Daily Cardiology Research Analysis

BACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multielectrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy) trial showed that radiofrequency renal denervation (RDN) using the Symplicity Spyral catheter yielded significant blood pressure (BP) reductions at 6 and 24 months compared with sham control in patients with hypertension on antihypertensive medications. In this prespecified analysis through the final follow-up, we evaluate the durability of BP reductions, antihypertensive medication use, and safety through 3 years. METHODS: SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial enrolling patients with uncontrolled hypertension. Patients were prescribed 1 to 3 antihypertensive medications and randomized to RDN or a sham procedure. After 6 months, patients were unblinded, and sham patients could cross over to RDN. Crossover patients' values for BP and antihypertensive medications were imputed to 36 months using their last observation before crossover to RDN carried forward. Statistical analyses, including imputation, were exploratory and conducted on the intention-to-treat population. RESULTS: After 6 months, 74% of sham patients crossed over to undergo RDN. Patients undergoing RDN had statistically significant 24-hour ambulatory systolic BP reductions (treatment difference, -4.7 mm Hg; CONCLUSIONS: Compared with sham patients through 3 years, patients undergoing RDN had significantly greater 24-hour ambulatory and office BP reductions, with a similar medication burden. RDN maintained a durable safety profile through 3 years. REGISTRATION: URL: https://clinicaltrials.gov/study; Unique identifier: NCT02439775.

BACKGROUND: Implantation of drug eluting stents (DESs) is currently the default approach for percutaneous coronary interventions, but long-term adverse events still exist. An approach with minimal stenting deserves to be assessed in a randomized trial. We studied a novel sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a biodegradable polymer microreservoir technology. METHODS: In a multicenter, open-label, randomized trial, we compared an SEB-based strategy with provisional DES with one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter. Subjects were randomized 1:1 before percutaneous coronary intervention. The primary end point was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. It was tested for noninferiority at 1 year with the use of an absolute margin equal to 50% of the combined event rate at a significance level of 0.025. The primary analysis population included all randomized subjects with completed or attempted percutaneous revascularization, analyzed according to the intention-to-treat principle. A sensitivity analysis was performed on the per-protocol population. RESULTS: Between August 27, 2021, and July 29, 2024, 3323 participants were randomized and treated in 62 sites. Among 1661 participants in the SEB strategy group, bailout stenting was performed in 343 (20.7%). Target vessel failure occurred over 365 days in 88 (5.3%) and 73 (4.4%) participants in the SEB and the systematic DES strategy groups, respectively (risk difference, 0.91% [95% CI -0.55% to 2.38%]; 1-sided CONCLUSIONS: At 1 year, in the primary intention-to-treat analysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure. The per-protocol population sensitivity analysis did not confirm noninferiority. Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group. At 5 years, target vessel failure will be tested again for noninferiority and for superiority if noninferiority is achieved. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04859985.

BACKGROUND: The optimal antithrombotic regimen for peripheral artery disease, balancing thromboembolic and bleeding risks, remains uncertain. This study aimed to compare the efficacy and safety of antithrombotic regimens in patients with peripheral artery disease. METHODS: We reviewed randomized controlled trials evaluating antithrombotic therapies for peripheral artery disease, including aspirin, P2Y12 inhibitors, cilostazol, and rivaroxaban. The primary outcome was major adverse cardiac events, defined as a composite of cardiovascular death, myocardial infarction, and stroke. The secondary outcomes included major adverse limb events, defined as a composite of acute limb ischemia, revascularization, and amputation. The safety outcome was major bleeding, primarily assessed using the Thrombolysis in Myocardial Infarction criteria. We performed a network meta-analysis to compare antithrombotic regimens. RESULTS: Seventeen randomized controlled trials involving 44 532 participants were included. Compared with aspirin monotherapy, the following were associated with lower risks of major adverse cardiac events: clopidogrel, 75 mg/d, plus cilostazol, 200 mg/d (hazard ratio [HR], 0.37 [95% CI, 0.20-0.72]), clopidogrel, 75 mg/d, monotherapy (HR, 0.80 [95% CI, 0.67-0.96]), aspirin plus low-dose rivaroxaban, 2.5 mg twice daily (HR, 0.81 [95% CI, 0.72-0.92]), and aspirin plus ticagrelor, 60 to 90 mg twice daily (HR, 0.81 [95% CI, 0.69-0.96]). Aspirin plus rivaroxaban or ticagrelor showed a lower risk of major adverse limb events compared with aspirin alone. Rivaroxaban monotherapy, 5 mg twice daily, and aspirin plus rivaroxaban or clopidogrel were associated with a higher risk of major bleeding. CONCLUSIONS: Clopidogrel plus cilostazol or clopidogrel monotherapy might be a balanced strategy in patients with peripheral artery disease.