Cosmo Godino

Incidence and Predictors of Drug-Eluting Stent Thrombosis During and After Discontinuation of Thienopyridine Treatment

Background— The need for prolonged aspirin and thienopyridine therapy and the risk of stent thrombosis (ST) remain as drawbacks associated with drug-eluting stents. Methods and Results— A prospective observational cohort study was conducted between June 2002 and January 2004 on 3021 patients consecutively and successfully treated in 5389 lesions with drug-eluting stents. Detailed patient information was collected on antiplatelet therapy. We analyzed the incidence of ST throughout the 18-month follow-up period and its relationship with thienopyridine therapy. ST occurred in 58 patients (1.9%) at 18 months. Forty-two patients (1.4%) experienced the event within 6 months of stent implantation. Acute myocardial infarction (fatal or nonfatal) occurred in 46 patients (79%) and death in 23 patients (39%) with ST. The median interval from discontinuation of thienopyridine therapy to ST was 13.5 days (interquartile range 5.2 to 25.7 days) for the first 6 months and 90 days (interquartile range 30 to 365 days) between 6 and 18 months. On multivariable analysis, the strongest predictor for ST within 6 months of stenting was discontinuation of thienopyridine therapy (hazard ratio, 13.74; 95% CI, 4.04 to 46.68; P<0.001). Thienopyridine discontinuation after 6 months did not predict the occurrence of ST (hazard ratio, 0.94; 95% CI, 0.30 to 2.98; P=0.92). Conclusions— Discontinuation of thienopyridine therapy was the major determinant of ST within the first 6 months, but insufficient information is available to determine whether there is benefit in continuing a thienopyridine beyond 6 months.

Long-Term Outcome of Percutaneous Coronary Intervention for Chronic Total Occlusions

OBJECTIVES The aim of this study was to evaluate long-term clinical outcomes after percutaneous coronary intervention (PCI) for chronic total occlusions (CTO). BACKGROUND Despite technical advancements, there is a paucity of data on long-term outcomes after PCI of CTO. METHODS We evaluated long-term clinical outcomes in 1,791 patients who underwent PCI of 1,852 CTO at 3 tertiary care centers in the United States, South Korea, and Italy between 1998 and 2007. Median follow-up was 2.9 years (interquartile range: 1.5 to 4.6 years). RESULTS Procedural success was obtained in 1,226 (68%) patients. Stents were implanted in 1,160 patients (95%); 396 patients (34%) received bare-metal stents (BMS), and 764 patients (66%) received drug-eluting stents (DES). After multivariable analysis, successful CTO PCI was an independent predictor of a lower cardiac mortality (hazard ratio [HR]: 0.40, 95% confidence interval [CI]: 0.21 to 0.75, p < 0.01) and reduced need for coronary artery bypass graft surgery (HR: 0.21, 95% CI: 0.13 to 0.40, p < 0.01); it also correlated with a strong trend toward lower all-cause mortality (HR: 0.63, 95% CI: 0.40 to 1.00, p = 0.05) at 5-year follow-up. Among patients who underwent stent implantation, treatment with DES rather than BMS resulted in less target vessel revascularization at long-term follow-up (17.2% vs. 31.1%, p < 0.01); definite/probable stent thrombosis rates were similar (DES 1.7%, BMS 2.3%, p = 0.58). Within the DES subgroup, patients treated with paclitaxel-eluting stents and sirolimus-eluting stents had similar clinical outcomes. CONCLUSIONS Successful CTO PCI is associated with reduced long-term cardiac mortality and need for coronary artery bypass graft surgery. Treatment of CTO with DES rather than BMS is associated with a significant reduction in target vessel revascularization with similar rates of stent thrombosis. Paclitaxel-eluting stents and sirolimus-eluting stents had similar long-term safety and efficacy outcomes.

5-year outcomes following percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass graft for unprotected left main coronary artery lesions: The Milan experience

OBJECTIVES We sought to evaluate at 5 years the occurrence of cardiac death; cardiac death, and/or myocardial infarction (MI); cardiac death, MI, and/or stroke; target vessel revascularization; and major adverse cardiac and cerebrovascular events following percutaneous coronary intervention (PCI) with drug-eluting stent (DES) versus coronary artery bypass graft (CABG) in unprotected left main coronary artery lesions. BACKGROUND Preliminary results at 1 year showed comparable occurrence of major adverse cardiac and cerebrovascular events in our center between PCI and CABG. METHODS All consecutive patients with an unprotected left main coronary artery stenosis electively treated with DES implantation versus CABG in our center, between March 2002 and July 2004, were analyzed. A propensity analysis was performed to adjust for baseline differences between the 2 cohorts. RESULTS We included 249 patients in the study: 107 were treated with PCI and DES implantation and 142 with CABG. At 5-year clinical follow-up, no difference was found between PCI and CABG in the occurrence of cardiac death (adjusted odds ratio [OR]: 0.502; 95% confidence interval [CI]: 0.162 to 1.461; p = 0.24). The PCI group showed a trend toward a lower occurrence of the composite end point of cardiac death and MI (adjusted OR: 0.408; 95% CI: 0.146 to 1.061; p = 0.06). Percutaneous coronary intervention was associated with a lower rate of the composite end point of death, MI, and/or stroke (OR: 0.399; 95% CI: 0.151 to 0.989; p = 0.04). Indeed, CABG was correlated with lower target vessel revascularization (adjusted OR: 4.411; 95% CI: 1.825 to 11.371; p = 0.0004). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular events (adjusted OR: 1.578; 95% CI: 0.825 to 3.054; p = 0.18). CONCLUSIONS At 5-year clinical follow-up, there was still no difference in the occurrence of major adverse cardiac and cerebrovascular events between elective PCI with DES implantation and CABG in unprotected left main coronary artery lesions in this single-center experience. There was an advantage of PCI in the composite end point of death, MI, and/or stroke, whereas a benefit in the need for reintervention was still found in CABG.

Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.

OBJECTIVES Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion. BACKGROUND Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis. METHODS We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach. RESULTS A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events. CONCLUSIONS Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.

Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after corevalve implantation and the impact of postdilatation†

Objective: To investigate the predictors of moderate‐to‐severe aortic regurgitation (AR≥2+) after CoreValve implantation and evaluate the feasibility and safety of postdilatation in reducing the degree of AR. Background: Although transcatheter aortic valve implantation is an alternative treatment for high surgical risk patients with severe aortic stenosis, post‐implantation paravalvular AR remains a complication. Methods: From July 2008 to July 2010, we enrolled 79 consecutive patients with severe aortic stenosis who underwent CoreValve implantation. Results: On univariable analysis, the predictors of AR≥2+ immediately after CoreValve implantation were: larger annulus size, low implantation, prosthesis mismatch, chronic renal insufficiency, a history of heart failure, and peripheral vascular disease. On multivariable analysis, the independent predictors of AR≥2+ were: larger annulus diameter (OR 1.78, 95%CI 1.25–2.55; P = 0.002), low implantation (OR 3.67, 95%CI 1.01–13.35, P = 0.05), and peripheral vascular disease (OR 3.54, 95%CI 1.19–10.56, P = 0.02). Post‐CoreValve implantation, AR ≥ 2 was seen in 40.5% (32/79). Twenty‐one patients underwent postdilatation with improvement in AR grade in the majority (17/21). Of the four patients who did not respond to postdilatation, two underwent valve‐in‐valve implantation. In one patient, the valve was pulled more proximally by the snare technique. The remaining 10 patients were treated conservatively. Conclusion: The appropriate strategy for treating patients with AR≥2+ depends on the causes and severity of AR post‐TAVI. This study suggests that we should carefully select the size of CoreValve prosthesis to prevent prosthesis mismatch, especially when implanted in larger annulus sizes. For valves implanted in the appropriate position, postdilatation appears effective in reducing the degree of AR.

A new technique for vascular access management in transcatheter aortic valve implantation

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty‐two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards‐Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards‐Sapien) or one (CoreValve). There were serious “on‐table” complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure—iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites.

Dual Antiplatelet Therapy After Percutaneous Coronary Intervention With Stent Implantation in Patients Taking Chronic Oral Anticoagulation

OBJECTIVES The purpose of this study was to evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. BACKGROUND The optimal antithrombotic strategy after percutaneous coronary intervention (PCI) for patients receiving AC is unclear. METHODS Consecutive patients who underwent stent implantation and were discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC) were analyzed. RESULTS Of the 127 patients with 224 lesions, 86.6% were men, with a mean age of 69.9 +/- 8.8 years. Drug-eluting stents (DES) were positioned in 71 (55.9%), and bare-metal stents (BMS) were positioned in 56 (44.1%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment. The mean triple therapy duration was 5.6 +/- 4.6 months, and clinical follow-up was 21.0 +/- 19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (5.6% vs. 3.6%, respectively, p = 1.0) and minor (1.4% vs. 3.6%, respectively, p = 0.57) bleeding and mortality (5.6% vs. 1.8%, respectively, p = 0.39). A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 26.8%, p = 0.041). CONCLUSIONS While receiving triple therapy, major bleeding occurred in 4.7% of patients; one-half of the events were lethal, and most occurred within the first month.

Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforation

OBJECTIVES The aim of this study was to evaluate the incidence, predictors, management, and clinical outcomes in patients with grade III coronary perforation during percutaneous coronary intervention. BACKGROUND Grade III coronary perforation is a rare but recognized complication associated with high morbidity and mortality. METHODS From 24,465 patients undergoing percutaneous coronary intervention from May 1993 to December 2009, 56 patients had grade III coronary perforation. RESULTS Most lesions were complex: 44.6% type B2, 51.8% type C, and 28.6% chronic total occlusions, and within a small vessel (≤ 2.5 mm) in 32.1%. Glycoprotein IIb/IIIa inhibitors were administered in 17.9% of patients. The device causing perforation was intracoronary balloon in 50%: 53.6% compliant, 46.4% noncompliant; intracoronary guidewire in 17.9%; rotablation in 3.6%; and directional atherectomy in 3.6%. Following perforation, immediate treatment and success rates, respectively, were prolonged balloon inflation 58.9%, 54.5%; covered stent implantation 46.4%, 84.6%; coronary artery bypass graft surgery (CABG) and surgical repair 16.0%, 44.4%; and coil embolization 1.8%, 100%. Multiple methods were required in 39.3%. During the procedure (n = 56), 19.6% required cardiopulmonary resuscitation and 3.6% died. In-hospital (n = 54), 3.7% required CABG, 14.8% died. The combined procedural and in-hospital myocardial infarction rate was 42.9%, and major adverse cardiac event rate was 55.4%. At clinical follow-up (n = 46) (median: 38.1 months, range 7.6 to 122.8), 4.3% had a myocardial infarction, 4.3% required CABG, and 15.2% died. The target lesion revascularization rate was 13%, with target vessel revascularization in 19.6%, and major adverse cardiac events in 41.3%. CONCLUSIONS Grade III coronary perforation is associated with complex lesions and high acute and long-term major adverse cardiac event rates.

Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions

AIMS Little information is available on the outcome after rotational atherectomy (RA) followed by drug-eluting stent (DES) implantation in calcified coronary lesions. The aim of this study was to evaluate the outcome of patients with severe lesion calcification undergoing RA followed by implantation of DES. METHODS AND RESULTS Ninety-five patients with 96 de novo severely calcified lesions were included. Twenty-nine patients (30.5%) had diabetes mellitus and seven patients (7.4%) had chronic renal failure. The total stent length per lesion was 48.4+/-24.9 mm. Procedural success rate was 95.8%. The incidence of cumulative major adverse cardiac events, defined as death, myocardial infarction (MI) and target vessel revascularisation (TVR), was 15.8% at the mean follow-up period of 14.7 months (range 6.0-57.7). Death occurred in four patients (4.2%). Non Q-wave MI occurred in 3 patients (3.2%) and Q-wave MI occurred in two patients (2.1%). The rate of target lesion revascularisation (TLR) was 9.5%. The rate of TVR was 11.6%. Two definite (2.1%) and 2 possible (2.1%) stent thromboses were observed. CONCLUSIONS RA followed by DES implantation in severely calcified coronary lesions appears to be feasible including high rate of procedural success and low-incidence of TLR considering this complex lesion subset.

Periprocedural and Short-Term Outcomes of Transfemoral Transcatheter Aortic Valve Implantation With the Sapien XT as Compared With the Edwards Sapien Valve

OBJECTIVES The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California). BACKGROUND The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV. METHODS All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used. RESULTS Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV. CONCLUSIONS The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application.