Klaus Bonaventura

Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial.

AIMS Percutaneous coronary interventions for bifurcation lesions are often complex and associated with an unsatisfactory result. The aim of this first-in-man, observational study was to investigate the efficacy and safety of a paclitaxel-eluting balloon in these lesions. METHODS AND RESULTS Twenty-eight patients presenting significant coronary bifurcational lesions of the left coronary artery were studied. The main branch (MB) and the side branch (SB) were dilated with a drug-eluting balloon (DEB; SeQuent Please balloon catheter , 3 µg paclitaxel/mm2 balloon surface). An open-cell bare-metal stent (BMS; Coroflex) was then deployed in the MB. Only if the SB had a TIMI flow <III and/or a residual stenosis of ≥ 50%, a BMS was implanted in the SB. The procedure was successful in all patients. At nine months, the late lumen loss (LLL) in the MB was 0.38 ± 0.46 mm and 0.21 ± 0.48 mm in the SB resulting in an MLD of 2.2 ± 0.60 mm in the MB and 1.7 ± 0.44 mm in the SB. Three patients had angiographic restenosis and in one a target lesion revascularisation (TLR) was performed. Two patients experienced a late stent thrombosis at six and eight months. No patient died. CONCLUSIONS Percutaneous treatment of bifurcation lesions with a drug-eluting balloon resulted in a procedural success of 100%. Follow-up angiography at nine months showed DES-like results in MB and SB. However, when the DEB was used in combination with a BMS (MB), the possibility of late stent thrombosis cannot be ruled out.

Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group

AbstractAims Drug-coated balloon catheters (DCB) are a new clinical treatment modality for coronary and peripheral artery disease. The goal of the consensus group is to develop recommendations for the clinical use of DCB based on randomized clinical trials and the best available clinical evidence. The present paper gives an update on the recommendations against the background of a variety of new data published since the first paper was presented.Methods and results The general concept of our recommendations for the coronary use of DCB includes the preparation of the lesion to facilitate drug delivery and to estimate the need for stent implantation, especially after relevant dissections. Lesion preparation includes conventional angioplasty. In more complex lesions, additional treatments and imaging or functional measurements are helpful. In case of no flow-limiting dissection and an acceptable but not stent-like primary result, DCB use without additional stent implantation may be considered. The proposed advantages of the DCB only concept over a direct stent approach include reduced restenosis rates in indications where DES show limited efficacy, the reduction of DAPT especially in patients with contraindications for prolonged DAPT, and the option of leaving no foreign object behind resulting in vascular restoration with potentially plaque regression instead of neo-atherosclerosis.ConclusionsDCB allow for local drug delivery in endovascular therapy leaving no permanent implant behind.

Potential lifetime cost-effectiveness of catheter-based renal sympathetic denervation in patients with resistant hypertension

AIMS Recent studies have demonstrated the safety and efficacy of catheter-based renal sympathetic denervation (RDN) for the treatment of resistant hypertension. We aimed to determine the cost-effectiveness of this approach separately for men and women of different ages. METHODS AND RESULTS A Markov state-transition model accounting for costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness was developed to compare RDN with best medical therapy (BMT) in patients with resistant hypertension. The model ran from age 30 to 100 years or death, with a cycle length of 1 year. The efficacy of RDN was modelled as a reduction in the risk of hypertension-related disease events and death. Analyses were conducted from a payers perspective. Costs and QALYs were discounted at 3% annually. Both deterministic and probabilistic sensitivity analyses were performed. When compared with BMT, RDN gained 0.98 QALYs in men and 0.88 QALYs in women 60 years of age at an additional cost of €2589 and €2044, respectively. As the incremental cost-effectiveness ratios increased with patient age, RDN consistently yielded more QALYs at lower costs in lower age groups. Considering a willingness-to-pay threshold of €35 000/QALY, there was a 95% probability that RDN would remain cost-effective up to an age of 78 and 76 years in men and women, respectively. Cost-effectiveness was influenced mostly by the magnitude of effect of RDN on systolic blood pressure, the rate of RDN non-responders, and the procedure costs of RDN. CONCLUSION Renal sympathetic denervation is a cost-effective intervention for patients with resistant hypertension. Earlier treatment produces better cost-effectiveness ratios.

Cost-effectiveness of cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary artery disease in Germany

BackgroundRecent studies have demonstrated a superior diagnostic accuracy of cardiovascular magnetic resonance (CMR) for the detection of coronary artery disease (CAD). We aimed to determine the comparative cost-effectiveness of CMR versus single-photon emission computed tomography (SPECT).MethodsBased on Bayes’ theorem, a mathematical model was developed to compare the cost-effectiveness and utility of CMR with SPECT in patients with suspected CAD. Invasive coronary angiography served as the standard of reference. Effectiveness was defined as the accurate detection of CAD, and utility as the number of quality-adjusted life-years (QALYs) gained. Model input parameters were derived from the literature, and the cost analysis was conducted from a German health care payer’s perspective. Extensive sensitivity analyses were performed.ResultsReimbursement fees represented only a minor fraction of the total costs incurred by a diagnostic strategy. Increases in the prevalence of CAD were generally associated with improved cost-effectiveness and decreased costs per utility unit (ΔQALY). By comparison, CMR was consistently more cost-effective than SPECT, and showed lower costs per QALY gained. Given a CAD prevalence of 0.50, CMR was associated with total costs of €6,120 for one patient correctly diagnosed as having CAD and with €2,246 per ΔQALY gained versus €7,065 and €2,931 for SPECT, respectively. Above a threshold value of CAD prevalence of 0.60, proceeding directly to invasive angiography was the most cost-effective approach.ConclusionsIn patients with low to intermediate CAD probabilities, CMR is more cost-effective than SPECT. Moreover, lower costs per utility unit indicate a superior clinical utility of CMR.

Potential cost-effectiveness of therapeutic drug monitoring in patients with resistant hypertension.

Background: Nonadherence to drug therapy poses a significant problem in the treatment of patients with presumed resistant hypertension. It has been shown that therapeutic drug monitoring (TDM) is a useful tool for detecting nonadherence and identifying barriers to treatment adherence, leading to effective blood pressure (BP) control. However, the cost-effectiveness of TDM in the management of resistant hypertension has not been investigated. Method: A Markov model was used to evaluate life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios in resistant hypertension patients receiving either TDM optimized therapy or standard best medical therapy. The model ran from the age of 30 to 100 years or death, using a cycle length of 1 year. Efficacy of TDM was modeled by reducing risk of hypertension-related morbidity and mortality. Cost analyses were performed from a payers perspective. Deterministic and probabilistic sensitivity analyses were conducted. Results: In the age group of 60-year olds, TDM gained 1.07 QALYs in men and 0.97 QALYs in women at additional costs of &OV0556;3854 and &OV0556;3922, respectively. Given a willingness-to-pay threshold of &OV0556;35 000 per QALY gained, the probability of TDM being cost-effective was 95% or more in all age groups from 30 to 90 years. Results were influenced mostly by the frequency of TDM testing, the rate of nonresponders to TDM, and the magnitude of effect of TDM on BP. Conclusion: Therapeutic drug monitoring presents a potential cost-effective healthcare intervention in patients diagnosed with resistant hypertension. Importantly, this finding is valid for a wide range of patients, independent of sex and age.

A novel drug‐coated scoring balloon for the treatment of coronary in‐stent restenosis: Results from the multi‐center randomized controlled PATENT‐C first in human trial

Scoring balloons produce excellent acute results in the treatment of in‐stent restenosis (ISR), fibro‐calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel‐coated scoring balloon (SB) was developed and tested to overcome this limitation.

Cost-Effectiveness of Paclitaxel-Coated Balloon Angioplasty in Patients With Drug-Eluting Stent Restenosis

The economic impact of drug‐eluting stent (DES) in‐stent restenosis (ISR) is substantial, highlighting the need for cost‐effective treatment strategies.

Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons.

The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures can be reduced with the implantation of metallic stents into the stenotic vessels. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES) which require long lasting antiplatelet therapy to avoid thrombotic complications. In the last years, the drug-eluting balloon (DEB) technology has emerged as an alternative option for the treatment of coronary and peripheral arteries. Clinical studies demonstrated the safety and effectiveness of DEB in various clinical scenarios and support the use of paclitaxel-eluting balloons for the treatment of in-stent restenosis, of small coronary arteries and bifurcations lesions. The protocols of DEB studies suggest that the dual antiplatelet therapy with aspirin and clopidogrel of four weeks after DEB is safe and effective.

No indication for an unexpected high rate of coronary artery aneurysms after angioplasty with drug-coated balloons.

AIMS Coronary artery aneurysms (CAA) are a rare complication after percutaneous coronary intervention (PCI) and are reported with an incidence of 0.6% to 3.9%. While in recent years the use of paclitaxel drug-coated balloons (DCB) has increased, so far no CAA formation after DCB intervention has been reported. METHODS AND RESULTS During the years 2010 and 2011 we used DCBs in 704 PCIs. Follow-up angiography was scheduled at four months in all patients and has so far been achieved in 380 PCIs. In three patients we found development of a CAA at the former PCI site within four months of observation. Aneurysm length varied between 8.4 mm and 13 mm and lumina increased 58% to 131%. Retrospectively all patients with CAA development showed small intimal dissection partially with tiny persisting contrast bands parallel to the lumen according to type B and type C of the NHLBI classification after PCI. CONCLUSIONS CAA formation after DCB intervention was found in three out of 380 PCIs with DCB, consistent with an incidence of 0.8%. Thus, PCI with DCB does not cause an unexpectedly high rate of coronary artery aneurysms.

TCT-458 Angiographic localized haziness after drug-coated balloon angioplasty in de-novo lesions does not increase the risk of acute coronary thrombosis

Michael Lee, Tae Yang, Ehtisham Mahmud, Kyung Woo Park, Hyo-Soo Kim, Moo Hyun Kim, George Dangas, James Hermiller Jr, Mitchell Krucoff, David Rutledge UCLA School of Medicine, Los Angeles, CA, USA, Henry Ford Hospital, Detroit, MI, University of California, San Diego, San Diego, CA, Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea, Republic of, Seoul National University College of Medicine, Seoul, Korea, Republic of, Dong-A University, Busan, Korea, Republic of, Mount Sinai, New York, New York, United States, St Vincent Heart Center of Indiana, Indianapolis, USA, Duke Clinical Research Institute, Durham, North Carolina, Abbott Vascular, Santa Clara, CA