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One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes.

ABSTRACT: Background/Objectives: The need to determine the safest duration of dual antiplatelet therapy duration after elective angioplasty to reduce bleeding events without an adverse effect on major adverse cardiovascular events (MACE) remains a challenge. Methods: In this investigator-initiated, single-centre cohort study, we identified all patients who underwent PCI for de novo coronary disease for stable angina between January 2015 and November 2019. We compared 1-month and 12-month durations of dual antiplatelet therapy (DAPT) to determine if there was any difference in the primary outcome of major bleeding. The secondary outcome was a patient-oriented composite endpoint of all-cause mortality; any myocardial infarction, stroke, or revascularisation; and the individual components of this composite endpoint. Data were analysed using Cox regression models and cumulative hazard plots. Results: A total of 1025 patients were analysed, of which 340 received 1 month of DAPT and 685 received 12 months of DAPT. There was no difference in major bleeding between the two groups (2.6% vs. 2.5% respectively). On univariable cox regression analysis, no characteristics were predictors of major bleeding. A proportion of 99.7% of patients in the 1-month DAPT arm were treated with a DCB strategy, whilst 93% in the 12-month DAPT group were treated with a DES. There was no difference between the two groups with regards to the composite patient-oriented MACE (11% vs. 12%, respectively) or any individual component of this. These results were unchanged after propensity score matched analysis. Conclusions: A 1-month duration of DAPT, for which 99.7% of patients were treated with a DCB strategy, appears safe and effective when compared with a 12-month duration of DAPT with no difference in major bleeding or MACE.

SUBMITTER: Corballis N

PROVIDER: S-EPMC11312761 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes.

Corballis Natasha N Bhalraam U U Merinopoulos Ioannis I Gunawardena Tharusha T Tsampasian Vasiliki V Wickramarachchi Upul U Eccleshall Simon S Vassiliou Vassilios S VS

Journal of clinical medicine 20240802 15

<b>Background/Objectives</b>: The need to determine the safest duration of dual antiplatelet therapy duration after elective angioplasty to reduce bleeding events without an adverse effect on major adverse cardiovascular events (MACE) remains a challenge. <b>Methods</b>: In this investigator-initiated, single-centre cohort study, we identified all patients who underwent PCI for de novo coronary disease for stable angina between January 2015 and November 2019. We compared 1-month and 12-month dur ...[more]

PMID: 39124787

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Project description:Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3-5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. Results: All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. Conclusion: The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.

Project description:BackgroundThere are limited data on the safety of colonoscopy in patients with lower gastrointestinal bleeding (LGIB). We examined the various adverse events associated with colonoscopy in acute LGIB compared with non-GIB patients.MethodsEmergency hospitalized LGIB patients (n = 161) and age- and gender-matched non-GIB controls (n = 161) were selected. Primary outcomes were any adverse events during preparation and colonoscopy procedure. Secondary outcomes were five bowel preparation-related adverse events--hypotension, systolic blood pressure <100 mmHg, volume overload, vomiting, aspiration pneumonia and loss of consciousness--and four colonoscopy-related adverse events--including hypotension, perforation, cerebrocardiovascular events and sepsis.ResultsDuring bowel preparation, 16 (9%) LGIB patients experienced an adverse event. None of the LGIB patients experienced volume overload, aspiration pneumonia or loss of consciousness; however, 12 (7%) had hypotension and 4 (2%) vomited. There were no significant differences in the five bowel preparation-related adverse events between LGIB and non-GIB patients. During colonoscopy, 25 (15%) LGIB patients experienced an adverse event. None LGIB patient had perforation or sepsis; however, 23 (14%) had hypotension and 2 (1%) experienced a cerebrocardiovascular event. There was no significant difference in the four colonoscopy-related adverse events between LGIB and non-GIB patients. In addition, no significant difference in any of the nine adverse events was found among subgroups: patients aged ≥65 years, those with comorbidities, and those with antithrombotic drug use.ConclusionsAdverse events in bowel preparation and colonoscopy among acute LGIB patients were low. No significant difference was found in adverse events between LGIB and non-GIB patients. These adverse events were also low in elderly LGIB patients, as well as in those with co-morbidities and antithrombotic drug use, suggesting that colonoscopy performed during acute LGIB did not increase adverse events.

Project description:ImportanceVery short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option.ObjectiveTo test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events.Design, setting, and participantsMulticenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019.InterventionsPatients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522).Main outcomes and measuresThe primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding.ResultsAmong 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority).Conclusions and relevanceAmong patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations.Trial registrationClinicalTrials.gov Identifier: NCT02619760.

Dataset Information

One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes.

Publications

One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes.

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