Abstract Background The optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated. Objectives The aim of this study was ...to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES. Methods The SECURITY (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial was a 1:1 randomized, multicenter, international, investigator-driven, noninferiority study conducted from July 2009 to June 2014. Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months. Results Overall, 1,399 patients were enrolled in the study and randomized to receive 6 months (n = 682) versus 12 months (n = 717) DAPT. The primary composite endpoint occurred, respectively, in 4.5% versus 3.7% (risk difference 0.8%; 95% confidence interval CI: −2.4% to 1.7%; p = 0.469) at 12 months. The upper 95% CI limit was lower than the pre-set margin of 2%, confirming the noninferiority hypothesis (p < 0.05). Moreover, no differences were observed in the occurrence of the secondary endpoint at 12 months (5.3% vs. 4.0%, difference: 1.2%; 95% CI: −1.0 to 3.4; p = 0.273) and between 12 and 24 months (1.5% vs. 2.2%, difference: −0.7%; 95% CI: −2.1 to 0.6; p = 0.289). Finally, no differences were observed in definite or probable stent thrombosis at 12 months (0.3% vs. 0.4%; difference: −0.1%; 95% CI: −0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1% vs. 0%; difference: 0.1%; 95% CI: −0.1 to 0.4; p = 0.305). Conclusions In a low-risk population, the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death, MI, stroke, definite/probable stent thrombosis, and BARC type 3 or 5 bleeding at 12 months. (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; NCT00944333 )
Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate.
The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was ...to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy.
The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG); a comparative 1-year clinical follow-up was performed.
A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity score-matching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT.
Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.
Abstract Background The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low ...restenosis risk. Objectives This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). Methods We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Median DAPT duration was 32 days (interquartile range IQR: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). Conclusions Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates ZEUS Study; NCT01385319 )
The differential impact on ischaemic and bleeding events of the type of drug-eluting stent durable polymer stents DES vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS) and length of ...dual antiplatelet therapy (DAPT) remains to be defined.
Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) a composite of death, myocardial infarction (MI), and target vessel revascularization. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent everolimus-eluting (EES), zotarolimus-eluting (ZES) with 12mDAPT, EES/ZES with <12 months of DAPT, and EES/ZES with >12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT.
Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.
Abstract Incidence, predictors and impact on prognosis of target lesion revascularization (TLR) for patients treated with second generation drug eluting stents (DESs) on unprotected left main (ULM) ...remain to be defined. The present is a multicenter study including patients treated with a second generation DES on ULM from June 2007 to January 2015. Rate of target lesion revascularization was the primary end point. All cause death, myocardial infarction, target vessel revascularization and stent thrombosis were the secondary end points. 1270 patients were enrolled: after a follow up of 650 days (230-1170) 47 (3.7%) of them underwent a re-PCI TLR on the left main, 22 during a planned angiographic follow up. Extent of CAD was similar among groups (median value of Syntax of 27±10 vs. 26±9, p 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM; 56% presented with a focal re-stenosis, 33% diffuse and 10% proliferative. At multivariate analysis), insulin dependent diabetes mellitus increased risk of TLR (HR 2.0: 1.1-3.6, p 0.04), while use of IVUS resulted protective (HR 0.5: 0.3-0.9, p 0.02) At follow up, rates of cardiovascular death did not differ among the two groups (4% vs.4%, p 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1-1.6, p 0.22), while cardiogenic shock and III tertile of Syntax portended a worse prognosis (respectively HR 4.5: 2.1-10.2 p 0.01 and HR 1.4:1.1-1.6 p 0.03).. In conclusion, repeated revascularization after implantation of second generation DES on ULM represents an unfrequent event, being increased in insulin dependent patients and reduced by IVUS. Impact on prognosis remains neutral, being related to clinical presentation and extent of CAD.
The aim of this multicentre study was to investigate the in-hospital and midterm outcomes of rotational atherectomy (RA) followed by metallic stent implantation.
Between 2002 and 2013, 1,176 de novo ...lesions with calcified coronary lesions treated by RA and metallic stent implantation at nine institutions were assessed. Patients with ST-segment elevation myocardial infarction (STEMI) within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis were excluded from the current analysis. In-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16.0% at one-year and 24.9% at two-year follow-up, both driven by target vessel revascularisation (13.5% at one year and 19.8% at two years). Multivariable analysis revealed that dialysis was an independent predictor for both in-hospital MACE (OR 2.33, 95% CI: 1.11-4.87, p=0.03) and follow-up MACE (HR 4.14, 95% CI: 2.87-5.96, p<0.001), whilst drug-eluting stent (DES) use was associated with a reduction in follow-up MACE (HR 0.42, 95% CI: 0.26-0.67, p<0.001).
RA appears to be safe and effective with acceptable in-hospital and follow-up MACE considering the severity of patient and lesion characteristics. DES implantation following RA was associated with a reduction in MACE during the follow-up period.
Heavily calcified unprotected left main (ULM) disease continues to be a challenging situation and represent a high-risk subset for interventional cardiologist. To date, there are limited data ...investigating the results after rotational atherectomy (RA) in this setting. The aim of this study was to investigate the in-hospital and 1-year outcomes after RA of heavily calcified ULM lesions. A retrospective cohort analysis was performed on all calcified patients with ULM (n = 86) enrolled in the multicenter international ROTATE registry (overall patients, n = 962). End points of the study were the in-hospital and 1-year incidence of major adverse cardiovascular events (MACE): a composite of death, myocardial infarction, and target-vessel revascularization in the ULM versus non-ULM group. Patients in the ULM group were older (p = 0.01) and more frequently with diabetes (p = 0.001) compared with the non-ULM group, whereas intravascular ultrasound guidance was higher, even if not systematic, in the ULM group (p <0.001). No difference was reported between ULM versus non-ULM groups in terms of in-hospital MACE (5.8% vs 8%). At 1 year, MACE rate was higher in ULM versus non-ULM (26.4% vs 14.9%, p = 0.002) mostly driven by target-vessel revascularization (20.3% vs 12.7%, p = 0.05). Even definite/probable stent thrombosis rate was higher in the ULM group (3.9% vs 0.8%). All these events were subacute and 2/3 (75%) were fatal. In conclusion, our multicenter experience shows that RA followed by stent implantation in patients with heavily calcified ULM narrowing is feasible and associated with good in-hospital results. Patient (age and diabetes) and procedural aspects (relatively low intravascular ultrasound guidance) may affect the worse subacute mid-term prognosis in the more complex ULM group.
Abstract Trans-radial access (TRA) is often avoided in favour of the trans-femoral access (TFA) during percutaneous coronary interventions (PCI) of the unprotected left main coronary artery (ULM), ...due to technical and safety concerns. Aim of this study was to compare the performance of TRA and TFA in the treatment of ULM with second-generation drug-eluting stents (DES-II). Consecutive patients undergoing PCI on ULM with DES-II were retrospectively enrolled in the multicenter FAILS 2 registry. Patients were stratified according to the arterial access. Choice between TRA and TFA was left to each operator’s preferences. Bleedings during index hospitalization were the primary end-point. Secondary end-points were major adverse cardiovascular events (MACE, a composite of death, reinfarction, target lesion revascularization TLR), the single components of MACE at follow-up and stent thrombosis. Propensity score matching was executed to account for possible confounding. Overall, 1247 patients were enrolled (289, 23.2%, of female sex, mean age 70.2±10.2 years). Diagnosis at presentation was stable angina in 603(48.7%) cases, NSTE-ACS in 465(37.3%), STEMI in 117(9.5%). Mean follow-up was 726±654 days. After propensity score with matching, 354 patients were included. The primary end-point was significantly reduced in patients treated with TRA (2.0% vs. 4.0%, p 0.042), while no differences emerged pertaining the secondary end-points, including TLR and reinfarction. In conclusion, TRA may reduce in-hospital bleedings in patients undergoing percutaneous treatment of the ULM, without increasing the rate of adverse cardiovascular events at follow-up, and may therefore be safely used in the treatment of the ULM.
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