduction of target lesion revascularization with DES compared with BMS-8% versus 21%, respectively, (p < 0.004). The Cox proportional hazards model identified: DES versus BMS (adjusted hazard ratio [HR]: 0.338, 95% confidence interval [CI]: 0.19 to 0.60, p = 0.0001), lesion length (HR: 1.033, 95% CI: 1.008 to 1.058, p = 0.012), and final minimal lumen diameter (HR: 0.456, 95% CI: 0.232 to 0.898, p = 0.023) as independent predictors of MACE at 3-year follow-up. CONCLUSIONS After 3 years, DES were superior to BMS in reducing MACE in patients with CTO and should be considered the preferred treatment strategy.

Clinical outcome of patients with chronic total occlusion treated with drug-eluting stents

BACKGROUND There is limited evidence on the medium-term prognosis of patients with chronic total occlusion successfully treated with drug-eluting stent (DES) implantation. METHODS We compared the medium-term outcome of 111 patients with chronic total occlusion (CTO) successfully treated with implantation of sirolimus-or paclitaxel-eluting stents versus 112 patients treated with bare metal stents. RESULTS During an overall follow-up period of 18 months, the composite endpoint of death, myocardial infarction or target lesion revascularization was significantly lower in the drug-eluting stent than in the bare metal stent group: 8.1% vs. 21.6%, respectively (p=0.005). The difference was due to the reduction of target lesion revascularization with DES compared to bare metal stents: 3.6% vs. 18.9%, respectively (p<0.001). The Cox proportional hazards model identified DES as an independent predictor of adverse cardiac events (adjusted hazard ratio, 0.16; 95% confidence interval 0.05 to 0.52, p=0.002). CONCLUSIONS During medium-term follow-up use of DES is associated with improved outcome compared to use of bare metal stents in patients with CTO.

Late (3 Years) Follow-Up of Successful Versus Unsuccessful Revascularization in Chronic Total Coronary Occlusions Treated by Drug Eluting Stent

The success rate of recanalization of coronary chronic total occlusion (CTO) has improved in recent years, but the clinical benefit associated with successful CTO recanalization in the drug-eluting stent (DES) era is not well known. A cohort of 317 consecutive patients (mean age 65 ± 10, 84% men) with CTOs (defined as Thrombolysis In Myocardial Infarction [TIMI] flow grade 0 and duration >3 months) of native coronary vessels in which percutaneous coronary intervention was attempted was enrolled from June 2005 to March 2009. All successful procedures (196 patients) were performed by DES implantation. The incidence of major adverse cardiac events (MACEs; a composite of cardiac death, myocardial infarction, and repeat revascularization) was assessed during a mean follow-up period of 3 years. MACE predictors were assessed in clinical, angiographic, and procedural data, including procedural success. Patients with successful percutaneous coronary intervention experienced a significantly lower MACE rate compared to those with failed procedures (17 [9%] vs 32 [26%], p = 0.008). Patients with multivessel disease experienced MACEs more frequently than those with single-vessel disease (45 [22%] vs 4 [4%], p = 0.002). On multiple Cox regression analysis, the presence of multivessel disease and CTO opening failure were independent predictors of MACEs (hazard ratio 2.31, 95% confidence interval 1.17 to 4.96, p = 0.01, and hazard ratio 1.81, 95% confidence interval 1.33 to 4.12, p = 0.02, respectively). The worst prognosis was confined to patients with multivessel disease and failed procedures (hazard ratio 2.73, 95% confidence interval 1.21 to 3.92, p = 0.03). In conclusion, successful recanalization of CTOs with DES translates into a reduction of the 3-year MACE rate compared to failed procedures, and the worst prognosis is observed in patients with failed procedures and multivessel disease, a notion that might be taken into account in the management of patients with coronary CTOs.

Endovascular treatment of aortic coarctation: Long-term effects on hypertension

INTRODUCTION Endovascular management of aortic coarctation (CoA) is safe but few data are available concerning the long-term cure of hypertension. Aim of this study was to evaluate immediate and long-term clinical and haemodynamic outcome in a consecutive series of adolescent and adult patients with CoA submitted to endovascular treatment. METHODS A total of 21 adolescent and adult patients underwent successful transcatheter intervention of CoA. Follow-up comprised cardiological examination with special attention to blood pressure (BP), echocardiogram, 24/h ambulatory blood pressure monitoring (ABP), exercise test and spiral computed tomography. RESULTS Pre-intervention CoA diameter and degree of stenosis were 4.8+/-2.1 mm and 73.7+/-9.8%, respectively, and 14.8+/-3.0 mm and 13.5+/-6.5% post-intervention (p<0.001). Systolic arterial hypertension persisted in 2 patients at rest (9.5%). Mean number of antihypertensive medications per patient was 1.5+/-1.1 and 0.5+/-0.9 at 1 year after treatment (p<0.05). At ABP 3 patients (14%) were hypertensive. The Doppler gradient across the coarctation site decreased from 58.8+/-16.9 to 10.5+/-4.9 mmHg (p<0.001) as well as left ventricular mass (199+/-14.6 and 189.3+/-9.1; p<0.001). Overall, 18 patients (86%) underwent a treadmill exercise test and 4 patients (22%), normotensive at rest, showed a pathological blood pressure response. Overall, 7/21 patients (33%) showed persistent hypertension. CONCLUSION Endovascular treatment of native or recurrent CoA in adolescent and adult patients is safe but 33% of patients showed persistent hypertension. Meticulous clinical follow-up is mandatory, including an exercise test in order to monitor eventual blood pressure increase and to assess effort tolerance.

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study.

BACKGROUND/OBJECTIVES A prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. METHODS A total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. RESULTS Two-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6 months, 1 year and 2 years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). CONCLUSIONS Our results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2 years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Long-term outcome of sirolimus-eluting vs bare-metal stent in the setting of acute myocardial infarction: 5-year results of the SESAMI trial

BACKGROUND few long-term randomized data on safety and effectiveness of sirolimus-eluting stent (SES) in the ST-segment elevation myocardial infarction (STEMI) setting are available. The aim of the present investigation was to evaluate the 5-year clinical outcome of SES vs bare-metal stent (BMS) implantation in patients with STEMI. METHODS 320 STEMI patients were randomized to receive SES or BMS. The primary end-point was the incidence of target vessel failure (TVF) at 5-year follow-up. The secondary end-points were the rate of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), death or non-fatal MI and stent thrombosis (ST). Event rates from 1 to 5 years in patients undergoing TLR and those TLR free at 1 year were also investigated. RESULTS The 5-year survival rate free from TVF and TLR was significantly higher in the SES than in the BMS group (85% vs 76% p=0.038; 92% vs 85% p=0.045, respectively). The lower incidence of adverse events was achieved in the first year of follow-up. The cumulative incidence of MACE, death or non-fatal MI and ST was comparable in the 2 groups at 5-year follow-up. Moreover death or MI incidence was 5% in the patients who did not experience TLR within 1-year and 16% in those who experience TLR in the same period (p=0.033). Predictors of death or MI during 5-year follow-up were TLR within 1 year (OR 3.4, 95% CI 1.1-10.1; p=0.04) and small vessels treatment (OR 4.8 95% CI 1.7-13.0; p=0.002). CONCLUSIONS The clinical benefits of SES are maintained up to 5years without safety concerns.

Five-Year Outcomes in Patients With Chronic Total Coronary Occlusion Treated With Drug-Eluting vs Bare-Metal Stents: A Case-Control Study

BACKGROUND Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS). METHODS We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years. RESULTS After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively. CONCLUSIONS After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.

Comparison of one-year cardiac events with drug-eluting versus bare metal stent implantation in rescue coronary angioplasty.

Rescue percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation is useful in patients with acute myocardial infarction (AMI) and failed thrombolysis. Drug-eluting stent (DESs) are more effective in reducing restenosis compared to BMS. No data are available comparing the clinical outcomes between the 2 types of stents nor has information ever been provided about the predictors of events in patients treated with rescue PCI in the current era. The aims of the present study were to evaluate the outcomes of patients undergoing rescue PCI with DES implantation compared to BMS implantation and to determine the independent predictors of events during 1 year of follow-up. The study population consisted of 311 consecutive patients with ST-segment elevation AMI and evidence of failed fibrinolysis undergoing successful revascularization with DES (n = 134) or BMS (n = 177) implantation. The end point of the present study was the incidence of major adverse cardiac events (MACE) defined as death, recurrent AMI, and target vessel revascularization. No differences were found in the number of MACE at 1 year of follow-up between the DES and BMS groups (n = 10 and 19, respectively, p = 0.29). The Cox proportional hazards model identified cardiogenic shock (adjusted hazard ratio 7.05, 95% confidence interval 2.08 to 23.9, p = 0.001), age (hazard ratio 1.51, 95% CI 1.09 to 2.08, p = 0.011), and final minimal lumen diameter (hazard ratio 0.42, 95% confidence interval 0.21 to 0.83, p = 0.013) as independent predictors of MACE at 1 year of follow-up. After propensity score adjustments, the predictors did not change. In conclusion, we found no differences between DESs and BMSs with respect to MACE at 1 year of follow-up in patients with AMI treated with rescue PCI. Cardiogenic shock, age, and final minimal luminal diameter were identified as predictors of MACE.