Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

INTRODUCTION: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. METHODS: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). RESULTS: Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5 years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60 ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). CONCLUSIONS: In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES: The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation. METHODS: The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. RESULTS: A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). CONCLUSIONS: Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).

Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.

OBJECTIVES: To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). METHODS: Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. RESULTS: Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. CONCLUSION: A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.

Typical atrial flutter but not fibrillation predicts coronary artery disease in formerly healthy patients.

AIMS: Long-term mortality after ablation of typical atrial flutter has been found to be increased two-fold in comparison to atrial fibrillation ablations through a period of 5 years with unclear mechanism. METHODS AND RESULTS: We analysed 189 consecutive patients who underwent ablation for typical atrial flutter (AFL), in which the incidence of AF was the first manifestation of cardiac disease. According to the clinical standards of our centre, the routine recommendation was to evaluate for coronary artery disease (CAD) by invasive angiogram or computed tomography scan. We compared the AFL patients to 141 patients with paroxysmal atrial fibrillation (AFIB) without known structural heart disease who underwent ablation in the same period and who had routine coronary angiograms performed. Out of 189 patients who presented with AFL, coronary status was available in 152 patients (80.4%). Both groups were balanced for mean age (64.9 years in AFL vs. 63.2 years in AFIB; P = 0.15), body mass index (BMI; 28.8 vs. 28.5 kg/m2; P = 0.15), CHA2DS2-VASc-Score (2.20 vs. 2.04; P = 0.35), smoking status (22.2% smokers vs. 28.4%; P = 0.23), and renal function (GFR >60 mL/min in 96.7% of all patients vs. 95.7%; P = 0.76). There were significantly lower values for left ventricular ejection fraction (52.5% vs. 59.7%; P < 0.001), female sex (17.0% vs. 47.5%; P < 0.001), hyperlipidaemia (37.9% vs. 58.9%; P < 0.001), and family history of cardiovascular disease (CVD) (15.0 vs. 31.9%; P = 0.001) in the AFL vs. AFIB cohorts. Coronary artery disease with stenoses >50% was found in 26.3% of all patients with available coronary status in AFL and in 7.0% in AFIB (P < 0.001). Coronary artery disease with stenoses >75% in 16.4% in AFL whereas only in 1.4% in AFIB (P < 0.001). Multivessel disease was detected in 10.5% in AFL and 0.7% in AFIB (P < 0.001). After correction for age, left ventricular ejection fraction, BMI, CHA2DS2-VASc-Score and its individual components, smoking status, hyperlipidaemia, and family history of CVD, there was a more than five-fold increase in the likelihood of CAD with stenosis >50% in AFL as compared to AFIB [odds ratio (OR 5.26)]. A multivariate analysis was performed in the AFL group. Patients with clinically relevant stenoses (>75%) were older (70.6 years vs. 63.8 years; P = 0.001), had a higher number of risk factors (3.08 vs. 2.24; P ≤ 0.0016) and a higher CHA2DS2-VASc-Score (3.20 vs. 2.00; P < 0.0001). With logistic regression, significant CAD could be predicted by higher values for CHA2DS2-VASc-Score with an exponential rise to a pretest-probability of 42.1% at a value of 4 points. CONCLUSION: These data suggest that typical atrial flutter constitutes a manifestation of previously asymptomatic CAD. Due to the inclusion criteria, CAD has to be considered silent and chronic in most of the patients. Therefore, the presence of typical atrial flutter in formerly healthy patients should raise suspicion of otherwise silent CAD and initiate further investigations and risk stratification with particular emphasis on the individual CHA2DS2-VASc-Scores.

Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial.

AIMS: To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS. METHODS: This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR). RESULTS: Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947). CONCLUSIONS: Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.

Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent.

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.

Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium.

Device success of earlier generation balloon-expandable transcatheter heart valves (BE-THV) is lower in patients with severe landing zone calcium (LZC). We sought to explore the impact of LZC on the outcome of transcatheter aortic valve implantation (TAVI) with the next generation Edwards Sapien 3 BE-THV. In the present study, severe LZC was defined as severe aortic valve cusp calcium (AVC) and/or left ventricular outflow tract calcium (LVOTC) on computed tomography. Patients who underwent TAVI for pure/predominant aortic regurgitation, bicuspid aortic valve disease, or failed bioprosthetic valve were excluded. Out of 350 patients who underwent TAVI with the Edwards Sapien 3 (age 80.7 ± 6.1, female: 45.1%, Society of Thoracic Surgeons score: 4.9 ± 3.8, transfemoral: 97.4%), 106 (30.3%) had severe LZC; 78 severe AVC (22.3%) and 49 severe LVOTC (14.0%). Severe LZC was associated with lower device success (96.2% vs 100%, p = 0.008) driven by more prosthetic valve regurgitation (PVR, p = 0.008). On multivariable analysis, PVR was associated with severe LVOTC (odds ratio [95% confidence interval] 2.130 [1.092 to 4.158]) but not with severe AVC (1.529 [0.835 to 2.800]). Balloon predilatation (BPreD) was performed in 42.5% of patients with severe LZC (vs 19.3% in nonsevere LZC; p <0.001) and was associated with prolonged procedural time (p = 0.001) and higher irradiation exposure (p = 0.027). Device success (p = 0.311), major procedural complications (p = 0.132), 30-day safety end point (p = 0.815), and PVR (p = 0.684) were not significantly different between patients with severe LZC who underwent BPreD versus direct TAVI. In conclusion, device success of the third generation BE-THV is lower in severe LZC driven by more PVR, especially in patients with severe LVOTC. In those patients, BPreD prolonged the procedure without improving THV performance.

Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial.

BACKGROUND: Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. METHODS: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. FINDINGS: Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. INTERPRETATION: Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. FUNDING: Biotronik AG.

High-speed rotational atherectomy of the left main coronary artery: a single-center experience in 50 high-risk patients.

BACKGROUND: Certain patients with complex calcified left main (LM) disease have a prohibitive risk for bypass surgery. Rotational atherectomy (RA) prior to stent implantation is an option for this subset of patients. OBJECTIVE: To analyze acute and long-term results of RA in the LM location. METHODS: We present a single-center analysis of RA in severe LM disease applied in patients with high surgical risk. RESULTS: RA was performed in the LM location in 50 consecutive patients with a mean age of 73years. In 30% of the patients clinical presentation was an acute coronary syndrome, and 42% had diabetes. LM bifurcation was involved in 80% of the cases, 36% had a Medina class 1.1.1 lesion, and 38% of RA procedures were performed as bailout. In 38% of patients the left main was protected. Median logistic EuroSCORE was 12.4% (interquartile range, IQR, 5.24-36.11%) and mean SYNTAX Score was 28.6±8.2. The median burr size was 1.5mm and a two-stent strategy was required in 58% of interventions. Drug-eluting stents were implanted in 86% of procedures. Angiographic success rate was 96%, and in-hospital major adverse cardiac event rate was 10%. Survival free of cardiac death at 12 and 24months was 87.6% and 78.4%. Target lesion revascularization rates (TLR) were 13.3% and 18.8%, respectively. Cardiac deaths were significantly higher in patients with acute coronary syndromes compared with patients with stable angina (cardiac death free survival was 72.7% and 94% at 12months, p=0.01). The TLR rate was numerically higher in diabetic patients (21.1% vs. 7.7% at one year, p=0.18). CONCLUSION: Acute and long-term outcomes after LM rotational atherectomy are satisfactory, considering the high procedure- and patient-related risks.

Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry.

AIMS: Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon have been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients. METHODS AND RESULTS: Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months. CONCLUSIONS: Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).

Long-term follow-up of coronary venous bypass graft lesions treated with a new generation drug-eluting stent with bioabsorbable polymer.

BACKGROUND: To date, no published data are available regarding long-term follow-up of new generation DES implanted in coronary artery bypass graft (CABG) lesions. OBJECTIVES: To assess the long-term clinical outcome of patients receiving the new generation Biolimus A9-coated drug-eluting stent (DES) with biodegradable polymer in saphenous vein grafts (SVG). METHODS: Three thousand sixty-seven patients were included in the NOBORI 2 registry: 71 patients with a total of 117 lesions received at least 1 biolimus A9 DES in SVG lesions and 2,959 patients received percutaneous coronary intervention in other lesions. Clinical follow-up was performed at 1, 6, and 12 months, and annually up to 3 years. RESULTS: Compared to the non-CABG group, patients with CABG lesions were older (P < 0.001), had a higher Charlson Comorbidity Index (P = 0.004), and presented more often with acute coronary syndrome (P = 0.02). At 3-year follow-up, cardiac death occurred in 9.7% versus 2.1% (P < 0.001), myocardial infarction (MI) in 8.3% versus 3.0% (P = 0.02), target lesion failure in 13.9% versus 6.4% (P = 0.03), and major adverse cardiac event in 18.1% versus 8.6% (P = 0.01). No differences were observed in TV-MI and TLR, nor stent thrombosis (ST) which was generally low in both groups (1.4% vs 0.8%, P = NS). CONCLUSION: Albeit 3-year outcomes were less favorable in the CABG group, the higher cardiac mortality was apparently not driven by ST, target vessel MI, or TLR, but is likely due to advanced disease and age as well as comorbidity. The low TLR rate as well as the absence of late and very late ST suggest that BES are safe and effective for the treatment of CABG lesions.

Comparison of cardiogoniometry and electrocardiography with perfusion cardiac magnetic resonance imaging and late gadolinium enhancement.

AIMS: Cardiogoniometry (CGM) is a spatio-temporal five-lead resting electrocardiographic method utilizing automated analysis. The purpose of this study was to determine CGM's and electrocardiography (ECG)'s accuracy for detecting myocardial ischaemia and/or lesions in comparison with perfusion cardiac magnetic resonance imaging (CMRI) and late gadolinium enhancement (LGE). METHODS AND RESULTS: Forty (n= 40) patients with suspected or known stable coronary artery disease were examined by CGM and resting ECG directly prior to CMRI including adenosine stress perfusion (ASP) and LGE. The investigators visually reading the CMRI were blinded to the CGM and ECG results. Half of the patients (n= 20) had a normal CMRI while the other half presented with either abnormal ASP and/or detectable LGE. Cardiogoniometry yielded an accuracy of 83% (sensitivity 70%) and ECG of 63% (sensitivity 35%) compared with CMRI. CONCLUSIONS: In this pilot study CGM compares more favourably than ECG with the detection of ischaemia and/or structural myocardial lesions on CMRI.

Comparison of outcomes in patients having isolated transcatheter aortic valve implantation versus combined with preprocedural percutaneous coronary intervention.

Coronary artery disease negatively affects the outcome of patients undergoing surgical aortic valve replacement and practice guidelines recommend revascularization at time of surgery. In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of preprocedural percutaneous coronary intervention (PCI) on TAVI outcome has not been examined. We aimed in the present study to assess the feasibility and safety of performing PCI before TAVI and to evaluate procedural, 30-day, and 6-month clinical outcomes. We retrospectively analyzed 125 patients who underwent successful TAVI at a single institution and divided them into an isolated TAVI and a PCI + TAVI group. During the study period, a strategy of preprocedural PCI of all significant (>50%) lesions in major epicardial vessels was adopted. Study end points were adjudicated in accordance with the Valve Academic Research Consortium consensus on event definition. All patients were treated with the Medtronic CoreValve prosthesis (n = 55 with PCI + TAVI and n = 70 with isolated TAVI). Thirty-day mortality was 2% versus 6% for patients treated with PCI + TAVI versus isolated TAVI, respectively (p = 0.27). Neither periprocedural nor spontaneous myocardial infarction occurred in either group. Rates of 30-day stroke, major bleeding, major vascular complications, and the Valve Academic Research Consortium-defined combined safety end point (11% vs 13%, p = 0.74) did not differ between the 2 groups. Patients' symptoms significantly improved in the first month after TAVI, and extent of improvement did not differ between groups. Adverse events at 6 months were comparable. In conclusion, PCI before TAVI appears feasible and safe. Based on these early results revascularization should become an important consideration in patients with coronary artery disease undergoing TAVI.

Long-term clinical outcome of thin-strut cobalt-chromium stents in the drug-eluting stent era: results of the COBALT (comparison of bare-metal stents in all-comers' lesion treatment) registry.

BACKGROUND: Despite widespread penetration of drug-eluting stents (DES) in clinical practice, a relevant percentage of patients with coronary artery disease are still treated with bare-metal stents (BMS). Contemporary BMS, however, are less well investigated and comparative data on clinical outcome are lacking. METHODS AND RESULTS: This single-center registry aimed to assess characteristics and outcome of patients treated with 2 different new-generation cobalt-chromium BMS, the MULTI-LINK VISION and PRO-Kinetic stents. During the study, adopted criteria for BMS selection were: (1) limited compliance to dual antiplatelet therapy, (2) ST-elevation myocardial infarction (MI) or saphenous vein graft (SVG) interventions, and (3) noncomplex lesions located either in the right coronary artery or in the nonproximal segments of the left coronary artery. During a 24-month period 1,176 patients were treated with the VISION (n = 438) or PRO-Kinetic stent (n = 738). Median duration of follow-up was 549.5 and 528.5 days, respectively. Target lesion revascularization (TLR) and target vessel revascularization were numerically lower in the VISION group (10.4 vs. 12.3% and 11.9 vs. 15.2%, P = 0.24 and 0.11). Death (4.1 vs. 4.3%, P = 0.85), MI (2 vs. 2.3%, P = 0.78), and ARC definite stent thrombosis (0.5 vs. 0.5%, P = 0.84) were similar. By multivariate analysis, variables associated with TLR were SVG interventions (HR 2.21, 95% CI 1.26-3.86), total stent length (HR 1.01, 95% CI 1.00-1.02), and smoking (HR 1.51, 95% CI 1.05-2.16). CONCLUSION: In the DES era, the use of last-generation thin-strut BMS in selected patients is associated with acceptable clinical outcome, with similar clinical results for both the MULTI-LINK VISION and PRO-Kinetic stents.

Impact of smoking on the outcome of patients treated with drug-eluting stents: 1-year results from the prospective multicentre German Drug-Eluting Stent Registry (DES.DE).

BACKGROUND: Cigarette smoking strongly increases morbidity and mortality from cardiovascular causes, but the relevance of smoking in patients treated with drug-eluting stents (DES) is unknown. AIMS: To assess the impact of smoking on the presentation and outcome of patients treated with DES. METHODS AND RESULTS: We analyzed data from the prospective multicentre German Drug-Eluting Stent Registry (DES.DE) and identified 1,122 patients who had never smoked and 1,052 patients who were current smokers. Smokers were younger (56.5 vs. 69.4 years, p < 0.0001), more often males, with less frequent diabetes and hypertension compared to non-smokers. Smokers presented more often with acute coronary syndromes. After a mean follow-up of 12.5 months, smokers had both higher mortality (4.6 vs. 2.7%, p < 0.05) and myocardial infarction (MI) rates (4.9 vs. 3%, p < 0.01). There was no significant difference between smokers and non-smokers in the rate of target vessel revascularization (9.8 vs. 11.4%, p = 0.26). Major adverse cardiac and cerebrovascular events (defined as the composite of death, MI and stroke, MACCE) were higher in smokers (10.6 vs. 6.1%, p < 0.001). Moreover, after adjustment for baseline clinical and angiographic variables, smoking continued to be a strong independent predictor for MACCE (OR = 2.34, 95% CI 1.49-3.68). In a subgroup analysis, we found that the increased risk of smoking was most prominent in patients presenting with stable angina pectoris (OR = 3.71, 95% CI 1.24-2.57, p < 0.05). Smoking almost doubled the risk for MACCE in acute MI patients, though this did not reach statistical significance (adjusted OR = 1.91, 95% CI 0.93-3.94, p = 0.74). CONCLUSION: This large multicentre DES registry provides evidence that smokers treated with DES, despite lower incidence of predisposing risk factors for atherosclerosis, experience higher rates of death and MI compared to non-smokers, particularly in the setting of stable coronary artery disease. Smoking has only marginal effects on target vessel revascularization rates in patients treated with DES.

Sirolimus-eluting stent treatment for unprotected versus protected left main coronary artery disease in widespread clinical routine: 6-month and 3-year clinical follow-up results from the prospective multicentre German Cypher Registry.

BACKGROUND: Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery. OBJECTIVE: To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry. SETTING AND PATIENTS: The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point. RESULTS: One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2). CONCLUSION: Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.

The effects of facilitated primary PCI by guide wire on procedural and clinical outcomes in acute ST-segment elevation myocardial infarction.

BACKGROUND: Reperfusion of the infarct related artery (IRA) prior to PCI is prognostically important in patients with acute ST segment elevation myocardial infarction (STEMI). Reperfusion is either achieved spontaneously, facilitated by GP IIb/ IIIa inhibitors, or mechanically by crossing the guide wire beyond the lesion. In order to test the hypothesis that a visible coronary anatomy is independently associated with procedural and clinical outcomes, we evaluated the frequency and prognostic impact of guide wire facilitated reperfusion of the IRA before primary PCI. METHODS AND RESULTS: We enrolled 311 consecutive patients with successful primary PCI for STEMI (TIMI grade > or =2 flow) within 12 h after onset of symptoms. Among these, 90 patients (28.9%) had a spontaneously reperfused IRA on initial angiogram, 56 patients (18.0%) achieved reperfusion after crossing of the guide wire, and 165 patients (53.1%) successful reperfusion only after PCI. Variables associated with successful guide wire facilitated reperfusion were younger age, no history of arterial hypertension, active smoking status, negative cardiac troponin T on admission, and an infarct in the territory of the right coronary artery. Patients with spontaneous reperfusion or reperfusion after crossing of the guide wire required less fluoroscopic time and less contrast material during angiography and had higher procedural success rates (TIMI grade 3 flow 91.1 vs 79.4%, p=0.048) than patients without initial reperfusion. In addition, patients with reperfusion after crossing the lesion with the guide wire had lower mortality rates at 30 days (3.6 vs 9.1%) and after a median of 16 months (3.6 vs 13.9%, p=0.03) than those with reperfusion after PCI. CONCLUSIONS: Reperfusion of an occluded IRA by crossing the guide wire is associated with higher procedural success rates and better outcomes. Better roadmapping and device selection represent potential reasons but the exact mechanism for these benefits is still illusive.

Drug-eluting stents versus bare metal stents following rotational atherectomy for heavily calcified coronary lesions: late angiographic and clinical follow-up results.

OBJECTIVES: To study the effectiveness of drug-eluting stents following rotablation of severely calcified lesions. BACKGROUND: Drug-eluting stents are increasingly showing promising results in complex lesions and high-risk patients. Heavily calcified stenoses have not been adequately studied, and form a challenge both for the immediate and late outcomes. METHODS: Single-center prospective study among 27 patients treated by rotablation followed by a drug-eluting stent implantation for angiographically heavily calcified lesions, compared with a historical control of 34 patients treated by rotablation followed by bare stent implantation for the same indication. The primary endpoint was the late lumen loss at 9 months; secondary endpoints were binary restenosis and major adverse cardiac events at 9 months. A 2-year follow-up directed to death and myocardial infarction was added. RESULTS: Both groups were comparable regarding baseline and procedural characteristics. Angiographic success was 100% for both groups. At 9 months, there was a significant difference in the late lumen loss (0.11 +/- 0.7 mm in the DES group and 1.11 +/- 0.9 mm in the BMS group, P = 0.001). This difference was manifest in the clinical event rates at late follow-up (combined incidence of death due to any cause, MI, and TLR was 7.4% in the DES group and 38.2% in the BMS group; P = 0.004). At 2 years, there were 5 deaths in each group (P = 0.5) and 2 infarctions in the BMS group versus none in the DES group (P = 1.0). CONCLUSION: The combination of rotablation and drug-eluting stent implantation (Rota-DES) has a favorable effect on clinical and angiographic outcomes at 9 months when treating heavily calcified lesions compared to rotablation followed by bare metal stent implantation. No safety concerns are observed at 2 years.

Incidence and predictors of target vessel revascularization after sirolimus-eluting stent treatment for proximal left anterior descending artery stenoses among 2274 patients from the prospective multicenter German Cypher Stent Registry.

BACKGROUND: Involvement of the proximal LAD is considered an indication for coronary artery bypass graft (CABG) surgery due to the high restenosis rates associated with this location after percutaneous coronary interventions (PCI). This seems to be different, however, when using sirolimus-eluting stents, a finding if proven to be true could have a major impact on clinical decision making regarding the optimal revascularization strategy for these patients. METHODS: We analyzed 2274 patients treated for proximal LAD stenoses using SES from the German Cypher Stent Registry. The incidence of TVR and other major clinical adverse events were determined and independent predictors of TVR were specified using a multiple logistic regression model. RESULTS: Event-free survival was achieved in 89.5% of patients. TVR was performed in 179 patients (7.9%) and the combined incidence of all cause death, myocardial infarction and TVR was 10.5% (231 patients). Independent predictors of TVR were multivessel disease (OR 1.74, 95% CI 1.16-2.62, p = 0.008), stent diameter < or = 2.75 mm (OR 1.61, 95% CI 1.10-2.40, p = 0.02) and the administration of GP IIb/ IIIa antagonists (OR 1.60, 95% CI 1.05-2.60, p = 0.03). TVR rate was as high as 11.2% for 2.5 mm SES and as low as 4.0% for 3.5 mm SES (p < 0.001 for trend test). CONCLUSION: TVR among patients treated with SES for proximal LAD stenoses is low and is related in part to operator dependent factors. Treatment with SES should be considered as an effective treatment for these patients.

Sirolimus-eluting stent treatment for complex proximal left anterior descending artery stenoses: 7-month clinical and angiographic results.

BACKGROUND: High-grade involvement of the proximal left anterior descending artery (LAD), either in isolation or as part of multivessel coronary artery disease, remains a frequent indication for surgical revascularization. This is particularly true in complex proximal LAD lesions among high-risk patients, since stenting is usually ineffective in the long term as regards freedom from angina and target vessel revascularization (TVR) in such patient subsets. The sirolimus-eluting stent (SES) has been reported to significantly reduce clinical and angiographic restenosis rates. We therefore analyzed the clinical and angiographic long-term results of a group of complex patients treated with SES for proximal LAD stenoses. METHODS: A total of 80 consecutive patients treated with sirolimus-eluting stents (SES) for complex proximal LAD stenoses were analyzed. This high-risk cohort included diabetic patients, long, bifurcated, ostial and heavily calcified lesions, chronic total occlusions and in-stent restenoses. Late lumen loss and clinically-driven target lesion revascularization (TLR) were analyzed at 7 months. RESULTS: Late lumen loss was 0.19 +/- 0.06 mm in the analysis segment (stent with 5 mm proximal and distal to it) at 7 months. TLR was performed in 6.3% of cases, and the combined rate of death from any cause, nonfatal MI and TLR was also 6.3% at 7 months. CONCLUSION: SES, once successfully implanted into complex proximal LAD stenoses, appear effective, with rather acceptable rates of adverse events at 7-month follow-up. Accordingly, treating the proximal LAD using SES in complex patients may narrow the gap between PCI and surgery for this indication.